化学药物杂质研究进展  

Advances in Researches on Impurities in Chemical Drugs

作　　者：岳悦[1,2] 骆雪芳[1] 钟文英[1] 侯雯 

机构地区：[1]中国药科大学分析化学教研室,江苏南京210009 [2]南京卡文迪许生物工程技术有限公司,江苏南京210033

出　　处：《药学进展》2015年第7期533-539,共7页Progress in Pharmaceutical Sciences

摘　　要：药物杂质的分析和控制是用药安全有效的基础。从杂质谱分析、杂质检测、杂质限度的制定等方面综述了近年来国内外化学药物杂质研究进展,旨在为化学药物杂质的研究提供有效思路和方法。Analysis and control of drug impurities are the basics for effective and safe use of drugs. This paper reviews the advances in researches on impurities in chemical drugs from the aspects of impurity profiling, impurity detection and formulation of impurity limit, so as to provide constructive ideas and effective methods for researches on impurities in chemical drugs.

关 键 词：杂质谱 杂质检测 杂质限度 有关物质 手性杂质 遗传毒性杂质 

分 类 号：TQ460.72[医药卫生—药物分析学]