遗传毒性杂质的警示结构  

Structural alerts of genotoxic impurities

作　　者：马磊[1] 马玉楠[1] 陈震[1] 蒋煜[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》2014年第18期2106-2111,共6页Chinese Journal of New Drugs

摘　　要：遗传毒性杂质在很低的浓度下即可诱导基因突变以及染色体的断裂和重排,因而具有潜在的致癌性。在缺乏杂质安全性数据支持的情况下,在EMA,FDA以及ICH发布的指导原则中均将警示结构作为区分普通杂质和潜在遗传毒性杂质的主要标志。本文就警示结构的起源、发展和识别进行简要论述。Genotoxic impurities have been demonstrated to induce mutation, chromosomal breaks and/or chromosomal rearrangements even at trace level, and thus senee of sufficient safety experimental data, the structural have the potential to cause cancer in humans. In the abalert is used as a sign to differentiate the routine impurities and the carcinogenic impurities in EMA, FDA and ICH guidelines. This article reviews the origin, development and identification of structural alerts

关 键 词：遗传毒性杂质 致癌性杂质 警示结构 

分 类 号：R95[医药卫生—药学]