[Research strategy and practice of "multi-dimensional structure and process dynamics quality control system" of...

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.