[關(guān)鍵詞]
[摘要]
嚙齒類動物骨髓微核試驗(in vivo Mammalian Bone Marrow Micronucleus Test)是臨床前藥物遺傳毒性研究標(biāo)準組合試驗之一,在醫(yī)學(xué)、公共衛(wèi)生、食品和藥物安全性評價等領(lǐng)域有巨大應(yīng)用前景。在GLP條件下確立標(biāo)準化試驗方法和條件,積累一定的背景數(shù)據(jù)范圍,可有效確保試驗系統(tǒng)的可靠性,為數(shù)據(jù)分析提供有力依據(jù)。以國家藥物安全評價監(jiān)測中心2007-2015年開展的小鼠及大鼠骨髓微核試驗背景數(shù)據(jù)采集為例,介紹嚙齒類動物骨髓微核試驗規(guī)范化采集方法。
[Key word]
[Abstract]
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.
[中圖分類號]
[基金項目]
中國食品藥品檢定研究院中青年發(fā)展研究基金課題(2014C1),國家“重大新藥創(chuàng)制”科技重大專項(2015ZX09501004-002)