Tang Jun, Hattori Masao
Key Laboratory of Combinatorial Biosynthesis and Drug Discovery, College of Pharmacy, Wuhan University, Wuhan 430071, China.
Yao Xue Xue Bao. 2011 Jul;46(7):762-72.
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.
众所周知,许多用于传统中药的药用植物都含有肝毒性吡咯里西啶生物碱(HPAs),其中一些甚至在多版《中国药典》(ChP)中都有记载。为了阐明这些含PA的中药材和中成药的现状,对最新版《中国药典》2010年版以及相关安全问题进行了全面调查,并根据当前研究进展进行了分析。共发现9种药材(不包括炮制后的饮片)含有HPAs,用这些药材制备的数十种中成药中可能也含有HPAs。由于大多数专论中缺乏生物碱限量规定,它们对人类健康的潜在威胁可能被低估。因此,应重视这一问题的重要性。关键是要立即对这些含PA的草药植物或产品开展基础研究,仔细评估其可能的危害。还应进一步努力提高质量控制标准,确保临床用药对人类健康的安全性。