Quality control in manufacturing process of traditional Chinese medicine (TCM) preparations and its application in evaluation and decision-making of changes in marketed TCM preparations.
10.19540/j.cnki.cjcmm.20250207.601
- Author:
Hao CHEN
1
;
Chang-Ming YANG
1
;
Wei HAN
1
;
Jian-Bo QU
1
;
Ping YANG
1
;
Xia CHEN
1
;
Ruo-Jin WANG
2
Author Information
1. Center for Drug Evaluation, National Medical Products Administration Beijing 100076, China State Key Laboratory of Drug Regulatory Science Beijing 100076, China.
2. Center for Drug Evaluation, National Medical Products Administration Beijing 100076, China.
- Publication Type:English Abstract
- Keywords:
TCM regulatory science;
marketed TCM preparations;
quality control in manufacturing process;
traditional Chinese medicine(TCM) preparations
- MeSH:
Quality Control;
Drugs, Chinese Herbal/chemistry*;
Medicine, Chinese Traditional/standards*;
Decision Making;
Humans
- From:
China Journal of Chinese Materia Medica
2025;50(9):2589-2595
- CountryChina
- Language:Chinese
-
Abstract:
The manufacturing process is crucial for ensuring the safety and efficacy of traditional Chinese medicine(TCM) preparations. Using advanced technologies, innovative methods, and new equipment tailored for TCM to enhance the quality control of TCM preparations in the manufacturing process helps to ensure the product quality and foster high-quality development of the TCM industry. Upon current technical requirements, such as Guideline for Studies on Pharmaceutical Changes in Marketed Traditional Chinese Medicine Preparations(Trial) and Guideline for Study on Quality Control in Manufacturing Process of Oral Traditional Chinese Medicine Preparations(Trial), this paper analyzes the characteristics and current development of quality control in the manufacturing process of TCM preparations. It also discusses the significant roles that quality control in manufacturing process plays in ensuring the quality consistency and in the evaluation and decision-making of changes in marketed TCM preparations. Furthermore, to benefit the high-quality development of the TCM industry, this paper offers recommendations for improving quality control of TCM preparations in the manufacturing process and implementing new technologies and methods.
