关于中药质量生物检定的几点商榷

Some opinions on bioassay for the quality control of Chinese medicines

中药质量生物检定已逐步成为中药学和生药学特别是中药质量评价与控制的重要发展方向。本文就生物检定在中药质量控制的作用和地位以及存在的问题和误区,提出:(1)虽然药物质控模式发展历程是先有生物检定后有化学检定,但生物检定并不代表落后或要被淘汰;(2)在中药质量控制体系中,生物检定是不可或缺的;(3)生物检定不是取代现有中药质量控制方法,只是现有方法的有益补充;(4)中药质量生物检定不等于中药药理实验,它既要符合定量药理学又要满足药检分析的要求;(5)中药质量生物检定尚处于探索阶段,不应求全责备,无论是检测指标的专属性还是方法学质量,不应以化学检定的要求来苛求生物检定。中药质量生物检定任重而道不远。

Bioassay has been an important and promising aspect for the quality control of Chinese medicines. In order to promote and standardize the bioassay for Chinese medicines, some problems and misunderstandings, as well as its role and function about bioassay, are discussed in this paper. The main suggestions are as follows： （1） The developmental history of drug quality control patterns shows that the bioassay appeared earlier than chemical analysis, but this does not mean the bioassay pattern is outdated. （2） In the quality control system of Chinese medicines, the bioassay method is important and indispensable.（3） The bioassay method may be used to complement the current quality control system rather than to replace it.（4） The bioassay is not equal to the pharmacological investigation, as it has to meet the requirements of both quantitative pharmacology and pharmaceutical analytics.（5） As bioassay application in Chinese medicine is at the initial stage, the requirements of chemical analysis are not fully suitable in not only the specificity of detection parameters but also the quality of methodology. Being under development and improvement, the bioassay for quality control of Chinese medicines will be accessible in the near future.