Abstract：Chinese medicinal materials and decoction pieces are the material basis for the inheritance and development of traditional Chinese medicine(TCM). Their quality is directly related to the effectiveness and safety of TCM clinical practice. Quality standards can promote and guide the quality control, evaluation, and quality improvement of TCM.However, due to the profound theory of TCM, the mechanism of TCM prevention and treatment of diseases is not in-depth and systematic, lead to lack of scientific basis for the standard research and revising work, scientific nature, rationality and practicability of the standard is often questioned.This paper analyzed the outstanding problems existing in the standard study, such as weak correlation between standard indicators and quality attributes,and unreasonable acceptable limit, and put forward the standard formulation principles in accordance with the quality characteristics of Chinese medicinal materials and decoction pieces. First, adhere to the characteristics of TCM theory, based on TCM clinical quality recognition, formulate effective standards. The second is to adhere to the quality characteristics of Chinese medicinal materials, establish quality indicators around quality attributes, and establish effective standards. Third, we should guard the bottom line of authenticity and safety, and formulate safety standards based on risk assessment. This paper analyzes and discusses the common problems and misunderstanding in the study of quality standards of Chinese medicinal materials and decoction pieces and emphasizes that the standards are not only for inspection and supervision, but also for guiding the technical compliance of the whole process of production, circulation and clinical use of Chinese medicinal materials and decoction pieces, and should be scientific, reasonable and feasible. At the same time, the standards can guide and promote the sustainable utilization of TCM resources and the high-quality development of TCM industry. Finally, from the perspective of quality improvement and perfect the standard, suggestions to strengthen the whole industry chain production technology norms and standards, strengthen the quality evaluation standard research, at the same time with the construction of Daodi authentic and standardized production bases as the engine, the newly promulgated “Good Agriculture Performance of Chinese Medicinal Materials Production” will be implemented and effective, so as to fundamentally improve the quality of Chinese medicinal materials and ensure the high-quality development of traditional Chinese medicine.
魏锋, 程显隆, 荆文光, 陈佳, 余坤子, 张萍, 严华, 李明华, 杨建波, 马双成. 中药材及饮片质量标准研究有关问题思考[J]. 中国药学杂志, 2022, 57(18): 1493-1503.
WEI Feng, CHENG Xian-long, JING Wen-guang, CHEN Jia, YU Kun-zi, ZHANG Ping, YAN Hua, LI Ming-hua, YANG Jian-bo, MA Shuang-cheng. Some Concerns About the Standard Establishment of Chinese Medicinal Medicines and Decoction Pieces. Chinese Pharmaceutical Journal, 2022, 57(18): 1493-1503.
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