Zhang Ming-Hua, Gu Jun-Fei, Feng Liang, Jia Xiao-Bin
School of Pharmacy, Jiangsu University, Zhenjiang 212013, China.
Key Laboratory of New Drug Delivery System of Traditional Chinese Medicine under State Administration of Traditional Chinese Medicine, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China.
Zhongguo Zhong Yao Za Zhi. 2013 Nov;38(21):3608-12.
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.
质量控制是中药现代化和国际化的关键问题之一。由于中药具有整体性和系统性的特点，其在疾病防治中的作用是多成分协同作用的结果。目前，中药质量控制大多采用单一指标衡量，无法体现中药的整体性。由于中药成分可通过多种靶点和途径发挥防治疾病的作用，只有阐明其内在成分的具体组成和结构关系，确定中药在防治疾病中的最佳组成和结构比例，揭示其最佳有效性、安全性和稳定性，才能摆脱传统的定量模式，真正实现科学的整体质量控制。基于成分结构理论，本文提出“多维结构与过程动态质量控制系统”，并系统阐述中药的最佳有效性，为提高中药制剂产品疗效提供理论依据。
