关于中药质量控制与体内代谢研究的思考

质量控制是保证中药安全、有效的重要基础。体内代谢研究可以为阐明中药的治病机制提供依据。本文以蟾酥为例,讨论了当前中药质量控制及体内代谢研究存在的主要问题和解决办法:认为把中药指纹图谱的全面指认与多指标成分定量相结合是有效控制中药质量的可行途径;液相色谱-质谱联用技术(LC/MS)将在中药化学研究、体内代谢研究等方面发挥重要作用;中药的化学指纹图谱应与药理活性相关联,从而建立合理的中药质量评价体系;结构修饰对基于天然产物的新药发现具有重要意义。

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Quality control is critically important for the safety and efficacy of traditional Chinese medicine. DMPK (drug metabolism and pharmacokinetic) studies facilitate the clarification of the mechanism of action of traditional Chinese medicine. In this paper, we discuss the current barriers in the quality control and DMPK studies of traditional Chinese medicine by using our studies on toad venom (Chan-Su) as example. It is concluded that the combination of full assignments of the chemical fingerprint and the simultaneous quantitation of multiple compounds is a feasible way for the comprehensive quality control of traditional Chinese medicines. Liquid chromatography/mass spectrometry (LC/MS) will play an important role in chemistry and DMPK studies of traditional Chinese medicine. The chemical fingerprints of traditional Chinese medicines should be correlated with their pharmacological activities so as to establish a reasonable traditional Chinese medicine quality evaluation system. Structural modification could be valuable for natural product-based drug discovery.