Introduction in English
PHARMACOPOEIA OF THE PEOPLE'S REPUBLIC OF CHINA (2000 English Edition)
This edition of the Pharmacopoeia of the People's Republic of China (known as Chinese Pharmacopoeia 2000 or in abbreviation as Ch. P 2000) has been prepared in accordance with the principles and requirements by the Seventh Pharmacopoeia Commission and accomplished with the effort of more than three years. The draft text has been reviewed and approved by the Executive Committee of the Pharmacopoeia Commission and authorized by the State Drug Administration for publication. This is the seventh edition of the Pharmacopoeia of People's Republic of China since the founding of the People's Republic of China.
Chinese Pharmacopoeia 2000 is published in 2 volumes, with rather extensive revision in comparison with previous edition. It contains up to 2691 monographs of drugs and other articles with 399 new admissions. In volume I, it contains 992 monographs of Chinese crude drugs and traditional Chinese patent medicines, etc., in which 76 new admissions and 248 monographs are revised; Volume II deals with 1699 monographs of chemical drugs, antibiotics, biochemicals, radiopharmaceuticals and biological products, of which 323 monographs are new admissions and 314 monographs are revised. A system of national pharmaceutical specification with the pharmacopoeia as the main part has been established appropriately.Among all new admissions of biotechnological products such as the recombinant insulin etc. are included for the first time. There are 90 monographs admitted to Appendix of vo1ume I of which l0 are new admissions and 31 are revised and 2 admissions have been de1eted. There are 124 monographs in Appendix of volume II with 27 new admissions, 32 revised and 2 deleted. Appropriate monographs admitted in general to both volumes are presented in each volume, respective1y. 83 monographs admitted to Chinese Pharmacopoeia l995 are deleted in this edition.
Contemporary analytical techniques are adopted more extensive1y in the requirements of the monographs admitted to this edition. In Volume I, the number of monographs adopted the thin 1ayer chromatography in test for identification reaches 602 and 308 monographs adopted assay as pharmaceutical requirements, quite an increase in number compared with those in the l995 edition. In Volume II, the application of high performance liquid chromatography has been adopted in the requirements of 282 monographs and in assay of most antibiotics and synthetic hormones admitted. 44 monographs in Volume II have adopted gas chromatography, and 69 monographs requested test of bacterial endotoxin. The dissolution test and Test for content uniformity for quality control are adopted for 183 and 121 monographs, respectively. Monographs of the biologica1 products in Volume II have been revised in accordance with the features and format of national pharmaceutical specification system and they are presented in one section in Volume II.
Considerab1e changes and improvements are made in the new or amended general monographs in Appendix in this edition. New admissions under General Requirement for Preparations are Cataplasms(Babu Plasters), liniments, Nasal Drops, Ear Drops, Transdermal Patch, etc. 1n Vo1ume II, new admissions under General Requirement for tablets are dispersing tablets, sublingual tablets, etc.
Aeroso1s have been divided into aerosols (aerosol powder)and sprays with new definitions.New general testing methods have been admitted such as Organic Chloro-pesticide Residues, Test for Related substances in Injections, Determination of Molecular Weights and Molecular Weights Distribution of po1ysaccharides. Capillary Electrophoresis, Limit Test for Particulate Matter, Determination of Mo1ecu1ar Concentration by Osmotic Pressure, Method of Thermal Ana1ysis, X-ray Diffraction and Test for Tablet Friability, etc. Photo resistance method has been added for the Testing of Insoluble particulates for Injection, and chromatic aberration detector has been used for testing of Color of Solution. Appropriate limit of microbial counts has been set for various preparations in Microbial limit test admitted to the general requirement of monographs adopted in Volume I and II.The appendices are more precise, complete and standardized. Appendices in volume II adopted 6 guidelines for Validation of Analytical Method Adopted in Pharmaceutical Quality, Guideline to the Stability Testing of Drug Substances and Preparations, etc, for the first time. 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.
"General Notices"is a vital part of the pharmacopoeia. Considerable changes have been made in the layout of General Notices in this edition. They have been grouped into sections by content and each section has a title to facilitate usage. In the provisions of General Notices result calculation and its limitation for the requirement are further clearly indicated. These would benefit for the correct interpretation and implementation of the Chinese Pharmacopoeia 2000.
As for the titles and layouts of drugs and medicines in this edition, the alternative titles for granules has no longer been used in volume I, in volume II only titles for drugs have been used and their subtitle have no longer been used. As for the drugs with new title in this edition, International Nonproprietary Name system are adopted for titles of the monographs admitted. The table is provided in comparison the new titles with the old ones in the hope that they can be used according to the regulations made by State Drug Administration of the State Council. 1n English version of Chinese Pharmacopoeia 2000, volume I adopted Latin titles for Chinese crude drugs and simple preparations, and Chinese phonetic symbols titles for Chinese patent medicines, volume II adopted English titles. Appendix is arranged and classified into sections.
The"Dosage"and"precaution"in the preceding editions were adopted for guidance in volume II, they could not reflect the actual clinical needs and therefore have been deleted in this edition in line with the internationa1 practice. Relevant contents(e.g.. skin test for penicillins)are included in the"A Guide to Clinical Information".
Introduction in Chinese