《中华人民共和国药典》收录孕妇禁用和慎用中药材生殖毒性研究进展  

Advances in reproduction toxicity study on traditional Chinese materia medica recorded in Chinese Pharmacopoeia as prohibited or used with caution during pregnancy

作　　者：游云[1] 黄芳华[2] 韩玲[2] YOU Yun;HUANG Fang-hua;HAN Ling(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Center of Drug Evaluation,State Food and Drug Administration,Beijing 100038,China)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国药理学与毒理学杂志》2018年第5期364-370,共7页Chinese Journal of Pharmacology and Toxicology

基　　金：国家自然科学基金(81274006)

摘　　要：以手工检索《中华人民共和国药典》(2015)(简称《药典》)确定孕妇禁用和慎用中药材及其饮片,根据中医临床适应证进行归类。以"药材名称+生殖毒/妊娠"为关键词,检索中国知网(CNKI)数据库,筛选出相关研究论文进行综合分析。研究发现,孕妇禁用和慎用药材涵盖了多种临床功效。部分单味药的水煎剂如大黄、附子和瞿麦等致生殖毒性剂量相当于《药典》推荐临床剂量的1~3倍,提示这些单味药在临床常用剂量具有对人体产生生殖毒性的风险。生川乌、生草乌和大戟致动物生殖毒性剂量超过了临床剂量的10倍以上,其原因有待深入研究。此外,中药雄黄生殖毒性的种属差异性及红花和莪术在正常妊娠动物和血瘀证妊娠动物生殖毒性的差异性,均提示中药生殖毒性研究应与临床实践紧密结合。通过逐步建立并完善包括药学、药理、毒理和临床应用的中药安全数据库,配合生殖毒性的潜在物质基础和分子机制研究,为中药临床安全用药服务。In Chinese Pharmacopoeia（2015） 60 kinds of traditional Chinese materia medica（TCMM）are stipulated as used with caution and 39 kinds as contraindicated for pregnant women. These 99 kinds of TCMM cover a variety of traditional Chinese medicine indications. From CNKI database, it was found that some TCMM and their extracts such as Rheum Palmatum L., Radix Aconiti Carmichaeli and Herba Dianthi showed obvious reproductive toxicity in animals at doses 2 to 4 times the clinical dosage according to the Chinese Pharmacopoeia（2015）, which suggests reproductive risks in clinic. Radix Aconiti Shengchuanwu, Radix Aconiti Kusnezoffii Caowu and Euphorbia pekinensis Rupr. caused reproductive toxicity more than 10 times the clinical dose, which needs to be further studied. Different reproductive toxicity of Realgar was observed between rats and rabbits, different reproductive toxicity of safflower or sputum was also observed between normal pregnant animals and blood stasis syndrome pregnant animals, which suggests that reproductive toxicity study of TCMM should be integrated with clinical practices. Through comprehensive analysis of the available data on the reproductive toxicity of TCMM, it is proposed that systematic and standardized research ought to be conducted on the toxicology of TCMM and safety databases have to be established to serve clinical medication.

关 键 词：中国药典 中药材 妊娠毒性 生殖毒性 

分 类 号：R285.1[医药卫生—中药学]