【作者】 杨柳； 郭治昕； 孙鹤；

【Author】 Liu Yang1,Zhixin Guo2,He Sun

【机构】 天士力集团研究院国际法规与注册研究中心； 天津中医药大学； 天士力北美药业有限公司； 天津大学药学院教授博导药事管理学部； 中科院上海生命科学研究院；

【摘要】 本文旨在研究复方丹参滴丸与常用合并用药间的药物相互作用及其安全性。回顾了目前复方丹参滴丸及其药用成分丹参,三七等与常见合并用药之间药物相互作用的报道与研究,总结了动物实验及临床试验研究结果,并简述了丹参、三七及二者合提浸膏在人肝微粒中对细胞色素P450酶活性抑制(P450s1A2,2B6,2C8,2C9,2C19,2D6和3A4/5)的研究结果。体外药代动力学实验表明复方丹参滴丸对常见合并用药的代谢没有影响。临床试验未有报道复方丹参滴丸与心血管常用合并用药间的相互作用。动物实验表明丹参可能对华法林有影响,体外试验表明三七可能对CYP450代谢亚酶1A2有影响,然而目前尚未有系统的临床试验对此进行研究。结论:需要控制良好的临床试验研究进一步确认复方丹参滴丸与华法令及通过CYP1A2代谢的药物之间是否存在药物相互作用。更多还原

【Abstract】 The primary objective of this study is to investigate the drug-drug interaction potential of Dantonic with drugs commonly used for treatment of Coronary Heart Diseases. A secondary objective is to investigate the safety and tolerability of Dantonic in combination use with other drugs. In vitro and in vivo studies involving the concomitant medications with Dantonic or its herbal ingredient Danshen and Sanqi have been reviewed. A in vitro study to evaluate the potential of Danshen, Sanqi, and their extract mixture to inhibit seven specific isoforms of human cytochromes P450 (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4/5) using pooled human liver microsomes has been conducted. No drug-drug interactions of Dantonic have been reported. Some in vitro and in vivo studies had shown that Danshen may have effects on Warfarin, and Sanqi may have effect on CYP 1A2, while well-controlled clinical trials are lacked to confirm the possible drug-drug interaction between Dantonic and concomitant medications. Well-controlled clinical trials are needed to further investigate the potential drug-drug interaction between Dantonic and concomitant medications.更多还原