摘要
啮齿类动物骨髓微核试验(in vivo Mammalian Bone Marrow Micronucleus Test)是临床前药物遗传毒性研究标准组合试验之一,在医学、公共卫生、食品和药物安全性评价等领域有巨大应用前景。在GLP条件下确立标准化试验方法和条件,积累一定的背景数据范围,可有效确保试验系统的可靠性,为数据分析提供有力依据。以国家药物安全评价监测中心2007-2015年开展的小鼠及大鼠骨髓微核试验背景数据采集为例,介绍啮齿类动物骨髓微核试验规范化采集方法。
In vivo Mammalian Bone Marrow Micronucleus Test is included in the standard battery genotoxicity testing,with great application prospects in medicine,public health,food and drug safety evaluation fields.Establishing standardized experimental methods and conditions in GLP condition and accumulating a certain range of background data could effectively ensure the reliability of the test system,and also provide strong basis to support the experimental data.We herein summarized the background data of mouse and rat bone marrow micronucleus tests performed from 2007 to 2015,to expound the standardized data collection method for rodent animal bone marrow micronucleus test.
出处
《药物评价研究》
CAS
2017年第5期638-641,647,共5页
Drug Evaluation Research
基金
中国食品药品检定研究院中青年发展研究基金课题(2014C1)
国家"重大新药创制"科技重大专项(2015ZX09501004-002)
关键词
骨髓微核试验
背景数据
遗传毒性
染色体断裂
环磷酰胺
bone marrow micronucleus test
background data
genetic toxicity
chromosome breakage
cyclophosphamide
