[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.