仿制药一致性评价中有关物质研究的思考  

Refl ections on the Research of Related Substances in Consistency Evaluation for Generic Drugs

作　　者：周立春[1] ZHOU Lichun(Beijing Institute For Drug Control, Beijing 102206, China)

机构地区：[1]北京市药品检验所,北京102206

出　　处：《药学进展》2016年第12期924-927,共4页Progress in Pharmaceutical Sciences

摘　　要：有关物质是药品的关键质量属性之一,也是仿制药一致性评价的重要内容,其涉及药品的安全性及其质量的可控性。文章梳理了仿制药有关物质的来源及研究重点,评估仿制药有关物质的文献分析方法,总结归纳仿制药与被仿制药实际样品的杂质谱分析比较及其意义,探讨杂质限度的确定原则与方法。As one of the key quality attributes of drugs, related substance is an important part in consistency evaluation for generic drugs, and associated with drug safety and quality controllability. In this paper, the sources of related substances of generic drugs and the research focuses were analyzed, and the literature analysis methods for related substances of generic drugs were evaluated. In addition, the analysis and comparison of impurity spectra of generics and their brand name counterparts as well as the significance thereof were summarized, and the principles and methods for determining impurity limits were discussed.

关 键 词：仿制药 有关物质 一致性评价 文献分析方法 杂质谱 杂质限度 

分 类 号：R927.1[医药卫生—药学]