Analysis of the range of drugs used in physiotherapy. Start in science

In market conditions of management, the internal factors of the enterprise are exposed to the influence of the components external environment. In this case, the main vector of the task of an economic entity is the task of increasing competitiveness.

At the same time, the concept of competitiveness is defined simultaneously as the ability to withstand competition and as the ability to meet consumer requirements.

If in the conditions of a limit-distributive economy, the participation of the latter was insignificant, then at the stage of introducing market conditions for managing the consumer, the consumer is not a passive buyer, but a full participant commercial activities, its regulator. This statement is based on the fact that for entrepreneurs, the most important factor in concluding transactions is income (economic benefit), and for consumers, the benefit is the product (service) he needs if it satisfies his needs (consumer interests) to a greater extent.

The current assortment of an enterprise is a factor in achieving competitiveness, regardless of the perspective of perception of this concept.

Thus, the study of the processes of implementing the functions of assortment management at the level of enterprises is an important element of the operational study of the degree of development of the spheres of production and circulation.

The qualitative and quantitative indicators of the assortment of an enterprise are the fundamental determinants of its competitiveness as the ability not only to withstand competition, but also to sufficiently meet the requirements of consumers.

A well-projected assortment policy of an enterprise should contribute to the development of the concept not so much of the complete satisfaction of consumer requirements, but of management and partial formation of consumer demand, which, in turn, will ensure the possibility of implementing one's own strategy of commercial behavior, subject to optimal independence from the actions of competing firms.

These provisions apply to enterprises of all industries, including pharmacies.

Therefore, the study of the range of solid dosage forms of a pharmacy organization is carried out in the work.

Tasks control work:

· Dahl classification of solid dosage forms;

· Conduct an analysis of the range of solid dosage forms on the example of MUP "pharmacy No. 2";

1. Classification of solid dosage forms

Medicinal products are substances used for the prevention, diagnosis, treatment of a disease, prevention of pregnancy, obtained from blood, blood plasma, as well as organs, tissues of a person or animal, plants, microorganisms, minerals by synthesis methods or using biological technologies.

solid forms medicines- a type of dosage forms characterized by the constancy of volume and geometric shape due to the properties of hardness and elasticity.

Solid forms of drugs are the most common type of dosage forms, providing the best conditions for use and storage. They have many varieties - powders, capsules, granules, tablets, dragees, etc. The most common are tablets and capsules, with special manufacturing technologies of which it is possible to provide the necessary sequence of dissolution and absorption of the ingredients included in them in various parts of the gastrointestinal tract in some cases.

Solid dosage forms include: briquettes, granules, medical sponges, dragees, caramels, capsules, pencils, microcapsules, microspheres, liposomes, pellets, medicinal films, powders, chewing gums, fees, tablets.

Dragee is a solid dosage form obtained by layer-by-layer application of medicinal substances onto microparticles of excipients using sugar syrups.

Briquette - a solid dosage form obtained by pressing medicinal substances or crushed medicinal plant materials (or a mixture of various types of plant materials) without the addition of excipients and intended for the preparation of solutions, infusions (briquette for infusion) and decoctions (briquette for decoction).

Caramel is a solid dosage form with a high content of invert sugar intended for use in oral cavity. Homeopathic caramel contains a homeopathic medicine.

An implant is a sterile solid depot dosage form for insertion into body tissues. Implants include: implantable tablets, depot tablets, subcutaneous capsules, implantable rods.

Microcapsules - capsules consisting of a thin shell of polymer or other material, spherical or irregular shape, ranging in size from 1 to 2000 microns, containing solid or liquid medicinal substances with or without the addition of excipients. Microcapsules are part of other, final dosage forms - capsules, powder, ointment, suspension, tablets, emulsion.

Therapeutic system is a dosage form (delivery system) with a controlled (prolonged) release of a medicinal substance at a rate set in advance, after a certain time, in a certain place, in accordance with the real need of the body. According to the principle of release, therapeutic systems are distinguished: physical (diffusion, osmotic, hydrostatic) and chemical immobilized, chemically modified; at the site of action: gastrointestinal (oral), ophthalmic, intrauterine, cutaneous (transdermal), dental.

Tablets - a solid dosage form obtained by pressing powders and granules containing one or more medicinal substances with or without the addition of excipients.

Among the tablets are distinguished:

Actually tablets (pressed);

Trituration tablets (molded; microtablets);

uncovered, covered;

Effervescent;

Gastro-resistant (enteric);

With modified release;

For oral use;

To prepare a solution or suspension, etc.

Divisible tablets - tablets with a diameter of more than 9 mm, having one or two risks (notches) perpendicular to each other, which allows you to divide the tablet into two or four parts and thus vary the dosage of the drug.

Crushable tablets - tablets for the preparation of a solution or suspension that require preliminary grinding.

Coated and uncoated - containing special excipients or obtained by special technology, which allows you to program the speed or place of release of the drug substance.

Coated tablets - tablets coated with one or more layers of excipients of natural or synthetic origin, sometimes with the addition of drugs or surfactants to the substances that form the coating. Depending on the composition and method of application, coatings are distinguished: coated, film, pressed; depending on the medium in which the coating should dissolve: gastro-soluble (gastric soluble) and enteric-soluble (enteric-soluble).

Enteric tablets (gastrointestinal tablets) are tablets that are stable in gastric juice and release the drug or substances in the intestinal juice. Obtained by coating tablets with an enteric coating (enteric tablets) or by pressing granules and particles previously coated with an enteric coating or by compressing drugs mixed with an enteric-resistant filler (durules).

Tablets that are stable in gastric juice and release the drug or substances in the intestinal juice. Enteric tablets are obtained by coating tablets with an enteric coating or by compressing granules and particles coated with an enteric coating, or by compressing medicinal substances in a mixture with an acid-stable excipient.

Film-coated tablets - tablets coated with a thin shell (film) that is less than 10% by weight of the tablet. Film coatings can be soluble in water (from solutions of natural cellulose, polyethylene glycols, gelatin and gum arabic, etc.) and insoluble in water, or varnishes (from some macromolecular compounds)

Modified release tablets are coated or uncoated tablets containing special excipients or obtained by a special technology that allows you to program the rate or place of release of the drug substance. The term is used for controlled release tablets, sustained release tablets, slow release tablets, etc. The term is not used for tablets referred to as depot tablets, implantable tablets, retard tablets, rapid retard tablets.

Retard tablets - tablets with prolonged (periodic) release of the medicinal substance from the stock. Usually they are microgranules with a medicinal substance, surrounded by a biopolymer matrix (base); the base or microgranules dissolve in layers, releasing the next portion of the medicinal substance.

Rapid retard tablets are biphasic release tablets containing a mixture of fast and sustained release microgranules.

Depending on the dosage of the medicinal substance, there are:

Mite tablets are tablets with a minimum dosage and a minimally pronounced effect of the medicinal substance.

PRACTICAL PHARMACY

UDC 615.45:615.012

PHARMACY MANUFACTURE OF DOSAGE FORMS FOR MEDICAL AND PREVENTIVE INSTITUTIONS: STUDY OF MODERN NOMENCLATURE

Kazan State Medical University

R.R. Saberzhan S.N. EGOROV

An analysis of the modern nomenclature of dosage forms manufactured in pharmacies for the needs of medical institutions was carried out. The compositions of extemporaneous dosage forms, promising for transfer to industrial production, have been established.

e-mail: [email protected]

Keywords: pharmacy, dosage forms, pharmaceutical production

Currently, the nomenclature of dosage forms manufactured in a pharmacy is undergoing significant changes, since Federal Law No. 61 “On the Circulation of Medicines” limits the possibility of pharmacy manufacturing dosage forms that are not produced by industrial pharmaceutical enterprises.

The purpose of this study was to study the modern nomenclature of dosage forms manufactured in pharmacies for the needs of medical institutions (HCIs).

The objects of the study were the data of municipal procurement quotations posted on the Internet as of 2010 and December 2011-2012. The study was carried out by the method of content analysis in search engine Yandex by keywords: "pharmaceutical production for the needs of healthcare facilities", "delivery of extemporal", "purchase of extemporal".

Experimental part. As a result of the study, 43 quotations were found, of which 31 were as of 2010 and 12 were as of December 2011-2012.

It was established that the number of medicinal substances used decreased after the Federal Law No. 61 "On the Circulation of Medicines" was issued from 73 (2010) to 46 (2011-2012).

The structure of the assortment of extemporaneous production by types of dosage forms is shown in fig. 1 (2010) and fig. 2 (2011-2012).

As follows from the data presented in Fig. 1 and 2, the structure of the assortment of extemporaneous dosage forms has changed: the share of solutions has decreased from 81 to 59% (due to a reduction in the pharmacy production of infusion solutions), powders - from 5 to 2%, oils - from 13 to 6%, and the share of ointments has increased - from 1 to 33%.

■ Solutions

■ Oils By

Rice. 1. The structure of the assortment of extemporaneous production for health facilities by types of dosage forms (2010)

Rice. Fig. 2. The structure of the range of extemporaneous production for health facilities by types of dosage forms (2011-2012).

It was of interest to study the assortment of the most widely manufactured extemporaneous dosage forms at the present time in order to resolve the issue of the possibility of introducing them into industrial production.

In the assortment of powders, glucose is widely represented at 30-50 g for oral administration in the study of the "sugar curve". There are also powders for internal use in children of the composition: diphenhydramine 0.002 g, glucose 0.2 g. These dosage forms can be mastered by industrial enterprises: glucose is produced both in the form of dosed powders and in the form of briquettes for dissolution, and dosage - in tablets.

In healthcare facilities, undosed zinc oxide powder for external use is in demand, which can also be produced in the form of a finished dosage form (powder for external use - powder).

The leader in the range of powders is potassium permanganate in a package of mainly 0.01 g for AIDS styling - for preparing a solution used for the purpose of post-exposure prevention of HIV infection among medical personnel. The extemporaneous production of this dosage form cannot be considered rational: the weighing operation on pharmaceutical scales can be carried out with sufficient accuracy only with a sample weight of 0.05 g or more; except that-

First, potassium permanganate slowly dissolves in water at room temperature, and this increases the risk of burns of the mucous membranes with crystals of the medicinal substance during emergency dissolution of the substance by medical personnel in a vial with sterile distilled water and the application of the resulting solution. In our opinion, when potassium permanganate solutions are in demand, it is more appropriate to use pharmacy-made solutions.

However, it should be noted that in the quotes there is also a packaging of potassium permanganate of 0.05 g.

It has been established that at present, non-sterile solutions are produced for the needs of healthcare facilities (68.02% of the total number of solution bottles).

The range of non-sterile solutions is dominated by solutions of various volumes (100-400 ml) for electrophoresis: magnesium sulfate 3 and 5%, copper sulfate 1%, sodium bromide 3%, potassium iodide 2, 3 and 5%, calcium chloride 5%, sodium thiosulfate 3%, novocaine 2 and 5%, zinc sulfate 3%, aminocaproic acid 5%, aminophylline 1%. This nomenclature should attract the attention of manufacturers of finished medicinal products, since data on the stability of aqueous solutions of a number of medicinal substances, allowing them to be sterilized without the addition of stabilizers, make it possible to transfer such formulations as solutions of calcium chloride 5% and magnesium sulfate 3-5% to industrial production.

Pharmacies produce at the request of healthcare facilities a solution of sodium bicarbonate 4% for baths, sodium chloride 0.9% for treatment of mucous membranes, etc.

Quotations also include colloidal solutions protargol - 1-5% and collargol 1-5%.

The analysis of quotations revealed the widespread use of extemporaneous aqueous solutions of antiseptic agents in healthcare facilities: iodopyrone 1%, hydrogen peroxide 3.6%, silver nitrate 33% - 5.0; furacilin 0.02%, chlorhexidine bigluconate

0.25%, boric acid 1% and 2%, and solutions of potassium permanganate 0.5% - 100 ml, 6% - 100 ml, 5% - 10 ml and 5% - 400 ml. The largest number questions of practical workers are caused by the expiration dates of solutions of potassium permanganate prepared under aseptic conditions, in particular a solution of potassium permanganate 5% - 10 ml for treating the umbilical cord of newborns, the expiration date of which is 2 days according to the order of the Ministry of Health of the Russian Federation No. 214 of 07/16/1997. On quality control of medicines manufactured in pharmacies. IN modern conditions When many health facilities do not have a production pharmacy and competitive bidding is announced for the manufacture and supply of extemporaneous dosage forms, compliance with the expiration dates - 2 days - becomes very problematic. Thus, there is an urgent need to review the expiration dates of drugs manufactured in the pharmacy, and, if possible, replace unstable extemporaneous dosage forms in the treatment standards with finished drugs.

Non-sterile extemporaneous solutions are used in healthcare facilities not only for therapeutic purposes, but also for diagnostic procedures: a colloidal solution is made that is used when measuring intraocular pressure by the contact method of composition: collargol 1.2, glycerol 0.9, purified water up to 10 ml.

For colposcopy, the quotes indicate Lugol's aqueous solution 1% (iodine 1.0, potassium iodide 2.0, purified water up to 100.0), which, unlike Lugol's glycerin solution, has no industrial analogue, and acetic acid solution 3% .

Aqueous solutions are also made for the paraclinical departments of health care facilities: 10% formalin solution for biopsies, 70% acetic acid solution for treating a physiotherapy room, 10% formalin solution for disinfecting various objects, 25% potassium chloride solution (reagent), 5% sodium citrate solution for stabilization of blood in the study of the hemostasis system and a solution of 50% citric acid for decalcification of hemodialysis equipment.

Despite the decrease in the share of solutions in the general formulation, they make up more than half of the range of extemporaneous dosage forms manufactured for the needs of health care facilities. From the data of the studied quotations presented in fig. 3,

one can see a drop in the number of manufactured vials in 2011-2012, apparently due to the purchase of infusion solutions and other liquid dosage forms of industrial production from healthcare facilities.

Fig.3. Dynamics of production of extemporaneous liquid dosage forms for healthcare facilities

A significant proportion of extemporaneous dosage forms manufactured for healthcare facilities are infusion and other sterile solutions that have no industrial analogues.

For drinking by newborns, sterile solutions of dibazol 0.01%, glucose 5%, sodium bromide 1% are made in 10 ml packages.

The quotations represent water for injection, as well as infusion and injection solutions of various volumes that differ from those available in industrial production: sodium bicarbonate 3% and 4%, novocaine 0.5%, 1% and 2%, glucose 5% and 20%, potassium chloride 7.5% and 10%, calcium chloride 1% and 3%, sodium chloride 10%.

Sterile solutions for external use are made: solutions of sodium chloride 10% and 20%, furacilin 0.2%, chlorhexidine bigluconate 0.25% and 0.3%.

The range of alcohol solutions of extemporaneous manufacture for health care facilities is small and is represented by prescriptions for antiseptics, for example, alcohol iodine solution 5% - 3.5 ml, ethyl alcohol 70% - 50.0; solution of chlorhexidine bigluconate 20% - 1.25, ethyl alcohol 70% -50.0.

Sterile oils and glycerin are in high demand in healthcare facilities; the quotations include prescriptions: sunflower oil 10.0, vaseline oil 10.0 and 30.0 and glycerin 20.0, which indicates the feasibility of industrial production of these dosage forms.

Soft dosage forms are represented by ointments containing dikain, furatsilin, furagin, hydrocortisone, trilon B (for phonophoresis). A significant increase in the production of ointments for healthcare facilities is associated with an increase in the need for packaging of vaseline (100.0), in a number of quotations it is indicated “for processing catheters”. This packaging of vaseline can be introduced into industrial production.

The manufacturing technology of extemporaneous dosage forms for the needs of health care facilities does not cause difficulties.

SCIENTIFIC STATEMENTS I Series Medicine. Pharmacy. 2012. No. 10 (129). Issue 18/2 35

Of interest are prescriptions that use finished dosage forms:

Nose drops (32 ml): dioxidine solution 1% - 10.0, adrenaline solution 0.1% - 1.0, diphenhydramine solution 1% - 1.0, ciprofloxacin solution 2 mg / ml - 20.0. This dosage form can be made by mixing a sterile dioxidine antiseptic solution, diphenhydramine and ciprofloxacin injection solutions, and an adrenaline hydrochloride solution.

Ointment (topically): hydrocortisone 125 mg (suspension for injection 5 ml), furagin 0.25 (5 tablets of furagin 0.05), vaseline 100.0. To prevent delamination of the ointment, grind the furagin tablets (in a mortar intended for odorous and coloring substances), grind with a suspension of hydrocortisone and add vaseline in parts. However, the problem of using finished dosage forms for extemporaneous production requires a legal solution.

1. The extemporaneous formulation for the needs of health care facilities is represented by formulations of dosage forms that have no industrial analogues.

2. The compositions of powders, sterile oils and glycerin, solutions for electrophoresis, Vaseline packaging, promising for transfer to industrial production, have been established.

Literature

1. On the circulation of medicines [ Electronic resource] : Feder. law of 12 April 2010 No. 61-FZ // Consultant plus. - Access mode: fr££p://base.consultant.ru/cons/cgi/online.cgi?req=doc;base=LAW;n=107431.

2. Order of the Ministry of Health of the Russian Federation No. 214 dated July 16, 1997 “On quality control of medicines manufactured in pharmacies”.

3. Egorova, S.N. Pharmaceutical production: dosage forms that have no industrial analogues // Novaya Apteka. - M., 2007. - No. 6. - S. 39-42.

PHARMACY PRODUCTION OF DRUG FORMS FOR MEDICAL AND PREVENTIVE TREATMENT FACILITIES: STUDYING OF THE CURRENT NOMENCLATURE

R.R. SABIRJAN S.N. EGOROVA

Kazan State Medical University e-mail: [email protected]

The analysis of the current nomenclature of the drug forms made in pharmacy for needs of medical and preventive treatment facilities is carried out. Compositions of extemporal drug forms, prospective for transfer to industrial production, are established.

Key words: pharmacy, drug forms, pharmaceutical production.

Liquid dosage forms are dispersed systems, in which drugs (solid, liquid and gaseous) are distributed in a liquid dispersion medium. Depending on the degree of grinding of the dispersed phase (DP) and the nature of its connection with the dispersion medium, liquid dosage forms can be: true solutions; solutions of macromolecular compounds; colloidal solutions; suspensions; emulsions; combinations of these types of dispersed systems (combined systems).

Liquid dosage forms include:

Solutions (drops, injection solutions, etc.) - dosage forms obtained by dissolving liquid, solid or gaseous substances in an appropriate solvent;

Suspensions (suspensions) - dosage forms, which are a dispersed system containing one or more solid drugs suspended in an appropriate liquid (particle size ranges from 0.1 to 10 microns); suspensions are used for internal and external use, as well as for injection;

Emulsions - a dosage form, which is a dispersed system containing two or more mutually insoluble or immiscible liquids, one of which is emulsified into the other; emulsions are used for internal and external use, as well as for injection;

Infusions and decoctions - water extracts from medicinal plant materials or aqueous solutions of extracts;

Mucus - dosage forms of high viscosity, as well as those prepared using starch from an aqueous extract of plant materials;

Medicinal syrups - a dosage form for internal use, which is a concentrated solution of various sugars, as well as their mixtures with drugs;

Tinctures - a dosage form, which is an alcohol and water-alcohol extract from medicinal plant materials, obtained without heating and removing the extractant;

Extracts - concentrated extracts from medicinal plant materials or raw materials of animal origin, which are mobile, viscous liquids or dry masses; distinguish between liquid extracts (mobile liquids), thick extracts (viscous masses with a moisture content of not more than 25%), dry extracts (loose masses with a moisture content of not more than 5%).

Liquid dosage forms account for more than 60% of the number of drugs prepared in pharmacies.

The preparation of liquid dosage forms is regulated by the order of the Ministry of Health of the Russian Federation No. 308 dated 10/21/1997, according to which solutions and other liquid dosage forms are made by methods: mass-volume, by weight, by volume. The current GF is adopted as the main mass-volume method for the manufacture of liquid dosage forms.

Mass-volume concentration- mass of the drug or individual substance (g) in the total volume of the liquid dosage form (ml).

Mass concentration- mass of the drug or individual substance (g) in the total mass of the liquid dosage form (g).

Volume concentration- the volume of a liquid drug or an individual substance (ml) in the total volume of a liquid dosage form (ml).

Examples

In prescriptions:

Rp.: Solutionis Natrii bromidi 2% - 200 ml (a) Rp.: Solutionis Camphorae oleosae 2% - 50.0 (b) Rp.: Solutionis Acidi hydrochlorici 2% - 200 ml (c).

As can be seen from the example, mass-volume concentration (a), mass concentration (b) and volume concentration (c) can be indicated as a percentage (%).

In addition, it is possible to separately enumerate the mass and volume of the drug (substance) and the dispersion medium (solvent):

Rp.: Natrii bromidi 4.0

Aquae purificatae 200 ml (a)

Rp.: Camphorae 1.0

Olei Helianthi 49.0 (b)

Aquae purificatae 196 ml (c); indicating the solvent to a given volume or mass:

Rp.: Natrii bromidi 4.0

Aquae purificatae ad 200 ml (a)

Rp.: Camphorae 1.0

Olei Helianthi ad 50.0 (b)

Rp.: Acid hydrochlorici 4 ml

Aquae purificatae ad 200 ml (c); indicating the ratio of the mass or volume of the dissolved drug (substance) and the volume or mass of the solution:

Rp.: Solutionis Natrii bromidi ex 4.0 - 200 ml

(seu 1:50 - 200 ml) (a)

Rp.: Solutionis Camphorae oleosae ex 1.0 - 50.0 (b) Rp.: Solutionis Acidi hydrochlorici ex 4 ml - 200 ml (seu 1:50 - 200 ml) (c). Mass-volume concentration is used for:

Production of aqueous and water-alcohol solutions of solid drugs;

Aqueous and water-alcohol suspensions with a solids content of less than 3%;

Dilution of standard solutions written in the prescription under the chemical name, indicating the concentration of the drug in the solution.

In concentration by weight, solutions of solid and liquid drugs are prepared in viscous and volatile solvents, dosed by weight, as well as suspensions and emulsions and homeopathic liquid drugs. The following are dosed by weight: fatty and mineral oils, glycerin, dimexide, polyethylene glycols (polyethylene oxides), silicone liquids, ether, chloroform, as well as benzyl benzoate, validol, vinylin (Shostakovsky's balm), birch tar, ichthyol, lactic acid, essential oils, turpentine, methyl salicylate, nitroglycerin, perhydrol.

Volumetric concentration is used in the manufacture of:

Alcohol solutions of various concentrations;

Solutions of hydrochloric acid;

Standard solutions written out in the prescription under the conditional name;

Purified water and water for injection;

Aqueous solutions of drugs;

Galenic and novogalenic drugs (tinctures, liquid extracts, etc.).

If the recipe does not specify a solvent, then an aqueous solution is made. Under the name “water”, in the absence of special instructions, purified water is understood. The term "alcohol" refers to ethyl alcohol. In the absence of instructions on the concentration of alcohol (in the recipe or the corresponding ND), 90% alcohol should be used. The name "ether" means medical ether. The term "glycerol" means glycerin containing 10-16% water, with a density of 1.223-3.233 g/cm 3 .

In the manufacture of aqueous solutions of substances containing water of crystallization in the molecule, the recalculation of the amount of drugs, taking into account the content of water of crystallization, is carried out in accordance with the current Global Fund or other ND in cases where this is regulated by the composition of the prescription and the method of quantitative determination. Strongly hygroscopic substances are used for the manufacture of liquid dosage forms in the form of concentrated solutions (for example, calcium chloride).

Liquid dosage forms are subjected to chemical control - qualitative or complete chemical, depending on the composition and purpose. According to the order of the Ministry of Health of the Russian Federation No. 214 dated July 16, 1997, a qualitative analysis is mandatory: concentrates, semi-finished products and liquid drugs in a burette installation and in barbells with pipettes in the assistant's room when filling.

Qualitative analysis is subjected to selectively following groups drugs.

Dosage forms manufactured according to individual prescriptions or requirements of healthcare facilities selectively, but not less than 10% of the total number of prescriptions. Particular attention is paid

on dosage forms for children, especially newborns, as well as those used in eye practice and containing poisonous and narcotic substances.

Mandatory full chemical analysis is carried out: all solutions for injections and infusions before sterilization, including the determination of the pH value, isotonizing and stabilizing substances; solutions for injections and infusions after sterilization are checked for pH value, authenticity and quantitative content of active substances; sterile solutions for external use; eye drops and ointments containing narcotic and poisonous substances; dosage forms for newborns; solutions of hydrochloric acid for internal use, atropine sulfate, silver nitrate; concentrates, semi-finished products, triturations, intra-pharmaceutical preparations, stabilizers and buffer solutions; the concentration of ethyl alcohol when diluted in a pharmacy.

Complete chemical control is subject to selective: dosage forms manufactured in a pharmacy according to individual prescriptions or requirements of medical organizations (at least 3 when working in one shift); dosage forms for children; used in eye practice; containing narcotic and poisonous substances; solutions for therapeutic enemas.

The results of qualitative and complete chemical control are recorded in journals (see Appendix 2). The journal also records cases of unsatisfactory manufacture of drugs found during the quality control of their manufacture in a pharmacy by pharmacists-analysts of the center for quality control of drugs. The detected marriage is seized for re-analysis with the preparation of an act of seizure and an explanatory note. The drug is made anew and its quality is again controlled.

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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 peculiar evolution took place from "grandmother's" recipes to whole science- pharmaceutical technology, which led to the creation a large number medicines. 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 technology system 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 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 nitric acid and heat up. 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%, thus, 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 study guides and tutorials:

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

Ministry of Health 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.

Annex 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

Annex 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