: People's Medical Publishing HousePublished Date
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This edition of the Pharmacopoeia of the People’s Republic of China (known as the Chinese Pharmacopoeia 2005 or in abbreviation as Ch. P 2005) has been prepared in accordance with the principles and designed plan decided by the Eighth Chinese Pharmacopoeia Commission and accomplished with the effort made by Commission members and its Secretariat over more than two years. The Chinese Pharmacopoeia 2005 adopted by the Executive Commission of the Chinese Pharmacopoeia Commission is approved for implementation by the State Food and Drug Administration of China. This is the eighth edition of Chinese Pharmacopoeia since the founding of the People’s Republic of China.
The Chinese Pharmacopoeia 2005 has been considerably revised and improved in General Notices, Requirements of Monographs, General Requirements for Preparations in Appendices and new testing methods, etc. Based on the introduction of advanced technology and experimental methods widely adopted in China and abroad, the contents of Appendices are revised y and large in consistence with those nowadays applied internationally for drug quality control. On the premise that every effort should be made to follow the principle of “safety for use, reliability of therapeutic effect, feasibility of processes, controllability of manufacturing quality and perfection of specification”, the monographs admitted in the Pharmacopoeia on the whole reflect the actual clinical use of drugs in china. Furthermore, stylistic rules and layout, working, units, and symbols, etc. have also been standardized.
The Chinese Pharmacopoeia 2005 is published in three volumes. Volume I contains monographs of Chinese material medica and prepared slice, vegetable oil/fat and its extract, Chinese traditional patent medicines, single ingredient of Chinese crude drug preparations etc.; Volume II deals with monographs of chemical drugs, antibiotics, biochemical preparations, radiopharmaceuticals and excipients for pharmaceutical use; Volume III contains biological products. The Requirements for Biologics of the People’s Republic of China is now incorporated into the Chinese Pharmacopoeia for the first time. Based on the characteristics and the needs of improvement of Chinese traditional medicines, chemical drugs and biological products, the research work and the studies are carried out in an active way on drug standards and methodology. At the same time; great effort are made to unify the national drug standards and to bring them in line with the international standards progressively. In addition, emphasis have been put to harmonization in Appendices of different volumes of Pharmacopoeia, to a sound connection between individual monographs and the relevant appendices, and to the standardization of text working so as to make the edition more precise and better structured.
The increase of the number of monographs in the Chinese Pharmacopoeia 2005 is obvious which contains up to 3214 monographs of drugs, with 525 new admissions in total. Volume I contains 1146 monographs, with 154 new admissions and 453 revised; Volume II deals with 1967 monographs, w3ith 327 new admissions and 522 revised; Volume III contains 101 monographs, with 44 new admissions and 57 revised. 9 monographs adopted in the Chinese Pharmacopoeia 2000 are not admitted in this edition and 123 monographs adopted in the Requirements for Biologics of the People’s Republic of China 2000 and in its Supplement 2000 are not admitted in this edition.
The number of monographs in Appendices of the edition is much expanded. There are 98 monographs admitted in Appendices of Volume I with 12 new admissions, 31 revised and 1 deleted. There are 137 monographs in Appendices of Volume II with 13 new admissions, 65 revised an 1 deleted. There are 140 monographs in Appendices of Volume III with 62 new admissions, 78 revised and 1 deleted. The monographs in Appendices common to all the three volumes are presented in each volume respectively in a harmonized and unified form.
Extensive applications of contemporary techniques of analysis are shown in this edition. In Volume I, the number of monographs adoption this layer chromatography in the test for identification reaches 1523 and 45 monographs for content determination; the number of monographs adopting high performance liquid chromatography)HPLC) reaches 479 and 518 items are involved; and the number of monographs adopting gas chromatography in the tests for identification and content reaches 47. In volume II, the comparison with that in 2000 edition, and this method is mostly used for the analysis of complex formulation and those drugs containing much more interfering factors such as impurities or excipients, and used for content determination in 223 newly admitted monographs. The number of monographs required for identification by infrared analysis reaches 70; the tests for dissolution and test of content uniformity are added in test items in 93 and 37 monographs, respectively, and the test for related substances is added in 226 monographs, and the requirements for systematic suitability testing are more reasonable. Based on the validation of methodology, the test for bacterial endotoxins instead of pyrogen test in rabbits is introduced to 73 monographs’ on the premise that the drug purity is ensured, the test for undue toxicity for 42 monographs is deleted.
Significant revisions and expansion are made in the Appendices of this edition leading a great improvement in the monographs of Appendices. In order to adapt the need of drug administration, new preparations such as implants, rinsing agents, enemas, paint, and smeared films, etc. are admitted in the General Requirement for Preparation. Many subtypes of dosage form are also admitted in General Requirement for Preparation, such as soluble tablets and vaginal effervescent tablets admitted into General Requirement for tablets; sustained release capsules and controlled release capsules admitted into General Requirement for capsules, etc. Test for sterility is added in test items in some of preparations of General Requirement for Preparations. New general testing methods have been admitted, such as Determination of Total Organic Carbon in the Water for Pharmaceutical Use, Test for Visible Particles in Injections, Mass Spectrometry, Determination of Cataplasms Adhension, Test for Allergen, Biological Assay of Calcitonin and Growth Hormone, etc. Furthermore, considerable revisions are made for a number of Appendices according to modern techniques and practical situation, for example, the tests on 12 pesticides containing organic phosphorous and 3 pesticides containing pyrethroid are added for determination of pesticide residues; the test for small volume of injection is included in the Test for Particulate Matter in Injections; the test for system suitability is admitted for Thin-layer Chromatography; Microbial Limit Tests is revised according to the requirements of drug administration route and tests for validation are added; the time of incubation in sterility test has been changed from 7 to 14 days.
In the section of guidelines, such guidelines have been revised to keep pace with the development of research and production of drugs as the Guidelines the Stability Testing of Drug Substances and Preparations and the Guidelines for Sustained, Controlled and Delayed Release Preparations, and new guidelines are admitted such as the Guidelines for Hygroscopicity and Guidelines for Near-Infrared (NIR) Spectrophotometry, etc. Although those guidelines do not serve as legal requirements, they play an important role in assessment of drug quality, in establishing, standardizing and implementing uniform pharmaceutical specification of drugs and medicines.
The safety of pharmaceuticals is another important issue of the Chinese pharmacopoeia 2005. In Appendices of Volume I, for example, atomic absorption spectrophotometry or inductively coupled plasma mass spectrometry is introduced to determine 6 kinds of heavy metals and deleterious elements, and the limits for lead, cadmium, mercury, arsenic and cupper are stipulated for the first time’ the harmful solvents, such as benzene etc. used in pharmaceuticals should be substituted by other solvents as far as possible. The Guidelines for Application of Safety Tests for Injection of Traditional Chinese Medicine is also admitted in this edition; In Volume II, the Test for Particulate Matter in Injections is applied to 126 Injections intended for intravenous injection; the number of monographs adopting the Test for Bacterial Endotoxin reaches 112; the Determination of Residual Solvent includes the requirements of the International Conference on Harmonization (ICH) for residual solvents, and the test is required for 24 drug substances; the Guidelines for the Analysis of Impurities in Drugs, Guidance for the Quality Control of Positron Emission Tomographic and Technetium [99mTc] Radiopharmaceutical Preparations are also admitted. In Volume III, new methods such as Determination of Reverse Transcriptase Activity and Test for Residual Aluminum Content in Human Albumin etc. are admitted, and some test methods are improved such as the test for residual bovine serum albumin and test for residual CHO cell protein, etc. On consideration of the status quo of medical industry and practical situation of drugs for clinical use, the requirements set forth in Detailed Regulations for clarity Test and Criteria formerly issued by the Ministry of Health are replaced by the method for Determination of Visible Particles in this edition so as to enhance the safety of pharmaceuticals including injection.
According to the theory of traditional Chinese medicine – diagnosis and treatment based on an overall analysis of the illness and the patient’s condition, the Indications under the Chinese patent preparations have been scientifically standardized, so as to avoid the phenomenon of easy misleading usage of drugs and to give prominence to features of the above theory. At the same time, the attention should be paid to the fact that a phenomenon of “different diseases having same syndrome” and “same disease having different syndromes” exists between “Syndrome” in traditional Chinese medicine and “Disease” in Western medicine. The close combination of “Syndrome” in traditional Chinese medicine and corresponding “Disease” in Western medicine embodies the scientificity and accuracy of the expression of Indications, so as to ensure clinicians to understand the Indications precisely and make use of drugs rationally, thus facilitating the sound development of traditional Chinese medicine in the new era.
The working procedures for preparation of this edition also has been improved. In addition to the traditional way of requesting for comments, the contents of revised appendices and monographs should be publicized on the website of the Chinese Pharmacopoeia Commission for three months, aiming at collecting comments widely from various institutions and organizations. All the feedbacks and inputs should be reviewed by the relevant subcommittee to ensure the feasibility and practicability of the standards and methods revised in this edition of Pharmacopoeia, and ensure that the principle of “openness, justice and fairness” is kept in the process of compiling and editing.