Making solutions for medical care. Medical care in the laboratory

Of the various disinfectants, chlorine-containing compounds are most often used, the antimicrobial properties of which are associated with the action of hypochlorous acid, which is released when chlorine and its compounds are dissolved in water.

A solution of bleach is prepared according to certain rules. 1 kg of dry bleach is mixed into 10 liters of water, obtaining the so-called chloride-lime milk, and left in a tightly closed glass sun-protection container for 24 hours until clear. In the future, for wet cleaning, usually a 0.5% clarified bleach solution is used, for which 9.5 liters of water and 0.5 liters of a 10% bleach solution are taken per 10 liters of solution. To prepare a 3% bleach solution, 3 liters of a 10% clarified bleach solution are taken with the addition of 7 liters of water.

A solution of chloramine is most often used in the form of a 0.2-3% solution, while the required amount of chloramine is first added to a small amount of water, stirred, after which the remaining volume of water is added to obtain the desired concentration of the chloramine solution.

To prepare a 1% solution of chloramine, 100 g of chloramine is taken per 10 liters of water (10 g per 1 liter of water);

2% solution of chloramine - 200 g of chloramine per 10 liters of water (20 g per 1 liter).

Solutions for general and current processing

Soap-soda solution - dilute 50 g of soap in 10 liters of hot water, add 10 g of soda and 50 g of ammonia.

Chlorine-soap-soda solution: in 10 liters of 1% (0.5%) solution of chloramine, add 50 g of soap and 10 g of soda ash.

Currently, disinfectants Samarovka, Clindamizin, Amiksan are widely used for general and current processing.

It should be remembered that when processing vertical surfaces and ceilings from a hydraulic console, a 0.5% solution of chloramine should be used.

The device of the reception and diagnostic department

The reception and diagnostic department consists of a vestibule-waiting room, reception and examination boxes, a sanitary checkpoint, and a room for storing clothes of patients who have arrived. In large multidisciplinary hospitals, the admission and diagnostic department has doctor's offices, a diagnostic room, a procedural dressing room, an emergency laboratory, a room for medical personnel, and sanitary rooms. It is possible to separate the therapeutic and surgical reception and diagnostic department.

The main functions of the admission and diagnostic department:

■ organization of admission and hospitalization of patients, while establishing a preliminary clinical diagnosis, assessing the validity of hospitalization;

■ consultations of patients in the direction of local doctors and who appeared "by gravity";

■ provision of emergency medical care, if necessary;

■ prevention of the introduction of infections into the hospital - isolation of an infectious patient and organization of specialized medical care for him;

■ sanitization of the patient;

■ transportation of the patient to the department;

■ reference and information service;

■ recording the movement of patients in the hospital.

Documentation of the reception and diagnostic department:

● register of admitted patients and hospitalization refusals (form No. 001/y);

● alphabetical log of admitted patients;

● log of consultations;

● examination log for pediculosis;

● register of free places in the hospital;

● medical record of an inpatient (form No. 003/y).

In large medical institutions, there is a special staff of medical workers. In small medical institutions, patients are received by on-duty staff. Patients are admitted in a strict sequence: registration, medical examination, necessary medical assistance, sanitary and hygienic treatment, transportation of the patient to the appropriate department.

Functional duties of a nurse in the admission and diagnostic department:

♦ fills in the title page of the inpatient medical record (case history): passport part, date and time of admission, diagnosis of the referring institution;

♦ fills in the register of admitted patients and the alphabetical book for the information service;

♦ performs thermometry of the patient;

♦ conducts anthropometric measurements;

♦ examines the patient's skin and pharynx to rule out an infectious disease;

♦ examines the patient for head lice and scabies;

♦ fills out a statistical coupon for an admitted patient;

♦ carries out sanitization of the hospitalized patient and transports him to the medical department.

The result of disinfection measures directly depends on how disinfectants are prepared and stored for the treatment of hospital premises, tools and objects of the hospital environment.

Persons who have undergone special training are allowed to work with working solutions.

The main thing in the article

Disinfection in health care facilities is the responsibility of the middle and junior medical staff, and the control of the effectiveness of these activities lies with the head nurse and senior nurses of the hospital departments.

Permission to work with disinfectants

Specialists working with medical disinfectants must be familiar with the provisions of the instructive and methodological documentation for the preparation and storage of working solutions, as well as know the safety precautions and precautions when working with them.

Samples and special collections of standard procedures for nursing, which can be downloaded.

In addition, medical personnel undergo:

  • professional training and certification (including work safety and first aid in case of chemical poisoning);
  • preliminary and periodic preventive medical examinations.

Minors, persons with allergic and dermatological diseases, as well as persons sensitive to the effects of fumes of chemical compounds are not allowed to work with disinfectants.

All authorized employees must be provided with special clothing, footwear, personal protective equipment and a first aid kit.

Methods for preparing working solutions of disinfectants

There are two ways dilution of disinfectants:

  1. Centralized.
  2. Decentralized.

With the centralized method, solutions are prepared in a separate well-ventilated room equipped with supply and exhaust ventilation.

It is forbidden to store food and personal belongings of staff, eat and smoke here. Persons not allowed to work with disinfectants are not allowed to be in this room.

The decentralized method involves the preparation of working solutions in treatment and diagnostic rooms. In this case, the place in which the solution is prepared must be equipped with an exhaust system.

The choice of method for preparing a disinfectant depends on the size of the organization and the volume and types of services provided to it.

Instructions, criteria for choosing disinfectants, what documents are attached to them, how often it is necessary to change disinfectants, find out in the Chief Nurse System.

  • the ubiquitous resistance of microorganisms to the disinfectants used;
  • formed microbiological background;
  • an increase in the number of cases of infections associated with the provision of medical care (HCAI).

Rules for breeding disinfectants: precautions, algorithm

Disinfectant solutions are toxic and irritating to mucous membranes, skin and organs of vision, therefore, precautions when diluting and working with them are necessary to avoid serious health problems.

Dilution of disinfectants: It is strictly forbidden to add a new disinfectant to an old solution, as well as to mix old and new solutions.

Dilution of disinfectants should be done in a hat, gown, goggles and a respirator. The skin must be protected with rubber gloves.

Contact with the chemical on the skin, mucous membranes, eyes and stomach should be avoided. First aid measures in case of accidental poisoning or contact are indicated in the instructions for use of a specific disinfectant.

You can prevent the negative impact of medical disinfectant solutions by observing the following rules:

  • personnel should be regularly trained in the use of disinfectant solutions;
  • responsible persons should regularly check that the instructions for use of a specific disinfectant are strictly followed when preparing a working solution;
  • in a conspicuous place there should be a stand with information on the procedure for use and precautions when working with disinfectants, on the rules for preparing working solutions, on periodic visual and express control.

The rules for working with disinfectants and their use should be controlled by an employee appointed as responsible for carrying out disinfection measures in health facilities.

Shelf life and service life of the working solution

The working solution of a disinfectant, like any chemical compound, can change its initial properties during storage and operation. This is influenced by such external factors as temperature, light, impurities. The shelf life of the solution in this case is reduced.

Distinguish limit and maximum shelf life of the working solution. The first expiration date is usually understood as the period of preservation of the initial concentration of the active substance, acid-base balance, bactericidal activity before its use.

The expiration date is set by the manufacturer, it is indicated in the instructions for use. The working solution expiration date report is calculated from the moment of its preparation.

The disinfectant solution cannot be used before the deadline for use if the activity of the working solutions has not been monitored using test strips.

The maximum shelf life of the solution is the period during which the antimicrobial activity stated in the instructions is maintained, and the concentration does not fall below the required level.

It is impossible to say how much the antimicrobial activity of a medical disinfectant will decrease after it has been subjected to several treatments. For this reason, the expiration date is set according to the results of chemical and visual control.

In this case, the countdown is from the moment the instruments or products are first immersed in the solution.



Storage of working solutions

Reusable disinfectant solutions are prepared for future use and stored in a closed container in a separate room or a specially designated place for a day or more.

It is forbidden to use adapted containers (for example, food cans) as containers for disinfectants.

All containers in working solutions must be labeled. They must have a tight-fitting lid and be used strictly for processing one specific object.

The name of the disinfectant solution, its concentration, date of preparation and expiration date are applied to the container with an indelible marker. You can attach an adhesive label with the same data to it.

The calculator will help you calculate how much disinfectant you will need. for disinfection of patient care items, cleaning equipment, laboratory glassware and toys.

Monitoring the activity of the working solution

It is impossible to use working solutions for disinfecting the premises of healthcare facilities, equipment and tools, the toxicity and effectiveness of which do not correspond to the declared values.

In some cases, control methods are indicated in the instructions for the use of disinfectants.

The activity of disinfectant solutions is checked using the following methods:

  • visual - assessment of the appearance of the solution, its transparency, color, the presence of impurities;
  • chemical - using means of quantitative control of the content of the active substance (carried out upon acceptance of each incoming batch, with unsatisfactory results of chemical control of the concentration of working solutions, and also once every six months - as part of production control);
  • express control - using test strips, carried out in order to promptly check the activity of the active substance in the disinfectant at least once every 7 days, at least one sample of each type (express control of the active substance in working solutions used to disinfect endoscopic equipment and accessories to it, is carried out strictly once per shift).

For accounting results express control in health care facilities a separate log is started. Its form is not regulated by law, so it can be approved by the head of the medical institution.

Testing using test strips allows you to monitor the consistency of the concentration of the medical disinfectant solution immediately after preparation and during use.

If the concentration in the solution is below the norm specified by the manufacturer, it is considered unsuitable and must be replaced.

In order to assess the effectiveness of disinfecting measures, bacteriological control is carried out in health care facilities every six months, which consists in taking swabs from surfaces as part of production control.

How often to carry out express control of working solutions?

The frequency of quality control of the disinfectant solution depends on the active substance.

For example, it is allowed to store solutions of certain products based on quaternary ammonium compounds for up to 30 days. In this case, it is advisable to carry out a control each time before use.

If the disinfectant working solution must be used during the work shift, then its control can be carried out immediately after preparation. Another option is not to conduct a check at all, if it is allowed by the regulatory and methodological documentation.

Violation of sanitary rules and regulations

Supervisory authorities during scheduled and unannounced inspections often reveal the following violations of sanitary rules in medical institutions:

  • there are no results of monitoring the concentration of working solutions of medical disinfectants;
  • non-compliance of the disinfectant with the areas of application, preparation and storage indicated by the manufacturer.

For these violations, the management of the health facility and officials may be punished in accordance with Article 6.3. Code of Administrative Offenses of the Russian Federation.

Methods for monitoring the activity of working solutions, its frequency and criteria for evaluating the results obtained must be fixed in the Production Control Program, which is approved by the head physician. The administration is responsible for its implementation.

It is recommended to reuse the working solutions of medical disinfectants only during one working shift, despite their expiration date, as with longer use, microorganisms with resistance properties can get into them.

In this case, the solution becomes dangerous from the point of view of the spread of infection, since microorganisms develop resistance mechanisms to disinfecting solutions.

Consumption rates and breeding rules for some DS

Note. The consumption rate and the rule of dilution of the drug for the active substance are listed in

Medical solutions of factory production. Intensification of the dissolution process. Cleaning methods.
TABLE OF CONTENTS


INTRODUCTION

Liquid dosage forms (LDF) of pharmacies account for more than 60% of the total number of all drugs prepared in pharmacies.

The widespread use of ZLF is due to a number of advantages over other dosage forms:

  • due to the use of certain technological methods (dissolution, peptization, suspension or emulsification), the medicinal substance in any state of aggregation can be brought to the optimal degree of particle dispersion, dissolved or evenly distributed in the solvent, which is of great importance for the therapeutic effect of the medicinal substance on organism and confirmed by biopharmaceutical studies;
  • liquid dosage forms are characterized by a wide variety of composition and methods of application;
  • in the composition of the ZhLF, it is possible to reduce the irritating effect of certain medicinal substances (bromides, iodides, etc.);
  • these dosage forms are simple and easy to use;
  • in ZhLF it is possible to mask the unpleasant taste and smell of medicinal substances, which is especially important in pediatric practice;
  • when taken orally, they are absorbed and act faster than solid dosage forms (powders, tablets, etc.), the effect of which is manifested after their dissolution in the body;
  • the emollient and enveloping effect of a number of medicinal substances is most fully manifested in the form of liquid medicines.

However, liquid medicines have a number of disadvantages:

  • they are less stable during storage, since the dissolved substances are more reactive;
  • solutions are more quickly subjected to microbiological deterioration, respectively, they have a limited shelf life - no more than 3 days;
  • ZhLF require quite a lot of time and special utensils for cooking, are inconvenient during transportation;
  • liquid medicines are inferior in dosing accuracy to other dosage forms, as they are dosed with spoons, drops.

Thus, ZLF is a widely used dosage form today. Due to their advantages, liquid medicines have great prospects in the future when creating new medicines, so the study of this topic is highly advisable.

In addition, such a drawback of LLF as storage instability does not allow reducing the number of extemporaneous drugs and increasing the number of finished liquid drugs, so the study of LLF technology remains very relevant.

The purpose and objectives of this work is to study a factory-made medical solution.


Chapter 1 GENERAL CHARACTERISTICS OF MEDICAL SOLUTIONS

1.1 Characterization and classification of solutions

Solutions are liquid homogeneous systems consisting of a solvent and one or more components distributed in it in the form of ions or molecules. 1 .

Medical solutions are distinguished by a wide variety of properties, composition, methods of preparation and purpose. Separate solutions, the manufacture of which involves chemical reactions, are obtained at chemical and pharmaceutical plants.

Solutions have a number of advantages over other dosage forms, as they are absorbed much faster in the gastrointestinal tract. The disadvantage of solutions is their large volume, possible hydrolytic and microbiological processes that cause rapid destruction of the finished product.

Knowledge of solution technology is also important in the manufacture of almost all other dosage forms, where solutions are intermediates or auxiliary components in the manufacture of a particular dosage form.

Solutions occupy an intermediate position between chemical compounds and mechanical mixtures. Solutions differ from chemical compounds in the variability of their composition, and from mechanical mixtures in homogeneity. That is why solutions are called single-phase systems of variable composition, formed by at least two independent components. The most important feature of the dissolution process is its spontaneity (spontaneity). A simple contact of the solute with the solvent is sufficient to form a homogeneous system - a solution - after a while.

Solvents can be polar and non-polar substances. The former include liquids that combine a large dielectric constant, a large dipole moment with the presence of functional groups that ensure the formation of coordination (mostly hydrogen) bonds: water, acids, lower alcohols and glycols, amines, etc. Non-polar solvents are liquids with a small dipole moment, which do not have active functional groups, for example, hydrocarbons, haloalkyls, etc.

When choosing a solvent, one has to use predominantly empirical rules, since the proposed theories of solubility cannot always explain the complex, as a rule, relationships between the composition and properties of solutions.

Most often they are guided by the old rule: “Like dissolves in like” (“Similia similibus solventur”). In practice, this means that those solvents that are structurally similar and, therefore, have similar or similar chemical properties are most suitable for dissolving a substance. 2 .

The solubility of liquids in liquids varies widely. Liquids are known that dissolve indefinitely in each other (alcohol and water), i.e., liquids similar in type of intermolecular action. There are liquids that are partially soluble in each other (ether and water), and, finally, liquids that are practically insoluble in each other (benzene and water).

Limited solubility is observed in mixtures of a number of polar and nonpolar liquids, the polarizability of the molecules of which, and hence the energy of intermolecular dispersion interactions, differ sharply. In the absence of chemical interactions, solubility is maximum in those solvents whose intermolecular field is close in intensity to the molecular field of the solute. For polar liquid substances, the particle field intensity is proportional to the dielectric constant.

The dielectric constant of water is 80.4 (at 20°C). Consequently, substances having high dielectric constants will be more or less soluble in water. For example, glycerin (dielectric constant 56.2), ethyl alcohol (26), etc., mixes well with water. On the contrary, petroleum ether (1.8), carbon tetrachloride (2.24), etc. are insoluble in water. However, this rule is not always valid, especially when applied to organic compounds. In these cases, the solubility of substances is influenced by various competing functional groups, their number, relative molecular weight, size and shape of the molecule, and other factors. For example, dichloroethane, which has a dielectric constant of 10.4, is practically insoluble in water, while diethyl ether, which has a dielectric constant of 4.3, is 6.6% soluble in water at 20°C. Apparently, the explanation for this should be sought in the ability of the ethereal oxygen atom to form unstable complexes of the type of oxonium compounds with water molecules. 3 .

With an increase in temperature, the mutual solubility of sparingly soluble liquids in most cases increases and often, when a certain temperature for each pair of liquids, called critical, is reached, the liquids completely mix with each other (phenol and water at a critical temperature of 68.8 ° C and higher dissolve in each other). another in any proportion). With a change in pressure, the mutual solubility changes slightly.

The solubility of gases in liquids is usually expressed by the absorption coefficient, which indicates how many volumes of a given gas, reduced to normal conditions (temperature 0 ° C, pressure 1 atm), are dissolved in one volume of liquid at a given temperature and a partial gas pressure of 1 atm. The solubility of a gas in liquids depends on the nature of the liquids and gas, pressure and temperature. The dependence of gas solubility on pressure is expressed by Henry's law, according to which the solubility of a gas in a liquid is directly proportional to its pressure over a solution at a constant temperature, but at high pressures, especially for gases that chemically interact with a solvent, there is a deviation from Henry's law. As the temperature rises, the solubility of a gas in a liquid decreases.

Any liquid has a limited dissolving power. This means that a given amount of solvent can dissolve the drug in amounts not exceeding a certain limit. The solubility of a substance is its ability to form solutions with other substances. Information about the solubility of medicinal substances is given in pharmacopoeial articles. For convenience, SP XI indicates the number of parts of the solvent required to dissolve 1 part of the medicinal substance at 20 ° C. Substances are classified according to their degree of solubility. 4 :

1. Very easily soluble, requiring no more than 1 part of the solvent for their dissolution.

2. Easily soluble - from 1 to 10 parts of the solvent.

3. Soluble - 10 to 20 parts solvent.

4. Sparingly soluble - from 30 to 100 parts of the solvent.

5. Slightly soluble - from 100 to 1000 parts of the solvent.

6. Very slightly soluble (almost insoluble) - from 1000 to 10,000 parts of the solvent.

7. Practically insoluble - more than 10,000 parts of solvent.

The solubility of a given drug substance in water (and in another solvent) depends on temperature. For the vast majority of solids, their solubility increases with increasing temperature. However, there are exceptions (for example, calcium salts).

Some medicinal substances can dissolve slowly (although they dissolve in significant concentrations). In order to accelerate the dissolution of such substances, they resort to heating, preliminary grinding of the dissolved substance, and mixing of the mixture.

The solutions used in pharmacy are very diverse. Depending on the solvent used, the entire variety of solutions can be divided into the following groups 5 .

— Water . Solutiones aquosae seu Liquores.

- Alcoholic. Solutions spirituosae.

- Glycerin. Solutions glycerinatae.

— Oily . Solutiones oleosae seu olea medicata.

According to the state of aggregation of medicinal substances soluble in them:

— Solutions of solids.

— Solutions of liquid substances.

- Solutions with gaseous drugs.

1.2 Intensification of the dissolution process

To speed up the dissolution process, heating or increasing the contact surface of the dissolved substance and the solvent can be used, which is achieved by preliminary grinding of the dissolved substance, as well as by shaking the solution. As a general rule, the higher the temperature of the solvent, the greater the solubility of the solid, but sometimes the solubility of the solid decreases with increasing temperature (eg calcium glycerophosphate and citrate, cellulose ethers). The increase in the dissolution rate is due to the fact that when heated, the strength of the crystal lattice decreases, the diffusion rate increases, and the viscosity of solvents decreases. In this case, the diffusion force acts positively, especially in non-polar solvents, where diffusion forces are of primary importance (there is no formation of solvates). It should be noted that with increasing temperature, the solubility of certain substances in water increases sharply (boric acid, phenacetin, quinine sulfate), and others - slightly (ammonium chloride, sodium barbital). The maximum degree of heating is largely determined by the properties of solutes: some tolerate heating in liquids up to 100 ° C without changes, while others decompose already at a slightly elevated temperature (for example, aqueous solutions of some antibiotics, vitamins, etc.). We must also not forget that an increase in temperature can cause the loss of volatile substances (menthol, camphor, etc.). As already mentioned, the solubility of a solid also increases as the contact surface between the solute and the solvent increases. In most cases, an increase in the contact surface is achieved by grinding the solid (for example, tartaric acid crystals are more difficult to dissolve than powder). In addition, to increase the contact surface of a solid with a solvent in pharmacy practice, shaking is often used. Stirring facilitates the access of the solvent to the substance, contributes to a change in the concentration of the solution near its surface, creates favorable conditions for dissolution 6 .

1.3 Cleaning methods

Filtration is the process of separating heterogeneous systems with a solid dispersed phase using a porous partition that allows liquid (filtrate) to pass through and retains suspended solids (precipitate). This process is carried out not only due to the retention of particles larger than the diameter of the capillaries of the partition, but also due to the adsorption of particles by the porous partition, and due to the layer of precipitate formed (slurry type of filtration).

The movement of liquid through the porous filtering partition is mainly laminar. If we assume that the capillaries of the partition have a circular cross section and the same length, then the dependence of the volume of the filtrate on various factors obeys the Poisel law 7 :

Q = F z π r Δ P τ /8 ŋ l α , where

F - filter surface, m²;

z - number of capillaries per 1 m²;

r - average radius of capillaries, m;

∆P - pressure difference on both sides of the filtering partition (or pressure difference at the ends of capillaries), N/m²;

τ is the duration of filtration, sec;

ŋ- absolute viscosity of the liquid phase in n/s m²;

l - average length of capillaries, m²;

α - correction factor for capillary curvature;

Q - filtrate volume, m³.

Otherwise, the volume of the filtered liquid is directly proportional to the filter surface ( F ), porosity (r , z ), pressure drop (ΔР), filtration duration (τ) and is inversely proportional to the liquid viscosity, filtering septum thickness and capillary curvature. From the Poisel equation, the filtration rate equation is derived ( V ), which is determined by the amount of fluid that has passed through a unit surface per unit time.

V = Q / F τ

After the transformation of the Poisel equation, it takes the form:

V = Δ P / R draft + R baffles

where R is the resistance to fluid movement. From this equation follows a number of practical recommendations for the rational conduct of the filtering process. Namely, to increase the pressure difference above and below the baffle, either an increased pressure is created above the filtering baffle, or a vacuum is created below it.

The separation of solids from liquids using a filter septum is a complex process. For such a separation, it is not necessary to use a septum with pores whose average size is less than the average size of the solid particles.

It has been found that solid particles are successfully retained by pores larger than the average size of retained particles. The solid particles entrained by the liquid flow to the filter wall are subjected to various conditions.

The simplest case is when the particle lingers on the surface of the partition, having a size larger than the initial cross section of the pores. If the particle size is smaller than the size of the capillary in the narrowest section, then 8 :

  • the particle can pass through the partition along with the filtrate;
  • the particle can linger inside the partition as a result of adsorption on the pore walls;
  • the particle can be delayed due to mechanical deceleration at the site of the pore gyrus.

Turbidity of the filter at the beginning of filtration is due to the penetration of solid particles through the pores of the filter membrane. The filtrate becomes transparent when the septum acquires sufficient retention capacity.

Thus, filtering occurs by two mechanisms:

  • due to the formation of sediment, since solid particles almost do not penetrate into the pores and remain on the surface of the partition (sludge type of filtration);
  • due to clogging of pores (blocking type of filtration); in this case, almost no precipitate is formed, since the particles are retained inside the pores.

In practice, these two types of filtering are combined (mixed type of filtering).

Factors affecting the volume of the filtrate and, consequently, the speed of filtration are divided into 9 :

Hydrodynamic;

Physical and chemical.

Hydrodynamic factors are the porosity of the filtering partition, its surface area, the pressure difference on both sides of the partition and other factors that are taken into account in the Poisel equation.

Physico-chemical factors are the degree of coagulation or peptization of suspended particles; content in the solid phase of resinous, colloidal impurities; the influence of a double electric layer that appears at the boundary of the solid and liquid phases; the presence of a solvate shell around solid particles, etc. The influence of physicochemical factors, closely related to surface phenomena at the phase boundary, becomes noticeable at small sizes of solid particles, which is exactly what is observed in pharmaceutical solutions to be filtered.

Depending on the size of the particles to be removed and the purpose of filtration, the following filtration methods are distinguished:

1. Coarse filtration - to separate particles with a size of 50 microns or more;

2. Fine filtration - ensures the removal of particles with a size
1-50 microns.

3. Sterile filtration (microfiltration) is used to remove particles and microbes with a size of 5-0.05 microns. In this variety, ultrafiltration is sometimes isolated to remove pyrogens and other particles with a size of 0.1-0.001 microns. Sterile filtration will be discussed in the topic: “Injectable dosage forms”.

All filtering apparatus in industry are called filters; their main working part is filtering partitions.

Filters operating under vacuum are suction filters.

Nutsch - filters are convenient in those cases when it is necessary to obtain clean washed sediments. It is not advisable to use these filters for liquids with slimy sediments, ether and alcohol extracts and solutions, since ether and ethanol evaporate faster when rarefied, are sucked off into a vacuum line and enter the atmosphere.

Filters operating under excess pressure - druk - filters. The pressure drop is much greater than in suction filters and can range from 2 to 12 atm. These filters are simple in design, highly productive, allow filtering viscous, highly volatile and high resistivity liquid sediments. However, to discharge the sediment it is necessary to remove the top of the filter and collect it by hand.

Frame filter - the press consists of a series of alternating hollow frames and plates with corrugations and grooves on both sides. Each frame and plate are separated by a filter cloth. The number of frames and slabs is selected based on the productivity, quantity and purpose of the sediment, within 10-60 pcs. Filtration is carried out under a pressure of 12 atm. Filter-presses have high productivity, well-washed sediments and clarified filtrate are obtained in them, they have all the advantages of druk filters. However, very strong materials must be used for filtering.

The “Fungus” filter can work both under vacuum and at overpressure. The filtration unit consists of a container for the filtered liquid; filter "Fungus" in the form of a funnel, on which a filter cloth (cotton wool, gauze, paper, belting, etc.) is fixed; receiver, filtrate collector, vacuum pump.

Thus, filtering is an important process in the technological sense. It is used either independently, or can be an integral part of the scheme for the production of such pharmaceutical products as solutions, extractable preparations, purified precipitates, etc. The quality of these products depends on properly selected filtering apparatus, filter materials, filtration speed, solid-liquid phase ratio, structure solid phase and its surface properties.


Chapter 2 EXPERIMENTAL

2.1 Quality control of a solution of sodium bromide 6.0, magnesium sulfate 6.0, glucose 25.0, purified water up to 100.0 ml

Features of chemical control. Qualitative and quantitative analyzes are carried out without prior separation of the ingredients.

The most express method for determining glucose in liquid dosage forms is the refractometry method.

Organoleptic control. Colorless transparent liquid, odorless.

Definition of authenticity

Sodium bromide

1. To 0.5 ml of the dosage form, add 0.1 ml of diluted hydrochloric acid, 0.2 ml of chloramine solution, 1 ml of chloroform, and shake. The chloroform layer turns yellow (bromide ion).

2. Place 0.1 ml of the solution in a porcelain dish and evaporate on a water bath. 0.1 ml of copper sulfate solution and 0.1 ml of concentrated sulfuric acid are added to the dry residue. A black color appears, disappearing with the addition of 0.2 ml of water (bromide ion).

2NaBr + CuSO4 → CuBr2↓ + Na2SO4

3. Part of the solution on a graphite rod is introduced into a colorless flame. The flame turns yellow (sodium).

4. To 0.1 ml of the dosage form on a glass slide, add 0.1 ml of a solution of picric acid, evaporate to dryness. Yellow crystals of a specific shape are examined under a microscope (sodium).

Magnesium sulfate

1. To 0.5 ml of the dosage form, add 0.3 ml of ammonium chloride solution, sodium phosphate and 0.2 ml of ammonia solution. A white crystalline precipitate is formed, soluble in dilute acetic acid (magnesium).

2. 0.3 ml of barium chloride solution is added to 0.5 ml of the dosage form. A white precipitate is formed, insoluble in dilute mineral acids (sulfates).

Glucose. To 0.5 ml of the dosage form, add 1-2 ml of Fehling's reagent and heat to a boil. A brick-red precipitate forms.

Quantitation.

Sodium bromide. 1. Argentometric method. To 0.5 ml of the mixture, add 10 ml of water, 0.1 ml of bromophenol blue, dropwise diluted acetic acid to a greenish-yellow color, and titrate with 0.1 mol/l silver nitrate solution to a violet color.

1 ml of 0.1 mol/l silver nitrate solution corresponds to 0.01029 g of sodium bromide.

Magnesium sulfate. complexometric method. To 0.5 ml of the mixture, add 20 ml of water, 5 ml of an ammonia buffer solution, 0.05 g of an indicator mixture of acidic chromium black special (or acidic chromium dark blue) and titrate with a 0.05 mol/l solution of Trilon B until a blue color.

1 ml of a 0.05 mol/l Trilon B solution corresponds to 0.01232 g of magnesium sulfate.

Glucose. The determination is carried out refractometrically.

Where:

n is the refractive index of the analyzed solution at 20 0 C; n 0 - refractive index of water at 20 0 C;

F NaBr - refractive index increment factor of 1% sodium bromide solution, equal to 0.00134;

C NaBr - concentration of sodium bromide in the solution, found by the argentometric or mercurimetric method, in%;

F MgSO4 7Н2О - refractive index increment factor of 2.5% magnesium sulfate solution, equal to 0.000953;

C MgSO4 7Н2О - the concentration of magnesium sulfate in solution, found by the trilonometric method, in%;

1.11 - conversion factor for glucose containing 1 molecule of water of crystallization;

R SILENT GLUCK. - factor of increase in the refractive index of anhydrous glucose solution, equal to 0.00142.

2.2 Quality control of novocaine solution (physiological) composition: Novocaine 0.5, hydrochloric acid solution 0.1 mol/l 0.4 ml, sodium chloride 0.81, water for injection up to 100.0 ml

Features of chemical control. Novocaine is a salt formed by a strong acid and a weak base, therefore, during sterilization, it can undergo hydrolysis. To prevent this process, hydrochloric acid is added to the dosage form.

In the quantitative determination of hydrochloric acid by the method of neutralization, methyl red is used as an indicator (in this case, only free hydrochloric acid is titrated and hydrochloric acid associated with novocaine is not titrated).

Organoleptic control. Colorless, transparent liquid, with a characteristic odor.

Definition of authenticity.

Novocaine. 1. To 0.3 ml of the dosage form, add 0.3 ml of diluted hydrochloric acid 0.2 ml of 0.1 mol / l sodium nitrite solution and pour 0.1-0.3 ml of the resulting mixture into 1-2 ml of freshly prepared alkaline solution r-naphthol. An orange-red precipitate forms. Upon addition of 1-2 ml of 96% ethanol, the precipitate dissolves and a cherry red color appears.

2. Place 0.1 ml of the dosage form on a strip of newsprint and add 0.1 ml of dilute hydrochloric acid. An orange spot appears on the paper.

Sodium chloride. 1. Part of the solution on a graphite rod is introduced into a colorless flame. The flame turns yellow (sodium).

2. To 0.1 ml of solution add 0.2 ml of water, 0.1 ml of dilute nitric acid and 0.1 ml of silver nitrate solution. A white cheesy precipitate (chloride ion) is formed.

Hydrochloric acid. 1. 0.1 ml of methyl red solution is added to 1 ml of the dosage form. The solution turns red.

2. Determination of the pH of the dosage form is carried out potentiometrically.

Quantitation.

Novocaine. nitritometric method. To 5 ml of the dosage form, add 2-3 ml of water, 1 ml of diluted hydrochloric acid, 0.2 g of potassium bromide, 0.1 ml of tropeolin 00 solution, 0.1 ml of methylene blue solution and titrate at 18-20 ° C dropwise 0.1 mol/l sodium nitrite solution until the red-violet color changes to blue. In parallel, conduct a control experiment.

1 ml of 0.1 mol/l sodium nitrite solution corresponds to 0.0272 g of novocaine.

Hydrochloric acid. alkalimetric method. 10 ml of the dosage form is titrated with 0.02 mol/l sodium hydroxide solution until yellow coloration (indicator - methyl red, 0.1 ml).

The number of milliliters of 0.1 mol / l hydrochloric acid is calculated by the formula:

Where

0.0007292 - titer of 0.02 mol / l sodium hydroxide solution for hydrochloric acid;

0.3646 - the content of hydrogen chloride (g) in 100 ml of 0.1 mol / l hydrochloric acid.

Novocaine, hydrochloric acid, sodium chloride.

Argentometry is the method of Faience. To 1 ml of the dosage form, add 0.1 ml of a solution of bromophenol blue, drop by drop diluted acetic acid to a greenish-yellow color and titrate with a 0.1 mol/l solution of silver nitrate to a violet color. The number of milliliters of silver nitrate spent on interaction with sodium chloride is calculated from the difference between the volumes of silver nitrate and sodium nitrite.

1 ml of 0.1 mol/l silver nitrate solution corresponds to 0.005844 g of sodium chloride.


FINDINGS

Dissolution is a spontaneous, spontaneous diffusion-kinetic process that occurs when a solute comes into contact with a solvent.

In pharmaceutical practice, solutions are obtained from solid, powder, liquid and gaseous substances. As a rule, obtaining solutions from liquid substances that are mutually soluble in each other or miscible with each other proceeds without much difficulty as a simple mixing of two liquids. The dissolution of solids, especially slowly and sparingly soluble ones, is a complex and time-consuming process. During dissolution, the following stages can be conditionally distinguished:

1. The surface of a solid body is in contact with a solvent. The contact is accompanied by wetting, adsorption, and penetration of the solvent into the micropores of solid particles.

2. Solvent molecules interact with layers of matter on the interface. In this case, solvation of molecules or ions occurs and their detachment from the interface.

3. Solvated molecules or ions pass into the liquid phase.

4. Equalization of concentrations in all layers of the solvent.

The duration of the 1st and 4th stages depends mainly on

rates of diffusion processes. The 2nd and 3rd stages often proceed instantly or quickly enough and have a kinetic character (the mechanism of chemical reactions). It follows from this that the dissolution rate mainly depends on diffusion processes.


LIST OF USED LITERATURE

  1. GOST R 52249-2004. Rules for the production and quality control of medicines.
  2. State Pharmacopoeia of the Russian Federation. – 11th ed. - M. : Medicine, 2008. - Issue. 1. - 336 p.; issue 2. - 400 s.
  3. State Register of Medicines / Ministry of Health of the Russian Federation; ed. A. V. Katlinsky. - M. : RLS, 2011. - 1300 p.
  4. Mashkovsky M. D. Medicines: in 2 volumes / M. D. Mashkovsky. – 14th ed. - M. : New Wave, 2011. - T. 1. - 540 p.
  5. Mashkovsky M. D. Medicines: in 2 volumes / M. D. Mashkovsky. – 14th ed. - M. : New Wave, 2011. - T. 2. - 608 p.
  6. Muravyov I. A. Drug technology: in 2 volumes / I. A. Muravyov. - M. : Medicine, 2010. - T. 1. - 391 p.
  7. OST 42-503-95. Control-analytical and microbiological laboratories of technical control departments of industrial enterprises producing medicines. Requirements and procedure for accreditation.
  8. OST 42-504-96. Quality control of medicines at industrial enterprises and organizations. General provisions.
  9. OST 64-02-003-2002. Products of the medical industry. Technological regulations of production. Content, procedure for development, coordination and approval.
  10. OST 91500.05.001-00. Pharmaceutical quality standards. Basic provisions.
  11. Industrial technology of medicines: textbook. for universities: in 2 volumes / V. I. Chueshov [and others]. - Kharkov: NFAU, 2012. - T. 1. - 560 p.
  12. Technology of dosage forms: in 2 volumes / ed. L. A. Ivanova. - M. : Medicine, 2011. - T. 2. - 544 p.
  13. Technology of dosage forms: in 2 volumes / ed. T. S. Kondratieva. - M. : Medicine, 2011. - T. 1. - 496 p.

2 Chueshov V. I. Industrial technology of drugs: textbook. for universities: in 2 volumes / V. I. Chueshov [and others]. - Kharkov: NFAU, 2012. - T. 2. - 716 p.

3 Chueshov V. I. Industrial technology of drugs: textbook. for universities: in 2 volumes / V. I. Chueshov [and others]. - Kharkov: NFAU, 2012. - T. 2. - 716 p.

4 Chueshov V. I. Industrial technology of drugs: textbook. for universities: in 2 volumes / V. I. Chueshov [and others]. - Kharkov: NFAU, 2012. - T. 2. - 716 p.

5 Chueshov V. I. Industrial technology of drugs: textbook. for universities: in 2 volumes / V. I. Chueshov [and others]. - Kharkov: NFAU, 2012. - T. 2. - 716 p.

6 Workshop on the technology of dosage forms of factory production / T. A. Brezhneva [and others]. - Voronezh: Voronezh Publishing House. state un-ta, 2010. - 335 p.

7 Workshop on the technology of dosage forms of factory production / T. A. Brezhneva [and others]. - Voronezh: Voronezh Publishing House. state un-ta, 2010. - 335 p.

8 Muravyov I. A. Drug technology: in 2 volumes / I. A. Muravyov. - M. : Medicine, 2010. - T. 2. - 313 p.

9 Mashkovsky M. D. Medicines: in 2 volumes / M. D. Mashkovsky. – 14th ed. - M. : New Wave, 2011. - T. 2. - 608

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Egorova Svetlana
Head Department of Pharmacy FPKiPPS Kazan State Medical University, Doctor of Pharmacy, prof.

Industrial pharmacies are a necessary link in drug supply. But we do not proceed from the fact that it is necessary to preserve the pharmacy, but from the fact that it is necessary to ensure the proper treatment process, to determine which pharmaceutical drugs are necessary for the effective functioning of healthcare.

Industrial pharmacies, firstly, make it possible to meet the needs of healthcare in dosage forms that have no industrial analogues; secondly, to ensure individual dosing of medicinal substances; thirdly, to make dosage forms without preservatives and other non-indifferent additives, when it is necessary for public health.

Example. Throughout the country, a sterile solution of chlorhexidine bigluconate 0.02% and 0.05% sterile in vials (100 ml - 400 ml) is needed for all departments of the surgical profile - for washing cavities during operations. Neither purulent surgery nor ENT practice works without it, surgical dentistry should not work without it - where there is a wound. And where there is no production pharmacy, what is used instead of a sterile solution? There are a lot of non-sterile solutions, there are both flavorings and additives. This means that in those regions where there is no production pharmacy, problems with the quality of medical care may inevitably occur. What will the cavities be washed with? Replacement with a non-sterile solution is unacceptable, because. it will not withstand the annual storage period due to its physical and chemical properties.

Sterile solutions for drinking newborns are also needed in 10 ml or 5 ml bottles (sterile purified water, a little 5% sterile glucose solution, etc.). We know the position of the WHO that children should receive sterile milk, but they need to be supplemented in maternity wards - not in large quantities, only for medical reasons with just such solutions. Here is the link to the document approved by the Decree of the Chief State Sanitary Doctor of the Russian Federation dated May 18, 2010 No. 58 "Sanitary and epidemiological requirements for organizations engaged in medical activities", as well as "Sanitary and epidemiological rules and regulations" - SanPiN 2.1.3.2630-10 , which emphasizes that “for the prevention of nosocomial infections in obstetric hospitals (departments) and the organization of an anti-epidemic regime water and solutions for drinking must be sterile in individual single packaging". And if there is no industrial pharmacy in the maternity hospital, what is the newborn to drink? Who sterilizes the penicillin vials that nurses dispense the solution into? Where do they get 5% glucose that does not contain stabilizers? That is, avoiding problems with the production pharmacy, others get more terrible ones.

That document says:

  • Do not feed multiple babies from the same bottle. It is unacceptable to use any medicines from ampoules - in order to avoid injury from glass fragments!
  • It is unacceptable to use solutions for injections of factory production due to the content of stabilizers!
  • It is unacceptable to pour solutions for drinking newborns into penicillin bottles by medical personnel!
  • Where there are no production pharmacies, where they take sterile vaseline oil for treating the skin of newborns?

How does purulent surgery work, where there are no industrial pharmacies? Why don't they use sterile hypertonic sodium chloride solution 10% in vials(100 ml - 400 ml) - for local use in purulent surgery (traumatology, gynecology). Nothing has yet been invented better than this solution, and patients do not bring it with them.

So, glucose powders(20 g - 70 g) for the study of the "sugar curve" is prescribed individually, depending on the characteristics of the patient. In those hospitals where there are no industrial pharmacies, how is the “sugar curve” determined? How many sugar cubes? This is wrong! The accuracy of the study cannot be achieved, on the basis of which very serious diagnoses are made!

Instructions for use of a sterile injection novocaine solution does not say that it is for electrophoresis! It's not there! On the basis of which this novocaine solution is used off-lable, i.e. outside of the recorded readings? There is no such basis. This solution should be only pharmacy-made.

Thus, it is unacceptable to replace solutions for medicinal electrophoresis of pharmacy manufacture with factory injection solutions of novocaine, aminophylline, ascorbic acid, nicotinic acid and zinc sulfate eye drops due to the content of excipients (stabilizers, antioxidants).

Ointments, solutions of protargol, collargol for ENT practices it is also more effective when they are pharmacy production.

This is how we see the directions of development of pharmaceutical manufacturing. As for the nomenclature of pharmaceutical preparations, it is necessary to use modern effective medicinal substances in pharmacy practice, especially for children's dosage forms. And when we consider the assortment of a modern industrial pharmacy, it is worth noting the fact that the existing substances have long been obsolete. As long as there are no modern substances in the pharmacy, it will not be competitive. In particular, the substance of elteroxin is needed, because. its microquantities are prescribed according to vital indications. This issue is now being resolved. But if the newborns do not immediately begin to give the drug, then all their development will go with violations.

Also, for the nomenclature of dosage forms, modern excipients are needed, such as antioxidants (they are listed in the Pharmacopoeia), stabilizers, and in special cases, preservatives.

A fundamental revision of the order of the Ministry of Health of Russia of July 16, 1997 No. 214 "On Quality Control of Medicines Manufactured in Pharmacies" is necessary. There are many problems. The problem of equipping pharmacies with modern analytical equipment is very important for us.

How has the equipment of, for example, clinical laboratories changed recently? If there is no modern equipment, then it is possible to carry out control under the contract in accredited organizations. A pharmacist-analyst with a pipette does not correspond to the current level of development of pharmacy, it will be difficult to provide the required quality.

In our opinion, in modern pediatric centers, where the currently unresolved problem of individual dosing of adult dosage forms for children is especially acute, a prerequisite for licensing should be the availability of a production pharmacy provided with the necessary substances.

In this order, there are problems with the expiration dates of intra-pharmacy preparations (after all, the order was created when there was a production pharmacy at each hospital), as well as packaging of finished medicines in individual packages for inpatients. Abroad, a patient in a hospital receives a package for each day, where it is written: what drugs to take on that day, series and regimen. In this case, it is realistic to exercise control over the correctness of the reception. We have different ways of distributing medicines at medical posts. To whom they give for a week, to whom for three days, and often, especially for bedridden patients, the medical staff packs them into tubes, bags and gives them out for a long time. All over the world, this is the function of a pharmacy. If we strive for international standards, then we must act in such a way that the medical staff performs medical functions, and the pharmacy performs its own, i.e. provided medicines. And now in hospitals, pharmaceutical activities - I note, without a license - are nurses everywhere. It shouldn't be like that. Quality control of these medicinal products is not carried out after violation of primary and often secondary packaging.

Next is the problem of the rules of pharmacy technology, expiration dates. Order of the Ministry of Health of Russia dated October 21, 1997 No. 308 “On approval of the Instructions for the manufacture of liquid dosage forms in pharmacies” also needs to be revised in accordance with the modern recipe, because the product is the most popular, pharmacies produce the most drugs in liquid forms. And in the Pharmacopoeia there are a variety of articles - "suspensions", "emulsions", "powders", etc., but there are no articles ... "solutions", "potions". This departmental order, which we are guided by in the manufacture of the dosage form, needs to be revised in accordance with the modern formulation.

The requirement to account for each medicinal substance in the manufacture of solutions containing one ingredient is very debatable, accounting for the maximum percentage concentration at which the change in the total volume is within the allowable deviation. We offer a return to the previously established norms - no more than 2-3% - to facilitate the work of pharmacies, which does not lead to any significant changes in the quality of manufactured dosage forms - only to labor costs and possible errors.

Also, in the preamble of this order, it is indicated that all intra-pharmaceutical preparations must be made under aseptic conditions. And the aseptic block is a separately allocated territory of the pharmacy. These provisions are completely inconsistent with reality.

There is no legal solution to the issue of intra-pharmacy procurement of extemporaneous dosage forms according to frequently repeated prescriptions. Should it be considered as mass production?

The expiration dates of medicines manufactured in pharmacies require experimental justification and revision taking into account modern formulations (Order of the Ministry of Health of Russia dated July 16, 1997 No. 214 "On Quality Control of Medicines Manufactured in Pharmacies").

For decades, the container and packaging of pharmaceutical dosage forms has not changed. Abroad, pharmacies widely use starch wafers - in shape, like checkers, and in consistency, like corn sticks.

A legal solution is needed for the possibility of using polymer containers in the pharmaceutical production of liquid and soft dosage forms.

The requirements for the sanitary regime in pharmacy organizations have not changed since 1997, and we consider it a priority to revise the order of the Ministry of Health of Russia dated October 21, 1997 No. regarding premises and equipment, and, in our opinion, relaxing the requirements for the manufacture of non-sterile dosage forms.

The requirements for the layout of premises for the manufacture of medicines in aseptic conditions are not universally observed, with the rare exception of pharmacies that have "clean rooms".

There is also a need for a modern concept of a production pharmacy in terms of layout and sanitary requirements for sterile and non-sterile manufacturing.

Speaking of pharmaceutical personnel, it should be said that the modern program on pharmaceutical technology (pharmacy technology) for the training of both pharmacists and pharmacists contains sections that are contrary to the changed requirements for pharmacy manufacturing. For example, take the section "Dosage forms for injection":

  • obtaining water for injections in a pharmacy;
  • injection technology, incl. infusion, solutions;
  • technology of emulsions and suspensions.

Examples of prescriptions given in textbooks often duplicate the nomenclature of finished medicinal products and contain unregistered pharmaceutical substances. It is necessary to introduce new prescriptions, incl. for children, use modern substances, modern equipment for intra-pharmacy quality control.

Summary: A production pharmacy is a necessary link in the healthcare system!