Pig-a基因突变检测方法在药物遗传毒性评价中的应用及研究进展  

Development of Pig-a gene mutation assay in genotoxicity evaluation and research applications

作　　者：邓媛元[1] 郭隽[1] 王雪[1] 李波[1] 

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心,北京100176

出　　处：《中国新药杂志》2012年第24期2895-2898,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2008ZX09305-002)

摘　　要：ICH修订技术指导原则将动物实验的3Rs原则(减少、替代、优化)引入到遗传毒性试验中,对新试验方法体系提出了更高的要求。Pig-a基因突变检测是近年建立的遗传毒性体内试验方法,其特点是使用流式细胞仪对外周血红细胞进行分析,所需血液样品量较少,同时具有无创、连续、动态监测和检测窗口期长等优点。此外,该方法能够结合重复给药毒性试验进行多终点检测,符合动物实验3Rs原则,适应当前毒理学研究的发展趋势。本文对Pig-a基因突变检测方法及研究进展作一综述。International Conference of Harmonizition（ICH） guidelines allowed 3Rs（reduction,replacement,refinement） into genotoxicity tests and added new demands to genotoxicity tests.The method of Pig-a mutation assay in vivo has sprung up in recent years,which analyzes peripheral blood by flow cytometry.There are likely several advantages of this system compared to conventional approaches,including the need of a small amount of blood,a non-invasive,continuous and dynamic monitoring,and long period detection window.Adapting to current trends in toxicology research,this method can combine with the general toxicity tests with different endpoints by the principles of animal experiments 3Rs.Here,we reviewed the recent progress in Pig-a mutation assay.

关 键 词：PIG-A 糖化磷脂酰肌醇 遗传毒性试验 基因突变检测 流式细胞术(FCM) 

分 类 号：R965.3[医药卫生—药理学]