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生殖毒性作为中药学重要研究内容之一,是中药安全性研究的重要组成部分。目前对中药生殖毒性研究评价主要采用国内外新药临床前安全性评价指南所推荐的三阶段试验,然而存在费用高、实验周期长等缺点。欧洲替代方法研究中心(ECVAM)所推荐的胚胎干细胞试验、胚胎细胞微团培养试验及全胚胎培养试验等体外替代试验已应用于中药生殖、胚胎毒性的研究。该文就中药单体或复方生殖毒性体外试验评价的现状,对体外替代试验方法及其优缺点、必要性等进行了讨论。
Reproductive toxicity is one of the important research contents of traditional Chinese medicine, which is an important part of the safety research of traditional Chinese medicine. At present, the research on the reproductive toxicity of traditional Chinese medicine mainly uses the three-stage test recommended by the guidelines for the preclinical safety assessment of new drugs at home and abroad, however, there are disadvantages such as high cost and long experimental period. In vitro alternative tests such as embryonic stem cell assay, embryo cell micromass culture test and whole embryo culture test recommended by ECVAM have been applied to the study of reproductive and embryotoxicity of traditional Chinese medicine. In this paper, the status of traditional Chinese medicine monomer or compound reproductive toxicity in vitro test evaluation, in vitro alternative test methods and their advantages and disadvantages, the necessity of such were discussed.