天然药物成分致突变性风险预测与评价方法研究进展  

Research progress on prediction and evaluation methods of mutagenicity risk of natural medicinal ingredients

作　　者：文海若 兰洁 叶倩 赵婷婷 汪祺[1] 耿兴超[1] WEN Hairuo;LAN Jie;YE Qian;ZHAO Tingting;WANG Qi;GENG Xingchao(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物评价研究》2022年第7期1221-1226,共6页Drug Evaluation Research

基　　金：国家自然科学基金资助项目(81503347);国家十三五“重大新药创制”专项(2018ZX09201017)。

摘　　要：天然药物成分复杂,无法逐一完成系统的致癌性风险评价及体内遗传毒性试验。鉴于计算机毒理学结合体外致突变风险评价方法在遗传毒性杂质致突变性评价方面的快速发展,也可考虑将此评价模式应用于天然药物成分的致突变性筛选与机制研究。从计算机毒理学和体外致突变性评价两方面出发,综述天然药物致突变性的研究方法,为其遗传毒性试验评价及监管提供借鉴。The composition of natural medicine is complex,it is impossible to complete the systematic carcinogenic risk assessment and in vivo enotoxicity test.In view of the rapid development of computational toxicology combined with in vitro mutagenicity assessment methods in the mutagenicity evaluation of genotoxic impurities,this evaluation method could also be applied to the mutagenicity evaluation and mechanism study of natural medicine components.Therefore,from the perspectives of computational toxicology and in vitro mutagenicity evaluation,this article reviewed the existing methods and results of studying the mutagenicity of natural medicines,which can provide reference for its genotoxicity evaluation and supervision.

关 键 词：天然药物 致突变性 定量构效关系 警示结构 细菌回复突变试验 体外Pig-a基因突变试验 

分 类 号：R991[医药卫生—毒理学]