适合纳米材料遗传毒性评价方法的选择

doi:10.3969/j.issn.1004-616x.2018.04.016

癌变·畸变·突变 ›› 2018, Vol. 30 ›› Issue (4): 326-331.doi: 10.3969/j.issn.1004-616x.2018.04.016

• 综述 • 上一篇

适合纳米材料遗传毒性评价方法的选择

文海若¹, 邵安良², 陈亮², 淡墨¹, 胡燕平¹, 王雪¹, 徐丽明²

1. 中国食品药品检定研究院国家药物安全评价监测中心, 药物非临床安全性评价研究北京市重点实验室, 北京 100176;
2. 中国食品药品检定研究院医疗器械检定所, 北京 102629

收稿日期:2018-02-28 修回日期:2018-06-30 出版日期:2018-07-30 发布日期:2018-07-30
通讯作者: 徐丽明,E-mail:xuliming@nifdc.org.cn;王雪,E-mail:xue_wang@nifdc.org.cn E-mail:xuliming@nifdc.org.cn;xue_wang@nifdc.org.cn
作者简介:文海若,E-mail:wenhairuo@nifdc.org.cn
基金资助:
国家重点研发计划（2016YFA0200903）

Received:2018-02-28 Revised:2018-06-30 Online:2018-07-30 Published:2018-07-30

摘要/Abstract

摘要： 纳米材料独特的小尺寸和大的比表面积等物理化学性质，及其与生物体相互作用的高活性特性，为其在多种领域提供了广阔应用前景。与此同时，也可能带来潜在的安全风险。纳米材料的代谢和分布方式与普通化合物存在一定差异，如何科学地评价纳米材料对人体的潜在毒性风险，尤其是遗传毒性，是目前科学界及各相关监管部门亟需解决的问题。本文对现有常用遗传毒性评价方法用以评价纳米材料时存在的试验体系的局限性和灵敏度方面存在的优势与劣势进行回顾，总结了纳米材料遗传毒性评价时的关注点；并基于经济合作与发展（OECD）专家工作组的相关建议及相关遗传毒性评价指导原则，初步提出纳米材料遗传毒性试验组合优化方案。以期填补相关领域的空白，为纳米材料毒性评价和含纳米材料产品的上市前技术审评工作提供有益的借鉴。

关键词: 纳米材料, 毒性风险, 遗传毒性试验, 微核试验, Ames试验, 标准化试验组合

中图分类号:

R394.6

文海若, 邵安良, 陈亮, 淡墨, 胡燕平, 王雪, 徐丽明. 适合纳米材料遗传毒性评价方法的选择[J]. 癌变·畸变·突变, 2018, 30(4): 326-331.

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适合纳米材料遗传毒性评价方法的选择

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