对碱性彗星试验主要影响因素的探讨

发布时间：2018-07-07 17:42

本文选题：碱性彗星试验 + 肝脏彗星试验　；参考：《中国新药杂志》2015年23期

【摘要】：彗星试验在化合物遗传毒性评价中的应用日益广泛,ICH S2(R1)已将肝脏彗星试验列为第2个组织/终点的体内试验;经济合作与发展组织(Organization for Economic Co-operation and Development,OECD)体内哺乳动物碱性彗星试验的指导原则(TG489)也已颁布,但彗星试验的具体操作程序各异,需要严格控制的影响因素较多,且因组织差异性,国际上无统一的标准试验方案。毒理工作者们对该试验方法的不同影响因素进行研究,以望能够形成标准的试验方案,在不影响灵敏度和特异性的前提下,提高彗星试验的可操作性,推动彗星试验在评价化合物遗传毒性方面更广泛的应用。本文主要对彗星试验的取样、制片、解旋和电泳等过程中关键的影响因素进行探讨总结,为开展和验证彗星试验方法的实验室提供参考。
[Abstract]:The application of comet assay in the genotoxicity evaluation of compounds has been widely used in ICH S2 (R1), which has listed the liver comet assay as the second tissue / end point in vivo test. The guidelines for mammalian basic comet assay (TG489) in the Organization for Economic Co-operation and Development Organization (OECD) have also been promulgated, but the specific operation procedures of comet assay are different, and there are many factors that need to be strictly controlled. There is no international standard test program. Toxicologists studied the different factors affecting the test method in order to form a standard test scheme to improve the maneuverability of comet assay without affecting sensitivity and specificity. To promote the wider application of comet assay in evaluating the genotoxicity of compounds. In this paper, the key influencing factors in the process of comet assay, such as sampling, film-making, unspinning and electrophoresis, are discussed and summarized in order to provide a reference for the laboratory to carry out and verify the comet test methods.
【作者单位】：中国医药工业研究总院国家上海新药安全评价研究中心;
【基金】：国家“重大新药创制”科技重大专项(2012ZX09302002)
【分类号】：R96

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