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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。
Through the “People’s Republic of China Pharmacopoeia” 2010 edition (a) careful study, combined with their own practical work and professional knowledge, the new Pharmacopoeia improvements and deficiencies were analyzed and discussed for the “People’s Republic of China Pharmacopoeia” revision And improve for reference. The new Pharmacopoeia has significantly increased the number of varieties carried, increased safety testing methods, strengthened the application of testing new technologies and more emphasis on the overall control of drug quality, but there is still a low proportion of determination of the content, the determination of the content of the determination of ingredients Not enough science, content determination and identification of duplication, inconsistent determination of the content of medicinal herbs and the corresponding Pieces, pesticide residues and the inspection of heavy metals and harmful elements need to be improved and so on.