Recent research progress in key technologies of Chinese materia medica manufacturing process quality control
10.7501/j.issn.0253-2670.2020.16.030
- VernacularTitle: 中药生产过程质量控制关键技术研究进展
- Author:
Hao-Shu XIONG
1
Author Information
1. National & Local United Engineering Laboratory of TCM Advanced Manufacturing Technology, Tasly Pharmaceutical Co., Ltd.
- Publication Type:Journal Article
- Keywords:
Design of experiment (DOE);
Manufacture process of Chinese materia medica (CMM);
Multivariate statistical analysis;
Process analytical technology (PAT);
Quality by design (QbD);
Quality control
- From:
Chinese Traditional and Herbal Drugs
2020;51(16):4331-4337
- CountryChina
- Language:Chinese
-
Abstract:
The development of Chinese materia medica (CMM) has risen to the level of national strategy. Under the new situation that the pharmaceutical industry implements the "Made in China 2025" strategy, quality control of the production process of CMM is one of the key areas in which the CMM industry needs to accelerate its breakthrough. The key common issues in process design, analysis and detection, process modeling, and manufacturing equipment and other aspects in the field of quality control of CMM production processes was analyzed in the paper. The progress in the three aspects of process understanding, real-time analysis method development and process control strategy establishment in the quality control system of CMM production process was reviewed. Combined with the author's corporate research practices, this paper introduces the application progress of key technologies such as quality by design (QbD), process analytical technology (PAT), experimental design (DOE), and multivariate statistical analysis in the above three research directions, and analyzes the difficulties problems in practical industrial application. The application prospect is prospected. The purpose of this article is to provide reference for CMM enterprises to apply and improve the quality control technology in the production process.
