抗生素杂质研究与控制的策略探讨  

The strategic decision of impurity study and control for antibiotics

作　　者：张哲峰[1] 蒋煜[1] 马磊[1] 李雪梅[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2015年第12期1341-1348,共8页Chinese Journal of New Drugs

摘　　要：药品中的杂质可能与临床不良反应相关,因此杂质研究及控制是药品研发中风险控制的重要环节。抗生素药品因制备工艺、化学结构及组分等方面的特殊性,决定了抗生素杂质研究与控制具有不同于化学合成药的特点.本文对抗生素杂质的一般特点、杂质谱分析及其途径等方面进行了分析讨论,系统提出了抗生素杂质控制策略与基本思路。The impurities in chemical drugs maybe related to clinical adverse reaction, so the impurity study and control is the key point in the risk management of drug development. The speciality of antibiotics in man- ufacturing process, chemical structure and composition etc. decide the difference between antibiotics and chemistry synthetic drugs in impurity study and control. The article is focus on the discussion of general characteristic, impu- rity profile analysis and strategic decision of antibiotics and given the strategy of antibiotics impurity control and the basic mindset.

关 键 词：抗生素杂质 组分与杂质 研究与控制 杂质限度 杂质谱分析 

分 类 号：R95[医药卫生—药学]