基于标准汤剂的中药整体质量控制模式探讨

近年来,我国中药质量控制取得了较大的进步,国内外学者陆续提出了一系列的研究策略和方法,随着指纹图谱或特征图谱、一标多测以及多组分薄层色谱鉴别在2015年版《中国药典》中的广泛应用,"中药整体质量控制"框架越来越清晰。同时,有学者提出了中药饮片标准汤剂的概念,初步对标准汤剂的内涵及外延进行了阐述,并对其制备工艺及质量控制方法作了归纳。本文明确了标准汤剂的概念、属性及制备方法,并通过案例说明标准汤剂对单方制剂与经典名方等产品研发、质量控制及上市后再评价的意义和作用。讨论了基于标准汤剂的中药整体质量控制模式及案例分析,为中药整体质量控制提供了方法和参考。

Discussion on Whole Quality Control Mode of Traditional Chinese Medicine Based on Standard Decoction

In recent years,great progress has been made in the quality control of traditional Chinese medicine (TCM),a series of research strategies and methods have been put forward successively by scholars at home and abroad.With the extensive application of fingerprint,multi-measurement with a single standard,multi-component thin-layer chromatography in the 2015 edition of Chinese Pharmacopoeia,the framework of the whole quality control of TCM is more and more clear.In the meantime,some scholars put forward the concept of standard decoction of prepared slices of Chinese crude drugs,and they described the connotation and denotation of standard decoction initially,and summed up its preparation technology and quality control method.This paper defined the concept of standard decoction and discussed its properties and preparation methods;and illustrated its function and significance in product development,quality control,and post-marketing drug evaluation of single or classical formulas.The whole quality control mode of TCM based on standard decoction were investigated based on case analysis.The paper provides a method and reference for the whole quality control of TCM.