General pharmacopoeial articles and pharmacopoeial articles of the State Pharmacopoeia of the Russian Federation
XIII edition
V.A. Merkulov, E.I. Sakanyan, TB Shemierhankina, O.A. Mochikina, N.D. Bunyatan
Federal State Budgetary Institution "Scientific Center of Expertise Medical Application" Ministry of Health of the Russian Federation, 127051, Moscow, Russia
Summary: The State Pharmacopoeia of the Russian Federation is a set of general pharmacopoeia articles and pharmacopoeia articles and is subject to reissue at least 1 time in 5 years. The next publication of the State Pharmacopoeia of the Russian Federation, planned to enter the light in 2015, will include both first developed in the practice of domestic, and in some cases and global pharmacopy analysis of general pharmacopy articles and pharmacopoeia articles and articles that are updated and revised options General pharmacopoeial articles and pharmacopoeial articles. The introduction of general pharmacopy articles and pharmacopoeial articles of this edition of the State Pharmacopoeia of the Russian Federation will significantly increase the level of domestic pharmacopoeia analysis and will ensure its compliance with the requirements of world standards.
Keywords: state pharmacopoeia; General pharmacopoeial article; Pharmacopoeia article; medicinal quality; Pharmacopoeia analysis.
Bibliographic Description: Merkulov VA, Sakanyan EI, Shemereankina TB, Mochikina OA, Bunyatian ND. General pharmacopoeial articles and pharmacopoeial articles of the State Pharmacopoeia of the Russian Federation of the XIII edition. Vedomosti scientific center examination of medical applications 2015; (2): 54-58.
General Monographs and Pharmacopoeial Monographs of the State Pharmacopoeia of the Russian Federation, XIII EDITION V.A. Merkulov, E.I. Sakanyan, T.B. Shemeryankina, O.A. Mochikina, N.D. Bunyatyan.
Federal State Budgetary Institution "Scientific Center for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation, 127051, Moscow, RUSSIA
Abstract: The State Pharmacopoeia of the Russian Federation Is a Collection of General Monographs and Pharmacopoeial Monographs. IT SHOLD BE REISSUED AT LEAST ONCE IN 5 YEARS. The next scheduled edition of the State Pharmacopoeia of the Russian Federation is planned for publication in 2015. It will include both first developed in national and, in some cases, global pharmacopoeial analysis general and pharmacopoeial monographs, and updated revised general and pharmacopoeial monographs. The Implementation of the General and Pharmacopoeial Monographs of The Mentioned Edition of the State Megmacopoeia of the Russian Federation Will Significantly Increase The Level Of National Pharmacopoeial Analysis and Ensure Its Compliance with International Standards.
Key Words: State Pharmacopoeia; General Monograph; Pharmacopoeial Monograph; Drug Quality; Pharmacopoeial Analysis.
Bibliographic Description: Merkulov Va, Sakanyan Ei, Shemeryankina TB, Mochikina Oa, Bunyatyan ND. General Monographs and Pharmacopoeial Monographs of the State Pharmacopoeia of Russian Federation, XIII EDITION. Scientific Center for Expert Evaluation of Medicinal Products Bulletin 2015; (2): 54-58.
The main goal that the State Pharmacopoeia of the Russian Federation (GF RF) is pursued is the rationing of the quality of drugs in circulation in the domestic pharmaceutical market.
Currently, in the territory of the Russian Federation, the GF X of the publication (1968), GF XI edition (part 1 - 1987, part 2 - 1989), as well as the GF XII publication (part 1 - 2007). The specified deadlines for the release of these publications of GF suggests that they do not comply with the requirements of the current Federal Law of April 12, 2010. "On the circulation of medicines" No. 61-ФЗ in terms of reprinting the State Pharmacopoeia.
Despite this, general pharmacopoeia articles (OFSs) and pharmacopoeia articles (FS) included in the public pharmacopoeia X-x11 editions are not canceled. Some of them need a revision, some of the articles have already lost their relevance in connection with the abnormality. These include such an Office as "the biological method for determining the activity of 0.1% of the hydrochloride adrenaline solution", "biological testing
nova Novasenol and Mairsenol, "" determination of the degree of whiteness of powdered medicines "and others. It is also necessary to cancel FS for drugs withdrawn from circulation. In addition, they need to revise the FS, approved in the period between the issues of pharmacopy, for which individual enterprises produce drugs and monitor their quality, as the methods of pharmacopoeia analysis are constantly being improved.
Currently, for inclusion in the next XIII, the Edition of the Russian Federation of the Russian Federation has been trained 229 OFS and 179 FS. They can be divided into relevant sections.
Section "General Pharmacopoeia Articles" Contains: Articles on General Methods, Office for Analysis Methods, Reagents, Drug Forms and Methods for Analysis; Medicinal vegetative raw materials and methods for assessing its quality; groups of immunobiological drugs and methods for their analysis; Medicinal preparations of blood and plasma of human blood and animals and analysis methods used in assessing their quality; Radio Pharmaceutical Medicines.
Pharmacopoeia articles are presented in the sections "Pharmaceutical substances" and "Medicinal preparations". The "Pharmaceutical Substance" section is represented by pharmacopoeial articles on pharmaceutical substances of synthetic or mineral origin used as valid and / or auxiliary substances. In addition, in the form of a separate subsection, pharmacopoeial articles are presented for medicinal vegetable raw materials used in pharmaceutical production, including medicinal plant preparations. The "Medicinal preparations" section consists of two subsections: immunobiological drugs and medicinal products derived from blood and blood plasma.
Annexes to the GF of the Russian Federation XIII editions are represented by reference tables: a table of atomic masses, alcohol-starving tables, the table of isotonic equivalents of medicinal substances in sodium chloride, a table of quantity of drops in 1 g and in 1 ml and a mass of 1 drop of liquid drugs at 20 ° C According to the standard carriage, the drawings of the IR spectra of standard samples of pharmaceutical substances.
From this number, for the first time for the Russian Federation of the Russian Federation, the XIII of the publication was developed and recommended for approval of 102 of the Office, among which 30 OFS on the methods of analysis, 5 OFS for dosage forms and 12 OFS for the methods of determining pharmaceutical and technological indicators of dosage forms, 2 OFS for medicinal plant raw materials and 3 OFS on methods for its analysis, 7 OFS for groups of immunobiological drugs and 31 OFSs on the methods of their tests, 3 OFS on groups of drugs from the blood and plasma of human and animal blood, 9 OFS on the methods of analyzing drugs derived from blood and plasma blood of man and animals.
In addition, for inclusion in the state pharmacope of the Russian Federation, the XIII editions were first prepared 17 pharmacopoeia articles, including 4 FS for pharmaceutical substances, 4 FS for medicinal vegetative raw materials, 5 fs for immunobiological drugs and 4 fs for drugs from blood and blood plasma .
A row of Offs, previously represented in the State Pharmacopoeia of the USSR X and XI editions (GF of the USSR X Edition, GF of the USSR XI editions), is excluded from the practice of modern pharmacopy analysis as unclaimed. Other operating Offices and FS GF of the USSR X editions, GF of the USSR XI editions (Issue 1, 2) and the State Pharmacopoeia of the Russian Federation of the XII Edition (RF GF of the XII Edition) revised and supplemented with materials, taking into account modern requirements, scientific and practical achievements in the field of pharmacopy analysis.
The Office "Rules for the use of pharmacopoeia articles" is complemented by partitions "Humidity" and "Storage". In addition, appropriate clarifications were made to the section "Description", "Mass", "Volume", "Temperature", "Accurate Handset", "Solvents", "Indicators", "Content Limits", "Filming".
In the Office of Sampling, the terms are made to definitions, general provisions, supplemented by the "Sampling Rules" section. Also introduced new sections: "Sampling from non-self-installed drugs and materials
lov "," Selection of samples of drugs in consumer packaging "," Packaging, marking, storage of selected samples "," Requirements for premises for sampling, equipment and personnel. "
The Sita Analysis Office was developed instead of the XI XI Office of the Edition "Determination of Powders and Sita's Criminal Proceedings" and the appointment of sieve analysis, conditions and methods for its conduct, classification of typical sizes in accordance with the requirements of world standards.
In the new edition of the Office "Sterilization", modern actual methods and conditions of sterilization of pharmaceutical substances, drugs, auxiliary substances, etc., criterion of the level of sterilization is given, the characteristic of biological indicators of sterilization is given.
In accordance with additional toxic data data in the Office "Residual Organic Solvents", clarifications are made and added information on solvents with insufficient toxicity.
In the Office "Radio Pharmaceuticals" expanded the section "The list of quality indicators, which should correspond to the Radio Pharmaceutical Preparations of Industrial Production and EXTEMERPORAL MANUAGE", and the section "half-life" is supplemented by the half-wave equation.
In the Pharmaceutical Substance Office, there are significant additions to the section that characterizes the requirements for the quality of pharmaceutical substances (for example, "residual organic solvents", "bacterial endotoxins or a pyro-geanness", etc.). The edited definition of the term "pharmaceutical substance" is given. The Office is supplemented by sections according to biological analysis methods: "anomalous toxicity" and "histamine and / or de pressing substances". It contains such tables as "limits of control, identification and qualifications of related impurities for pharmaceutical substances", "limits of control, identification and qualifications of related impurities in the peptides obtained by the synthetic way" and "criteria for the rationing of the permissible content of heavy metals".
The Office "The shelf life of drugs" is supplemented by section "Testing stability by the method of" accelerated aging ".
In the Office "General reactions to authenticity" additionally introduced the section "Aluminum", and in the Office "The combustion method in the flask with oxygen" was "selenged".
The description of the purity tests and permissible limits of impurities in drugs are continued. So, for the first time, methods for determining aluminum impurities, phosphates, mercury and selenium are given. Methods for determining ammonium impurities, calcium, arsenic, sulfates, chlorides and zinc and regulatory requirements for their content are harmonized with the requirements of world standards. In the Office "Heavy Metals" additionally indicate the methods of quantitative determination of individual ions, and in the Office "Iron" clarifications are made regarding the concentration of reagents.
The definition of fluorine in drugs is recommended to conduct three methods: tutrimetry, spectrophotometric and ionometric.
In addition to determining the number of washythiation, acidic, ethereal and iodine numbers in the Russian Federation of the Russian Federation, XIII publications include an Office on the definition of re-acid, hydroxyl and ani-acidic numbers. In contrast to the peroxidant, an ani-coded number characterizes the content in the test pharmaceutical substance and / or drug of secondary oxidation products (aldehydes, ketones) and thus gives a complete picture of the quality of the drug analyzed.
The Office "Definition of Protein" was significantly revised: the construction of the article was changed, a refinement was made to determine interfering substances, a description of spectrophotometric and colorimetric methods for determining the protein was introduced, a fluorimetric method of determining the protein using O-phthalaldehyde was introduced. This method is excluded as the definition of a protein with a nonstable reagent - this method is included in a separate Office "Determination of protein nitrogen with a nonstable reagent with preliminary precipitation of protein material in immunobiological drugs."
For the characteristics of the main indicator of the quality of antacids drugs in the Russian Federation of the Russian Federation, the XIII edition is first included for the definition of acid-demitable ability.
Modern spectroscopic methods of studying the structure and quality of drugs are the methods of Raman spectrometry, X-ray fluorescent spectrometry, spectrometry method in the near infrared spectrum, spectrometry in the infrared field of spectrum, spectrophotometry in the ultraviolet and visible regions of the spectrum, atomic emission spectrometry, fluorimetry, nuclear magnetic spectroscopy Resonance, mass spectrometry, etc. Taking into account the current capabilities of spectroscopic methods, such an Office as "Raman spectrometry", "X-ray fluorescent spectrometry", "Mass spectrometry" and "spectrometry in the near infrared region" were developed for the first time.
The need to introduce polymorphism and crystallinity is due to the relevance of the estimation of polymorphism and the degree of crystallinity or the content of the amorphous fraction in pharmaceutical substances, which subsequently determines the therapeutic effect of drugs, significantly affects the parameters of their biological accessibility.
OFS "Atomic-emission spectrometry and atomic absorption spectrometry" GF XII edition (part 1) is divided into two Offs: "Atomic emission spectrometry" and "Atomic absorption spectrometry". In the next edition of the Russian Federation of the Russian Federation, a revised and augmented version of the Atomic Emission Spectrometry will be presented.
The formulation of the definition of the method in the direction of greater conciseness and versatility was changed in the new edition of the Fluorimetry, the pharmaceutical substances for which this method of determining is available, the sources of exciting radiation are described, the concept of Stokes shift is given with a brief substantiation of the cause of this phenomenon, the groups of compounds with fluorescence are specified. properties-
mi supplemented a list of factors affecting the fluorescence intensity.
For the first time, general pharmacopoeia articles "Optical microscopy" and "Determination of particle distribution on the size of the laser diffraction of light" are included in the State Pharmacopope. In contrast to the microscopy method, the method of studying dispersed systems based on the scattering of laser light allows us to evaluate all particles, is non-structured and allows measuring the particle size in the range from 0.1 μm to 3 mm, in contrast to the optical microscopy used to characterize particles of 1 μm and more.
Two separate articles are devoted to weight loss during drying and determining water. In addition to the Lumikromethodology, K. Fishera describes a capulometric method (micrometeode), which allows to quantify the microcolism of water in medicines.
In the Office "Viscosity", a definition was changed for non-newtonissions of liquids, the conditions for determining viscosity on a rotary viscometer were characterized. As new, the following subsections were made: "Viscometers with a concentric cylinder (absolute viscometeries)", "Viscometers with a cone-plane system (absolute viscometers)" and "Viscometer with a spindle (relative viscometers)".
Development of the Office "Electricity" was caused by the need to include this indicator of the quality and method of determining it in the FS "Water purified" and "water for injection".
Alternative or additional to chromat-graphical test methods is the electrophoresis method. With the revision of the Office "Electrophoresis", a separate attention was paid to the description of the most widely sought-after in the pharmaceutical analysis of the method of electrophoresis of proteins in a polyacrylamide gel with sodium dodecyl sulfate. Compared to traditional electrophoresis, the introduction of capillary electrophoresis made it possible to automated quantitative determination of not only charged large molecules or microparticles, but cations, anions and neutral connections.
The electrophoresis method in the polyacrylamide gel is widely used in separating various proteins and estimate their molecular weight. Variating the concentration of polyacrylamide in the gel can be monitored by the range of molecular weights of shared proteins, which is very convenient to obtain accurate results. Fractions of protein molecules using this method is widely used to control the quality of protein medicines.
For the first time in the practice of domestic pharmaceutical analysis, an automatic elemental analysis is introduced, which can significantly simplify the analysis of organic compounds containing in its composition nitrogen, sulfur, chlorine, bromine, oxygen and other elements. The definition is based on the high-temperature oxidative decomposition of the studied substances and the subsequent selective determination of the decomposition of gas chromatography corresponding to these elements. One of the advantages of automatic elemental analysis is the ability to use one standard sample with a known content of the element defined to assess the quality of various drugs on this element.
The determination of the adsorption activity of enterosor-benfes is a specific indicator of the quality of this class of drugs. Adsorption activity is used to characterize the absorbency of enterosorbents, the methods of determination was reflected in this Office.
Included in the Russian Federation of the Russian Federation XIII editions of the article describing biological methods of quality control of medicines correspond to the modern approach to biological testing. In the Office "Bacterial endotoxins" a description of photometric methods for determining bacterial endotoxins are introduced: turbidimetric and chromogenic.
From the Office "Biological methods for assessing the activity of medicinal plant raw materials and drugs containing heart glycosides" with its revision, the method of biological assessment of the content of heart glycosides conducted on cats is excluded.
The Office "Microbiological purity" is significantly finalized and supplemented with new sections, including relative to the requirements for immunobiological drugs.
The revision of the Office "Determination of the effectiveness of antimicrobial preservatives" made it possible to make appropriate additions and clarifications regarding categories of medicines, which include preservatives and criteria for evaluating the effectiveness of antimicrobial preservatives of drugs.
Revision of the Office "Reagents. Indicators "led to a significant increase in the list of reagents and indicators used in pharmacopoeane analysis. Chemical names of reagents and indicators are given in accordance with the requirements of the International Union of Theoretical and Applied Chemistry (IUPAC). The CAS registration numbers (Chemical Abstracts Service) of the chemical substances included in the chemical reference service register are listed. Claims and additions are made to chemical formulas and physical parameters of reagents and indicators.
When revising the Office "Statistical processing of the results of a chemical experiment and biological testing" was divided into two Offices: "Statistical processing of the results of a chemical experiment" and "Statistical processing of the results of determining the specific pharmacological activity of drugs by biological methods".
For the first time in the Russian Federation of the Russian Federation, the XIII editions are developed and included such an Office as "dosage forms", "dosage forms for inhalations", "Transder-Mal Plockers", "solutions" and "cut-pressed granules".
Dosage forms of Office contains basic terms and definitions, classification of dosage forms, general requirements for production / manufacturing, quality assessment, packaging, labeling and storage of drugs in appropriate dosage forms. This Office provides quality indicators that are mandatory to assess the quality of the drug in any dosage form, as well as quality indicators, the characteristics of the production / manufacturing of the drug and the composition of the active and auxiliary substances.
17 OFS for dosage forms was introduced instead of the corresponding articles of the USSR of the XI Edition, with add-ons and changes.
Most OFS on the methods of assessing pharmaceutical and technological indicators of the quality of dosage forms are included in the Russian Federation of the XIII publication for the first time. Separate Offices are developed on the methods of analysis, previously described in the articles of GF XI for dosage forms (methods for determining the extracted amount of dosage forms for parenteral use, the abrasion of the tablets, the time of complete deformation of the Lie suppositories on Lee-Pofili, the disintegrance of tablets and capsules).
First developed and included in the Russian Federation of the Russian Federation, XIII edition of the Office on such methods for determining pharmaceutical and technological indicators of the quality of dosage forms, as "visible mechanical inclusions in dosage forms for parenteral use and eye medicinal forms", "invisible mechanical inclusions in dosage forms for parenteral applications" , "Mass (volume) of the contents of packaging", "Dosing homogeneity", "The homogeneity of the mass of dosage forms", "the strength of the pills to crushing", "the disintegration of suppositories and vaginal tablets", "dissolution for lipophilic-based suppositories", "Fruit Powders, "" dissolution for transdermal plasters. "
Subsection "Medicinal vegetable raw materials and methods of its analysis" includes 23 Offs and 55 FS. Requirements for sampling, storage, packaging, labeling and transportation of medicinal plant materials and medicinal plant preparations are presented in the "General Articles" subsection in the Office "Selection of Medicinal Petry Samples and Medicinal Plant Preparations", OFS "Storage of Medicinal Petry and Medicinal Purgeons "And offs" Packaging, labeling and transportation of medicinal plant materials and medicinal plant preparations ".
General requirements for medicinal vegetation raw materials are set forth in the Office "Medicinal Vegetable Raw Material". 12 OFS are devoted to methods for analyzing medicinal plant materials and medicinal plant preparations. In 8 offs, the requirements for the methods of analyzing medicinal plant raw materials are described depending on the morphological groups: flowers, fruits, seeds, kidneys, herbs, leaves, bark and underground organs. Also in this section presents 2 OFS for medicinal products of plant origin: Oil "Oil fat vegetable" and "oils of essentials".
Office "Medicinal Vegetable Raw Material" is designed and included for the first time in the Russian Federation. This article presents the classification of medicinal plant materials depending on the morphological groups, from the grain, the content of a group of biologically active substances, shows the main indicators of the quality of medicinal plant raw materials and general requirements for storage and packaging.
Of the 12 Offices on the methods of analyzing medicinal plant raw materials 3 of the Office included in the Russian Federation of the XIII publication for the first time, 9 of the Office was reworked and administered instead of articles of the USSR XI edition. For the first time included in the practice of domestic pharmaceutical analysis: the Office "Determination of heavy metals and arsenic in medicinal vegetation and medicinal plant
preparations ", OFS" Determination of the content of residual pesticides in medicinal vegetation raw materials and medicinal plant preparations ", offspiece" Definition of the coefficient of water absorption and the consuming coefficient of medicinal plant raw materials ".
In the Russian Federation of the Russian Federation, XIII publications included new types of medicinal vegetable raw materials allowed for medical use, such as aronia of black-fed dry fruits, ginkgo two-sighted leaves, the donon of grass and poplar kidney. The structure of pharmacopoeia articles on medicinal vegetable raw materials is harmonized with the requirements of world pharmacopy standards for medicinal vegetable raw materials.
The subsection of the "Group of immunobiological drugs and methods of their analysis" includes 43 OFS and 48 FS to immunobiological preparations.
The ILP includes vaccines, anatoksins, serums and allergens.
For the first time in the practice of domestic pharmaceutical analysis, an Office was introduced into separate groups of ILPs, such as "bacteriophages of therapeutic and prophylactic", "pro-biotics", "bifido-containing probiotics", "Colorso-holding probiotics", "Lake-containing probiotic", "Sploral probiotics "And" medicines received by the methods of recombinant DNA. "
Of the 48 fS of the XIII Edition included in the Russian Federation of the Russian Federation, 5 FS were developed for the first time in the practice of domestic pharmacopoeia analysis: "Vaccine dysenteric against Schigell Lipopolysaccharide zone", "Vaccine against crushing culture live", "Vaccine-free inactivated", "Human immunoglobulin" " FS "Pyrohenal, Rectal Suppositories" was developed for the first time in the practice of domestic and global pharmaceutical analysis.
Medicinal preparations of blood and plasma of human and animals are represented by 13 OFS and 8 FS.
The drugs from the blood and plasma of human blood include drugs of Albumin human
kA, human immunoglobulin preparations and blood coagulation factors containing one of the coagulation factors or a combination of them.
12 OFS for drugs from the blood and plasma of the blood of man and animals in the Russian Federation of the Russian Federation, the XIII publications are presented for the first time.
In pharmacopoeial articles on pharmaceutical substances of synthetic and mineral origin, the chemical names of medicinal substances are given in accordance with the requirements of the International Union of Theoretical and Applied Chemistry (Shran), quality indicators, their normalized values \u200b\u200band the corresponding methods for analyzing these indicators.
As the main method of identification, the method of infrared spectrometry, which gives the most reliable result. For a number of substances in an annex to the Russian Federation of the Russian Federation, the XIII editions are drawd pictures of the IR spectra of standard samples of these pharmaceutical substances.
With quantitative determination, preference is given to classic tyrimetric analysis methods. Along with this, modern methods of physicochemical analysis are widely used, such as spectroscopy in the ultraviolet region, gas and highly efficient liquid chromatography, which imply the use of standard samples. The content of the active substance is given in terms of dry (if the mass loss is determined during drying), anhydrous (if water is determined) or anhydrous, not containing residual organic solvents.
Thus, the introduction of the Offices and FS, prepared for the next, XIII edition of the Russian Federation of the Russian Federation will not only cancel or replace the morally obsolete articles of the Russian Federation of the Russian Federation of previous publications, but also ensures that the level of domestic pharmacopy analysis will ensure the requirements of world standards.
literature
1. State Pharmacopoeia of the USSR. 10th ed. M.: Medicine; 1968.
2. State Pharmacopoeia of the USSR. 11th ed. Vol. 1. M.: Medicine; 1987.
3. State Pharmacopoeia of the USSR. 11th ed. Vol. 2. M.: Medicine; 1989.
4. State Pharmacopus of the Russian Federation. 12th ed. Part 1. M.: Scientific Center Examination of Medicine Means; 2007.
Federal State Budgetary Institution "Scientific Center for Examination Medical Application Medical Applications" of the Ministry of Health of the Russian Federation. Russian Federation, 127051, Moscow, Petrovsky Boulevard, 8.
Merkulov Vadim Anatolyevich. First Deputy General Director, Dr. Med. Science, professor.
Sakanyan Elena Ivanovna. Director of the Center for Pharmacopoeia and International Cooperation, Dr. Farm. Science, professor.
Shemierhankina Tatyana Borisovna. Head of the State Pharmacopoeia and Pharmacopoeial Analysis Department, Cand. Farm. science Mochikina Olga Alekseevna. Researcher of the Department of State Pharmacopoeia and Pharmacopoeia Analysis.
Bunyatan Natalia Dmitrievna. Deputy General Director for Research, Dr. Farm. Science, professor.
1. The State Pharmacopoeia of UsSr. 10th Ed. Moscow: meditsina; 1968 (in russian).
2. The State Pharmacopoeia of USSR. 11th Ed. V. 1. MOSCOW: MEDITSINA; 1987 (in russian).
3. The State Pharmacopoeia of USSR. 11th Ed. V. 2. MOSCOW: MEDITSINA; 1989 (in russian).
4. The State Pharmacopoeia of Russian Federation. 12 TH ED. V. 1. MOSCOW: Federal State Budgetary Institution "Scientific Center for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation; 2007 (in russian).
Federal State Budgetary Institution "Scientific Center for Expert Evaluation of Medicinal Products" of The Ministry of Health Of The Russian Federation, 8 Petrovsky Boulevard, Moscow, 127051, Russian Federation.
Merkulov VA. FIRST DEPUTY DIRECTOR GENERAL. Doctor of Medical Sciences, Professor. Sakanyan EI. Director of Center for Pharmacopoeia and International Cooperation. Doctor of Pharmaceutical Sciencees, Professor.
Shemeryankina TB. Head of the Department of State Pharmacopoeia and Pharmacopoeia Analysis. Candidate of Pharmaceutical Sciences.
Mochikina OA. ResearCer of the Department of State Pharmacopoeia and Pharmacopoeia Analysis.
Bunyatyan ND. Depeut Director General For Scientific Work. Doctor of Pharmaceutical Sciencees, Professor.
A pharmacopoeial article is a document in which the quality norms of drugs or raw materials are indicated. Also, information about the packaging, conditions, storage times, control methods is prescribed. The document is approved by federal bodies, so it has state importance. It includes the name of raw materials in Russian and Latin.
Pharmacopoeia article of the enterprise
At every enterprise, producing medicines, the quality standard is valid. It involves the use of drug control methods at all stages of production. Typically used technology that has been verified and registered by the standards
In production, all standards should be used, not lower than the requirements in the State Document. The pharmacopoeial article has a period of action that claims when adopting it. Usually the term is no more than 5 years. The technological process is necessarily taken into account.
Offs
The total pharmacopoeial article is a state standard of quality of drugs. It is prescribed requirements for drugs, as well as a description of control methods. The main information is:
- list of indicators and testing methods;
- chemical, physical, biological properties;
- requirements for drugs.
A pharmacopoeial article is accepted by the management of the Department, and then register in an organization that carries out activities for the production of drugs.
ChFS.
Private pharmacopoeia articles are documents in which the quality and safety of drugs is prescribed. Make them for drugs under the international non-specific name.
Temporary pharmacopoeial article
This document is produced during the development of industrial preparation. It is necessary to process ways to establish quality or indicators of a new medicine for a period of no more than 3 years.
What is the article about?
A pharmacopoeial article includes many important information. In the introductory section, you can find information about the period of collecting raw materials, as well as its characterization. For processing, products are dried, mounted, fresh, freshly frozen. Plants can be wild and cultivated. Indicates life form, name.
Compulsory information includes external signs that serve as confirmation of the purity and quality of products. The composition of raw materials and signs should include a pharmacopoeia article. Drugs are also valued by microscopy method, which allows you to establish the authenticity of products. This section includes signs of the structure of raw materials, as well as the type of microclimate, where the study was carried out.
Alcohol on pharmacopoeial articles, as well as other drugs are checked for various reactions or samples. This is necessary to verify product authentication. Qualitative reactions determine the methods for performing verification and results.
Numerical indicators
The section consists of specific indicators and their norms:
- solid, cut, powderous raw materials is determined on quality; necessarily checks all drug raw materials;
- finding in the preparations of existing components, ash common and insoluble.
number
Makes a method for determining the main existing components in the form of a sum based on any number of a particular component. When an individual substance is obtained, its content is normalized.
Other features
The document is indicated necessary for all drugs, as well as the mass of the substance needed for one box. With the help of microbiological purity, the level of microorganisms and their number is revealed.
The marking performed on the basis of the generally accepted graphic design requirements is important. The necessary information includes the requirements for loading, unloading. The rules of competent transportation, in which the properties of products do not change.
The document contains information on the conditions for storing drugs, including protection against the effects of nature factors. An important information includes the shelf life, during which the medicine can be used for its intended purpose. After it to do it is unacceptable because it represents a threat to health. The pharmacological action section includes information about the group to which the medicine belongs.
Storage
The article has information about proper storage of products. Special premises must comply with all standards to ensure the safety of drug quality.
The complex of the premises should consist of:
- acceptance area, where unpacking, packaging drugs;
- funds selection zones;
- premises for quarantine;
- plot for storing special preparations;
- premises for defective and overdue goods.
Each zone must be indicated. It is important to match the premises of sanitary and hygienic requirements. The legislation establishes the need to support the climatic regime based on the temperatures and humidity rates taken.
The documentation has information about the control over the air exchange room for the storage of medicines. Such rooms must have natural and artificial lighting. If required, the Sun protection is set. With the help of these and other rules, production, storage and release of drugs.
In accordance with Article 7 of the Federal Law of April 12, 2010 No. 61-FZ "On the Arrangement of Medicines" (meeting of the legislation of the Russian Federation, 2010, No. 16, Art. 1815; No. 31, Art. 4161) I order:
To approve the procedure for the development of general pharmacopoeia articles and pharmacopoeial articles and including them in the State Pharmacopoeia, as well as placement on the official website in the Internet "Internet" data on the State Pharmacopoeia.
application
The procedure for the development of general pharmacopy articles and pharmacopoeial articles and including them in the State Pharmacopoeia, as well as placement on the official website in the Internet "Internet" data on the State Pharmacopoeia
1. This procedure establishes the rules for the development, approval of common pharmacopoeial articles and pharmacopoeial articles, including them in the State Pharmacopoeia and publication of the State Pharmacopoeia, as well as the rules and timing of the placement on the official website in the "Internet" data on the state pharmacopoeia and applications to it.
2. The basic concepts are in the present order are used in the same meaning as in the federal law of April 12, 2010 No. 61-FZ "On the circulation of medicines".
3. Common pharmacopoeia articles and pharmacopoeia articles are developed and revised taking into account new achievements in the field of biological, biochemical, microbiological, physicochemical, physical, chemical and other methods for analyzing medicines for medical use.
4. Common pharmacopoeia articles and pharmacopoeia articles are developed by the Ministry of Health and Social Development of the Russian Federation, including on the basis of proposals received from the subjects of drug circulation.
5. General pharmacopoeial articles and pharmacopoeia articles are approved by the Ministry of Health and Social Development of the Russian Federation and constitute a state pharmacopoeia.
6. Development of a pharmacopoeia article on the original drug and the inclusion of it in the State Pharmacopoeia during the term of protection of the exclusive right, certified by a patent on the original drug, are carried out with the consent of its developer.
7. A common pharmacopoeia article contains a list of quality indicators and (or) methods for controlling the quality of a particular dosage form, medicinal plant materials, descriptions of biological, biochemical, microbiological, physical and chemical, physical, chemical and other drug analysis methods for medical applications, as well as Requirements for used to carry out this analysis by reactivities, titrated solutions, indicators.
8. The pharmacopoeial article contains a list of quality indicators and methods of drug quality control for medical use.
The structure and indicators of the pharmacopoeia article in each particular case can be individual on the basis of the specifics of the profile and nature of the origin of the drug. The pharmacopoeial article is being developed for the drug under the international non-specific name, if it is available (for monocomponent drugs), and contains a mandatory list of indicators and quality control methods, taking into account its dosage form.
9. Upon completion of the development of a general pharmacopoeia article and a pharmacopoeia article by the Responsible Department of the Ministry of Health and Social Development of the Russian Federation (hereinafter - the Department) is a draft article on the official website of the Ministry of Health and Social Development of the Russian Federation on the Internet "Internet" for a public discussion for a period of thirty days .
10. Upon the expiration of the established period of public discussion, the Department sends to the Council of the Ministry of Health and Social Development of the Russian Federation under State Pharmacopoeia (hereinafter - the Council for the State Pharmacopoeia), a draft general pharmacopoeial article and a pharmacopoeia article with a documentary justification containing exhaustive data on the feasibility and the need for it Approval.
11. The State Pharmacopoeia Council is formed from representatives of scientific organizations, educational institutions of higher vocational education, representatives of the pharmaceutical industry, as well as representatives of the Department, in order to consider general pharmacopy articles and pharmacopy articles on their scientific validity and need for practical application.
12. The Council for the State Pharmacopoeia for 30 days is considering the draft general pharmacopoeial article and a pharmacopoeia article and makes a decision on the approval of the proposed project or the disapproval of the project indicating the reasons.
13. Within five working days after the approval of the project of a general pharmacopoeia article and a pharmacopoeia article, the Department prepares the draft order of the Ministry of Health and Social Development of the Russian Federation on approval of the general pharmacopoeia article and pharmacopoeia article.
14. In the case of disapproval of the project of a general pharmacopoeia article and a pharmacopoeia article, the Department is finalizing the draft general pharmacopoeia article and a pharmacopoeia article, taking into account the recommendations of the Council on State Pharmacopoeia. The deadline for the project should not exceed forty days.
15. Approved General Pharmacopoeia Articles and Pharmacopoeia Articles are made to the State Pharmacopoeia, which is published by the Ministry of Health and Social Development of the Russian Federation at least once every five years, in the period between which applications are published to the State Pharmacopoeia, containing general pharmacopoeia articles and pharmacopoeia articles, Approved after the publication or reprint of the State Pharmacopoeia.
16. Approved general pharmacopoeia articles and pharmacopoeia articles, the state pharmacopoeia and applications are published in specialized printed publications and are posted within three working days from the date of their approval and publication on the official website of the Ministry of Health and Social Development of the Russian Federation on the Internet.
17. The State Pharmacopoeia is published and posted on the official website of the Ministry of Health and Social Development of the Russian Federation on the Internet "Internet" by making the following information:
a) general pharmacopoeia articles included in the next edition of the State Pharmacopoeia;
b) pharmacopoeial articles included in the next edition of the State Pharmacopoeia;
c) Annexes to the State Pharmacopoeia, containing general pharmacopoeia articles and pharmacopoeial articles approved after the publication or reprint of the State Pharmacopoeia.
18. State Pharmacopoeia data posted on the official website of the Ministry of Health and Social Development of the Russian Federation in the Internet "Internet", open and publicly available.
19. Timely updating of the data of the State Pharmacopoeia, technical measures to protect the information contained in them, from unauthorized access is provided by the Department of Informatization of the Ministry of Health and Social Development of the Russian Federation.
20. Information update is carried out continuously. A backup copy of the State Pharmacopoeia data is formed in order to protect the information contained in it, at least once a day. The protection of these pharmacopoeia data from unauthorized access is carried out by the built-in tools of the operating system and the management system of the State Pharmacopoeia.
Order of the Ministry of Health and Social Development of the Russian Federation of August 26, 2010 No. 756N "On approval of the procedure for developing general pharmacopy articles and pharmacopy articles and including them in the State Pharmacopoeia, as well as placement on the official website" Internet "data on the State Pharmacopoeia"
Overview of the document
From September 1, 2010, a new law regulating drug treatment has entered into force.
In this regard, it is defined as pharmacopoeia articles (including common) are developed and included in the State Pharmacope.
A pharmacopoeial article is a document that lists the indicators and methods for controlling the quality of the drug. The general article includes indicators and (or) Ways to control the quality of a particular dosage form, medicinal plant materials, descriptions of drug analysis methods, requirements for reactivations used for this, titrated solutions, indicators.
Articles are developed and approved by the Ministry of Health and Social Development of Russia. They are revised taking into account new achievements in the field of drug analysis methods.
The draft article is posted on the Ministry website for 30 days for public discussion. He is then heading to the Council on the State Pharmacopoeia, where it is considered within 30 days.
The project not approved by the Council is being finalized.
Approved articles are entered into a state pharmacopoeia. It is published at least 1 time in 5 years. Between them are issued applications.
These articles, public pharmacopoeia and applications are published in specialized printed publications and are posted on the website of the Ministry of Health and Social Development of Russia.
Standardization of medicines It is usually the main guarantor of their high quality in mass production and ensures efficiency and safety of use. Quality management is achieved by implementing a set of activities, methods and means that provide and maintain product quality. Standardization solves the following main tasks: the development of regulatory requirements for the quality of finished products, as well as to the quality of raw materials, semi-finished products used in its manufacture; development of requirements and standards in the field of design and production, methods and means of its testing and control; ensuring the unity and correctness of measurements in the country, the development of new and improving existing standards of units of measurements; Pharmacopoeial article (FS) - This is a regulatory and technical document that establishes the requirements for the quality of the drug or medicinal plant, its packaging, the conditions and deadlines, the methods of quality control, approved by the authorized federal executive authority and the nature of the state standard. Pharmacopoeial articles (species): Pharmacopoeial article of the enterprise (FSP) - This is the standard of Quality LS under the trade name, contains a list of methods and indicators of quality control indicators of LS production of a particular enterprise, the specific technology of this enterprise, which has been examined and registered in the prescribed manner in accordance with the State Pharmacopoeia is taken into account. General Pharmacopoeia article (Office):- This is a state standard of Quality LS, containing basic drug requirements, as well as a description of the standard methods for controlling the quality of medicines. Pharmacopoeia article, a general pharmacopoeial article and a pharmacopoeial article of the enterprise are approved by the head of the department, and after they are registered in the Organization authorized by the Ministry of Health of the Russian Federation, with the obligatory assignment of the designation. Private pharmacopoeia article (FFS):- This is a regulatory and technical document regulating the quality and safety of the drug, a private pharmacopoeial article for a drug under the international non-specific name is created. Temporary pharmacopoeia article: - This is a regulatory and technical document approved for the period of development of the industrial output of the drug and for the development of industrial technology for determining the quality or indicators of a new drug for a period of no more than 3 years.
14.The main sections of the FS on the example of the pharmaceutical substance.
Pharmaceutical substance- Standardized biologically active substance or standardized mixture of biologically active substances obtained by synthesis methods or using biological, molecular genetic or cellular technologies intended for the preparation of drugs.
Many substances are salts of organic acids and organic grounds. The names of pharmacopoeia articles on such substances should include the name and cation, and anion. For example, sodium diclofenac, potassium diclofenac or amlodipine Blueless or doxazozin mesylate or ketamine hydrochloride. The names of substances, which are in their chemical nature with esters, are written in a punk. For example, the beclametazondipropionate, and not the beclametazone dipropionate or betamethazone, and not Betamethazone Valerat.
In the introductory part of the pharmacopoeial article, the substance is given a chemical name according to the nomenclature of the JUPAC, the structural formula, empirical formula and the relative molecular weight.
Description. Indicate the characteristics of the physical condition and the color of the substance. Do not include a description of taste. In the necessary cases, inform information about the smell and hygroscopicity.
For solid substances, an indication of the "crystalline", "fine-crystalline" or "amorphous powder" is necessary. The characteristic of the substance crystallinity is one of the important parameters on which the quality of solid dosage forms depends.
In some cases, a numerical range of particle size can be specified, as well as the study of the shape of crystals. Such tests are carried out in separate sections.
Assessment of the substance polymorphism is mandatory in cases where the polymorphic modification determines the pharmacological activity of the finished dosage form and its pharmacological and technological properties.
Solubility. To determine the solubility, solvents are used to cover a wide polarity scale, for example: water, 96% alcohol, acetone, hexane. The use of low-boiling and flammable (for example, diethyl ether) or very toxic (for example, benzene) solvents is not recommended.
Authenticity. To establish the authenticity of the substance, the optimal combination of physicochemical and chemical methods - infrared spectroscopy, absorption spectrophotometry, thin-layer, gas and highly efficient liquid chromatography (TLC, GC and HPLC) and high-quality (primarily specific) chemical reactions are recommended.
Melting temperature. Test is usually used to characterize solids.
A pharmacopoeial article is a state document, reflecting the quality criteria for medicines and raw materials for them. In the article, the article considers the concept of FS, the levels of their regulation, as well as the types and structure of pharmacopy articles
Pharmacopoeial article (FS) is a document reflecting the quality criteria for medicines and materials for them. There also specified information about packaging, timing, storage conditions and methods of high-quality control.
The article includes the concept of FS, the levels of their regulation, as well as the types and structure of pharmacopy articles.
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From the article you will learn:
Pharmacopoeia article is a regulatory document of state importance. It is approved by the executive bodies and contains the quality indicators of the medicinal product and methods of its control, and also describes how to study the quality of the medication and reagent requirements, solutions and indicators.
The name of raw materials for the drug in the document is indicated in both Russian and in Latin, while the latter plays the role of the international name.
Until January 1, 2018, the development of the FS was within the competence of the Ministry of Health. Since the beginning of this year, these powers are transferred to expert organizations.
Pharmacopoeia: regulation levels
Pharmacopoeia is a collection of quality requirements for medicines. The history of such documents begins with deep antiquity. Among the first of them - Papyrus Edwin Smith, Pariacoma of the Senior Plane, the "Garden of Tovo" Petaire Schüffel, as well as a pharmacope, made up in the Renaissance Epoch in Italy. The first pharmacopoeia, which was supervised by state power, was published in the middle of the XVI century in Germany.
In Russia, the first pharmacopoeia on Latin was published in the XVIII century, in Russian - in the XIX century. In fact, from the document published in the XIX century, the ordinal numbering of the FS began (the 11th edition was published at the end of the last century).
FS regulates the requirements for the quality of the active substances of drugs, auxiliary components, tools for diagnostics and prepared from them. It is based on its provisions - the achievements of pharmanalysis and pharmaceutical chemistry, their criteria, techniques and methods.
Here we are prescribed technology preparation and quality control of a particular medication, maximum dosages of drugs. Strict following the requirements set forth in the FS in the complex with the execution of the GMP standard standards - the key to the high quality of the obtained medicines and substances.
- State Pharmacopoeia article - the legislative document of the state level under the authority supervision; His provisions and norms are obligatory for all enterprises and industries, whose activities are related to the manufacture, storage and application of medicines (including based on medicinal plants).
- Pharmacopoeial article of the enterprise (FSP) - a document, which includes a list of criteria and methods of quality control of the drug production of a particular enterprise, taking into account the technologies used, examination and registration procedures (the maximum period of the FSP is 5 years).
- General Pharmacopoeia article (OFS) - includes basic requirements for the form of the drug and standard ways to assess its quality, as well as a list of norms and methods of examination for a specific lecture;
- Private pharmacopoeial article (FFS) is a regulatory and technical regulation of the security and quality of the medication, developed for the drug under the MNN recommended by WHO.
- Temporary pharmacopoeial article - is developed for the period of development of the industrial release of the drug and to improve the industrial technology of methods for assessing its properties and quality (relevant 3 years).
The FS is periodically revised taking into account achievements in the field of chemistry, pharmaceuticals, medicine and other scientific disciplines. The structure and criteria of the FS in each individual case may differ on the basis of the specifics of the profile and the origin of the medication and raw materials for it.
Pharmacopoeia contains in yourself:
- description of medication analysis techniques;
- data on indicators, solutions and reactivities used to assess the quality of the drug;
- description of articles on certain substances and substances;
- lists of toxic and potent components;
- lists of dosages for people of different ages.
National Pharmacopia
Pharmacopoeia articles are available in many countries of the world - in the USA, France, Great Britain, Belarus, Ukraine, Germany, etc. WHO is developing an international pharmacopoeia article, but it does not have the properties of the law, which you cannot say about national pharmacops.
The international or European pharmacopoeial article apply as a regulatory document only in those states where their own similar documents are not developed. In addition, many pharmaceutical giants produce medicines according to the requirements of the customer company, that is, or on the basis of one or another FS.
Structure of a pharmacopoeia article
FS contains a lot of most valuable information posted in the relevant sections.
They are presented in the table below:
| Introduction (preamble) | The raw materials collection time (calendar or vegetation phase) characteristic of raw materials according to the technological processing mode:
|
| Exterior signs | The composition of the raw size of raw materials is characteristic diagnostic signs of smell and taste (for non-toxic varieties) |
| Microscopy | Diagnostic signs of the anatomy of raw materials (for some species, fluorescent microscopy is used) a variety of microsperature on which a study is carried out |
| Qualitative reactions | High-quality and histochemical reactions Chromatographic samples of authenticity on the main groups of existing substances, methods of their implementation and results |
| Numerical indicators | Specific criteria and their norms for solid, cutter raw materials or raw materials in the form of powder Degree of grinding The concentration of active or extractive substances, impurities, ash of general and ash insoluble in the hydrochloric acid solution |
| Qualitative definition | The method of quantitative determination of the main active substances in the form of the amount, in terms of any substance contained in this raw material (if an individual substance is distinguished, the content of this component in the raw material is normalized) |
| Packaging | Types of packaging Mass of raw materials in a unit packaging |
| Microbiological purity | Methods of detection of microorganisms Permissible limits of microorganisms |
| Marking | Is given in accordance with the requirements for graphic design of drugs |
| Transportation | Requirements for transportation, loading and unloading drugs, appeal to them after transportation |
| Storage | Conditions for storage of drugs Protection measures from the influence of adverse factors |
| Shelf life | The time period in which raw materials can be used |
| pharmachologic effect | Pharmacological group in which concrete raw materials |
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