Four critical engineering and technical problems in manufacturing measurement of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20230330.301
- Author:
Zhi-Sheng WU
1
;
Yan-Jiang QIAO
1
;
Wei XIAO
2
;
Qi WANG
3
Author Information
1. School of Chinese Materia Medica, Beijing University of Chinese Medicine Beijing 102488, China Engineering Research Center of Chinese Materia Medica Production and New Drug Development, Ministry of Education Beijing 102488, China.
2. Engineering Research Center of Chinese Materia Medica Production and New Drug Development, Ministry of Education Beijing 102488, China National Key Laboratory on Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture Lianyungang 222001, China.
3. Engineering Research Center of Chinese Materia Medica Production and New Drug Development, Ministry of Education Beijing 102488, China National Institute of TCM Constitution and Preventive Medicine,Beijing University of Chinese Medicine Beijing 100029, China.
- Publication Type:Journal Article
- Keywords:
critical quality attributes;
manufacturing measurement of traditional Chinese medicine;
quality by design;
quality transfer;
whole-process quality control
- MeSH:
Medicine, Chinese Traditional;
Reproducibility of Results;
Commerce;
Drug Industry;
Quality Control
- From:
China Journal of Chinese Materia Medica
2023;48(11):2841-2855
- CountryChina
- Language:Chinese
-
Abstract:
Focusing on the development and quality improvement strategy of the traditional Chinese medicine(TCM) industry, the scientific and technological innovation of the new engineering of TCM should be paid attention to solve the "stuck neck" dilemma. Under the background of the ecological and industrial revolution of the scientific and technological innovation system, the super-scale information interaction and multi-dimensional integration will inevitably lead to profound changes in the manufacturing mode of TCM. Manufacturing measurement of TCM is formed on the basis of the reliability engineering theory of process control of TCM production. It is the development extension of system theory and system science ideas and a cross-fertilization discipline that combines theory with practice and adheres to the "four-oriented" re-epistemology improvement of the TCM discipline. In response to the problems of complex raw material sources, coarse process technology, unclear material basis, and poor applicability of equipment and technology in the manufacture of TCM, the transformation research mode of "aiming at the integration of pharmaceutical industry-developing intelligent production line-enabling industrial transformation" has been developed. This paper proposed the four key engineering technical problems, i.e., the identification of critical quality attributes(CQA) in the manufacture of TCM, the quality by design(QbD) and product development of the manufacturing process of TCM, the quality transfer principle and multivariate process capability index of TCM manufacturing, and the development of measurement technology and equipment of the manufacturing measurement of TCM, to achieve the systematization of quality control indicators, real-time process control, digitalization of manufacturing process, transparency of quality transfer, and intelligent whole-process control. In this paper, the new concepts, new theories, and new technologies provide a reference for the industrialization of TCM.
