Zheng Wen-Ke, Zhang Li, Zan Shu-Jie
Tianjin University of Traditional Chinese Medicine Tianjin 300193, China.
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300250, China.
Zhongguo Zhong Yao Za Zhi. 2019 Feb;44(3):624-628. doi: 10.19540/j.cnki.cjcmm.20180925.004.
Decoction 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.
饮片是中药方剂的基本单位，也是中药临床疗效的主要物质基础。中药饮片的临床疗效对中药方剂的整体疗效至关重要。然而，目前中药饮片的质量评价主要集中在内在物质和成分的含量上。毒理学和药理学等基础研究较为深入，但缺乏临床评价的证据支持。因此，现行的饮片质量评价体系难以客观反映中药的临床效果，形成了唯成分论或盲目追求药材的大剂量、重剂量。中药饮片质量标准存在偏差，令人担忧“中医将毁于中药”。因此，本文提出迫切需要对中药饮片进行临床评价，并将临床评价作为中药饮片质量评价的出发点和落脚点，以产地鉴定、产地评价、产品评价、含量评价和有害物质检测作为辅助支撑。最终形成以临床评价为核心的中药饮片质量评价新体系，该体系由六个步骤组成，旨在推动中药饮片质量提升。当然，由于中药饮片临床评价尚无成熟经验，该质量评价体系存在流程复杂、成本高等挑战，但对于保障药材质量和生命安全至关重要。因此，构建并实施该质量评价体系具有重要性和紧迫性。
