Analysis of the range of dosage forms on the example of the enterprise MPE "Apteka No. 2"

Enterprise characteristics

The pharmacy is a healthcare institution, it performs its work in accordance with, in contact with the health authorities and health facilities. By the nature of their activities, pharmacies are divided into: those that manufacture medicines according to doctor's prescriptions, prescriptions and requirements of medical and preventive institutions (industrial pharmacy); carrying out the sale of finished medicines (pharmacy of ready-made forms).

The main task of the pharmacy is to provide the population and healthcare facilities with medicines, dressings, patient care items and other pharmacy products.

All functions of a pharmacy can be classified into the following types:

production

trading

supply

warehouse

financial

economic

In order to perform its basic functions, a pharmacy must:

· Comply with the rules of in-pharmacy production and sale of products established by the current regulatory documents (according to the permitted assortment).

· Maintain the assortment list of products according to the profile and specialization of the pharmacy enterprise.

· Dispense medicines and medical products free of charge or at a discount to certain groups of the population and categories of citizens in accordance with applicable law.

· To study supply and demand in the pharmaceutical market in terms of the range and prices of medicines and medical products.

· Comply with the procedure for certification and quality control of products sold, execution of relevant documentation.

MUP Pharmacy No. 2 is located in the very center of Novosibirsk at the address: Krasny Prospekt, 15.

Pharmacy N 2 was opened in 1913 by the decision of the City Duma and soon acquired the status of "people's". And a few years later there was not just a pharmacy, but a whole “drug factory”. By 1935, the pharmacy became the largest not only in Novosibirsk, but throughout the region. Its staff consisted of over twenty people who were engaged in all types of pharmaceutical activities of that time - night duty, the manufacture of drugs, the release of drugs for free prescriptions, the manufacture of optics for the whole city, and much more.

In 1998, the institution was transferred to municipal ownership. Two years later, through the efforts of the city authorities, Pharmacy No. 2 was reconstructed, and the facade of the building acquired its original appearance.

List of pharmacy assortment products allowed for dispensing from pharmacies in accordance with OST 91500.05.0007-2003

There is no rental of patient care products in Pharmacy No. 2.

Pharmacy No. 2 operates under the DLO program. The DLO program has been implemented on the territory of the Russian Federation since January 1, 2005 (Federal Law No. 122-FZ dated August 22, 2004 "On Amending Legislative Acts Russian Federation and recognition as invalid of some legislative acts of the Russian Federation in connection with the adoption of the Federal Laws "On Amendments and Additions to the Federal Law" On the General Principles of Organization of Legislative (Representative) and Executive Bodies of State Power of the Subjects of the Russian Federation "and" On the General Principles of Organization of Local Self-Government In Russian federation").

The signboard of pharmacy No. 2 indicates the type of organization; organizational and legal form and form of ownership; corporate name of the organization; location, as well as the operating hours of the organization, addresses and telephone numbers of nearby and duty pharmacies.

The interior design of MUP Pharmacy No. 2 is strictly individual, and the furniture is simple and comfortable. The trading floor and shop windows of the pharmacy have a modern look, but at the same time, their design suits various categories of visitors. Special attention is paid to the placement of advertising products of manufacturers in the pharmacy so that it works effectively, but also does not cause irritation among visitors.

The colors used in the interior are white and green. Pharmacy furniture is made of materials that can withstand repeated wet cleaning. Showcases are equipped with additional lighting, and the design of racks for parapharmaceutical products allows them to be placed both against the wall and in the center of the trading floor. The workplace of the pharmacist is well visible from everywhere, office equipment is conveniently located

Today, Pharmacy No. 2 is a powerful structural unit of the hospital, which is endowed with the functions of supplying, manufacturing, teaching students of the Pharmaceutical Faculty of the Medical Academy, as it is the basis for students' industrial practice.

The prescription and production department manufactures to order various ointments, liquid forms, potions, powders, and suppositories. Work in the department is associated with great responsibility, accuracy of control, attentiveness during vacations.

The pharmacy is headed by a pharmacist.

The activity of the head of a pharmacy is determined by the regulation approved by the regulatory documents, the deputy head performs work on issues within his jurisdiction.

The head of the pharmacy department organizes the production work of the department and is responsible for fulfilling the tasks of the department.

Heads of departments who are not deputy heads of a pharmacy are appointed and dismissed by the head of the pharmacy. The rights and obligations of the heads of departments are determined by the functional and job descriptions approved by the head of the pharmacy.

Pharmacy No. 2 has two departments (prescription and production with stocks and a department of finished dosage forms).

Pharmacists with extensive experience in manufacturing pharmacies work in the prescription and production department of the pharmacy.

Characteristics of industrial premises (when describing the trading floor, indicate the presence of mandatory information for consumers). Additional premises for a production pharmacy. Room equipment. When describing the storage departments, note the storage conditions for medicines that require special conditions - protection from light, requiring a low storage temperature

The composition of the premises of pharmacy No. 2 includes: a trading floor, a room for the manufacture of medicines, a room for obtaining distilled water, a washing room, a manager's office, a staff room, a room for storing medicines, a toilet, a dressing room.

The size of the sales area - 50 sq.m.

The trading floor is equipped with workplaces for receiving prescriptions, dispensing manufactured and finished prescription drugs, dispensing medicines and medical products without prescriptions.

Payment of the cost of medicines by the population is carried out through the cash register.

The area of ​​​​the premises for the preparation of medicines is 15 square meters. m and is equipped with special pharmacy furniture, appliances, equipment for preparation, mixing, filtering, packaging, labeling, packaging and capping of medicines, safes (special cabinets) for storing poisonous and narcotic medicines, ethyl alcohol, rod-glasses, means for measuring weight, volume, beats weight, reagents for chemical control of drugs. In the premises for the preparation of medicines, workplaces for the preparation and quality control of medicines should be organized.

The area of ​​​​the premises for obtaining distilled water is 5 square meters. m. The room is equipped with devices for receiving and containers for storing distilled water in accordance with the current rules for the sanitary regime of pharmacies.

The area of ​​the washing room - 5 square meters. m. Its equipment ensures compliance with the requirements for the sanitary regime of pharmacies.

Autoclave area - 10 sq. m.

Premises for storing stocks of medicines and medical products have an area of ​​36 square meters. m and are equipped with racks, cabinets and other necessary equipment to ensure the safety of poisonous, narcotic, potent, flammable, thermolabile and other medicines, medicinal plant materials, medical products in accordance with their physical and chemical properties.

The staff room is 8 sq. m and is equipped with furniture for eating and relaxing employees.

The wardrobe area provides storage of home and work clothes in accordance with the requirements for the sanitary regime of pharmacies.

Pharmacy No. 2 places in convenient places for familiarization of the trading floor:

Copies of licenses for pharmaceutical activities and other activities in accordance with the current legislation of the Russian Federation;

Information about telephones and addresses of health and pharmaceutical authorities;

Book of reviews and suggestions;

Information about groups of the population entitled to free and preferential provision and extraordinary services, in accordance with the current legislation of the Russian Federation;

Information on the person responsible for drug provision of disabled veterans of the Great Patriotic War and equated categories of the population on benefits (for pharmacy organizations that sell drugs on preferential terms);

Information about phone numbers and working hours of the pharmaceutical reference service;

Information about the names of departments or distribution zones of the corresponding groups of goods;

Information on the shelf life of medicinal products manufactured in a pharmacy (pharmacy point);

Price tags for offered non-prescription drugs and other goods allowed for dispensing from pharmacy organizations;

Information about the employees of the pharmacy organization directly serving the population (tablets, badges indicating full name and position);

Information about the administrator on duty (full name, position) and the location of the signal call button of the administrator on duty;

A copy of the Federal Law "On Protection of Consumer Rights";

An extract from the Rules for the sale of certain types of goods, a list of durable goods that are not subject to the buyer's requirement to provide him free of charge for the period of repair or replacement of a similar product, and a list of non-food products of good quality that cannot be returned or exchanged for a similar product of a different size, shape, size, style, color or configuration", approved in the prescribed manner; - the list of medicines dispensed without a doctor's prescription, approved by Order of the Ministry of Health of Russia dated July 19, 1999 N 287 "On approval of the List of medicines dispensed without a doctor's prescription".

When dispensing medicinal products, an authorized employee of the pharmacy organization informs the buyer about the rules for taking the medicinal product: the mode of administration, single and daily dose, method of administration (taking into account food intake, etc.), storage rules.

Currently, the pharmacy employs 46 people.

Introduction

1. Tasks and functions of a hospital pharmacy. Its features

Conclusion

The history of pharmacy, as a pharmacy business, is inextricably linked with the activities of hospital pharmacies. The first hospital pharmacy was a pharmacy at the hospital, set up by Patriarch Nikon and maintained by the monastic income.

Reliable information about the existence of hospital (hospital) pharmacies appears only at the beginning of the 18th century, when, after Peter the Great traveled to Western Europe, he decided to open the first hospital in Russia for the population.

The Moscow General Hospital was opened on November 21, 1707. Almost immediately, a pharmacy garden was set up at the hospital, and in the summer the pharmacist was obliged to walk with his students out of town, around Moscow, to collect and disassemble medicinal plants. In medical practice, galenical preparations were mainly used. Tinctures, spirits, elixirs and highly complex decoctions were preferred to simple medicines. Recipes were made up of 20-30 ingredients.

The first Russian hospital charter, drawn up in Russia and approved by Empress Anna on December 24, 1735, contained requirements for the organization of the pharmacy business and the process of manufacturing medicines in hospital pharmacies: it is possible to compose ... also in this laboratory, wine is doubled and infused with certain herbs, which is given to him; both cubes and boilers are bought from the hospital amount; moreover, in the hospital, he should look at those who cook dococts for the sick, so that they are properly boiled and kept clean: also keep all apothecary utensils clean and in good storage, so that nothing is lost in vain.

The requirements prescribed in the hospital charter have not lost their relevance at the present time. Today it is difficult to imagine the work of a modern medical institution without such a unit as a pharmacy.

The close proximity of the hospital pharmacy to the hospital creates optimal conditions for drug provision of the treatment process. However, the legislative framework in the field of hospital pharmaceutical activity has not yet been created.

The Federal Law of the Russian Federation No. 86-FZ of June 22, 1998 “On Medicines” provides a clear definition of pharmaceutical activity. At the same time, the main function of hospital pharmacies related to the provision of drugs to hospitals is not included in the legislative definition of pharmaceutical activity.

Today there is no defined standard of hospital pharmacy. The regulation on the pharmacy of health care facilities was approved by order of the Ministry of Health of the Russian Federation of August 18, 1972 No. 689. Approximate norms for the technical and economic equipment of pharmacies were approved by order of the Ministry of Health of the Russian Federation of December 31, 1971 No. 949. States for self-supporting interhospital (hospital) pharmacies are calculated in accordance with by order of the Ministry of Health of the Russian Federation of 06.23.1983 No. 758. Accounting for the movement of medicines and medical devices in pharmacies of healthcare facilities is carried out in accordance with the order of the Ministry of Health of the Russian Federation of 02.06.1987 No. 747.

All these regulatory documents need to be updated and brought into line with new legislative acts in the field of drug circulation.

Noteworthy is the order of the Ministry of Health and Social Development of Russia No. 319 dated May 3, 2005, which regulates the “hospital pharmacy” among and types of pharmacy organizations. This order laid the foundation for modern state regulation of the activities of hospital (inter-hospital) pharmacies.

Relevance of the topic. The problem of hospital pharmacy today is more acute than all others, since this sector is now at a more backward level compared to other segments of the industry.

The regulatory framework governing the work of hospital and interhospital pharmacies was created in the 70-80s in a country with a different economy. Currently, there are no standards for the operation of hospital pharmacies, and a licensing system for hospital pharmacies has not yet been prescribed. A big problem is the limited staffing: for every 300 beds - 1 position of a pharmacist or pharmacist. For successful work, the certainty of the functions of the pharmacy of a healthcare institution is necessary, there is no specialty "hospital pharmacy" and the role of hospital pharmacy as a whole is underestimated. The role of hospital pharmacies needs to be considered in the overall context of quality care.

hospital pharmacy medicinal injectable

There are 2 types of pharmacies:

Open type, which serves both individuals and medical institutions;

Closed type - pharmacies at medical institutions ("hospital" pharmacies), which carry out only production functions, manufacturing medicines only for patients who are being treated in hospitals.

The main tasks of the hospital pharmacy are:

Provision of medical institutions according to their requirements with medicines and medical products of the pharmacy range;

Identification of the need for medicines and medical products of the pharmacy range in accordance with the profile and specifics of the work of medical institutions;

Organization of systematic information of doctors of attached institutions about medicines and medical products of the pharmacy range;

Fulfillment of planned targets and ensuring strict observance of state discipline.

In order to fulfill these necessary tasks, the pharmacy must perform certain functions, which are as follows:

Ensures the implementation of established targets;

Carries out timely supply of medical institutions with medicines and other medical products of the pharmacy assortment;

Analyzes the needs of medical institutions for medicines and medical products of the pharmacy assortment, draws up and submits requirements and applications-orders for the current and future needs for medicines and other medical products of the pharmacy assortment;

Produces the preparation of medicines at the request of the attached institutions and controls their quality;

Carries out systematic control over the correct storage and consumption of medicines and medical products of the pharmacy range in the subdivisions of attached institutions;

Ensures compliance with all requirements of the pharmaceutical order and sanitary regime;

Provides doctors with all the necessary information about medicines, their pharmacological effects, side effects, dosages, etc.;

Ensures the storage of medicines and other medical products of the pharmacy range in accordance with the requirements of the current State Pharmacopoeia and established rules;

Carries out accounting, operational and statistical accounting, draws up reports and submits them in accordance with the established procedure and terms;

Ensures the introduction of advanced methods and scientific organization of labor in the work of personnel.

The hospital pharmacy is mostly a manufacturing pharmacy, a pharmaceutical factory in miniature. Currently, the production function of hospital pharmacies is of particular social importance due to the fact that:

The pharmaceutical industry cannot focus on the needs of a single medical institution (HCI) and produces a limited number of infusion solutions;

The hospital pharmacy is able to flexibly vary the range of medicines in accordance with the profile and requests of the healthcare facility;

It is possible to select the individual composition and dosage of medicines, taking into account the characteristics of the patient's condition, concomitant diseases (i.e., manufacturing according to unified prescriptions), as well as to produce dosage forms for children;

The length of time between the preparation of medicines in a hospital pharmacy and its use in health facilities is reduced. This is very important, since some preparations do not withstand a long shelf life and require the introduction of special preservatives. Long-term storage may lead to a decrease in the activity of the main components;

Manufactured drugs have a lower cost compared to industrial drugs and imported drugs, which makes them accessible to low-income segments of the population.

Preserving the production functions of hospital pharmacies while ensuring the economic efficiency of economic and financial activities makes it necessary to consider a set of problems associated with the manufacture of medicines, which include:

Decreased profitability of hospital pharmacies due to increased distribution costs;

Low tariffs for the manufacture of medicines;

Weak technical equipment of hospital pharmacies;

Loss of specialists moving to organizations with a higher level of remuneration;

Late payment by medical institutions for medicines received from pharmacies.

In this regard, there is a need for fundamentally qualitative changes in the very process of providing this type of pharmaceutical assistance, in developing recommendations for improving the economic efficiency of financial and economic activities.

Hospital and interhospital pharmacies, being legal entities, are much freer in the formation of staffing levels and the organization of procurement of medicines. However, their activities should also be regulated by industry standards, since the standard for completely legal retail trade is also difficult to apply in the work of UZ pharmacies due to their specifics.

Around the world, hospital pharmacy innovations follow general trends in medical services. Basically they are:

Innovations in the provision of drug information as treatments become more complex;

Participation in the control of quality and cost of treatment, which is increasingly based on data from clinical trials;

Greater attention to the patient and the desire of pharmacists to participate in the management of individual patients.

In different countries, these changes occur in different ways. There is little definite information on specific steps in different countries, but certain trends can be identified that influence this.

2. Assortment of medicines in the hospital pharmacy

Hospital pharmacies are essential and should be in every clinic. Today they are at every hospital. Any stationary institution should have its own pharmacy of ready-made medicines, a room for storing medicines and a specialist. This would make it possible to strictly comply with the storage conditions for finished dosage forms and maintain a professional approach to working with drugs.

The list of essential medicines is the standard treatment for each nosology. It follows from this that each medical and preventive organization must necessarily have standards for the treatment of diseases of its contingent of patients.

Hospital pharmacies differ significantly from conventional green cross facilities, both in function and in the nature of their activities. The task of HCI pharmacies is to meet the needs of the medical process in pharmaceutical goods and services. Therefore, certain tasks are set for pharmacies at hospitals:

Provide medicines for the treatment process both in the provision of free medical care and paid services;

Provide medical staff with professional information about medicines;

Organize pharmaceutical supervision in the hospital.

Hospital pharmacies play an important role in the drug supply of medical institutions. An analysis of the nomenclature of some hospital pharmacies shows that a significant part of the pharmacy dosage forms are sterile dosage forms: solutions for injections, eye drops, as well as sterile dosage forms for external use. These dosage forms are prepared in a pharmacy in large volumes.

Thus, an isotonic sodium chloride solution is produced in an amount of more than 200 liters per shift. It should be noted the low cost of pharmaceutical dosage forms. For example, the cost of isotonic sodium chloride solution in a hospital pharmacy is almost six times cheaper than commercial production.

Prepared in large quantities in pharmacies furatsilina solutions on isotonic sodium chloride solution and without it. Such solutions of furacilin of the pharmaceutical industry are not produced. Among the dosage forms for internal use are common potions with motherwort of various compositions, Pavlov's mixture, cough mixtures with thermopsis and marshmallow of various compositions, as well as one-component solutions of calcium chloride 5 and 10%, potassium iodide 0, 25 and 3%, magnesium sulfate 33% and others.

Pharmacy prescriptions also contain water extracts, which can be used both for internal and external use, in particular for inhalation. An example of the first is breast collection, the second is an infusion of chamomile, peppermint, decoctions of wild rosemary, pine buds.

External dosage forms are represented by numerous ointments, such as simple sulfuric ointments of various concentrations, Lassar paste, zinc and packaged powdered medicinal substances - powders.

A special group is one-component solutions for electrophoresis. Their range is quite diverse - solutions of papaverine hydrochloride 2%, nicotinic acid 2%, novocaine 2%, potassium iodide 1 and 3%, etc. Suppositories are rarely found in the formulation of pharmacies. An analysis of the formulation and work of hospital pharmacies showed that the range and production volumes not only do not decrease, but also increase.

In the event of emergencies, the workload of hospital pharmacies can increase dramatically, especially for groups of sterile medicines. In the future, hospital pharmacies will have to switch to the manufacture of medicines in accordance with GMP rules, so now it is necessary:

Bring production facilities into an appropriate condition;

Implement complexes for obtaining purified water and water for injection using the reverse osmosis method;

Make wider use of membrane technologies;

Purchase high-quality and productive sterilizers;

Conduct staff training in accordance with the specified rules.

3.Features of drug technology in a hospital pharmacy

If we consider the performance of production functions by hospital (hospital) pharmacies as an important component of their activities, then the most rational way out may be the following:

Organization of small-scale production using small-sized automatic lines and other types of equipment that meets GMP requirements;

Creation of mobile autonomous complexes for the production of sterile solutions in the field, which is relevant for the medical units of the Ministry of Defense and the Ministry of Emergency Situations.

In the conditions of hospital (hospital) pharmacies, the share of sterile solutions accounts for about 70%, annually measured by tens of thousands of vials of the entire extemporaneous formulation. Sterile dosage forms require not only special manufacturing conditions, but also significant labor and time costs.

Solutions for injection should be prepared from medicinal substances that fully meet the requirements of private articles of the GF X or other scientific and technical documentation. In some cases, special purification of medicinal substances intended for injection is provided. Glucose, calcium gluconate, sodium caffeine-benzoate, sodium citrate, quinacrine, calcium chloride, magnesium sulfate and some others should have an increased degree of purity.

Auxiliary substances (stabilizers, solubilizers, preservatives, etc.) must also comply with the private articles of the GF X (if these substances are official) or other scientific and technical documentation in terms of quality.

Among injectable solutions in hospital pharmacies, a special group is made up of isotonic solutions, which are solutions with an osmotic pressure equal to the osmotic pressure of body fluids: plasma, blood, lacrimal fluid, lymph, etc. Solutions with a lower osmotic pressure are called hypotonic, with a large one - hypertonic.

The isotonicity of injectable solutions is very significant. Solutions that deviate from the osmotic pressure of the blood plasma cause a pronounced sensation of pain, and it is the stronger, the sharper the osmotic difference.

With the introduction of anesthetics (in dental and surgical practice), osmotic trauma causes sharp pain after anesthesia, lasting for hours. Sensitive tissues of the eyeball also require isotonization of the applied solutions. Introductions into the spinal canal should also not cause an osmotic jump. The osmotic pressure of blood and lacrimal fluid is normally kept at the level of 72.52-104 N/m2 (7.4 atm).

Technology for the manufacture of injection solutions. As solvents for the preparation of injection solutions, water for injection, peach and almond oils are used. Injection solutions must be clear. They are prepared by mass-volume method: the medicinal substance is taken by mass (weight), the solvent - to the required volume. The quantitative determination of medicinal substances in solutions is carried out according to the instructions in the relevant articles.

Source drugs must meet the requirements of GF X. Calcium chloride, caffeine-sodium benzoate, hexamethylenetetramine, sodium citrate, as well as magnesium sulfate, glucose, calcium gluconate and some others must be used in the form of a grade "for injection" with a high degree of purity.

In order to avoid contamination with dust, and with it the microflora, preparations used for the preparation of injection solutions and aseptic drugs are stored in a separate cabinet in small jars, closed with ground glass stoppers, protected from dust by glass caps. Strict observance of technology is required.

Poisonous substances necessary for the preparation of injectable drugs are weighed by the inspector-controller in the presence of an assistant and are immediately used by the latter for the preparation of the drug. When receiving a poisonous substance, the assistant is obliged to make sure that the name of the barbell corresponds to the purpose in the recipe, as well as that the set of weights and weighing are correct.

For all, without exception, injectable medicines prepared by an assistant, the latter is obliged to immediately draw up a control passport (coupon) with the exact indication of the names of the ingredients of the medicine taken, their quantities and personal signature.

All injectable medicines must be subjected to chemical control for authenticity before sterilization, and if there is an analytical chemist in the pharmacy, to quantitative analysis. Solutions of novocaine, atropine sulfate, calcium chloride, glucose and isotonic sodium chloride solution under any circumstances must be subject to qualitative (identification) and quantitative analysis.

In all cases, injectable drugs should be prepared under conditions of the least possible contamination of the drug with microflora (aseptic conditions). Compliance with this condition is mandatory for all injectable drugs, including those undergoing final sterilization.

Rp.: Sol. Calcii chloridi 10% 50.0

D.S. intravenous injection

To prepare the injection solution, sterilized utensils are needed: a dispensing bottle with a stopper, a volumetric flask, a funnel with a filter, a watch glass or a piece of sterile parchment as a roof for the funnel. To prepare a solution of calcium chloride for injection, you also need a sterilized graduated pipette with a pear to measure a concentrated solution of calcium chloride (50%). Before preparing the solution, the filter is repeatedly washed with sterile water, the dispensing bottle and stopper are washed and rinsed with filtered water.

Measure (or weigh out) the required amount of the drug substance, wash it into a volumetric flask, add a small amount of sterile water, then bring the volume of the solution to the mark. The prepared solution is filtered into a tempering flask. The vessel with the solution and the funnel during filtration are closed with a watch glass or sterile parchment. Examine the solution for the absence of mechanical impurities. After capping the vial with the injection solution, tightly tie the cork with wet parchment, write the composition and concentration of the solution on the piping, put a personal signature and sterilize the solution at 120°C for 20 minutes.

In pharmacy practice, bottles of the appropriate capacity are used to dispense sterile solutions. It is essential that they be of neutral grade glass to avoid leaching and precipitation and other undesirable changes in solutions. In some cases, containers made of glass AB-1 (slightly alkaline) are allowed.

Vials used for dispensing injection solutions must be checked for chemical stability according to certain methods. Vials for sterile solutions should be with well ground stoppers. Ordinary cork stoppers that form dust and transfer coloring and extractive substances into the solution are not allowed.

It is allowed to use rubber stoppers, previously sterilized by prolonged boiling in water. In hospital pharmacies, when sterile solutions are prepared for immediate use, the bottles are allowed to be sealed with a swab of non-defatted sterile cotton wool tied with sterile parchment. A piece of sterile gauze should be placed under the swab. M.I. Mamaychuk and V.A. Brailovskaya proved the possibility of capping flasks with sterile solutions with rubber and polyethylene caps, which make it possible to take the solution with a syringe by piercing the cap with a needle without violating the sterility of the solution.

A more perfect form of dispensing sterile solutions from the pharmacies of medical institutions to the hospital department is the dispensing in wide-mouthed standard bottles of various capacities with a standard rubber stopper fixed with a crimped aluminum cap, similar to antibiotic vials.

Potions. Pavlova's mixture is a complex preparation containing caffeine-sodium benzoate - 0.2 g, sodium bromide - 0.2 g, distilled water - 200 ml. Doses of the components of Pavlov's mixture may vary depending on the characteristics of the higher nervous activity of the patient and are determined by the doctor. The medicine is produced in glass bottles of 200 ml. The drug regulates higher nervous activity. Has a calming effect.

Rp .: inf. herbaeThermopsidis0,1 - 200 ml

Natriihydrocarbonatis

Liq. Ammonii anisati aa 1.0

Sirupi Althaeae 20ml

M.D.S. 1 tablespoon 3 times a day.

The total volume of the mixture is 221 ml. In its manufacture, a dry extract of thermopsis (1: 1) is used, which is placed in a stand in an amount of 0.1 g and dissolved in 170 ml of water. The resulting solution is filtered into a dispensing bottle, in which 20 ml of a 5% solution of sodium bicarbonate (1:20) and 10 ml of a 10% solution of sodium benzoate (1:10) are previously placed. Pre-mixed 20 ml of marshmallow syrup and 1 ml of ammonia-anise drops are added to the mixture.

Pharmacy manufacturing of medicines for hospitals remains relevant today, especially for hospitals - after all, the existing range of industrial medicines cannot fill the entire spectrum of medicines that patients need, especially since there are those that are not produced by the industry at all due to various reasons. This is, first of all, drugs needed for children and newborns .

The first group of drugs manufactured in a hospital pharmacy are sterile solutions for internal use by newborns. These solutions are prepared under aseptic conditions, purified water is used as a solvent, then the solution is sterilized. In solutions for injections and infusions for feeding newborns, the presence of stabilizers is unacceptable. The only exception is 0.25% novocaine solution.

Glucose solution 5, 10, 25% is prepared for newborns without a stabilizer. They cannot be replaced by infusion solutions of the same concentration, since the latter include the Weibel stabilizer - a solution of HCl and NaCl - and its pH is 3-4. The shelf life of glucose solutions for drinking newborns is only 1 month. For example, a common prescription for newborns: glucose solution 10% or 20% - 100.0, glutamic acid - 1.0 g in the factory industry, such a drug is not available.

Dibazol solution is also not applicable for internal use in the treatment of newborns, since the factory preparation contains hydrochloric acid.

There is another group of substances that can only be made in pharmacies - solutions for medicinal electrophoresis, the essence of which is reduced to therapeutic effects on the patient's body of an electric current and the introduction of this effect into the tissues of the patient's medicinal substance. Electrophoresis is widely used in various areas of health care, in most medical and treatment-and-prophylactic institutions: in sanatoriums, clinics, women's clinics and in all hospitals.

Electrophoresis requires aqueous solutions of medicinal substances: analgin, dibazol, diphenhydramine, papaverine, ichthyol, zinc sulfate, potassium chloride and many others. In this case, preservatives cannot be used due to their electrical non-indifference. As of today, industrial dosage forms for electrophoresis do not exist.

Hospital pharmacies also produce ointments. Pasta Lassara is in great demand. This is a homogeneous ointment of yellowish color, thick consistency. In a thin layer of paste rubbed on paper, when viewed with the naked eye, grains should not be detected.

Expenditure rates. To prepare 1 kg of Lassara pasta, you need:

Vaseline 480.5 g

Salicylic acid 19.9

Wheat starch 251.2

Zinc oxide 251.2

Technological process. Salicylic acid, starch and zinc oxide are crushed by sifting each powder separately through a No. 2 sieve.

Vaseline is loaded into a digester with a steam jacket and melted at a temperature of 50 - 55 ° C, then passing it through the canvas.

About half of the required amount of petroleum jelly is placed in a mixing kettle and thoroughly mixed with zinc oxide and salicylic acid. Then the sifted starch and the rest of the vaseline are introduced into the boiler in parts, everything is thoroughly mixed until the mass is completely homogeneous.

The ointment from the mixing boiler is passed through the mazeter until the smallest grains disappear (the OTK controller takes a sample for analysis).

Gray mercury ointment is an emulsion in which liquid metallic mercury is dispersed in a base. To obtain this ointment, it is necessary to expend a significant amount of mechanical energy, because mercury has a very high surface tension.

The ointment should be a completely homogeneous mass containing 30% metallic mercury. When examining an ointment rubbed in a thin layer on glossy paper, individual droplets of mercury should not be visible even through a magnifying glass.

Technological process. The entire manufacturing process is divided into the following main stages:

Making concentrated mercury ointment;

Preparation of the fat base;

Mixing mercury concentrate with a fat base;

Packing and storage.

Making concentrated mercury ointment. To make a concentrate, take 85 parts of mercury and 15 parts of anhydrous lanolin.

Depending on the amount of ointment produced, mortars of various sizes are used, which have a special device. Small mortars, as a rule, are cast iron, and large ones are stone (agate). The pestles during operation perform a double planetary motion: they rotate around their own axis and around the center of the mortar. 15 parts of anhydrous lanolin are placed in a mortar, then 85 parts of mercury are added in small portions. Grinding is continued for 14-18 hours, after which an average sample is taken to determine the homogeneity and percentage of mercury content. In pharmacies, the fat base is added to the concentrate as needed, since during long-term storage, fatty acids are released from fats, which form toxic compounds with mercury. With a lack of lanolin, the concentrate is sometimes made on a special emulsion base obtained from zinc oxide, vegetable oil and water.

It is obvious that the future fate of HCI pharmacies requires the speedy development of the industry standard "Pharmacy of Health Care Institutions", the exact procedure for licensing pharmaceutical activities in health care institutions. It is necessary to develop criteria for the compliance of pharmaceutical activities with established rules and a regulation on the pharmacist of a hospital pharmacy.

It is also necessary to change the regulatory framework for calculating the staffing of the pharmaceutical staff of hospital pharmacies and develop regulatory documents that meet the new requirements for HCI pharmacies.

There are about 70 thousand pharmaceutical enterprises in Russia. These are special organizations that, by the nature of their activities, must ensure the quality of drug care and its accessibility to the population. Performing the functions of drug supply, pharmacy enterprises conduct economic activities. Great importance has legislative regulation of both general economic and pharmaceutical aspects of the activities of pharmacy enterprises, especially hospital pharmacies. The regulatory framework is very extensive, but today the law “On Technical Regulation” is becoming increasingly important, which will play a huge role in the future.

The problem of hospital pharmacy today is more acute than all others, since this sector is now at a more backward level compared to other segments of the industry.

Currently, there are no standards for the operation of hospital pharmacies, so far there is no system for licensing hospital pharmacies (they are not legal entities, and only legal entities are subject to licensing). To obtain a license, a pharmacy must be registered in the charter of a medical institution, this does not always happen, and now a number of hospital pharmacies operate without a license at all.

Traditionally, there are four functions of the HCI pharmacy:

Acceptance of requirements for medicines;

Preparation of medicines;

Control of their quality;

Vacation in the departments of health care facilities.

However, these functions are clearly not enough. In particular, it is necessary to control the storage of medicines in the departments, informing medical workers about the medicines available in the pharmacy, etc.

To optimize the process of dispensing medicines, it is necessary to introduce intra-pharmacy packaging and dispense already packaged medicines to departments. It is necessary to keep personalized records in medical institutions.

Pharmacy regulation aims to ensure the quality of drug care, which includes the quality of the product itself, the quality of the facility, equipment and the quality of the implementation process.

In connection with the commercialization of the activities of pharmacies and the appearance on the shelves of pharmacies of falsified and counterfeit products, the development of a system for regulating pharmacy activities is of particular relevance.

The pharmaceutical order is a set of requirements for the premises, personnel, sanitary regime, storage conditions, forms of service, dispensing rules, input control of drugs, and other indicators that ensure the quality of drug care provided in a particular pharmacy enterprise, regulated by regulatory legal acts of the Russian Federation.

An analysis of the process of providing drug care allows us to propose a triad of quality assurance for the provision of this care by a pharmacy enterprise:

The quality of the premises (a set of premises, the design of the trading floor, equipment, compliance with the rules of the sanitary regime);

The initial quality of medicines (availability of documents confirming their quality, compliance with storage rules, control over expiration dates, etc.);

Quality of implementation (required staff qualifications, high-quality assortment, compliance with the holiday rules, information services, pricing, documentation).

These three main points will form the basis of the technical regulation on the retail trade in medicines, which is currently being prepared.

The elements of the pharmaceutical order are personnel, premises, acceptance of medicines, dispensing, medicines themselves, sanitary regime, working hours, information system, etc.

Bibliography

1. Weekly "Apteka" No. 42, 2004.

2. Weekly "Apteka" No. 22, 2005.

3.Internet: www. medical com.ua

4. Bulletin of Pharmacy, 2005.

5. Magazine "Pharmacist" No. 16,2004.

6.Interent: www. provizor. kharkov. ua.

7. Besedina I.V., Griboedova A.V., Korchevskaya V.K. Improving the conditions for the preparation of injection solutions in a pharmacy in order to ensure their apyrogenicity // Pharmacy.- 1988.- No. 2.- p. 71-72.

8. Besedina I.V., Karchevskaya V.V. Evaluation of the purity of injection solutions of pharmaceutical manufacture in the process of application // Pharmacy.- 1988.- No. 6.- p. 57-58.

9. Gubin M.M. Problems of manufacturing injection solutions in industrial pharmacies // Pharmacy. - 2006. - No. 1.

10.Moldover B.L. Aseptically manufactured dosage forms St. Petersburg, 199

11. Svetlanova S. Without a hospital pharmacy, the healing process will stop. // Pharmaceutical Bulletin. - 2005. - No. 26 (389) of August 16, 2005.

12.www.medkurs.ru/pharmacy/sterile_medicine/section2315/11725.html

13. Avamesyants E. M. Technology for the manufacture of dosage forms. Rostov-on-Don, "Phoenix", 2002.

14. State Pharmacopoeia of the USSR. – 10th ed. Moscow: Medicine, 1968.

15. Klimova L.D., Ber O.V. Making medicines. Educational-methodical recommendations. - Samara; GOUVPO SamGMU Roszdrav, 2006. - 70 p.

16. Order of the Ministry of Health of the Russian Federation of December 31, 1971. No. 949

17. Order of the Ministry of Health of the Russian Federation of 18.08.1972 No. 689

18. Order of the Ministry of Health of the Russian Federation of 06/23/1983. No. 758

19. Order of the Ministry of Health of the USSR No. 758 dated 06/23/1983 "On the position and states of self-supporting interhospital (hospital) pharmacies"

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Introduction

Medicines have been used by humans since prehistoric times. And if earlier people more often resorted to alternative medicine, which includes folk recipes, homeopathy, acupuncture, naturopathy and other methods, then in our time, many people turn to pharmacology, which uses clinically proven medicines.

Thus, over thousands of years, a kind of evolution took place from "grandmother's" recipes to a whole science - pharmaceutical technology, which led to the creation of a large number of drugs. Pharmacy counters are rapidly filling up with more and more new drugs, therefore, there is a need for a more thorough check of the quality of medicines in accordance with the current legislation, as the number of counterfeit drugs has also increased.

The use of low-quality drugs can harm human health and life, even death, since the pharmacological properties of low-quality drugs differ from the properties of the original ones.

About 90% of medicines produced by pharmacies are medicines for medical institutions: hospitals, hospitals, dispensaries. Most of the drugs manufactured for medical institutions are liquid dosage forms (LDF). The quality of their production depends on the life and health of many people. Therefore, the issue of the quality of liquid dosage forms will always be relevant.

That is why the purpose of this work is an analysis of the quality of liquid dosage forms produced by pharmacy No. 418, the only production pharmacy in the Kompressorny microdistrict.

To achieve this goal, it is necessary to solve the following tasks:

To study liquid dosage forms from a theoretical point of view;

Consider methods of intra-pharmacy control (VAK);

Analyze the range of products manufactured by the production department of pharmacy No. 418;

Choose liquid dosage forms for physical, complete chemical and organoleptic analysis (types of intra-pharmacy control available to me);

Conduct a physical, complete chemical and organoleptic analysis of selected liquid dosage forms;

To draw conclusions about the compliance of the quality of the studied liquid dosage forms with the current legislation.

Subject of study: liquid dosage forms produced by pharmacy No. 418.

Object of study: furacilin solution 1/5000 (sterile; for treating wounds), calcium chloride solution 5% (for oral administration), protargol solution 2% (nasal drops).

Research methods: statistical analysis, literature analysis, titration in aqueous media, observation method, refractometry method.

Theoretical part

Liquid dosage forms

Liquid dosage forms- these are comprehensively free disperse systems in which medicinal substances are distributed in a liquid dispersion medium.

2.1. Classification of liquid dosage forms

Liquid dosage forms can be divided into several groups:

By way of application	Composition	Depending on the type of dispersion systems	Depending on the environment
a) for internal use (drops, solutions, mixtures) b) for external use (lotions, rinses, douches, enemas, nasal drops, ear, dental, vaginal, urethral) c) for injections	a) Simple (one-component solutions - from one medicinal substance and solvent) b) Complex (multicomponent - from several medicinal substances and a solvent)	a) True solutions (molecular and ion-dispersion systems less than 1 mmc) b) IUD solutions c) Colloidal IUDs d) Suspensions e) Emulsions f) Combined disperse systems g) Water extracts (infusions, decoctions, mucus)	a) Aqueous solutions b) Non-aqueous solutions

Liquid dosage forms have both advantages and disadvantages.

In any case, for the effective use of medicines, strict adherence to the standard for the preparation of pharmacy products is necessary.

2.2 General technological scheme for the preparation of solutions of mass-volume or volume concentration

The technological scheme for the preparation of solutions includes several stages:

Stage 1 - calculation, verification of doses of substances with doses; calculation of substances and solvent;

Stage 2 - preparation for work;

stage 3 - dissolution;

Stage 4 - purification (filtration of the solution);

Stage 5 - packaging and capping;

stage 6 - registration;

Stage 7 - quality control.

At each stage of the preparation of liquid dosage forms, compliance with the requirements of intra-pharmacy control is mandatory.

2.3. Pharmacy control

Intra-pharmacy quality control of medicines is regulated by the order approved by the Ministry of Health of the Russian Federation No. 751n of 2015. This order applies to all pharmacies on the territory of the Russian Federation, regardless of ownership and departmental affiliation.

Work on quality control of medicines is assigned to the pharmacist and pharmacist-technologist, who are required to own all types of intra-pharmacy control.

Intra-pharmacy control includes all stages of the drug preparation process.

Directions for the implementation of intra-pharmacy control

1. Quality control of medicinal substances (PM) and other items used in the preparation of medicines: A) Compliance with the rules for the reception and storage of medicinal substances in a pharmacy; B) Proper processing of pharmacy utensils and auxiliary materials; C) Compliance with sanitary and pharmaceutical regimes, proper receipt and storage of purified water, concentrates and semi-finished products.

2. Quality control of manufactured medicines: A) Compliance with the rules for taking prescriptions and manufacturing technology of medicines; B) Carrying out all types of intra-pharmacy control

Mandatory types of intra-pharmacy control: written, organoleptic and control on vacation.

Written control provides for the filling of a written control passport in the manufacture of a dosage form. The passport indicates the date, prescription number, the name of the medicinal product in Latin, its quantity, the mass of individual doses and their number, calculation formulas, the necessary coefficients for the calculation, the signature of the person who manufactured the medicinal product, packaged, checked. All calculations are carried out before production and are recorded on the reverse side of the written control passport. The name of medicines and their quantities are listed in the written control passport in accordance with the manufacturing technology immediately after manufacture from memory. The written control passport is stored in the pharmacy for 2 months. In the manufacture of concentrates, semi-finished products, intra-pharmaceutical preparations and packaging of medicines, entries are made not in the passport, but in the registers of laboratory and packaging work.

Organoleptic control consists in checking the appearance of dosage forms, color, smell, uniformity of mixing, absence of mechanical impurities. The control results are recorded in the appropriate journal.

Vacation control includes verification of compliance: packaging of medicinal products with the properties of their constituent medicinal substances; registration of medicinal products - the requirements of regulatory documents; doses of drugs with normalized doses - the age of the patient; numbers on the prescription-number on the label; surnames on the receipt and label-surnames on the prescription; prescription copies; correct labeling. The person dispensing the medicine signs on the back of the prescription.

Selective types of intra-pharmacy control: interrogatory, physical and chemical.

Poll control is used selectively after the pharmacist makes no more than 5 dosage forms. When carrying out this type of control, the pharmacist-technologist names the name of the first ingredient included in the prescription (in complex dosage forms) and its quantity, after which the pharmacist from memory names all the medicines taken and their quantity (when using semi-finished products, he names their composition and concentration).

Physical control is carried out to check the total mass or volume of the medicinal product, the number and mass of individual doses (at least 3 doses) and the quality of the closure of all dosage forms.

Mandatory physical control is subject to:

Each package and intra-pharmacy preparation (at least 3 packages) of injection solutions, eye drops, medicines for newborns and children of the first year of life, sterile dosage forms for external use;

Each series of sterile dosage forms (at least 5 bottles, after packaging before their sterilization): injection solutions, eye drops, dosage forms for newborns and children of the first year of life, sterile dosage forms for external use;

Dosage forms with narcotic, psychotropic and potent substances;

Suppositories (solid at room temperature and melting (dissolving or disintegrating) at body temperature dosage forms).

Medicines are subjected to chemical control depending on the composition, purpose and type of dosage form.

Chemical control consists in assessing the quality of the manufactured medicinal product according to the following indicators: “authenticity”, “test for purity and permissible limits of impurities” (qualitative analysis) and “quantitative determination” (quantitative analysis) of the medicinal substances that make up its composition.

Qualitative analysis is subject to mandatory:

Purified water, water for injection (daily) for the absence of chlorides, sulfates, calcium and magnesium salts. Water for injection additionally for the absence of reducing substances, carbon dioxide and the content of ammonium salts. Quarterly purified water is sent to the control and testing laboratory for a complete chemical analysis;

All medicines coming from the storage rooms to the assistant, and in case of doubt: to the pharmacy, from the warehouse;

Concentrates and semi-finished products;

Medicinal products of industrial production, packaged in a pharmacy (each series);

Medicinal products received by the pharmacy - in case of doubt about their quality;

Homeopathic medicines in the form of an intra-pharmacy blank

and selectively: dosage forms manufactured according to individual prescriptions and requirements of medical institutions (at least 10% of the total number of manufactured drugs). Particular attention is paid to dosage forms for children, eye, as well as medicines containing poisonous and narcotic substances.

Qualitative and quantitative analysis (complete chemical analysis) is necessarily used for quality control:

All injectable solutions prior to their sterilization, including determination of pH, isotonizing (i.e., substances whose osmotic pressure of solutions is equal to the osmotic pressure of blood plasma) and stabilizing substances. Solutions for injection after sterilization are checked for pH value, authenticity and quantitative content of active substances;

Sterile solutions for external use (for example, solutions for the treatment of open wounds);

Eye drops and ointments with poisonous and narcotic substances;

Dosage forms for newborns;

Solutions of hydrochloric acid (for internal use); solutions of atropine sulfate and silver nitrate;

Concentrates, semi-finished products, triturations (dry mixtures of toxic and potent substances with indifferent substances in a certain (1/10, 1/100) ratio), intra-pharmaceutical preparation (each series);

Stabilizers used in the manufacture of solutions for injections and buffer solutions necessary in the manufacture of eye drops;

The concentration of ethyl alcohol when diluted in a pharmacy;

Ethyl alcohol, in case of doubt in the concentration upon admission to the pharmacy;

Homeopathic granules for disintegration;

Injectable homeopathic solutions.

Medicines made according to individual prescriptions are subject to chemical control selectively, but at least 3 times per shift. Particular attention is paid to dosage forms for children, ophthalmic dosage forms, narcotic and poisonous, solutions for therapeutic enemas. The results of a complete chemical control are recorded in the appropriate journal.

In the process of making solutions for injections, they are subjected to primary and secondary control. The primary control consists in carrying out a complete chemical control (including the determination of pH and ) after filtering and packaging the solution. Secondary control is carried out before packaging after sterilization. It consists in complete chemical control, control for the absence of mechanical impurities, control for sterility and pyrogenic substances (products of vital activity and decay of microorganisms), in checking the quality of vials capping and their filling volume.

The assessment of the quality of manufactured medicines is carried out according to two indicators: “satisfies” (suitable products) and “does not satisfy” (marriage).

After carrying out a complete chemical quality control of medicines, a pharmacist-analyst (a specialist with a higher pharmaceutical education working in the field of medicine production) puts the analysis number and his signature on the written control passport and on the back of the prescription.

From all of the above, we can conclude that the methods of intra-pharmacy control available to me are: physical, organoleptic and complete chemical analysis.

3. Research part

For the practical part of the study, a pharmacy was chosen within walking distance from the place of residence and education in the Kompressorny microdistrict.

1. Analysis of the produced assortment

I conducted an analysis of the manufactured assortment of the production department of pharmacy No. 418 for the month (from August 20, 2017 to September 20, 2017), based on the information provided by the person acting as the head of the pharmacy.

Analysis of the manufactured assortment of the production department of pharmacy No. 418 for the period from August 20, 2017 to September 20, 2017:

Liquid dosage forms 6571(90.4%)

Sterile 4934(67.9%)Non-sterile 1637(22.5%)

1. Injectable 1903(26.2%) 1. External 1568(21.6%)

(including water for injection 720(9.9%))

2. External sterile 1784(24.6%) 2. Internal 69(0.9%)

3. Sterile packaging 852(11.7%)

4. Eye drops 395(5.4%)

Ointments 501(6.9%) (including packaging 173(2.4%))

Powders 194(2.7%) (including packaging152(2.0%))

From the above statistics, we can conclude that liquid dosage forms predominate in the range of manufactured products.

1. Selection of liquid dosage forms for analysis

I opted for the following liquid dosage forms, which were available to me without a prescription:

Furacilin solution 1/5000(sterile; for wound care)

Manufacturing feature: A solution of furacilin is made in a boiling 0.9% (isotonic) solution of sodium chloride, since furacilin is a poorly soluble substance in water.

Also, this solution is produced in large quantities for medical institutions for the treatment of wounds.

Calcium chloride solution 5%(for oral administration)

Manufacturing feature: The substance calcium chloride is very hygroscopic, that is, it easily absorbs moisture from the air and melts very quickly. Therefore, in pharmacies, concentrated solutions are prepared from this substance, more often 1/50. And dosage forms are already made from this concentrated solution.

This solution is widely used in medical institutions and the population.

Protargol solution 2%(nasal drops)

Manufacturing feature: Protargol is poured onto the surface of the water and left alone until completely dissolved (about 30-45 minutes). It is impossible to shake the solution, since when shaking, foam is formed, which envelops the particles of protargol and significantly slows down the dissolution process.

It is widely used in pediatrics for the treatment of inflammation of the nasal mucosa.

Each of these drugs has a peculiarity in the manufacture and wide application in medicine. Based on these factors, I chose the above medicines for analysis.

1. Analysis of liquid dosage form No. 1

Solution of furatsilina 0.02% (1/5000) - 400 ml

Organoleptic control

Index	Requirement	Indicators of the manufactured LF
Appearance of LF	Clear, yellowish-colored solution	Corresponds
	Without smell	Corresponds
No mechanical inclusions		Corresponds

• Physical control

AND ABOUT. (deviation interval) = ±1% (see annex 1)

A.I. = 400 ml. (±1%) / 100% = ±4 ml

D.I.O. (permissible deviation interval) =396 ÷ 404 ml

V measured = 401 ml (Included in the tolerance range)

Complete chemical analysis

Since the analyzed solution of furacilin is prepared in an isotonic solution of sodium chloride, a complete chemical analysis checks not only the presence and content of furacilin, but also the presence and content of sodium chloride, too.

Qualitative Analysis

Furacilin: method of observation.

The method is based on the property of furacilin to fluoresce green in ultraviolet radiation.

Sodium chloride:

For chloride ion:

1 ml is added to 3 drops of the solution. purified water, 5-6 drops of HNO 3 (razb.) and 2-3 drops of AgNO 3 form a white cheesy precipitate.

NaCl + AgNO 3 → AgCl ↓ (white curd precipitate) + NaNO 3

To the sodium cation: using a microcrystalline reaction.

The sodium cation, reacting with 2,4,6-tinitrophenol (picric acid), forms yellow needle-like crystals of sodium picrate, emerging from one point.

O 2 N NO 2 O 2 N NO 2

NaCl + → HCl +

Quantitative analysis.

Furacilin:

Furacilin formula:

O 2 N O CH \u003d N - NH - C - NH 2

5-nitrofurfural semicarbazone

iodometry method

The method is based on the reducing properties of the drug due to the hydrazide group.

Methodology: To 2 ml. solution of furatsilina add an excess of 0.01 m iodine solution (2 ml.) and a solution of sodium hydroxide 10% dropwise until discoloration. Then dilute sulfuric acid (2 ml; for an acidic medium) is added and left in a dark place for some time (approximately 2-5 minutes). The released iodine is titrated with 0.01 m sodium thiosulfate solution until it becomes colorless. Indicator - starch (add 3 drops at the end of the titration).

Several reactions take place in parallel:

1. I 2 + 2NaOH → NaI + NaIO + H 2 O (iodine solution in an alkaline medium forms hypoiodite (NaIO)).

O + 2I 2 + 6NaOH → O +

O 2 N O CH \u003d N - NH - C - NH 2 O 2 N O C - H

n (C 6 H 6N4 O 4) \u003d 1 mol z (I 2) \u003d 2 * 2 \u003d 4 (z (I 2) \u003d n (I 2) * N atoms. (I))

N 2 + NH 3 + 4NaI + Na 2 CO 3 + 3H 2 O (nitrofural oxidation to 5-nitrofurfural)

3. NaI + NaIO + H 2 SO 4 → I 2 + Na 2 SO 4 + H 2 O (solution acidification)

4. I 2 + 2Na 2S2 O 3 → 2NaI + Na 2S4 O 6 (titration of the released excess iodine with sodium thiosulfate using an indicator - starch, which is added at the end of the titration)

The titer of sodium thiosulfate according to furacilin is:

M 1/z (molar mass of titrant equivalent)

M (C 6 H 6N4 O 4) \u003d 198.14 g / mol (table value; see Appendix 2)

M 1 / z \u003d \u003d 49.54 g / mol

C 1 / z = 0.01 mol / l (molar concentration of titrant equivalent)

T (C 6 H 6N4 O 4) \u003d 0.0004954 g / ml

ω(C 6 H 6N4 O 4) =

V 0.01 (I 2) \u003d 2 ml (total excess iodine)

V 0.01 (Na 2S2 O 3) \u003d 1.2 ml (volume of titrant spent on titration)

ω (C 6 H 6N4 O 4) = = 0.079264 g

AND ABOUT. (deviation interval) = ±15% (see appendix 1)

MA = 0.08 g (±15%) / 100% = ±0.012 g

D.I.O. (permissible deviation interval) = 0.068 ÷ 0.092 g

ω (C 6 H 6N4 O 4) \u003d 0.079264 g (included in the allowable deviation interval)

Sodium chloride:Mohr's method of argentometry

The method is based on the precipitation of chloride ions with silver cations.

Methodology: 2 ml of water, 2 drops of potassium chromate are added to 0.5 ml of the solution and titrated with 0.1 mol/l solution of silver nitrate until the precipitate turns orange-yellow.

NaCl + AgNO 3 → AgCl↓+ NaNO 3

n(C6H6N4O4) = 1 mol z (I2) = 1 * 1 = 1 (z (AgCl) = Valence (Ag) * N atoms. (Ag))

2AgNO 3 + K 2 CrO4 → Ag 2 CrO 4 ↓ + 2KNO 3

The titer of sodium chloride on silver nitrate is:

M(NaCl) = 58.44 g/mol (table value; see Appendix 2)

M 1 / z \u003d \u003d 58.44 g / mol

T(NaCl) = = 0.005844 g/ml

V 0.1 (AgNO 3) \u003d 0.8 ml (volume of titrant spent on titration)

V lf. = 400 ml (total dosage form volume)

K p. \u003d 1 (indicated on the packaging of the titrant)

a = 0.5 ml (volume of working solution taken for titration)

ω(NaCl) = = 3.74016 g

MA = 3.6 g (±4%) / 100% = ±0.144 g

D.I.O. (permissible deviation interval) = 3.456 ÷ 3.744 g

ω(NaCl) = 3.74016 g (included in the allowable deviation interval)

1. Analysis of liquid dosage form No. 2

Calcium chloride solution 5% - 100 ml

Organoleptic control

Index	Requirement	Indicators of the manufactured LF
Appearance of LF	Clear, colorless solution	Corresponds
	Without smell	Corresponds
No mechanical inclusions	There are no mechanical inclusions	Corresponds

Physical control

AND ABOUT. (deviation interval) = ±3% (see appendix 1)

A.I. = 100 ml. (±3%) / 100% = ±3 ml

D.I.O. (permissible deviation interval) =97 ÷ 103 ml

V measured = 102 ml (Included in the tolerance range)

Also, as part of physical control, it is checked

the quality of the capping of the medicinal product.

Complete chemical analysis

Qualitative Analysis

For chloride ion:

Precipitation of chloride ions by silver cations.

To 0.5 ml of the analyzed solution add 5-6 drops of HCl (razb.) (to acidify the medium) and 2-3 drops of AgNO 3 form a white cheesy precipitate.

CaCl 2 + 2AgNO 3 → 2AgCl ↓ (white curd precipitate) + Ca(NO 3) 2

For calcium cation:

To 0.5 ml of the test solution add 3 drops of ammonium oxalate. A white precipitate forms.

CaCl 2 + (NH 4) 2 C 2 O 4 → CaC 2 O 4 ↓ (white precipitate) + 2NH 4 Cl

Quantitative analysis.

Calcium chloride: refractometry method(since calcium chloride concentration ≥5%)

The refractive index of the analyzed solution (n) is determined at 20˚С. The concentration of CaCl 2 (X, in grams) is calculated by the formula:

X= (At 20˚C)

n 0 \u003d 1.333 (refractive index of light in water; taken from a refractometer)

n \u003d 1.339 (Refractive index of light in the CaCl 2 medium; taken from the refractometer)

V lf. = 100 ml (total dosage form volume)

F = 0.0012 (refractive factor CaCl 2 5%; tabular value, see appendix 3)

AND ABOUT. (deviation interval) = ±4% (see appendix 1)

MA = 5 g (±4%) / 100% = ±0.2 g

D.I.O. (permissible deviation interval) = 4.8 ÷ 5.2 g

X = 5.0 g (Included in the tolerance range)

Conclusion - this liquid dosage form meets the requirements of the order of the Ministry of Health of the Russian Federation dated 10.26.15. No. 751n.

1. Analysis of liquid dosage form No. 3

Protargol solution 2% - 10 ml

Organoleptic control

Index	Requirement	Indicators of the manufactured LF
Appearance of LF	Clear dark brown solution	Corresponds
	Without smell	Corresponds
No mechanical inclusions	There are no mechanical inclusions	Corresponds

• Physical control

AI = 10 ml. (±10%) / 100% = ±1 ml

D.I.O. (permissible deviation interval) = 9 ÷ 11 ml

V measured = 10 ml (Included in the tolerance range)

Also, as part of physical control, it is checked

the quality of the capping of the medicinal product.

Complete chemical analysis

Qualitative Analysis

per silver cation

Precipitation of silver cations by chloride ions.

To 0.5 ml of the test solution add 3 drops of nitric acid and heat. The liquid turns yellow, turbidity appears. Then 2 drops of hydrochloric acid are added, a yellowish-white cheesy precipitate is formed.

LS HNO3, t0 Ag +

HCl + Ag + → AgCl↓ + H +

For protein:

When heated, the protein in the analyzed solution is carbonized. There is a smell of burnt horn.

The analyzed solution is heated to charring of the protein, the smell of burnt horn is felt.

Quantitative Analysis

For silver: rhodanometry method (Folhard argentometry), direct titration method.

In pure protargol, silver is only 8%, the rest is protein. Therefore, the titer of protargol is considered through the conditional titer of silver. Protein is not quantified.

The method is based on the precipitation of silver cations by rhodanide ions.

To 2 ml of the drug, add 3 drops of nitric acid (to acidify the medium) and 3 drops of iron-ammonium alum, heat to discoloration and titrate the discolored solution with 0.1 m ammonium thiocyanate solution to a pinkish-red color.

Ag + + NH 4 SCN → AgSCN↓ + NH 4 +

n(Ag) \u003d 1 mol z (NH 4 SCN) \u003d 1 * 1 \u003d 1 (z (NH 4 SCN) \u003d Valence (NH 4) * N groups (NH 4))

3 NH 4 SCN + Fe 3+ → Fe(SCN) 3 + 3 NH 4 +

Silver titer for ammonium thiocyanate is:

M 1/z (molar mass equivalent)

M(Ag) = 107.9 g/mol (table value; see Appendix 2)

M 1 / z \u003d \u003d 107.9 g / mol

C 1 / z \u003d 0.1 mol / l (molar equivalent concentration)

T(Ag) = 0.01079 g/ml

T protargol conditional = = = 0.134875 g / ml

The mass fraction of silver in the analyzed solution in grams is equal to:

V 0.1 (NH 4 SCN) \u003d 0.3 ml (volume of titrant spent on titration)

V lf. = 10 ml (total dosage form volume)

K p. \u003d 1 (indicated on the packaging of the titrant)

a = 2 ml (volume of working solution taken for titration)

ω(Ag) = = 0.2023125 g

AND ABOUT. (deviation interval) = ±10% (see appendix 1)

AI \u003d 0.2g. (±10%) / 100% = ±0.02g

D.I.O. (permissible deviation interval) = 0.18 ÷ 0.22 g

ω(Ag) = 0.2023125 g (included in the allowable deviation interval)

Conclusion - this liquid dosage form meets the requirements of the order of the Ministry of Health of the Russian Federation dated 10.26.15. No. 751n.

4. Conclusion

1. I studied the classification of liquid dosage forms and the general technology for their manufacture, methods of intra-pharmacy control and found out which of them I can carry out.

2. In the experimental part, I analyzed the range of products manufactured by the production department of pharmacy No. 418. From the analysis, we can conclude that the vast majority of liquid dosage forms are produced - more than 90%, so the topic of my research work, where I consider only liquid dosage forms, is very relevant.

She also selected and analyzed liquid dosage forms and made conclusions about their quality compliance with current legislation. I believe that the tasks set by me were completed.

3. At Pharmacy No. 418, the quality control system for liquid medicines is organized in accordance with the current legislation.

5. List of references

Order of the Ministry of Health of the Russian Federation of October 26, 2015 N 751n “On approval of the rules

manufacturing and dispensing of medicinal products for medical

application by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities"

E.V. Ermilova, V.V. Dudko, T.V. Kadyrova "Analysis of complex dosage forms" Tutorial. Ministry of Education. Siberian State Medical University. Tomsk, 2012

Pletneva T.V., Uspenskaya E.V., Muradova L.I. Quality control of medicines. - M.: GEOTAR-Media, 2014. - 555 p.

Krasnyuk I.I., Mikhailova G.V., Muradova L.I. Pharmaceutical technology. Technology of dosage forms. - M.: GEOTAR-Media, 2013. - 560 p.

Internet - resources, electronic tutorials and textbooks:

GUARANTEE URL: http://www.garant.ru

Ministry of Health of the Russian Federation URL : http://www.rosminzdrav.ru/

http://xumuk.ru/

6.Applications

Annex 1

Permissible deviations in the total volume of LLF in the manufacture of mass-volume method.
Prescribed volume, ml	Deviations, %
Over 10 to 20 Over 20 to 50 Over 50 to 150 Over 150 to 200
Permissible deviations in the weight of the sample of individual medicinal substances in the LDF in the manufacture of the mass-volume method.
Registered weight, g	Deviations, %
Over 0.02 to 0.1 Over 0.1 to 0.2 Over 0.2 to 0.5 Over 0.5 to 0.8 Over 0.8 to 1.0 Over 1.0 to 2.0 Over 2.0 to 5.0

DEVIATIONS PERMISSIBLE IN THE MANUFACTURE OF LIQUID

DOSAGE FORMS IN THE PHARMACY.

Appendix 2

Table "MOLAR MASS OF DRUG SUBSTANCES"

	medicinal substance	Molar mass
	Acetylsalicylic acid
	Ascorbic acid
	Adrenaline hydrotartrate
	Anestezin
	Analgin
	Antipyrine
	Apomorphine hydrochloride
	Atropine sulfate
	Benzoic acid
	Boric acid
	Barbital
	barbital sodium
	Butadion
	Glutamic acid
	Hexamethylenetetramine
	Diphenhydramine
	calcium chloride
	calcium gluconate
	calcium lactate
	Codeine Phosphate
	caffeine anhydrous
	Potassium chloride
	Potassium bromide
	Potassium iodide
	Potassium permanganate
	Levomecithin
	Magnesium sulfate
	Morphine hydrochloride
	sodium benzoate
	Sodium bromide
	Sodium chloride
	sodium iodide
	sodium bicarbonate
	sodium nitrite
	Sodium salicylate
	Sodium tetraborate
	Sodium thiosulfate
	A nicotinic acid
	norsulfazol
	Norsulfazole sodium
	Novocaine
	Papavirine hydrochloride
	Pilocarpine hydrochloride
	Promedol
	Pyridoxine hydrochloride
	Hydrogen peroxide
	Resorcinol
	Riboflavin
	Silver nitrate
	Streptocid soluble
	Sulfacyl sodium
	Sulfadimezin
	Salicylic acid
	Theobromine
	Theophylline
	Thiamine bromide
	Thiamine chloride
	Mercury oxide yellow
	Phenobarbital
	Phenyl salicylate
	Ftalazol
	Furacilin
	Hydrochloric acid
	Quinine dihydrochloride
	Quinine hydrochloride
	Quinine sulfate
	Chloral hydrate
	zinc sulfate
	Ethaminal sodium
	Ethylmorphine hydrochloride
	Ephedrine hydrochloride
	Eufillina: theophylline
	Ethylenediamine

Appendix 3

REFRACTIVE INDEX TABLE FOR MEDICINAL SUBSTANCES

Amidopyrine 4%		Analgin
Ammonium bromide 5%		Analgin 20%
Ammonium bromide 20%		Antipyrine 1%
Ammonium chloride 10%		Antipyrine 5%
Ammonium chloride 20%		Atropine sulfate
Barbamil 3%		Barbital
Barbamil 5%		sodium barbital
Urotropin 10%		Glucose (moisture content 10%)
Urotropin 20%		Glucose b/w
Urotropin 40%
Potassium bromide 5%		Diphenhydramine
Potassium bromide 10%		K-ta aminocaproic 5%
Potassium bromide 20%		K-ta ascorbic
Potassium iodide		Boric acid 3%
Potassium chloride 10%		K-ta glutamine
Potassium chloride 5%		K-ta nicotine
calcium gluconate		Acetic acid
calcium lactate		Codeine Phosphate
Calcium chloride 5%		cardiamine
Calcium chloride 20%
Calcium chloride 50%		Caffeine-sodium benzoate
Magnesium sulfate up to 50%		Magnesium chloride
Magnesium sulfate up to 30%		copper sulfate
Valerian tincture		Sodium salicylate 20%
Sodium bromide 5%		Sodium chloride 5%
Sodium bromide 10%		Sodium chloride 10%
Sodium bromide 20%		Sodium tetraborate
sodium benzoate		Sodium thiosulfate 10%
sodium bicarbonate		Sodium thiosulfate 20%
sodium hydrocitrate		Sodium thiosulfate 40%
Sodium iodide 5%		Sodium thiosulfate 50%
Sodium iodide 10%		Sodium thiosulfate 60%
Sodium iodide 30%		sodium citrate
Sodium sulfate		Sodium etaminal
Sodium sulfate b/w		Novacainamide 10%
Sodium salicylate 10%		Novocaine
Pilocarpine hydrochloride
Pachycarpine hydroiodide		Pyridoxine g/h
papaverine hydrochloride		Promedol
		Alcohol ammonia
Sodium sulfate		Streptocide solution
Resorcinol		Quinine g/h
zinc sulfate		Chloral hydrate
Euffilin 10%		Ephedrine g/h

Introduction

Chapter 1. Marketing approaches to the study of the pharmaceutical market of medicines

1 The value of marketing research in the study of the market of medicines

2 Methods for analyzing the assortment of medicines

Chapter 2. Marketing analysis of the range of drugs based on oxacillin

1 Commodity characteristics of oxacillin (classification group taking into account various classifications, pharmacological action, use, features of storage and dispensing from a pharmacy)

1.2 Classification groups

1.3 Release forms

2 Analysis of the range of medicines produced on the basis of oxacillin, approved for use in the country by the number of trade names, by forms of release, by countries, manufacturing firms, by dates of registration)

Conclusion

Bibliography

Annex 1

marketing medicinal merchandising oxacillin

INTRODUCTION

Infectious diseases have been known to mankind since ancient times, when epidemics covered vast territories, including entire states and peoples. It is not for nothing that infectious diseases are called "pestilences".

Infectious diseases are diseases that are caused and maintained by the presence in the body of a living damaging foreign agent - the pathogen. It enters into a complex biological interaction with the human body, which leads to an infectious process, then an infectious disease. The infectious process is the interaction of the pathogen and the human body under certain environmental conditions, the body responds to the action of the pathogen with protective reactions. concept infection means the state of infection of the body and manifests itself in the form of a disease or carriage.

Infectious diseases are a serious global problem. According to the World Health Organization, 16 million people die from them every year in the world. Despite the differences in the structure of causes of death, this problem is acute not only for developing countries, but also for prosperous states. Western Europe And North America, as well as Russia. As emphasized at the G8 summit in St. Petersburg, this dictates the need to reduce the negative impact of infectious diseases on the population, as well as on the healthcare system and the economy of various countries.

The main group of drugs used in the treatment of infectious diseases are antibiotics. The invention of antimicrobials was one of the most important events in medicine of the 20th century and opened the era of antibiotic therapy, which made it possible to etiotropically treat infectious diseases. Currently, a huge number of synthetic and biosynthetic antibiotics are known to be active against various groups of microorganisms, and, consequently, various infectious diseases caused by them. The appointment of antibiotics is justified only if laboratory tests confirm the presence of a specific microorganism-causative agent. Based on the results of the data obtained, the doctor selects an antibiotic based on information about the sensitivity of the identified microorganism. In case of inadequate selection of the drug, not only the therapeutic effect may not occur, but the patient's health will be harmed. Self-medication with antibiotics is prohibited because it leads to the formation of antibiotic resistance in bacterial strains, which in turn increases mortality, as well as increases the cost of treatment.

Antibiotics are one of the most widely used groups of drugs used in various fields of clinical medicine. Means for the treatment of infectious diseases are the fourth largest in the world in terms of sales. Among them, a significant proportion falls on antibiotics.

The global market for antibiotics is estimated at about 22.5 billion dollars and accounts for 6-21% of the entire pharmaceutical market in different countries. The leading pharmacotherapeutic classes by sales volume include cephalosporins, broad-spectrum penicillins, and macrolides.

Currently, the pharmaceutical market of the Russian Federation is oversaturated with antibiotic drugs and their range is constantly expanding, the need for marketing research in this area, which is relevant and promising, is revealed.

One of the modern representatives of the class of antibiotics is oxacillin - a bactericidal antibiotic from the group of semi-synthetic penicillins, resistant to the action of penicillinase. The drug blocks the synthesis of the bacterial cell wall by disrupting the later stages of peptidoglycan synthesis (prevents the formation of peptide bonds by inhibiting transpeptidase), causes lysis of dividing bacterial cells. Active against gram-positive microorganisms: Staphylococcus spp. (including producing penicillinase), Streptococcus spp., incl. Streptococcus pneumoniae, Corynebacterium diphtheriae, Bacillus anthracis, anaerobic spore-forming rods, gram-negative cocci (Neisseria gonorrhoeae, Neisseria meningitidis), Actinomyces spp., Treponema spp. Inactive against most gram-negative bacteria, rickettsiae, viruses, protozoa, fungi. Resilience develops slowly.

The purpose of this work is to conduct a marketing analysis of the range of drugs based on the drug oxacillin.

To achieve the goal, you must complete the following tasks:

To study the importance of marketing research in the study of the drug market.

Consider the main methods of analysis of the assortment of drugs.

Carry out a merchandising characteristic of drugs based on the drug INN oxacillin.

To study the range of antibiotics based on INN oxacillin.

Objects of study: statistical, accounting reports of pharmacies, publications of scientific journals, register of medicines, etc.

CHAPTER 1. PHARMACEUTICAL MARKETING: PROBLEMS AND DEVELOPMENT TRENDS

1.1 general characteristics marketing in pharmacy

Trade, or exchange, seems to have existed throughout human history, although at first on a limited scale. Nevertheless, marketing as a leading force in society is a relatively new phenomenon. It could not become something really important until humanity began to produce more than is necessary to meet immediate vital needs. This happened at different times in different parts of the world. It is for this reason that the level of understanding of the laws of marketing is not the same all over the world, although the rapid development of international trade is gradually smoothing out the differences.

Marketing is the process of planning and implementing activities related to the creation of a product, pricing, promotion to the market and distribution of goods, services and ideas through the exchange of consumers and organizations in order to satisfy needs. The concept of marketing implies that the main goal of the organization should be customer satisfaction, and not profit maximization. In other words, the organization must be customer-centric, seek to understand customer needs and meet them quickly and efficiently in a way that benefits both the customer and the organization itself. This means that any organization should strive to obtain both information about customer needs and information that will help determine how these needs can be met most effectively. However, one should not forget about the financial interests of the organization itself, since in a market economy this seems impossible.

Marketing research is a critical part of the system that provides such data. There are two schools of marketing research: on the one hand, supporters of the formalization of research and its results, i.e., the use of quantitative estimates, the use of statistical and econometric models, etc., and, on the other hand, supporters of informal analysis, qualitative assessments, graphical models . In specific marketing research, a high degree of formalization of the research process (the use of mathematical apparatus, statistical modeling methods, etc.) is often combined with a non-formalized, descriptive characteristic of the studied phenomena and processes, and qualitative assessments. Marketing research methodology allows you to successfully combine both of these areas. It should be emphasized that the following statistical methods are most widely used in the list of marketing analysis methods: absolute, average and relative values; time series and distribution series; groupings; index analysis; graphical method, trend models, methods of expert assessments. The choice of analysis methods is dictated by a number of factors: the nature of the processes and phenomena being studied, the degree of urgency of obtaining conclusions, the structure of information, the availability or limitation of information, the possibilities of using computer technology, etc.

Marketing research can improve the quality of management decisions by providing relevant, accurate and timely information. Each specific decision involves the presentation of a unique need for information. The information that can be obtained as a result of marketing research contributes to the development of adequate strategies. Marketing research is the process by which an organization communicates with consumers and the public through information that is used to identify marketing opportunities and problems; generating, adjusting and evaluating marketing activities; monitoring of marketing activities; improve understanding of marketing as a process. In the course of marketing research, they obtain the information necessary to solve existing problems, develop methods for collecting information, analyze it, and formulate recommendations that are communicated to interested parties. Marketing information is figures, facts, information, estimates and other data necessary for the analysis and forecasting of marketing activities. It should be up-to-date, reliable, focused, complete and relevant.

The collection of information about the market, goods and services, needs and their demand, competitors and prices is carried out in the audit process - this is the name of marketing research necessary for conducting a situational analysis of the external environment and the activities of the organization itself.

Currently, the global market is dominated by the concept of social - ethical marketing. This concept is quite consistent with the tasks of pharmaceutical marketing. The most complete definition of this type of marketing belongs to N.B. competitive environment. The main tasks of pharmaceutical marketing are the formation of a range of products and a permanent consumer audience, the organization of sales and promotion of goods, increasing consumer satisfaction.

As noted above, the activities of any organization are aimed both at meeting the needs of consumers and at making a profit. In this regard, it is necessary to stimulate demand, try to interest the consumer and encourage him to make a purchase. However, the demand for medicines (drugs) is quite specific, it has a number of differences compared to the demand for other goods.

Stimulation of demand for medicines through pharmaceutical marketing leads to market transparency, and attempts to manage demand by controlling the flow of information and limiting marketing make market mechanisms ineffective.

The free flow of information is vital to a market economy whose main goal is to satisfy the needs of consumers. In healthcare, patients, doctors, and insurance companies make their choice of goods and services based on their own goals and economic assessments. In order to make an informed choice, each of these players needs complete information about the availability, cost, and quality of competing products and services.

In an efficient market for health products, the balance of supply and demand is constantly changing under the influence of information that is distributed through the marketing mix. This is the classic role of marketing in the economic system. However, there is an opinion that by stimulating the demand for products and services, marketing contributes to the increase in health care costs, forcing the system to use drugs unnecessarily and in excessive amounts. However, drug value decisions are best made by consumers who know their personal needs and can make good value for money decisions when they have good and truthful information.

Of course, the system is not perfect, and sometimes drugs are misused, but their poor use due to low levels of patient adherence to treatment or because the doctor did not prescribe them is much more common and costs society much more. Compared to other treatments, medication is usually the cheapest way to get effective results, and underuse of medication leads to higher treatment costs rather than savings.

Information about medicines is needed to ensure market transparency, so it is important that marketing practices are organized properly and that the information is correct. Examples of bad marketing practices by pharmaceutical companies include misinformation, unsubstantiated allegations, or bribes (hidden or overt). Therefore, the quality of information should be controlled, but not its quantity.

It is especially important that any changes in the drug market are carefully thought out and do not violate the efficiency of the market, achieved by several decades of development. The biggest drawbacks of marketing in the health care system relate to the fairness of the distribution of goods and services, including medicines. Therefore, the task of politicians is to ensure the general availability of medicines without destroying the efficiency, economy and innovativeness of the existing system.

In addition to the main activity associated with the definition and satisfaction of consumer needs, marketing must perform an additional task - to prove to organizations that pay for treatment, the economic value of the product. Government, healthcare organizations, employers, and other health care buyers are scrutinizing the prices and value of all elements of therapy, including drugs.

In the 1980s, pharmaceutical companies began to respond positively to these new market needs. They began to consider technology assessments and proof of value as the new rules of the game. The largest companies began to provide cost-effectiveness analysis data, confident (and for good reason) that the market demand for this kind of information would increase.

Pharmaceutical companies have played a critical role in shaping, funding and improving the new field of knowledge called pharmacoeconomics. The first fruitful efforts in this area were made no later than 1977 by Smith, Kline & French, which demonstrated the radical economic benefits of using cimetidine as an alternative to gastric ulcer surgery. In 1981, Duncan Neuhauser, a professor of epidemiology and public health at Case Western Reserve University, reviewed the company's economic study, appreciated its high contribution and expressed support for such an analysis "in a wide range of medical interventions."

Pharmacoeconomics has continued to evolve, and the scientific literature is now replete with comparisons of alternative drug therapies with each other, with other treatments, and with estimates of a drug's value relative to its price.

These currents have become the driving force behind market processes. The number of published evaluations of various drugs in terms of pharmacoeconomics has recently grown rapidly. Research has covered areas such as quality of life assessment, treatment outcome measurement and decision analysis. Companies pay special attention to ensuring that pharmacoeconomic research is an informative and evidence-based component of a product's marketing strategy. The technologies they invented are now used as serious decision-making tools by various bodies and government officials.

Thus, it should be noted that as Russia enters civilized market relations, realizes the role of marketing as a tool to increase the efficiency of solving various problems of society, the role of marketing will increase and its tools will increasingly adapt to specific market conditions and the specifics of the activities of individual organizations. including pharmaceuticals.

2 Methods for studying the range of medical and pharmaceutical products

The modern pharmaceutical market in Russia is characterized by the steady growth of the product range. Over the past decade, there has been a significant expansion, replenishment and deepening of the range of all major groups of medical and pharmaceutical products. This trend is especially pronounced for medicines. If at the beginning of the 90s of the last century in the country 1.5-2 thousand names of medicines were allowed for use, then in 2011 this figure amounted to more than 20 thousand items, taking into account the forms of release.

There have been qualitative changes in the range associated with the introduction of new drug groups in terms of the mechanism of action or chemical structure and individual original drugs. However, to a greater extent, the increase in the product range is associated with the registration on the Russian pharmaceutical market of a large number of generic drugs - generics of foreign and domestic manufacturers. This significantly increased the possibility of choosing the necessary drugs, taking into account modern approaches to the pharmacotherapy of various pathological conditions, individual characteristics of the course of diseases, consumer preferences of end users.

For employees of healthcare services and institutions organizing drug supply to the population, the actual problem is the formation of a rational assortment policy that contributes both to meeting the needs and strengthening the market position of a pharmaceutical organization. For this purpose, a detailed marketing analysis of the range of drugs registered with the Ministry of Health of the Russian Federation and approved for drug circulation on the Russian pharmaceutical market is required. In this regard, we briefly touch on the main methods for studying the range of medical and pharmaceutical products.

The concept of marketing analysis of the range of drugs presented on the Russian pharmaceutical market, developed by employees of the Kursk State Medical University (N. B. Dremova, E. V. Reprintseva, O. V. Khorlyakova, T. A. Oleinikova), includes the stages of preparing a systematic list Drugs designed to meet the needs of target segments of the pharmaceutical market, and its analysis in a number of different positions, including the names of active ingredients, drugs, firms and manufacturing countries, composition, origin, dosage forms, novelty and other features. This concept has been repeatedly tested on the example of individual groups of drugs.

In addition, one of the main conditions for the formation of a rational assortment policy, which allows to increase the market capacity and improve the drug supply of the population, is the study of the competitiveness of drugs. Dremovoy N. B. et al. an algorithm for assessing the competitiveness of drugs for wholesale and retail pharmaceutical organizations is proposed. A phased study includes the selection of drugs for comparison, the study of the parameters of competitiveness, the calculation of their weighting coefficients, the calculation of the integral indicator of competitiveness, taking into account consumer and economic indices. The results of the study allow us to identify the most competitive drugs that can be recommended for inclusion in the assortment portfolio of a pharmaceutical organization.

ABC and XYZ analysis are also applicable to the formation of an assortment portfolio of purchases. ABC analysis is based on the Pareto law, or the 20/80 rule, which means getting 80% of sales from selling 20% ​​of the items. These products make up the most valuable group - A, which requires constant and scrupulous accounting and control, since its share in the assortment is 20 (15)%, and in sales - 75-80%. Group B - less important goods: their share in the assortment is 30 (20)%, and in sales - 15-20%. Group C - low-value goods for a pharmacy, since their share in sales is 5-10%, and in the assortment - 50 (75)%. Thus, using this method, it is possible to identify the most important assortment positions of drugs that must be included in the procurement portfolio for sale to the population.

At present, various modifications of the ABC-analysis method have been developed. An example is the two-factor ABC analysis according to the method of P. V. Grek, the essence of which is to reduce the two-factor analysis into a convenient visual form for one index, as well as to replace the Lorenz curve illustrating the Pareto rule with the “Commodity loop”, which shows the turnover of goods well .analysis is an assessment of the significance of the analyzed goods depending on the frequency of consumption or variation in implementation. It allows you to structure the assortment according to the factor of consumption stability and the possibility of predicting changes in demand. Group X includes goods with occasional minor fluctuations; for them, as a rule, the sales forecast has a high accuracy (50-55% of the total number of assortment items), so it is possible to create stocks. Group Y consists of periodic consumer goods with known trends; when forecasting, the sale of goods has an average forecast accuracy (about 30% of the total assortment). Group Z includes goods without an identified consumption pattern, therefore it is difficult or impossible to develop a forecast for their consumption at all (approximately 15-20% of the total assortment), therefore these goods are purchased as the need arises.

Analysis of the range of drugs can also be carried out for medical prescriptions. In this case, the analysis is carried out according to the following sources of information: prescriptions, outpatient cards, case histories. The sample can be continuous for a certain period of time (10 days, month, quarter, year) or special (for individual medical specialists, for certain types of morbidity, etc.). The processing of the information received can be carried out using computer technology, for which the statistical characteristics of the sample, the coefficients of the intensity of prescriptions (consumption), as well as the completeness (degree) of using the range of drugs by pharmacotherapeutic groups are calculated.

Quite effective are the sociological methods of researching the assortment, which make it possible to obtain operational information based on public opinion in a short time. In this case, such methods of obtaining information as a questionnaire survey and interviews can be used. These methods are used to study the demographic and social structure consumers, the impact of their individual requests on the overall picture of demand. There is a mathematical algorithm that allows you to calculate the actual demand for individual products and use them to manage the formation of the range.

In addition, sociological methods of researching the assortment use such a technique as expert assessments - obtaining and studying the opinions of specialists in a particular industry related to the drug market. Methods for questioning experts include: interviewing, correspondence questioning, mixed questioning and business games (a method in which questions are not asked to an expert, but his reactions to a change in the situation are recorded). To obtain expert assessments that most accurately reflect the essence of the analyzed phenomenon, it is necessary to involve highly competent specialists in this field in the examination. It should also be remembered that the accuracy of assessments depends not only on the competence of experts, but also on their interest in the results, on a conscientious attitude to the work of both experts and organizers.

There is a method for studying the range of drugs, called graduation. This method is a qualitative assessment of the trade nomenclature of a particular institution using attributive and alternative characteristics such as: drugs of “favorable” and “unfavorable” market conditions, “risk” groups, etc. It can be carried out based on the results of statistical processing of questionnaires for expert evaluation of the therapeutic efficacy of drugs. The calculated weighted average drug scores are grouped and rounded off within the conditional score limits. Based on the results of the grouping of weighted average estimates, it is possible to calibrate the studied assortment of drugs. At the same time, the following groups of drugs are distinguished: having a “favorable” market situation - these are highly effective drugs that enjoy “authority” among experts, pharmacies are recommended to increase the volume of purchases of these drugs; Drugs of the “risk” group are drugs that have certain disadvantages, their sales tend to stabilize or reduce demand, which requires informed decisions on their purchases; Drugs with “unfavorable” market conditions are a group of drugs that are not in demand or have serious side effects, the decision to purchase such drugs should be negative; unvalued drugs are drugs with which this group of experts is not familiar, in most cases this group includes new drugs that have appeared on the pharmaceutical market in Russia in the last 3-5 years and which have not yet been in this market segment.

As can be seen from the above, a comprehensive study of the range of drugs of a certain group makes it possible to obtain a qualitative and quantitative assessment of the range of drugs that satisfy a certain need, taking into account their classification, technological and production characteristics.

The results of the analysis are necessary for the subsequent study of the availability and use of the relevant groups of drugs in regional and local pharmaceutical markets. On their basis, recommendations are developed on the formation of the optimal range of drugs in pharmaceutical organizations.

Chapter 2. MARKETING ANALYSIS OF THE RANGE OF DRUGS BASED ON OXACILLIN

1 Commodity characteristics of medicines based on oxacillin

1.1 Description of pharmaceutical properties

Oxacillin is a bactericidal antibiotic from the group of semi-synthetic penicillins, resistant to the action of penicillinase. Blocks the synthesis of the bacterial cell wall by disrupting the later stages of peptidoglycan synthesis (prevents the formation of peptide bonds due to inhibition of transpeptidase), causes lysis of dividing bacterial cells.

Active against gram-positive microorganisms: Staphylococcus spp. (including producing penicillinase), Streptococcus spp., incl. Streptococcus pneumoniae, Corynebacterium diphtheriae, Bacillus anthracis, anaerobic spore-forming rods, gram-negative cocci (Neisseria gonorrhoeae, Neisseria meningitidis), Actinomyces spp., Treponema spp.

Inactive against most gram-negative bacteria, rickettsiae, viruses, protozoa, fungi. Resilience develops slowly.

Pharmacokinetics:

Absorption is fast and complete. Stable in slightly acidic environment. Communication with plasma proteins - about 90%. Т1/2 - 30 min. The time to reach Cmax after i / m administration is 1-2 hours, the concentration decreases rapidly by 4 hours. With parenteral administration, higher concentrations are achieved in the blood than when taken orally. In the pleural fluid, it is found in concentrations reaching 10%, in synovial and ascitic fluid - 50%, in bile - 5-8% in relation to its concentration in blood serum. It does not penetrate through the intact BBB, with inflammation of the meninges, penetration increases. Penetrates through the placental barrier, found in breast milk. More than 40% after i / m administration is rapidly excreted by the kidneys, with bile - 10%.

Indications for use:

Infectious diseases caused by gram-positive microorganisms that produce and do not produce penicillinase:

Abscess;

Phlegmon;

Cholecystitis;

Osteomyelitis;

Postoperative, wound infections, infected burns;

Bacterial endocarditis;

Meningitis;

Sinusitis.

Dosing regimen:

Adults and children over 6 years old - 2-4 g /

Children under the age of 3 months - 60-80 mg / kg /, from 3 months to 2 years - 1 g / day, from 2 to 6 years old - 2 g / day

Newborns and premature babies - 20-40 mg / kg /

Side effect:

Allergic reactions: skin itching, urticaria, less often - angioedema, bronchospasm, in rare cases, anaphylactic shock, eosinophilia.

From the digestive system: dyspepsia (nausea, vomiting, diarrhea); pseudomembranous enterocolitis, oral candidiasis; hepatotoxic effect - more often develops when administered at a dose above 6 g / day (hyperthermia, nausea, vomiting, icterus of the sclera or skin, increased activity of hepatic transaminases).

From the genitourinary system: hematuria, proteinuria, interstitial nephritis, vaginal candidiasis.

Contraindications:

Hypersensitivity, incl. to other beta-lactam antibiotics.

With caution: a history of allergic reactions and / or bronchial asthma, chronic renal failure (CRF), enterocolitis against the background of the use of antibiotics (history).

With caution: chronic renal failure.

Special instructions:

It is not advisable to use for infections caused by microorganisms sensitive to benzylpenicillin.

Drug interaction:

Increases the toxicity of methotrexate (competition for tubular secretion).

It may be necessary to increase the dose of calcium folinate (the antidote of folic acid antagonists) and longer its use.

The combination of ampicillin or benzylpenicillin with oxacillin is rational, since the latter, by inhibiting the activity of penicillinase, thereby reduces the destruction of ampicillin and benzylpenicillin. The spectrum of action with this combination becomes wider.

It is necessary to avoid joint use with other drugs that have a hepatotoxic effect.

Drugs that block tubular secretion increase the concentration of oxacillin in the blood.

Antacids and laxatives reduce the absorption of the drug from the gastrointestinal tract.

Conditions for dispensing from pharmacies:

The drug is dispensed by prescription.

Terms and conditions of storage:

List B. Keep out of the reach of children, in a dry place at a temperature not exceeding 25°C. Shelf life - 2 years.

2.1.2 Classification groups

Anatomical-Therapeutic-Chemical Classification (ATC) is an international classification that takes into account the pharmacological group of the drug, its chemical nature and the nosology of the disease for which the drug is intended. - Antimicrobials for systemic use - Antimicrobials for systemic use - PenicillinsCF - Beta-lactamase resistant penicillins

J01CF04- Oxacillin<#"justify">2.1.3 Release forms

fl. oxacillin (in the form of sodium salt) 1 g.

Powder for solution for intravenous and intramuscular administration of white or almost white, hygroscopic.

Powder for solution for intravenous and intramuscular administration of white or almost white, hygroscopic.

fl. oxacillin (in the form of sodium salt) 250 mg.

Powder for solution for intramuscular injection of white or almost white color, hygroscopic.

fl. oxacillin (in the form of sodium salt) 500 mg.

Tablets 500 mg; 250 mg;.

2.2 Marketing research of drugs based on oxacillin in the Russian and regional pharmaceutical market

2.2.1. Subjects and methods of research

In the course of conducting a marketing analysis of the range of drugs based on oxacillin, a concept was used, the idea of ​​which is a phased analysis of the range according to specific characteristics: the country of manufacture, dosage forms, registration in the Russian Federation, and also by composition.

Monitoring of the market situation was carried out on the basis of a content analysis of official sources of information about drugs: the State Register of Medicines (2013), the Russian Register of Drugs (2006-2010), the Vidal reference book (2011), the reference book of drug synonyms ( 2011, 2013), as well as on the basis of 11 pharmacies in the city of Kursk - Pharmacy No. 6 of Kursk Pharmacy OJSC (Pavlunovskogo St., 5), Pharmacy No. 122 of Kursk Pharmacy OJSC (K. Marksa St., 65 a) , Pharmacy No. 3 OJSC Kursk Pharmacy (79, Internatsionalnaya St.), Avicenna Pharmacy LLC (47, Zapolnaya St.), Alla LLC (41, Zapolnaya St.), Alla, Ltd. (Studencheskaya st., 1), Farmakor (Radishcheva st., 80), IP Kholyavin M.M. (Dimitrova st., 37-b), Be healthy (Lenin st., 30), Healer (Radishcheva st., 87/7), IP Kustavinov A.N. (Ave. Khrushchev, 12).

2.2.2 Research process

Analysis period: March - April 2014.

At the initial stage, the range of drugs based on oxacillin, registered in the territory of the Russian Federation at the beginning of 2014, was studied on the basis of official literature sources. The analysis included preparations of all dosage forms. In total, during the content analysis, 18 TN and 26 MD were selected, the results of systematization of which are presented in tables in absolute terms (number) and relative values ​​(percentage of subgroups).

The structure of the assortment of the studied group of drugs, established in the course of marketing analysis, is presented in Appendix 1.

2.3 Marketing research of oxacillin-based drugs in the Russian pharmaceutical market

In the structure of the assortment on the basis of the country of manufacture, the share of domestic drugs prevails - 88.5% (23 drugs), foreign manufacturers occupy 11.5% (3 drugs) (Table 1, Fig. 2).

Thus, the main country producing INN Oxacillin is Russia (88.5%). An analysis of the assortment in the structure of foreign manufacturing countries showed that in total, proposals from 2 countries were registered in the Ministry of Health of the Russian Federation. Among them, India is the leader in terms of the number of drugs - 2 drugs (7.7%), the Republic of Belarus is in second place - 1 drug (3.8%).

Table 1

Producer countryK - in proposals (drugs)Share, %CompanyNumberShare,%Russia2388.5%Biosintez OJSC27.7Biochemist OJSC27.7Sintez OJSC1038.5Shchelkovsky Vitamin Plant OJSC13.8Bryntsalov-A CJSC519.3Kraspharma OJSC27.7Akrikhin KhFK OJSC13.8Republic of Belarus13 .8% Borisov Plant of Medical Preparations RUP13.8India27.7%Ranbaxy Laboratories Limited27.7Total: 26100%26100.0

Fig.2 Producing countries of drugs based on oxacillin (%)

Among the manufacturing plants, Sintez OJSC (Russia, Kurgan) produces the largest number of drugs - 38.5% (10 drugs), CJSC Bryntsalov-A (Russia, Moscow) is in second place - 19.3% (5 drugs) . The third place is shared by JSC Biosintez (Russia, Penza), JSC Biochemist (Russia, Saransk), JSC Kraspharma (Russia, Moscow) and Ranbaxy Laboratories Limited (India). Slightly more than 10% of the market of oxacillin preparations is divided among themselves by 3 manufacturing plants JSC Schelkovo Vitamin Plant (Russia, Shchelkovo), JSC Akrikhin KhPK (Russia, Moscow region) and RUE Borisov Plant of Medical Preparations (Republic of Belarus) (Fig. 3) .

Fig.3. Manufacturers of drugs based on oxacillin (%)

An analysis of drug registration numbers showed that the Russian pharmaceutical market was actively updated only in the first years of the 21st century.

table 2

Dynamics of registration of oxacillin preparations in the Russian pharmaceutical market

№ p/p Year of registration Registered LPTotalShare, %1200427.72200513.83200627.742007415.4520081350.06201027.77201127.7Total: 26100.0

Based on the data obtained, it can be concluded that half of the drugs in the Russian Federation were registered in 2008 - 50.0% (13 drugs). In 2007, 15.4% (4 drugs) were registered on the Russian pharmaceutical market, in 2004, 2006, 2010 and 2011 - 7.7% each (2 drugs each). The smallest number of drugs based on oxacillin was registered in 2005 - 3.8% (1 drug) (Table 2, Fig. 4).

Calculation of the assortment renewal index for the last 5 years.

The assortment renewal index is calculated by the formula:

n - the number of offers on the market registered during the last 5 years (2007-2011); - the total number of offers on the market (see table 1 of Appendix 1).

Y=21:26=0.81=0.81

Based on the calculations, we can conclude that the assortment renewal index over the past 5 years is quite high, it is 0.81.

Rice. 4. The structure of the range of drugs based on oxacillin by the date of registration (%)

The analysis revealed that the range of medicines consists of solid dosage forms (powders, tablets and capsules). The dominant position is occupied by powders - 72.1% (19 drugs), among them in approximately equal amounts, powders for preparing a solution for intravenous and intramuscular injection - 38.5% (10 drugs) and powder for preparing a solution for intramuscular injection - 34, 6% (9 drugs) (Table 3, Fig. 5). This is due to the fact that they are indispensable in emergency situations, when a disease (sepsis, abscess, postoperative, wound infections, infected burns, bacterial endocarditis) can threaten a person's life. They are followed by capsules - 19.2% (5 drugs), and the smallest share is occupied by drugs in the form of tablets - 7.7% (2 drugs). In the case of outpatient treatment (cholecystitis, cystitis, meningitis, sinusitis, etc.), the presence of solid dosage forms facilitates both the prescription of therapy and patient compliance with the drug regimen, they are more familiar to patients. Also, it enables them to be independent from the medical staff. Thus, the presence of solid dosage forms in the range of drugs based on oxacillin is also justified.

Table 3

Type of dosage formNumber of offers Share, %powder for solution for intravenous and intramuscular injection1038.5powder for solution for intramuscular injection934.6tablets27.7capsules519.2Total:26100.0

Rice. 5. The structure of the range of oxacillin preparations by types of dosage forms (%)

Based on the data entered in Table 4, it can be concluded that the range of Oxacillin INNs is represented by both combined - 61.5% (16 drugs) and mono-drugs - 38.5% (10 drugs) (Fig. 6).

Table 4

Number of offersCompositionSingle preparationsCombined Quantity Share, % Quantity Share, % 261038.51661.5Total: 1038.51661.5

Rice. 6. The structure of the range of oxacillin preparations by composition (%)

Marketing analysis showed that the domestic pharmaceutical market has a target segment of drugs based on the drug substance oxacillin, which allows doctors, together with pharmacists and patients, to select drug therapy individually for each patient, depending on the diagnosis. Based on the results of the analysis, an assortment contour was developed for the target segment of the Russian pharmaceutical market - drugs based on oxacillin (macrocontour), which is shown in Figure 7.

Rice. 7. Macrocontour of the range of the target segment of the pharmaceutical market of oxacillin preparations (%)

The macro-outline of the assortment has the following characteristics:

produced mainly in Russia - 88.5%;

most of the preparations based on oxacillin are produced by Sintez OJSC in the city of Kurgan - 38.5%;

by composition - these are mainly combined drugs - 61.5%

assortment;

on the territory of the Russian Federation, most drugs were registered in 2008 - 50.0%;

produced in the form of solid dosage forms - 100.0%, among which powders for intravenous and intramuscular administration predominate - 38.5%;

the degree of renewal of the assortment for 2007-2011. is 80.77%

This macro-contour of the target market segment will subsequently be used for a comparative analysis of the assortment of the local market in Kursk (meso-contour).

2.3 Market analysis of medicines based on oxacillin on the example of pharmacies in Kursk

At the next stage, a study was made of the actual range of drugs based on oxacillin in the local pharmaceutical markets of Russia: in 11 pharmacies in the city of Kursk: as a result, it was found that 13 TN and 19 LP are represented on the local market.

The structure of the range of drugs based on oxacillin by production characteristics

According to Table 5, in the structure of the assortment of the local market in Kursk, on the basis of production, Russian drugs prevail - 94.7% (18 drugs), the rest - 5.3% (1 drug) are imported drugs.

Of the 2 manufacturing countries, the drugs of which are registered with the Ministry of Health of the Russian Federation, on the local market of Kursk there are drugs from 1 country - the Republic of Belarus - 5.3% (1 drug). Oxacillin drugs manufactured in India are not represented on the regional pharmaceutical market (Table 5 and Fig. 8).

Table 5

Analysis of the range of drugs based on INN Oxacillin by country of origin and firms:

Producer countryK - in offers (drugs) Share, % FirmNumber - share, % Russia 1894.7% Biosintez JSC 210.5 Biochemist JSC 15.3 Synthesis JSC 736.8 Shchelkovsky vitamin plant JSC 15.3 Bryntsalov-A JSC 526.3 Kraspharma JSC 210.5 Republic of Belarus 15.3% Borisovsky plant of medical preparations RUP15.3Total: 19100% 19100.0

Rice. 8 Oxacillin-based preparation countries (%)

Among the manufacturing plants, Sintez OJSC (Russia, Kurgan) retained its leading position - 36.8% (7 drugs), followed by Bryntsalov-A CJSC (Russia, Moscow), whose share increased slightly - 26.3% (5 drugs). The third place is shared by JSC Biosintez (Russia, Penza) and JSC Kraspharma (Russia, Moscow) - 10.5% (2 drugs each). The smallest number of drugs on the Kursk market is represented by 3 manufacturing plants: JSC Biokhimik (Russia, Saransk), JSC Schelkovo Vitamin Plant (Russia, Schelkovo) and RUE Borisov Plant of Medical Preparations (Republic of Belarus) - 5.3 each % (for 1 preparation). Preparations based on oxacillin manufactured by Akrikhin KhFK OAO and Ranbaxy Laboratories Limited are not available on the regional market (Fig. 9).

Rice. 9. Manufacturers of drugs based on oxacillin (%)

Updating the range of drugs based on oxacillin

The analysis of drug registration numbers showed that drugs registered in recent years are represented on the pharmaceutical market of Kursk to a small extent (Table 6, Fig. 10).

Most drugs available on the pharmaceutical market in Kursk were registered in 2008 - 47.3% (9 drugs), significantly less than in 2007 - 21.1% (4 drugs). 10.5% (2 drugs each) are drugs produced in 2006 and 2010. The share of drugs registered in 2004 and 2005 is small - 5.3% each (1 drug each). It has been established that there are no “new” drugs based on oxacillin registered in 2011 on the pharmaceutical market in Kursk.

Assortment renewal index of the analyzed drug group for

the last five years was 0.79 (Iо = 15/19), which roughly corresponds to the Russian market.

Table 6

Dynamics of registration of oxacillin preparations in the pharmaceutical market of Kursk

№ p/p Year of registration Registered LPTotal Share, % 1200415.32200515.332006210.542007421.152008947.362010210.5

Rice. 10. The structure of the range of drugs based on oxacillin by the date of registration (%)

Characteristics of the range of drugs based on oxacillin by types of dosage forms

An analysis of the local market in Kursk showed that the range of drugs based on oxacillin does not include all types of dosage forms registered outside the territory of the Russian Federation. The leading place is still occupied by drugs produced in the form of powders - 84.2%, however, their ratio has changed. Powders for the preparation of a solution for intravenous and intramuscular administration and powders for the preparation of a solution for intramuscular administration have equal shares - 42.1% each (8 preparations each). Capsules make up the remaining 15.8% (3 preparations) (Table 7, Fig. 11). Such a dosage form as tablets is not represented on the pharmaceutical market of the city of Kursk.

Table 7

Analysis of the range of drugs based on INN Oxacillin by types of dosage forms

Type of dosage formNumber of offers Share, %powder for solution for intravenous and intramuscular injection842.1powder for solution for intramuscular injection842.1tablets-capsules315.8Total:19100.0

Rice. 11. The structure of the range of oxacillin preparations by types of dosage forms (%)

Characteristics of the range of medicines based on oxacillin by composition

Based on the data in Table 8, we can conclude that the range of Oxacillin INNs is represented by combined - 57.9% (11 drugs) and mono-drugs - 42.1% (8 drugs) (Table 8, Figure 12).

Table 8

Analysis of the range of drugs based on oxacillin by composition

Number of offersCompositionSingle preparationsCombined Quantity Share, % Quantity Share, %19842.11157.9Total:842.11157.9

Rice. 12. The structure of the range of oxacillin preparations by composition (%)

Thus, the marketing analysis showed that the target segment of oxacillin preparations is present in the domestic pharmaceutical market of Kursk. Based on the results of this analysis, an assortment contour was developed for the target segment of the pharmaceutical market in Kursk - drugs based on oxacillin (mesocontour), which is shown in Figure 13.

Rice. 13. Mesocontour of the assortment of the target segment of the pharmaceutical market of oxacillin preparations (%)

The assortment mesocontour has the following characteristics:

produced mainly in Russia - 94.7%;

most of the drugs based on oxacillin are produced by Sintez OJSC in the city of Kurgan - 36.8%;

by composition - these are mainly combined drugs - 57.9%

assortment;

on the territory of the Russian Federation, the majority of drugs were registered in 2008 - 47.3%;

produced in the form of solid dosage forms - 100.0%, among which equal proportions have powders for intravenous and intramuscular injection and powders for intramuscular administration - 42.1% each;

the degree of renewal of the assortment for 2007-2011. is 78.95%

2.4 Comparative characteristics of the Russian pharmaceutical market and the local market of the city of Kursk

A study was made of the actual range of drugs based on oxacillin in the local market of Kursk. In the course of the analysis, the level of availability of drugs from individual countries and manufacturers was established (Table 9). The analysis of the mesocontour of the assortment in the local market by groups of manufacturers showed. In pharmacies, drugs of domestic production are most represented - 94.7%, which confirms the presence of the prevailing part of these drugs in the general assortment on the Russian pharmaceutical market.

Imported drugs are not widely represented - 5.3%. It should be noted that there is no offer of such a country India in the regional market. The drug of the Republic of Belarus is presented in full on the regional market. Domestic medicines are represented quite widely - 78.3% (Table 9).

Table 9

The structure of the range of oxacillin preparations by country of origin (comparative analysis)

Country-manufacturerNumber of LPDsMarket share in Kursk,%Company-manufacturerNumber of LPDsMarket share in Kursk,% RFKurskRFKurskRussia231878.3Biosintez OJSC22100.0Biochemist OJSC2150.0Synthesis OJSC10770.0Shchelkovsky Vitamin Plant OJSC11100.0Bryntsalov-A ZAO55100.0Kraspharma, OJSC2210 0Akrikhin HFC JSC1--Republic of Belarus11100.0Borisov Plant of Medical Preparations RUE11100.0India2--Ranbaxi Laboratories Limited2--Total:261973.1261973.1

As noted earlier, the analysis of drug registration numbers showed that the pharmaceutical market in Kursk is largely represented by not the most modern drugs based on oxacillin. In full measure, the pharmaceutical market of our city contains drugs registered in 2005-2007 and 2010 - 100.0% each. The years 2004 and 2008 are significantly less represented - 50.0% and 69.2%, respectively. It should be noted that there are no “new” drugs of 2011 (Table 10).

Table 10

Dynamics of registration of hypertensive drugs in the Russian pharmaceutical market (comparative analysis)

№ p / p Year of registration LPD Market share in Kursk, % RFKursk120042150.02200511100.0320062 2100.04200744100.05200813969.26201022100.0720112--Total: 261973.1

When analyzing the types of dosage forms, it was found that the powder for preparing a solution for intramuscular injection (88.9%) is most fully represented, the powder for preparing a solution for intravenous and intramuscular administration is slightly inferior (80.0%). Capsules account for 60.0%. There is no such dosage form as tablets at all (Table 11).

Table 11

The structure of the range of drugs oxacillin by types of dosage forms (comparative analysis)

Type of dosage form LPD Market share in Kursk,% RFKursk powder for solution for intravenous and intramuscular injection 10880.0 powder for solution for intramuscular injection 9888.9 tablets 2-capsules 5360.0 Total: 261973.1

Table 12

Analysis of the range of drugs based on oxacillin by composition

Composition LPD Market share in the city of Kursk, % RFKursk Monopreparations 10880.0 Combination preparations 161168.8 Total: 261973.1

A detailed analysis of the local market in Kursk also revealed that single-component drugs are the most represented in pharmacies - 80.0%. Combined drugs, despite their greater number relative to single drugs, are presented in a smaller percentage - 68.8% (Table 12). In addition, indicators such as the range depth coefficient and the degree of assortment renewal were calculated: Range depth coefficient (KG):

KG \u003d Gbaz / Gfact, where

Gbaz - the number of drugs allowed for use available in the city of Kursk

Gfakt - the number of drugs registered in the Russian Federation

CG = 19 / 26 = 0.73

2) Degree of renewal (Yo):

Uo \u003d m / Ao, where

M - the number of new drugs approved for use in the last 5 years in Kursk

Ao - the total number of drug names approved for use in the Russian market over the past 5 years

Analyzing the data on the assortment depth indicator, it should be noted that the obtained value is insufficient - almost a quarter of the drugs registered in the Russian Federation are not represented. As for the "novelty" of the drug, the picture is similar, drugs registered in 2011 are not represented in the city at all.

Analyzing these indicators, it can be noted that the pharmaceutical market in Kursk does not have the full variety and number of dosage forms for drugs based on oxacillin - the most common LF - tablets, as well as the latest drugs are missing.

CONCLUSION

In this course work, the following studies were carried out:

1. The theoretical foundations of marketing research have been studied, from which it can be seen that they play an important role in pharmaceutical activities.

2. We also found out that today the main and most effective methods for analyzing the range of medicines are: ABC analysis, XYZ analysis and combined ABC / XYZ analysis.

3. Oxacillin is a bactericidal antibiotic from the group of semi-synthetic penicillins, resistant to the action of penicillinase. Active against gram-positive microorganisms. It is used for infectious diseases.

4. The analysis of the assortment of the medicinal product based on the INN oxacillin was carried out, the tables show that the pharmaceutical market is represented by 18 trade names (Table 1), of which 16 items (88.89%) are domestically produced and only 2 trade names (11 .11%) of imported production (Table 4)

The assortment of the medicinal product was analyzed by composition and it was determined that 6 items (33.33%) are mono drugs and 12 items (66.67%) are combined drugs (Table 2).

Further, it was determined that on the pharmaceutical market, INN oxacillin is produced in the form of powders for preparing a solution for intravenous and intramuscular injection, these are 6 trade names (33.33%), powder for preparing a solution for intramuscular injection is also 6 items (33.33%) , in the form of tablets 1 trade name (5.56%) and in the form of capsules - 5 trade names (27.78%). The results are presented in table 3.

At the final stage, we calculated the index of renewal of the assortment of the drug for the last 5 years, it was 0.67, which is a rather low indicator.

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Annex 1

The range of medicines offered on the market based on INN Oxacillin:

№ п/п Торговое наименование ДозировкаСоставЛекарственная формаСтранаФирмаРегистрационный номерНали-чие в аптеках г.КурскаМоно препаратКомбинированный 1Оксациллин500 мгОксациллина натрия моногидрат______порошок для приготовления раствора для внутривенного и внутримышечного введенияРоссияБиосинтез ОАО Р N000394/01 29.12.2006+250 мг2Оксамсар375 мг+125 мг_____Ампициллина натриевая соль, оксациллина натриевая сольпорошок для приготовления раствора для внутримышечного введенияРоссияБиохимик ОАО Р N002766/01 29.08.2008-3Ранклав250 мг + 125 мг_____Амоксициллин, Клавулановая кислотатаблетки покрытые оболочкойИндияРанбакси Лабораториз ЛимитедП N013099/01 27.07.2011-500 мг + 125 мг4Оксамп-натрий667 мг+333 мг_____Ампициллин натрия, оксациллин натрияпорошок для preparation of a solution for intravenous and intramuscular injectionRussiaSintez OAOLSR-004808/10 27.05.2010+5Oxamp-sodium333.5mg+166.5mg 133.4mg+66.6mg_____Ampicillin sodium, oxacillin sodiumpowder for solution preparation for intravenous and intramuscular injectionRussiaSynthesis OAOOR N002576/01 208+5.2 6Оксациллин500 мгОксациллина натриевая соль______порошок для приготовления раствора для внутримышечного введенияРоссияБиохимик ОАОР N002184/01-2003 25.12.2008 +7Ампициллин, Оксациллин-Боримед125 мг+125 мг_____Ампициллина тригидрат, оксациллин натриякапсулыРеспублика БеларусьБорисовский завод медицинских препаратов РУПП N010963 23.09.2005+8Оксамп125 мг+125 мг_____Ампициллина тригидрат, оксациллин натриякапсулыРоссияСинтез ОАОР N002258/01 22.10.2008-9Оксациллин500 мгОксациллина натриевая соль______порошок для приготовления раствора для внутривенного и внутримышечного введенияРоссияСинтез ОАОР N000067/03 18.09.2008-250 мг10Оксампицин125 мг+125 мг_____Ампициллина тригидрат, оксациллин натриякапсулыРоссияЩелковский витаминный завод ОАОР N003524/01 17.06.2004+ 11 Ampiox 0.125 mg + 0.125 mg _____ Ampicillin trihydrate, sodium oxacillin capsules Russia Bryntsalov-A ZAOR N003911/01 02/16/2010 + 12 Ampiox-sodium 333.5 mg + 166.5 mg _____ Ampicillin sodium, oxacillin sodium powder for solution for intravenous and intramuscular administration 1 ZAO Russia N0.013 R30.005 Bryntsalov 2008+133.4 mg+66.6 mg13 Ampiox-sodium333.5 mg+166.5 mg_____ Ampicillin sodium, oxacillin sodium powder for solution for intramuscular administration Russia Bryntsalov-A ZOR N000315/02 13.10.2008+133.4 mg+66.6 mg shock N000238/01 13. 08.2007+250 мг15Оксамп-натрий667 мг+333 мг_____Ампициллин натрия, оксациллин натрияпорошок для приготовления раствора для внутримышечного введенияРоссияСинтез ОАОЛСР-006432/08 11.08.2008+16Ампициллин+Оксациллин125 мг+125 мг_____Ампициллина тригидрат, оксациллин натриякапсулыРоссияАкрихин ХФК ОАОР N003733/01 10.11.2004-17Оксациллин500 mg 250 mg Oxacillin sodium salt ______ powder for solution for intramuscular injection Russia Sintez OAO R N000067/01 11/09/2007+18 Oxacillin 1000 m g Oxacillin sodium salt ______ powder for solution preparation for intravenous and intramuscular administration

Tags: Marketing analysis of the range of medicines based on oxacillin Diploma Marketing

MINISTRY OF EDUCATION

STATE BUDGET EDUCATIONAL INSTITUTION OF HIGHER PROFESSIONAL EDUCATION "SIBERIAN

STATE MEDICAL UNIVERSITY" OF THE MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION

Analysis of complex dosage forms

Part 1. Dosage forms of pharmaceutical production

Tutorial

For self-training and a guide to laboratory classes in pharmaceutical chemistry for students of pharmaceutical faculties of universities of full-time and part-time education

UDC 615.07 (071) BBK R 282 E 732

E.V. Ermilova, V.V. Dudko, T.V. Kadyrov Analysis of complex dosage forms Part 1. Pharmaceutical production dosage forms: Uch. allowance. - Tomsk: Ed. 20012 . – 169 p.

The manual contains methods for the analysis of dosage forms of pharmaceutical production. It discusses the terminology, classification of dosage forms, provides regulatory documents that control the quality of medicines in pharmacy production, indicates the features of intra-pharmacy express analysis; the main stages of the analysis of dosage forms are described in detail, while special attention is paid to chemical control.

The main part of the manual is devoted to the presentation of material on the analysis of dosage forms: liquid (mixtures, sterile) and solid (powders), numerous examples are given.

The appendix contains extracts from orders, refractometric tables, information on indicators, forms of reporting journals.

For students of pharmaceutical faculties of higher educational institutions.

Tab. 21. Fig. 27. Bibliography: 18 titles.

Preface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

I. INTRODUCTION TO DOSAGE ANALYSIS

1.1. Terms used in pharmacy. . . . . . . . . . . . . . . . ………. 5 1.1.1. Terms characterizing medicines.. ….5 1.1.2. Terms characterizing dosage forms. . . ….5 1.2. Classification of dosage forms. . . . . . . . . . . . . . . . . . . . . . 7

1.3. Normative documents and requirements for the quality of medicines of pharmaceutical production. . . . . . . . . . . . . …...7 1.4. Peculiarities of express-analysis of medicinal products of pharmaceutical production. . . . . . . . . . . . . . . . . . . . . . . . . . ……………8

1.4.1. Features of determining the authenticity of the express method. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ………..9

1.4.2. Features of quantitative express analysis. . . . . . . . …9

2.1. Organoleptic and physical control. . . . . . . . . . . . . . . . . . 10 2.1.1. Organoleptic control. . . . . . . . . . . . . . . . . . . . . . . . . . .10 2.1.2. Physical control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 2.2. Chemical control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 2.2.1. Tests for authenticity. . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 2.2.2.. Quantitative analysis. . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . 14

2.2.2.1. Ways of expressing concentrations. . . . . . . . . . . . . . . . .15 2.2.2.2. Methods of titrimetric analysis. . . . . . . . . . . . . . . 16 2.2.2.3. Calculation of the mass (volume) of the dosage form and the volume of the titrant for analysis. . . . . . . . . . . . . . . . . . . . . 17

2.2.2.4. Processing of measurement results. . . . . . . . . . . . . . . . . .19 2.2.2.5. Formulation of analysis results. . . . . . . . . . . . . . . . . . 32

III. ANALYSIS OF DOSAGE FORMS

Liquid dosage forms. . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

3.1. Mixture analysis. . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . .33 3.2. Analysis of sterile dosage forms. . . . . . . . . . . . . . . . . . . . .59

Solid dosage forms

3.3. Powders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89

Questions of self-training control. . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Test control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125

Test control responses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .130

APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131

Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .168

Foreword

The basis for writing the textbook was the program in pharmaceutical chemistry for students of pharmaceutical universities (faculties)

M.: GOU VUNMTS, 2003

One of constituent parts Pharmaceutical analysis is the analysis of medicines of pharmacy and factory production, carried out by the methods of pharmacopoeial analysis, according to the requirements of various guidelines,

manuals, instructions, etc.

The manual is devoted to the methods of research of dosage forms

(potions, sterile, powders) manufactured in a pharmacy, where all types of intra-pharmacy control are used, but the most effective is chemical control, which makes it possible to check the compliance of the manufactured dosage form with the prescription, both in terms of authenticity and quantitative content. Authenticity and quantitation methods are presented in such a way as to use the best methods of analysis, and the minimum amount of drug was spent on the analysis.

The main part contains numerous examples of the use of refractometry in the quantitative analysis of drugs, since this method is widely used in pharmacy practice.

The proposed textbook contributes to the development of students' chemical analytical thinking.

I. INTRODUCTION TO DOSAGE ANALYSIS

1.1. Terms used in pharmacy

1.1.1. Terms characterizing medicines

Medicines - substances used for prevention

diagnosis, treatment of disease, prevention of pregnancy, derived from

biological technologies.

medicinal substance- a medicinal product, which is an individual chemical compound or biological substance.

medicinal product- a medicinal product in the form of a specific

dosage form.

Dosage form- a condition that is convenient for use in which the desired therapeutic effect is achieved is attached to a medicinal product or medicinal plant material.

1.1.2. Terms characterizing dosage forms

Powders are a solid dosage form for internal and external use, consisting of one or more crushed substances and having the property of flowability.

Tablets - a dosage form obtained by pressing drugs or a mixture of drugs and excipients, intended for internal, external, sublingual,

implantation or parenteral use.

Capsules - a dosage form consisting of a drug enclosed in a shell.

Ointments are a soft dosage form intended for application to the skin, wounds or mucous membranes and consisting of a medicinal substance and a base.

Pastes - ointments with a content of powdery substances over 20-25%.

Suppositories are a dosage form that is solid at room temperature and melts at body temperature.

Solutions liquid dosage form obtained by dissolving one or more medicinal substances intended for injection, internal or external use.

Drops liquid dosage form intended for internal or external use, dosed in drops.

Suspensions are a liquid dosage form containing, as a dispersed phase, one or more powdered medicinal substances distributed in a liquid dispersion medium.

Emulsions uniform in appearance dosage form,

consisting of mutually insoluble finely dispersed liquids,

intended for internal, external or parenteral use.

Extracts - concentrated extracts from medicinal plant materials. There are liquid extracts (Extracta fluida); thick extracts (Extracta spissa) - viscous masses with a moisture content of not more than 25%;

dry extracts (Extracta sicca) - free-flowing masses with a moisture content of not more than

Infusions dosage form, which is an aqueous extract from medicinal plant materials or an aqueous solution of dry or liquid extracts (concentrates).

Decoctions infusions that differ in the mode of extraction.

Aerosols dosage form in which drugs and excipients are under the pressure of a propellant gas

(propellant) in an aerosol can, hermetically sealed with a valve.

1.2. Classification of dosage forms

Classification of dosage forms is carried out depending on:

1.2.1. Aggregate state Solid : powders, tablets, dragees, granules, etc.

Liquid: true and colloidal solutions, drops, suspensions, emulsions,

liniments, etc.

Soft: ointments, suppositories, pills, capsules, etc.

Gaseous: aerosols, gases.

1.2.2. Quantities of medicinal substances

One-component

Multicomponent

1.2.3. Places of manufacture

Factory

Pharmacy

1.2.4. Manufacturing method

Solutions for injections Medicines Eye drops Decoctions Infusions Aerosols Infusions

Homeopathic remedies, etc.

1.3. Regulatory documents and quality requirements

medicines of pharmaceutical production

All production activities of the pharmacy should be aimed at ensuring high-quality manufacturing of medicines.

One of the most important factors determining the quality of medicines manufactured in a pharmacy is the organization of intra-pharmacy control.

Intra-pharmacy control is a set of measures aimed at the timely detection and prevention of errors that occur in the process of manufacturing, processing and dispensing medicines.

Pharmaceutical production drugs are subject to several types of control, depending on the nature of the dosage form.

The system of intra-pharmacy quality control of medicinal products provides for preventive measures, acceptance, organoleptic, written, questionnaire, physical, chemical and dispensing control.

According to the instructions of the Ministry of Health of the Russian Federation "On the quality control of medicines manufactured in pharmacies" (Order No. 214 dated July 16, 1997), all medicines are subject to intra-pharmacy control: organoleptic, written and dispensing control - mandatory, questionnaire and physical - selectively, and chemical - in accordance with paragraph 8 of this order (see Appendix).

1.4. Features of express analysis of medicines

pharmacy production

The need for intra-pharmacy control is due to the corresponding high quality requirements for medicines manufactured in pharmacies.

Since the manufacture and distribution of drugs in pharmacies is limited to a short time, their quality is assessed by express methods.

The main requirements for express analysis are the consumption of minimal quantities of drugs with sufficient accuracy and sensitivity, simplicity and speed of execution, if possible, without separation of ingredients, the possibility of conducting an analysis without removing the prepared medicinal product.

If it is not possible to perform the analysis without separating the components, then the same separation principles are used as in macro analysis.

1.4.1. Features of determining the authenticity of the express method

The main difference between determining the authenticity of the express method from macro-analysis is the use of small amounts of the studied mixtures without separating them.

The analysis is performed by the drip method in micro-test tubes, porcelain cups, on watch glasses, while 0.001 to 0.01 g of powder or 15 drops of the test liquid are consumed.

To simplify the analysis, it is sufficient to carry out one reaction for a substance, and the simplest, for example, for atropine sulfate, it is enough to confirm the presence of a sulfate ion, for papaverine hydrochloride - a chloride ion by classical methods.

1.4.2. Features of quantitative express analysis

Quantitative analysis can be performed by titrimetric or physico-chemical methods.

Titrimetric express analysis differs from macro methods in the consumption of smaller quantities of analyzed preparations: 0.05 0.1 g of powder or 0.5 2 ml of solution, and the exact mass of the powder can be weighed on hand-held scales; to improve accuracy, dilute solutions of titrants can be used: 0.01 0.02 mol/l.

A weighed portion of a powder or a volume of a liquid dosage form is taken in such a way that 1–3 ml of the titrant solution is used for the determination.

Of the physicochemical methods in pharmacy practice, the economical method of refractometry is widely used in the analysis of concentrates,

semi-finished products and other dosage forms.

II. MAIN STAGES OF PHARMACEUTICAL ANALYSIS

2.1. Organoleptic and physical control

2.1.1. Organoleptic control

Organoleptic control consists in checking the dosage form for the following indicators: appearance("Description"), smell,

homogeneity, absence of mechanical impurities. The taste is checked selectively, and dosage forms prepared for children - everything.

Uniformity of powders, homeopathic triturations, ointments, pills,

suppositories are checked before dividing the mass into doses in accordance with the requirements of the current State Pharmacopoeia. The check is carried out selectively at each pharmacist during the working day, taking into account the types of dosage forms. The results of organoleptic control are recorded in the journal.

2.1.2. Physical control

Physical control consists in checking the total mass or volume of the dosage form, the number and mass of individual doses (at least three doses),

included in this dosage form.

This checks:

Each series of packaging or intra-pharmaceutical blanks in the amount of at least three packages;

Dosage forms manufactured according to individual prescriptions (requirements), selectively during the working day, taking into account all types of dosage forms, but not less than 3% of the number of dosage forms manufactured per day;