Research advances in secondary development of Chinese patent medicines based on quality by design concept.
10.19540/j.cnki.cjcmm.20170223.020
- Author:
Xing-Chu GONG
1
;
Teng CHEN
1
;
Hai-Bin QU
1
Author Information
1. Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
- Publication Type:Journal Article
- Keywords:
Chinese medicine;
control strategy;
design space;
pharmaceutical engineering;
quality by design
- From:
China Journal of Chinese Materia Medica
2017;42(6):1031-1036
- CountryChina
- Language:Chinese
-
Abstract:
Quality by design (QbD) concept is an advanced pharmaceutical quality control concept. The application of QbD concept in the research and development of pharmaceutical processes of traditional Chinese medicines (TCM) mainly contains five parts, including the definition of critical processes and their evaluation criteria, the determination of critical process parameters and critical material attributes, the establishment of quantitative models, the development of design space, as well as the application and continuous improvement of control strategy. In this work, recent research advances in QbD concept implementation methods in the secondary development of Chinese patent medicines were reviewed, and five promising fields of the implementation of QbD concept were pointed out, including the research and development of TCM new drugs and Chinese medicine granules for formulation, modeling of pharmaceutical processes, development of control strategy based on industrial big data, strengthening the research of process amplification rules, and the development of new pharmaceutical equipment..
