对《中华人民共和国药典》2010年版(一部)的分析和探讨

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。

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

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,volume I) based on a careful study as well as the authors’ expertise and performance experiences.The Pharmacopoeia included more medicinal 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 percentage 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.