Intelligent co-design of material, process, and equipment for manufacturing high-quality traditional Chinese medicine preparations.
10.19540/j.cnki.cjcmm.20230715.301
- Author:
Bing XU
1
;
Yan-Jiang QIAO
1
;
Shou-Ying DU
2
;
Zhi-Qiang ZHANG
3
;
Wei XIAO
4
Author Information
1. School of Chinese Materia Medica, Beijing University of Chinese Medicine Beijing 102488, China Beijing Key Laboratory for Production Process Control and Quality Evaluation of Chinese Medicine, Beijing Municipal Science & Technology Commission Beijing 102488, China.
2. School of Chinese Materia Medica, Beijing University of Chinese Medicine Beijing 102488, China.
3. Beijing Key Laboratory for Production Process Control and Quality Evaluation of Chinese Medicine, Beijing Municipal Science & Technology Commission Beijing 102488, China National and Regional Joint Engineering Research Center for Key Technologies of Chinese Medicine Formula Granules Tianjin 301700, China.
4. National Key Laboratory on Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture Lianyungang 222001, China.
- Publication Type:Journal Article
- Keywords:
manufacturing classification system;
material database;
pharmaceutical design tetrahedron;
quality by intelligent design(QbID);
reliability-based optimization;
system modeling and simulation
- MeSH:
Medicine, Chinese Traditional;
Reproducibility of Results;
Quality Control;
Computer Simulation;
Commerce;
Pharmaceutical Preparations;
Drugs, Chinese Herbal
- From:
China Journal of Chinese Materia Medica
2023;48(15):3977-3987
- CountryChina
- Language:Chinese
-
Abstract:
In the context of Pharma 4.0, the design tools that support the pharmaceutical Quality by Design(QbD) are iterating fast toward intelligent or smart design. The conventional development methods for traditional Chinese medicine(TCM) preparations have the limitations such as over dependence on experience, low dimensions for the designed experiment parameters, poor compatibility between the process and equipment, and high trial-and-error cost during process scale-up. Therefore, this paper innovatively proposed the intelligent co-design involving material, process, and equipment for manufacturing high-quality TCM preparations, and introduced the design philosophy, targets, tools, and applications with TCM oral solid dosage(OSD) as an example. In terms of design philosophy, the pharmaceutical design tetrahedron composed of critical material attributes, critical process parameters, critical equipment attributes, and critical quality attributes was developed. The design targets were put forward based on the product performance classification system. The design tools involve a design platform that contains several modules, such a as the iTCM material database, the processing route classification system, the system modeling and simulation, and reliability-based optimization. The roles of different modules in obtaining essential and universal design knowledge of the key common manufacturing units were introduced. At last, the applications of the co-design methodology involving material, process, and equipment in the high shear wet granulation process development and the improvement of the dissolving or dispersion capability of TCM formula granules are illustrated. The research on advanced pharmaceutical design theory and methodology will help enhance the efficiency and reliability of drug development, improve the product quality, and promote the innovation of high-end TCM products across the industry.
