Research and Practice on Quality Control of Chinese Medicine Production Process with Functional Substances as Quality Tar-get
10.14148/j.issn.1672-0482.2024.1030
- VernacularTitle:以功效物质为质量目标的中药生产过程质量控制研究与实践
- Author:
Wei XIAO
1
,
2
;
Xin ZHANG
;
Fangfang XU
;
Chenfeng ZHANG
;
Zhenzhong WANG
Author Information
1. 中药制药过程控制与智能制造技术全国重点实验室(江苏康缘药业股份有限公司/南京中医药大学),江苏 南京 210023
2. 江苏康缘药业股份有限公司,江苏 连云港 222001
- Keywords:
Chinese medicine manufacturing;
process quality control;
functional substances;
intelligent manufacturing;
process analytical technology
- From:
Journal of Nanjing University of Traditional Chinese Medicine
2024;40(10):1030-1038
- CountryChina
- Language:Chinese
-
Abstract:
The quality control during the manufacturing process of traditional Chinese medicine TCM)is paramount to ensuring the quality of the final product.However,the sheer diversity of TCM ingredients and the intricacies of the production process pose sig-nificant challenges to achieving precise quality control.The review introduced an intelligent control concept centered on functional sub-stances in TCM quality,which comprehensively explained the scientific essence of TCM quality,and provided a theoretical foundation for determining"what to control"and"how to control"within the complex system of TCM components.Furthermore,through the ad-vanced informatization,digitization,and intelligent technologies,our team has conducted extensive research and construction practices on the intelligent transformation and digital upgrade of traditional Chinese medicine TCM)manufacturing processes.Ultimately,the establishment of a quality control system tailored specifically for TCM manufacturing with functional substances serving as the primary quality target,which presented an opportunity to solve the difficult problem of process quality control in TCM manufacturing.
