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Preface
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 volume I of which 10 are new admissions and 31 are revised and 2 admissions have been deleted. There are 124 monographs in Appenndix 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, respectively. 83 monographs admitted to Chinese Pharmacopoeia 1995 are deleted in this edition.
Contemporary analytical techniques are adopted more extensively in the requirements of the monographs admitted to this edition. In Volume I , the number of monographs adopted the thin layer chromatography in test for identification reachs 602 and 308 monographs adopted assay as pharmaceutical requirements, quite an increase in number compared with those in the 1995 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 adoped 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 biological products in Volume II have been revised in accordance with the features and format of national pharmaceutical specifiction system and they are presented in one section in Volume II .
