论述中药生殖毒性研究及评价的必要性  

Importance of reproductive toxicity research and evaluation of traditional Chinese Medicine

作　　者：孙祖越[1,2,3] 周莉 韩玲[4] SUN Zu-yue;ZHOU Li;HAN Ling(National Evaluation Center for Toxicology of Fertility Regulating Drugs,Shanghai Institute of Planned Parenthood Research,Shanghai 200032,China;Institute of Reproduction and Development,Fudan University,Shanghai 200032,China;Key Lab of Reproduction Regulation of National Population and Family Planning Commission,Shanghai 200032,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]上海市计划生育科学研究所,中国生育调节中药毒理检测中心,上海200032 [2]复旦大学生殖与发育研究院,上海200032 [3]国家人口和计划生育委员会计划生育药具重点实验室,上海200032 [4]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国药理学与毒理学杂志》2020年第8期561-567,共7页Chinese Journal of Pharmacology and Toxicology

基　　金：国家科技重大专项(2018ZX09201017-002);上海市科学技术委员会研发平台专项(18DZ2292100)。

摘　　要：神农尝百草开启了中药毒理学研究,《山海经》最早记载了我国中药的生殖毒性。我们祖先非常重视中药的生殖毒性,一次又一次地更新《妊娠用药禁忌歌》的内容,为中医药发展做出了不朽的贡献!现代生物医学技术的运用,从整体、器官、组织、细胞和分子水平上,揭示了更多的中药存在生殖毒性。2020年2月18日,人用药品注册技术要求国际协调会正式颁布的《人用药品生殖与发育毒性检测S5(R3)》,对我国中药生殖毒性的研究是一个促进,也带来了新一轮的挑战。利用传统中药的配伍减毒和炮制减毒,借助现代医学及生物学技术的评价,重视并加强生殖毒性研究的力度,减少临床上生殖毒性的发生,这也许才是一条适合中药生殖毒性研究和评价且行之有效的正道。Shen Nong initiated the earliest toxicology studies of traditional Chinese medicine(TCM)by tasting herbal drugs and"Shan Hai Jing"was known as the first record of reproductive toxicity of TCM.Our ancestors took the reproductive toxicity of TCM seriously and made great contribution to the development of TCM by keeping updating the"Song of pregnancy medication Taboo".The applica⁃tion of modern biomedical technology reveals the reproductive toxicity of more TCM at different levels.On February 18,2020,the International Council for Harmonisation of Technical Requirements for Phar⁃maceuticals for Human Use launched the"S5(R3)Detection of Reproductive and Developmental Tox⁃icity for Human Pharmmaceuticals"and this guideline brought a great incentive and challenge to TCM research and development in China.It is feasible to evaluate and study the reproductive toxicity of TCM by developing compatible and processed TCM along with the application of modern biomedical technology.These measures could help research and safety evaluation of reproductive toxicity of TCM while reducing clinical adverse events.

关 键 词：中药 发育毒性 生殖毒性 

分 类 号：R285.1[医药卫生—中药学]