天然藥物成分復(fù)雜，無(wú)法逐一完成系統(tǒng)的致癌性風(fēng)險(xiǎn)評(píng)價(jià)及體內(nèi)遺傳毒性試驗(yàn)。鑒于計(jì)算機(jī)毒理學(xué)結(jié)合體外致突變風(fēng)險(xiǎn)評(píng)價(jià)方法在遺傳毒性雜質(zhì)致突變性評(píng)價(jià)方面的快速發(fā)展，也可考慮將此評(píng)價(jià)模式應(yīng)用于天然藥物成分的致突變性篩選與機(jī)制研究。從計(jì)算機(jī)毒理學(xué)和體外致突變性評(píng)價(jià)兩方面出發(fā)，綜述天然藥物致突變性的研究方法，為其遺傳毒性試驗(yàn)評(píng)價(jià)及監(jiān)管提供借鑒。

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.

國(guó)家自然科學(xué)基金資助項(xiàng)目（81503347）；國(guó)家十三五"重大新藥創(chuàng)制"專項(xiàng)（2018ZX09201017）