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机构地区:[1]中国医药工业研究总院,上海医药工业研究院,国家上海新药安全评价研究中心,上海201203
出 处:《中国新药杂志》2014年第23期2725-2728,共4页Chinese Journal of New Drugs
基 金:国家"重大新药创制"科技重大专项(2012ZX09302002)
摘 要:欧盟对化妆品指令的第七次修改中规定,全面禁止动物实验用于化妆品的遗传毒性评价,但目前现有的体外遗传毒性试验存在较高的假阳性率,这将限制一些安全有效成分的应用。近年来,应用3D模型进行化合物的遗传毒性评价成为遗传毒理工作者们关注的热点。本综述主要介绍目前正在验证的和拟应用于遗传毒性评价的3D模型,对比3D模型体外遗传毒性试验与现有的体外遗传毒性试验,阐述其优缺点,并对3D模型的应用前景进行展望。The ban on the test of cosmetics in animals by the European Union's 7th Amendment to the Cosmetics Directive will require genotoxicity safety assessments of cosmetics ingredients and final formulations to be based primarily on in vitro genotoxicity tests. While the current in vitro test produces a high rate of false positives, which would effectively prevent the use and the development of many ingredients that are actually safe and effective for human use. In recent years, the application of 3D models to evaluate the genotoxicity of compounds has become the focus of toxicology workers. Some different kinds of 3D models that are being validated and intended to be used to evaluate compounds' genotoxicity were introduced in this reviewed. The difference between the in vitro test using 3D models and the current in vitro tests, advantages and disadvantages were reviewed in this article. Finally, the prospect of the 3D model was put forward.
关 键 词:3D模型 遗传毒性 EpiDerm^TM模型 EPI/001模型 EpiAirway^TM模型 Episkin模型
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