杂质遗传毒性评价与研究方法

摘要/Abstract

摘要： 近年来N-亚硝胺类药品杂质超限事件引发社会热议，药品质量问题再次受到公众广泛关注。如何对遗传毒性杂质进行控制，以及如何评判药品中杂质是否存在遗传毒性/致癌性成为药品监管的热点问题。其中，毒理学数据是确定遗传毒性杂质监管策略的基石。只有选择适宜的方法，才能提供有效的评价数据用于分析和制定监管策略。本文就遗传毒性杂质评价与研究的试验方法，围绕适合杂质的遗传毒性评价方法、符合 ICH M7框架下的遗传毒性评价，以及数据权重分析进行阐述，为药物遗传毒性杂质的研究和监管提供有益借鉴。

关键词: font-size:medium, ">亚硝胺类；杂质；遗传毒性；评价方法；药品监管

Abstract: In recent years， the incidents of N-nitrosamine exceeded the limits in drugs has aroused heated debates in the society， and the quality of drugs has once again attracted widespread public attention. How to control genotoxic impurities and how to determine whether there is genotoxicity/carcinogenicity of impurities in drugs has become a hot topic in drug supervision. Among them， toxicology data is the cornerstone for formulating the regulatory strategy for genotoxic impurities. Only by choosing an appropriate method can we provide effective evaluation data for analysis and formulation of regulatory strategies. This article describes the test methods for the evaluation and research of genotoxic impurities， focusing on the genotoxicity evaluation methods suitable for impurities， the genotoxicity evaluation under the framework of ICH M7， and the data weighting analysis， which provides beneficial reference for the research and supervision of drug genotoxic impurities.

Key words: font-size:medium, ">Nitrosamines； Impurities； Genotoxicity； Evaluation method； Drug regulation

中图分类号:

文海若, 叶倩, 于敏, 耿兴超, 王雪. 杂质遗传毒性评价与研究方法[J]. 中国药物评价, 2021, 38(5): 365-370.

WEN Hai-ruo, YE Qian, YU Min, GENG Xing-chao, WANG Xue. Genotoxicity Evaluation Strategy and Research Method of Impurities[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2021, 38(5): 365-370.

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