PHARMACOPOEIA OF THE PEOPLE'S REPUBLIC OF CHINA (2000 English Edition)


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

《中华人民共和国药典》2000年版 (上下卷)

内容简介  

    《中国药典》2000年版主要由凡例、品种和附录三大部分组成,这三部分比1995年版 均有明显改进。

    2000年版药典收载品种增加,收载中、西药品种共计2691种,比1995年版药典增加399种。一部中药为992种,其中新增76种,修订248种;二部西药为1699种,其中新增品种323种,修订314种。删去1995年版收载的83个品种,其中中药有4种,西药有79种。新增品种主要是从近年批准的新药中遴选,其次是从地方标准经整顿上升为部、局标准和中药保护品种中优选。一般均为疗效确切、临床常用、质量标准较完善,知名度高的品种。

    药典的附录和凡例是制定药品质量标准的重要依据。2000年版药典的附录比较完善,改进较大。一部收载附录共90项,其中制剂通则26项,新增的有巴布剂通则等5项;收载通用检测方法64项,新增的有有机氯农药残留量检查法等5项。原有制剂通则和通用检测方法共有31项作了不同程度的增、修订。

    二部收载附录共124项,其中制剂通则24项,新增7项,如滴耳剂、滴鼻剂、透皮贴剂等;修订的有10项,如片剂通则项下增加了分散片、舌下片等。收载通用检测方法78项,其中新增24项,修定30项。从总体看,二部附录基本上已与国外先进的现行版药典接轨,即国外药典收载的制剂通则和主要检测方法,本版药典都有收载。

    二部“凡例”的编排由过去沿用的按序号编写,改为按内容分类整理编排,便于查阅和修订补充。另外对标准中的运算结果和限度进一步作出了明确规定,对有些条款作了适当的补充和文字修改。

    在正文品种中进一步加强内在质量控制,提高了标准水平。一部新增品种虽然不多,但突出重点提高标准质量,取得显著效果。除薄层色谱法继续扩大应用于中药的鉴别已达602种,含量测定的品种大幅度增加,总数达308种 ,其中增加最多的是高效液相色谱法,增加了94种,而1995年版药典仅有11种,增加了9倍。在含量控制方面还采用双指标,增加对中药质量的可控性。对国内外普遍关注的中药农药残留量、重金属和微生物限度三大问题,在新版药典中有所突破。对执行多年仍不够严格的微生物限度检查的部标标准,经过修改,已收入新版药典。

    二部比较突出的是收载的新药品种标准,经统一规范和完善,标准水平普遍较高,特别是加强了内在质量控制项目,如原料药绝大多数品种都有杂质检查,有许多制剂根据生产工艺和原料药的稳定情况增加了降解产物检查。替代兔法检查热原的细菌内毒法,已有47个品种(含放射药)采用,较1995年版药典增加4倍。生物制品在1995年药典中收载的内容很简单,新版药典中不仅增加了品种,而且根据其特殊性,参照国外药典把每个品种的制法、检查项目和指标都一一收载。