• Wen-Ke Zheng, Li Zhang, and Shu-Jie Zan.
• Tianjin University of Traditional Chinese Medicine Tianjin 300193, China.
• Zhongguo Zhong Yao Za Zhi. 2019 Feb 1; 44 (3): 624-628.

AbstractDecoction piece is the basic unit of traditional Chinese medicine(TCM) prescriptions, and it is also the main material basis for clinical efficacy of TCM. The clinical efficacy of TCM decoction pieces is very important for the overall efficacy of TCM prescriptions. However, the current quality evaluation of TCM decoction pieces mainly focuses on the amount of intrinsic substances and compositions. The basic researches such as toxicology and pharmacology are deeply, but lacking with the evidences from clinical evaluation. Therefore, the current decoction pieces quality evaluation system is difficult to objectively reflect the clinical effect of traditional Chinese medicine, forming the only componential theory or blindly pursuing the large volume and heavy weight of medicine materials. The quality standard of Chinese decoction pieces is biased,with concerns that "TCM will die from Chinese medicine". Therefore, this paper proposes that it is urgent to clinically evaluate the TCM decoction pieces,and regard the clinical evaluation as a starting point and a foothold for the quality evaluation of TCM decoction pieces, based on the origin identification, origin evaluation, product evaluation, content evaluation, and harmful substance detection as an auxiliary support. Finally a new quality evaluation system for TCM decoction pieces with a clinical evaluation as the core is formed, which is composed of six steps, aiming to promote the quality improvement of TCM decoction pieces. Of course, because there is no mature experience in the clinical evaluation of TCM decoction pieces, the quality evaluation system has some challenges such as complex processes and high cost, but it is essential for maintaining the quality of medicinal materials and life safety. Therefore, it is of importance and urgency to construct and implement the quality evaluation system.

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