Optimization of Extraction Process of Zhihuang Detumescence Gel Plaster Based on Quality by Design Concept
10.3870/j.issn.1004-0781.2025.08.021
- VernacularTitle:基于质量源于设计理念优化栀黄消肿贴膏提取工艺
- Author:
Yaolei HUANG
1
;
Xiaolan CHEN
1
;
Jian XU
1
;
Jinglan WU
1
;
Qin DENG
1
Author Information
1. 贵州中医药大学药学院,贵阳 550000
- Publication Type:Journal Article
- Keywords:
Zhihuang detumescence gel plaster;
Extraction process;
Quality by design;
Design space;
Risk assessment
- From:
Herald of Medicine
2025;44(8):1329-1335
- CountryChina
- Language:Chinese
-
Abstract:
Objective Based on the concept of quality by design(QbD),to establish the design space of Zhihuang detumescence gel plaster extraction process.Methods With Zhihuang detumescence gel plaster as the model drug,geniposide content and extract yield as critical quality attributes(CQA),failure mode effects analysis(FMEA)combined with fishbone diagram was used to evaluate the risk of extraction process,and single factor experiment was used to determine the critical process parameters(CPPs).The mathematical model of CPPs and CQAs was established by Box-Behnken experimental design,and the design space was obtained and verified by Monte Carlo method.Results The ethanol volume fraction,solvent multiplication and extraction times were determined as CPPs,the mathematical model established by Box-Behnken experimental design was statistically significant at P＜0.05,and combined with the production experience,the resulting operable space was:ethanol volume fraction of 67％-70％,solvent multiplication of 7.5-9 times,and the number of times of extraction was 3 times,Extraction time 1 h.Conclusion The establishment of the extraction process design space of Zhihuang detumescence gel plaster is helpful to improve the quality stability and controllability of the traditional Chinese medicine compound preparation,lay an experimental foundation for the development of subsequent preparations,and provide a reference for the application of the design space method to the compound preparation of traditional Chinese medicine.
