对《中华人民共和国药典》2010年版(一部)的分析和探讨  

Analysis and discussion on 2010 edition(volume I) of Chinese Pharmacopoeia

作　　者：蔡小兵[1] 胡欣[2] 金鹏飞[2] 

机构地区：[1]总参谋部警卫局卫生保健处,北京100017 [2]卫生部北京医院药学部,北京100730

出　　处：《中国新药杂志》2012年第16期1874-1877,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2008ZX09312-005);中央保健科研课题专项资金(B2009B032)

摘　　要：通过对《中华人民共和国药典》2010年版(一部)的仔细研读,并结合自身的实际工作和专业知识,对新版药典的改进和不足进行了分析和探讨,为《中华人民共和国药典》的修订和完善提供参考。新版药典大幅增加了收载品种、增加了安全性检验的方法、加强了检验新技术的应用并且更加注重药品质量的总体控制,但也存在着含量测定的比例仍然偏低、含量测定成分的选择不够科学、含量测定和鉴别重复、药材和其对应饮片的含量测定标准不一致、农药残留及重金属和有害元素限量检查有待改进等问题。To provide references for the revise and upgrade in Chinese Pharmacopoeia, this paper analyzed and discussed the improvements and deficient of the Chinese Pharmacopoeia （2010 edition, volumeⅠ） based on a careful study as well as the authors＇ expertise and performance experiences. The Pharmacopoeia included more me- dicinal herbs and preparations, involved more safety analysis methods, used more new analysis technologies and pay more attentions on polynary quality controls. However, there were also some deficiencies such as the low per- centage of content determination, the irrationality of determined compounds, the repetition between identification and content determination, the difference content requirements between the crude herbs and their prepared drug in pieces, the imperfect on the analysis of pesticide residues, heavy metals and harmful elements.

关 键 词：中华人民共和国药典 改进 不足 

分 类 号：R95[医药卫生—药学]