药学学报, 2011, 46(7): 762-772
引用本文:
汤 俊 服部征雄. 《中国药典》含吡咯里西啶生物碱的中药品种与用药安全[J]. 药学学报, 2011, 46(7): 762-772.
SHANG Dun, BI Bu-Zheng-Xiong. Pyrrolizidine alkaloids-containing Chinese medicines in the Chinese Pharmacopoeia and related safety concerns[J]. Acta Pharmaceutica Sinica, 2011, 46(7): 762-772.

《中国药典》含吡咯里西啶生物碱的中药品种与用药安全
汤 俊1*, 服部征雄2
(1. 武汉大学药学院, 组合生物合成与新药发现教育部重点实验室, 湖北 武汉 430071; 2. 日本富山大学和汉医药学综合研究所, 日本 富山 930-0194)
摘要:

吡咯里西啶类生物碱是一类分布广泛的天然有毒生物碱, 存在于许多中草药中, 一些品种还被历版《中国药典》所收载。为了掌握《中国药典》 (2010) 中含这类生物碱的中药品种的收载情况, 本文进行了系统的整理和分析; 同时, 结合该类生物碱的研究现状及本实验室一些最新研究数据, 探讨安全性问题与对策。结果发现新版药典一部现存9种药材品种 (不包括饮片) 含有肝毒吡咯里西啶类生物碱, 并涉及数十种成方制剂; 由于大多数品种缺乏该类成分的安全限量检查, 其潜在的用药风险可能被忽视。建议开展相关基础研究和进行毒性评价, 从而进一步提升相关品种的安全性控制水平, 为临床安全用药提供保障。

关键词:   
Pyrrolizidine alkaloids-containing Chinese medicines in the Chinese Pharmacopoeia and related safety concerns
Abstract:

It has been well-known that many medicinal plants used in traditional Chinese medicine contain hepatotoxic pyrrolizidine alkaloids (HPAs), and some even have been recorded in many editions of the Chinese Pharmacopoeia (ChP).  In order to clarify the current status of these PAs-containing Chinese materia medica and proprietary Chinese formulae, the ChP 2010, the newest version, and the related safety issues were thoroughly investigated and analyzed on the current advances in research.  Total nine crude drugs (not including the processed slices) were found to contain HPAs, which may be present in tens of Chinese proprietary drugs prepared with these crude drugs.  Because of the lack of the alkaloid limitation in most monographs, their potential threats to human health may be underestimated.  For this reason, attention should be drawn to the importance of the issue.  The key point is to conduct the basic studies immediately on these PA-containing herbal plants or products, whose possible hazards need to be carefully assessed.  Further efforts should also be made to elevate the criteria for quality control and ensure the drugs’ safety in clinic for human health.

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