染色體畸變試驗作為保健食品、化妝品、藥品、醫(yī)療器械上市前常規(guī)開展的毒理學試驗項目，是檢測化學物質(zhì)對染色體數(shù)量和結(jié)構(gòu)影響的基本方法。確立標準化試驗方法并積累一定的背景數(shù)據(jù)，是試驗系統(tǒng)和數(shù)據(jù)真實可靠性的有力保障，可為科研人員和審評專家的數(shù)據(jù)分析提供有力依據(jù)。首先就影響染色體畸變試驗結(jié)果的因素進行簡要綜述，繼而通過回顧國內(nèi)外2012-2017年期間發(fā)表的47篇有關(guān)哺乳動物細胞染色體畸變試驗的研究來討論如何規(guī)范化試驗條件，并以國家藥物安全評價監(jiān)測中心2002-2017年匯總的背景數(shù)據(jù)為例闡釋建立歷史背景數(shù)據(jù)的要點?？傊?，嚴格參考OECD指導原則開展規(guī)范化的染色體畸變試驗并通過長期積累建立一套對照受試物的背景數(shù)據(jù)是臨床前遺傳毒性研究的關(guān)鍵環(huán)節(jié)，有利于更好地對藥物等受試物的潛在致染色體損傷作用進行合理而有效的判斷。

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.

國家“重大新藥創(chuàng)制”科技重大專項（2015ZX09501004-002）；《中國藥典》藥品標準提高