Current status, trends, and challenges of continuous manufacturing technology for oral traditional Chinese medicine solid preparations.
10.19540/j.cnki.cjcmm.20230508.301
- Author:
Zi-Qian WANG
1
;
Xue-Cheng WANG
2
;
Zhi-Jian ZHONG
3
;
Zhen-Feng LIU
4
;
Ya-Qi WANG
2
;
Bing YI
5
;
Ming YANG
2
;
Wei-Feng ZHU
2
;
Zhen-Feng WU
2
Author Information
1. Key Laboratory of Modern Preparation of Traditional Chinese Medicine,Ministry of Education,Jiangxi University of Chinese Medicine Nanchang 330004,China Jiangxi Drug Inspection Center Nanchang 330000,China.
2. Key Laboratory of Modern Preparation of Traditional Chinese Medicine,Ministry of Education,Jiangxi University of Chinese Medicine Nanchang 330004,China.
3. China Resources Jiangzhong Pharmaceutical Group Co.,Ltd. Nanchang 330096,China.
4. Yichun Wanshen Pharmaceutical Co.,Ltd. Yichun 336000,China.
5. Jiangxi Hebeikanghua Pharmaceutical Equipment Co.,Ltd. Nanchang 330096,China.
- Publication Type:Journal Article
- Keywords:
continuous manufacturing(CM);
intelligent manufacturing;
quality by design;
solid preparation;
traditional Chinese medicine(TCM) pharmaceutical equipment
- MeSH:
Medicine, Chinese Traditional;
Quality Control;
Drug Industry;
Technology, Pharmaceutical/methods*;
Drugs, Chinese Herbal;
Pharmaceutical Preparations
- From:
China Journal of Chinese Materia Medica
2023;48(16):4536-4544
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, continuous manufacturing technology has attracted considerable attention in the pharmaceutical industry. This technology is highly sought after for its significant advantages in cost reduction, increased efficiency, and improved productivity, making it a growing trend in the future of the pharmaceutical industry. Compared to traditional batch production methods, continuous manufacturing technology features real-time control and environmentally friendly intelligence, enabling pharmaceutical companies to produce drugs more efficiently. However, the adoption of continuous manufacturing technology has been slow in the field of traditional Chinese medicine(TCM) pharmaceuticals. On the one hand, there is insufficient research on continuous manufacturing equipment and technology that align with the characteristics of TCM preparations. On the other hand, the scarcity of talent with diverse expertise hampers its development. Therefore, in order to promote the modernization and upgrading of the TCM pharmaceutical industry, this article combined the current development status of the TCM industry to outline the development status and regulatory requirements of continuous manufacturing technology. At the same time, it analyzed the problems with existing TCM manufacturing models and explored the prospects and challenges of applying continuous manufacturing technology in the field of TCM pharmaceuticals. The analysis focused on continuous manufacturing control strategies, technical tools, and pharmaceutical equipment, aiming to provide targeted recommendations to drive the development of the TCM pharmaceutical industry.
