含吡咯里西啶生物碱中成药潜在风险评估

吡咯里西啶生物碱(pyrrolizidine alkaloids,PAs)是一种双环吡咯啶生物碱,因多数具有肝毒性,又称肝毒性吡咯里西啶生物碱(hepatotoxic PAs)。PAs广泛存在于菊科、豆科、紫草科的多种药用植物中。《中国药典》2020年版共收载含有PAs的药材8种,包括千里光Senecionis Scandentis Herba、款冬花Farfarae Flos、佩兰Eupatorii Herba、紫草Arnebiae Radix等,涉及成方制剂数十种。此外,《卫生部药品标准》《药品注册标准》等收载含PAs制剂尚有200余种。除千里光药材外,其他含PAs中药及其制剂均没有关于PAs类成分的安全限量标准,其临床用药安全存在极大的风险。对含PAs中成药的研究概况进行了系统总结、分析,以期为此类中成药的临床用药安全提供警示和参考。

Risk evaluation of Chinese patent medicine containing pyrrolizidine alkaloids

Pyrrolizidine alkaloids (PAs) are a kind of alkaloids with bicyclic pyrrolidine rings. Most PAs are also called hepatotoxic PAs (HPAs) due to its highly hepatotoxicity. PAs are widely distributed in many medicinal plants from Compositae, Leguminosae, and Boraginacea Families. Totally, eight crude drugs, such as Qianliguang (Senecionis Scandentis Herba), Kuandonghua (Farfarae Flos), Peilan (Eupatorii Herba), Zicao (Arnebiae Radix), as well, and dozens of Chinese patent medicines (CPMs) prepared with these crude drugs have been officially recorded in the Chinese Pharmacopoeia, 2020 edition. In addition, they are also contained in about 200 CPMs that are recorded in other monographs such as the Ministry of Health Drug Standard and Drug Registration Specifications. However, there is no safety limitation standard of PAs in these crud drugs and CPMs, except for Senecionis Scandentis Herba. Their potential threats to human health may be underestimated in clinic. For this reason, a systematical investigation was conducted to get the information about these PA-containing CPMs for a better understanding of the drugs'' safety in clinic for human health.