Study on famous prescription of prestigious traditional Chinese medicine master Lu Zhizheng based on QbD concept: optimization of extraction process and granule forming process of Meiyan Shuqi Prescription.
10.19540/j.cnki.cjcmm.20190629.307
- Author:
Li YANG
1
;
Xing-Guo HUANG
1
;
Zhi-Zheng LU
2
;
Jing-Hua LU
3
;
Zong-Yue JIANG
3
;
Ji YANG
3
;
Zhi-Sheng WU
1
Author Information
1. School of Chinese Materia Medica,Beijing University of Chinese Medicine Beijing 102488,China.
2. China Academy of Chinese Medical Sciences Beijing 100700,China.
3. Beijing Qihuang Scientific Development of Traditional Chinese Medicine Foundation Beijing 100089,China.
- Publication Type:Journal Article
- Keywords:
design space;
extraction process;
flavonoids;
quality by design
- MeSH:
Drugs, Chinese Herbal;
Ethanol;
Flavonoids;
Medicine, Chinese Traditional;
Research Design
- From:
China Journal of Chinese Materia Medica
2019;44(20):4336-4341
- CountryChina
- Language:Chinese
-
Abstract:
Based on the concept of quality by design( QbD),the design space of Meiyan Shuqi Prescription extraction process was established,and its granules forming process was optimized. The content of total flavonoids was the critical quality attribute( CQA).The amount of water,extraction time and frequency were used as the critical process parameters( CPPs). Box-Behnken experimental design was used to optimize the extraction process. The design space of Meiyan Shuqi Prescription extraction process was established and verified. The results of variance analysis showed that the P value of the quadratic regression model was less than 0. 01,which indicated that the model had a statistical significance,and the relationship between each factor and response value could be functionalized by the established model. Through further optimization of design space,the optimal extraction process of Meiyan Shuqi prescription was13-fold volume of water,extraction for 3 times and each extraction time of 1. 4 hours. Furthermore,the forming process optimized by single factor was as follows: the excipient was dextrin; the ratio of extract powder to excipient was 1 ∶1; the wetting agent was 70% ethanol; and the amount of wetting agent was 0. 3 m L·g-1. The Meiyan Shuqi Prescription extraction process and the forming process based on QbD concept provide reference for the study of other traditional Chinese medicine prescriptions.
