A Multi-dimensional Indicator-based Approach for Quality Evaluation of Chinese Patent Medicines
10.13422/j.cnki.syfjx.20260866
- VernacularTitle:基于多维指标的中成药品质评价方法
- Author:
Shuangyan LI
1
;
Siyuan LI
1
;
Sha CHEN
1
;
Yue GUO
1
;
Jun ZHANG
1
;
Cong GUO
1
;
Yan LIU
1
;
An LIU
1
Author Information
1. State Key Laboratory for Quality Assurance and Sustainable Use of Dao-di Herbs， Institute of Chinese Materia Medica， China Academy of Chinese Medical Sciences， Beijing 100700， China
- Publication Type:Journal Article
- Keywords:
Chinese patent medicine;
quality consistency;
quality evaluation;
multi-dimensional comprehensive evaluation;
improved radar chart
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(19):229-237
- CountryChina
- Language:Chinese
-
Abstract:
Chinese patent medicines are the core preparations for disease prevention and treatment in clinical traditional Chinese medicine （TCM）. Their quality is the key to ensuring safe and effective medication and promoting the high-quality development of the TCM industry. At present， the quality evaluation of Chinese patent medicines faces prominent problems， such as inadequate control of quality consistency， over-reliance on single indicators， one-sided evaluation dimensions， unstable statistical methods， and poor implementability of research findings. These defects lead to insufficient scientificity of evaluation results， making it difficult to support the implementation of policies including centralized procurement， high quality， and favorable prices for Chinese patent medicines. According to the core requirements of quality evaluation for Chinese patent medicines， this study established a four-dimensional comprehensive evaluation system encompassing consistency index（CI）， content index（MI）， effect index（EI）， and preparation index（PI）. All evaluation indicators were normalized to achieve horizontal comparability. Meanwhile， an improved radar chart was introduced to realize the visualization of evaluation results. This method can systematically integrate four types of core quality attributes： Quality consistency， component content， biological activity， and preparation characteristics. It can effectively distinguish quality differences among products of the same specification from different manufacturers. The evaluation results are unique， stable， and not affected by the addition or reduction of samples， which takes scientificity， objectivity， and operability into account. This method can provide scientific and technical support for screening high-quality Chinese patent medicines and implementing policies of centralized procurement， high quality， and favorable prices. Moreover， it has important practical significance for improving the quality evaluation system of Chinese patent medicines and advancing the standard and modern development of TCM.
