Guidelines for Quality Evaluation Methods of Traditional Chinese Medicine - T/CACM 001-2017

Scope

Main technical content: The quality of traditional Chinese medicine (TCM) refers to the variety, origin, specifications, grade, quality, and attributes related to its efficacy. TCM quality is the fundamental guarantee of clinical efficacy. Currently, conventional TCM quality evaluation is often limited to general chemical and sensory assessments, which are difficult to reflect the intrinsic quality of TCM and its clinical efficacy and safety, and also difficult to provide targeted guidance for safe and rational clinical medication. Establishing strategies and methods for evaluating TCM quality that reflect clinical efficacy and safety has long been a critical scientific issue urgently needing to be addressed in the standardization, modernization, and internationalization of TCM. The main members of the drafting group of the "Guide for TCM Quality Evaluation Methods" (hereinafter referred to as the "Guide") systematically revealed the quality characteristics of TCM with multiple components and effects, and the differences in its material basis and quality control strategies from chemical drugs and biological drugs. They proposed and conducted efficacy-oriented TCM quality evaluation research, and explored and established a TCM quality biological evaluation system centered on biological potency, biological toxicity, direct activity determination, efficacy component index, biological effect expression profile, and biomarkers, which compensated for the shortcomings of chemical and sensory evaluations. By further integrating the technical advantages and characteristics of sensory evaluation, chemical evaluation, and biological evaluation, and guided by high-quality standards, they created an integrated TCM quality evaluation methodology system, the "Quality Control Pyramid", based on the Chinese Pharmacopoeia, and proposed and developed evaluation technical paths and methods for different types of TCM products and quality control requirements, including TCM raw materials

Development Information

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