Development of an overall evaluation system for traditional Chinese medicine
10.16438/j.0513-4870.2021-0307
- VernacularTitle:中药质量整体评价研究思路探讨
- Author:
Yu SUN
1
;
Gan XU
2
;
Shuang-cheng MA
3
Author Information
1. Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
2. Beijing University of Chinese Medicine, Beijing 102248, China
3. National Institutes for Food and Drug Control, Beijing 100050, China
- Publication Type:Research Article
- Keywords:
hole process quality control;
property of traditional Chinese medicine;
efficacy;
effective component;
quantitative evaluation
- From:
Acta Pharmaceutica Sinica
2021;56(7):1749-1756
- CountryChina
- Language:Chinese
-
Abstract:
This paper reviews modern science and technology with regard to traditional Chinese medicine (TCM) research methods, quality control, and discusses the establishment and improvement of the evaluation system for TCM, focusing on the following issues: 1) How to incorporate the efficacy of TCM in the overall evaluation of TCM quality; 2) how to quantify the efficacy and properties of TCM; 3) how to understand the correlation between the efficacy and properties of TCM and its application; 4) how to reflect the specificity of the effective components in the overall evaluation of TCM quality; and 5) how to reflect the quality value transfer of effective components in the whole process of production and metabolism in vivo to the overall evaluation of TCM quality. The overall quality evaluation of TCM needs to better reflect its clinically safety and effectiveness. It is suggested to establish a clinical quality assessment method based on the content of the chemical components of TCM to explore and establish an overall evaluation method of TCM quality that reflects the efficacy of TCM and conforms with clinical practice.
