哺乳动物细胞染色体畸变试验的标准化与背景数据采集

染色体畸变试验作为保健食品、化妆品、药品、医疗器械上市前常规开展的毒理学试验项目，是检测化学物质对染色体数量和结构影响的基本方法。确立标准化试验方法并积累一定的背景数据，是试验系统和数据真实可靠性的有力保障，可为科研人员和审评专家的数据分析提供有力依据。首先就影响染色体畸变试验结果的因素进行简要综述，继而通过回顾国内外2012-2017年期间发表的47篇有关哺乳动物细胞染色体畸变试验的研究来讨论如何规范化试验条件，并以国家药物安全评价监测中心2002-2017年汇总的背景数据为例阐释建立历史背景数据的要点。总之，严格参考OECD指导原则开展规范化的染色体畸变试验并通过长期积累建立一套对照受试物的背景数据是临床前遗传毒性研究的关键环节，有利于更好地对药物等受试物的潜在致染色体损伤作用进行合理而有效的判断。

Standarization and Historical Data Collection of Mammalian Cell Chromosome Aberration Test

Chromosome aberration test, as a routine toxicology test before the listing of health food, cosmetics, medicine and medical device, is the essential methods for detecting the effects of chemicals to the structure and quantity of chromosomes. The establishment of standardized test methods and accumulation of certain historical data are powerful guarantees for the authenticity and reliability of the test system and data, and provide a strong basis for data analysis by researchers and reviewers. In this paper, factors might affect the chromosome aberration test results are briefly reviewed. Subsequently, 47 papers on in mammalian cell chromosome aberration test at home and abroad published from 2012 to 2017 were analyzed for discussing the standarizing of test conditions, and the historical data of our center between 2002 to 2017 as an example were demonstrated to elucidate the key points in producing the historical data. In conclusion, conducting standarized chromosome aberration test strictly following the OECD guidelines and establishing a series of background data for control articles are the key in the pre-clinical genotoxicity study, and shall be benefical in making reasonable and effective judgements on the potential chromosome damage risk of drugs and other test articles.