2005年版《中国药典》一、二部附录的比较与探讨  

Comparison and Discussion on Appendices of Volume Ⅰ and Ⅱ of Chinese Pharmacopoeia of 2005 Edition

作　　者：田友清[1] 丁平[1] 苟琼心[1] 李陈波[1] 

机构地区：[1]江苏联合职业技术学院连云港中医药分院,连云港市222006

出　　处：《中国药房》2010年第5期468-469,共2页China Pharmacy

摘　　要：目的:为2005年版《中国药典》一、二部附录的修订提供依据。方法:对2005年版《中国药典》一、二部附录中的制剂通则和检验方法进行比较和分析,并找出存在的问题。结果:一、二部药典在制剂种类数量、排序、亚型、检测项目和检验方法的种类、内容方面有一定差异,编写规范性、技术标准一致性和技术水平先进性欠佳。结论:2005年版《中国药典》一、二部附录有待修订。OBJECTIVE： To provide the basis for the revision of appendices of volume Ⅰ and Ⅱ of Chinese Pharmacopoeia （2005 edition）. METHODS： The general standards of preparations and the examinational methods in the appendices of volume Ⅰ and Ⅱ of Chinese Pharmacopoeia （2005 edition） were compared and analyzed in order to find out the problems. RESULTS： Volume Ⅰ was different from volume Ⅱ in the respect of numbers, ordering, subtypes, examinational items of preparations and the kinds, contents of examinational methods. In addition, the specification, the consistency of standard and the advancement of technological level were not in line with the standards. CONCLUSION： The appendices of volume Ⅰ and Ⅱ of Chinese Pharmacopoeia （2005 edition） should be revised.

关 键 词：中国药典 附录 制剂 质量控制 

分 类 号：R95[医药卫生—药学]