中药“多维结构过程动态质量控制体系”的研究策略和实践

Research strategy and practice of "multi-dimensional structure and process dynamics quality control system" of traditional Chinese medicines

中药质量控制是中药现代化、国际化的关键问题之一。中药具有整体性和系统性特点,其防治疾病是多种组分/成分协同作用的结果。目前,针对中药的质量控制,多以单一的指标衡量,无法体现中药整体性特点。中药组分/成分经多靶点、多途径发挥防病治病的功效,因此,只有从中药内部微观结构出发,阐明其内在成分/组分(即组分间与组分内)特定的组成结构关系,确定中药防病治病,发挥优效并安全稳定的最优组成结构比,才能脱离传统的量化模式,实现真正的科学的整体性质量控制。该文基于组分结构理论,提出中药"多维结构过程动态质量控制体系",系统阐述了中药优效性的本质,为提高中药制剂产品的疗效提供理论依据。

The quality control is one of the key problems in the modernization and internationalization of traditional Chinese medicines（TCM）. As TCMs have the characteristics of integrity and systematicness, their effect in disease prevention and treatment is the result of multi-component synergistic effect. Currently, the quality control of TCMs is mostly measured with a single index, which can not reflect the integrity of TCMs. As TCM components could play the role in preventing and treating diseases through multiple targets and channels, only if we expound the specific composition and structural relations among inherent components, and determine the optimum composition and structure ratio of TCMs in preventing and treating diseases and revealing their optimal efficiency, safety and stability, can we get rid of the conventional quantitative model, and realize the scientific integral quality control in a real sense. On the basis of the component structure theory, we propose ＂multi-dimensional structure and process dynamics quality control system＂ in this article, and systematically expound the optimal efficiency of TCMs, in order to provide a theoretical basis for improving the efficacy of TCM preparation products.keywords：traditional Chinese medicine