中药肝毒性吡咯里西啶生物碱的质量控制研究进展

Research progress on quality control of hepatotoxic pyrrolizidine alkaloids in traditional Chinese medicine

吡咯里西啶生物碱在多种药用植物中普遍存在,现有证据表明其可引起不可逆的肝细胞损伤,具有较强的肝毒性,属于内源性毒性物质。近年来对肝毒性吡咯里西啶生物碱的质量研究有较多报道,但现行的大多数中药药品标准中并没有对该类毒性成分进行限量规定和风险提示,用药存在一定安全隐患。本文汇总了现行药材标准收录的可能含有肝毒性吡咯里西啶生物碱的品种及其含有的吡咯里西啶生物碱成分,归纳了常用的分析方法和存在的问题,并提出相关建议,为中药中该类成分的质量监管提供参考。

Pyrrolizidine alkaloids are common endogenous substances in plants,which can cause irreversible liver cell damage and have strong hepatotoxicity.In recent years,there have been many studies on the quality control of pyrrolizidine alkaloids,but there are few restrictions on such components in the current quality standards of traditional Chinese medicine,which indicates that there is a certain safety risk of medicine.This paper summarizes the varieties of pyrrolizidine alkaloids that may contain hepatotoxic pyrrolizidine alkaloids and the components of pyrrolizidine alkaloids contained in the current standards of Chinese medicine.It also summarizes the frequentlyused analysis methods and existing problems,and puts forward relevant suggestions for the quality regulation of such components in Chinese medicine.