含毒性药材中药复方制剂毒代动力学研究的探讨

Toxicokinetics of traditional Chinese materia medica compound preparation containing toxinic herbs

目前,大部分毒性药材的毒性成分未进行过药代/毒代动力学研究,甚至受试物检测分析也未能强制要求,且多数毒性成分无相关对照品可用。因此,建议鼓励和加强基础科学研究,引导其药代/毒代动力学方法学的建立和验证,从而提高含毒性药材的中药复方制剂的风险控制。本文对中药毒性药材的概念及其毒性成分和毒性作用进行了阐述,并针对含毒性药材的中药复方制剂毒代动力学研究进行了探讨。

Most of the toxic herbs have never been subjected to pharmacokinetic or toxicokinetic studies so far, and content testing has never become mandatory. To make matters worse, there is no reference substance available for these toxic components. Therefore, we should encourage and strengthen basic scientific research and guide the establishment and validation of the methodology for pharmacokinetics or toxicokinetics of the toxic herbs so as to improve the risk management of the traditional Chinese materia medica compound preparations of toxic herbs. This paper is intended to introduce the concept of toxic herbs and their toxic ingredients and effects, focusing on the toxicokinetics of the traditional Chinese materia medica compound preparations including toxic herbs.