Research progress and maturity assessment of continuous manufacturing of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20230228.301
- Author:
Zi-Chen LIANG
1
;
Xue-Fang TANG
1
;
Ping YANG
2
;
Ju SONG
2
;
Zhao-Zhou LIN
3
;
Xiang XU
4
;
Yan-Lin QIN
5
;
Yan-Yu BAO
6
;
Zhi-Qiang ZHANG
7
;
Xin ZHANG
8
;
Jian-Bo QU
2
;
Yan-Jiang QIAO
9
;
Bing XU
9
Author Information
1. Department of Chinese Medicine Informatics, Beijing University of Chinese Medicine Beijing 102400, China Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine, Beijing Municipal Science & Technology Commission Beijing 102400, China.
2. Center for Drug Evaluation, National Medical Products Administration Beijing 100022, China.
3. Beijing Zhongyan Tongrentang Medicine R&D Co., Ltd. Beijing 100079, China National Chinese Compound Medicine Research & Development Center Beijing 100079, China.
4. Shandong Buchang Pharmaceutical Co., Ltd. Heze 274000, China.
5. Tsinghua Deren Xi'an Happiness Pharmaceutical Co., Ltd. Xi'an 710043, China.
6. China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. Shenzhen 518110, China.
7. Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine, Beijing Municipal Science & Technology Commission Beijing 102400, China Beijing Tcmages Pharmaceutical Co., Ltd. Beijing 101301, China National and Regional Joint Engineering Research Center for Key Technologies of Chinese Medicine Formula Granules Tianjin 301700, China.
8. Jiangsu Kanion Pharmaceutical Co., Ltd. Lianyungang 222001, China National and Regional Joint Engineering Research Center for Key Technologies of Chinese Patent Medicine Lianyungang 222001, China State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process Lianyungang 222001, China.
9. Department of Chinese Medicine Informatics, Beijing University of Chinese Medicine Beijing 102400, China Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine, Beijing Municipal Science & Technology Commission Beijing 102400, China Engineering Research Center of Chinese Medicine Production and New Drug Development, Ministry of Education of People's Republic of China Beijing 102400, China.
- Publication Type:Journal Article
- Keywords:
continuous manufacturing;
intelligent equipment;
physical characterization;
process modeling;
system integration;
traditional Chinese medicine production
- MeSH:
Medicine, Chinese Traditional;
Reproducibility of Results;
China;
Quality Control;
Pharmaceutical Preparations
- From:
China Journal of Chinese Materia Medica
2023;48(12):3162-3168
- CountryChina
- Language:Chinese
-
Abstract:
The pharmaceutical manufacturing model is gradually changing from intermittent manufacturing to continuous manufacturing and intelligent manufacturing. This paper briefly reviewed the supervision and research progress in continuous pharmaceutical manufacturing in China and abroad and described the definition and advantages of continuous pharmaceutical manufacturing. The continuous manufacturing of traditional Chinese medicine(TCM) at the current stage was summarized in the following three terms: the enhancement of the continuity of intermittent manufacturing operations, the integration of continuous equipment to improve physical continuity between units, and the application of advanced process control strategies to improve process continuity. To achieve continuous manufacturing of TCM, the corresponding key technologies, such as material property characterization, process modeling and simulation, process analysis technology, and system integration, were analyzed from the process and equipment, respectively. It was proposed that the continuous manufacturing equipment system should have the characteristics of high speed, high response, and high reliability, "three high(H~3)" for short. Considering the characteristics and current situation of TCM manufacturing, based on the two dimensions of product quality control and production efficiency, a maturity assessment model for continuous manufacturing of TCM, consisting of operation continuity, equipment continuity, process continuity, and quality control continuity, was proposed to provide references for the application of continuous manufacturing technology for TCM. The implementation of continuous manufacturing or the application of key continuous manufacturing technologies in TCM can help to systematically integrate advanced pharmaceutical technology elements and promote the uniformity of TCM quality and the improvement of production efficiency.
