Optimization of the extraction process of Shenye buyi formula
- VernacularTitle:参叶补益方的提取工艺优选
- Author:
Yanrao WU
1
;
Mingming YU
2
;
Xiaojing NIU
1
;
Xiaoying DUAN
3
Author Information
1. Dept. of Pharmacy，the First Affiliated Hospital of Henan University of Chinese Medicine，Zhengzhou 450003，China;Henan Provincial Research Center for Clinical Application，Evaluation and Translation Engineering of Traditional Chinese Medicines，Zhengzhou 450003，China;Henan Provincial Key Laboratory of Traditional Chinese Medicines and Clinical Pharmacy，Zhengzhou 450003，China
2. Jiangsu Kanion Pharmaceutical Co.，Ltd.，Jiangsu Lianyungang 222001，China
3. Dept. of Pharmacy，the First Affiliated Hospital of Henan University of Chinese Medicine，Zhengzhou 450003，China;Henan Provincial Research Center for Clinical Application，Evaluation and Translation Engineering of Traditional Chinese Medicines，Zhengzhou 450003，China
- Publication Type:Journal Article
- Keywords:
Shenye buyi formula;
process optimization;
CPPs;
CQAs;
AHP-EWM;
Box-Behnken response surface method
- From:
China Pharmacy
2026;37(12):1573-1578
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To optimize the extraction process of Shenye buyi formula. METHODS Based on the quality by design （QbD） concept， the contents of rutin， nuciferine， sinapine thiocyanate， liquiritin，and glycyrrhizic acid ammonium salt， as well as the extract yield， were selected as the critical quality attributes （CQAs） for the extraction process of Shenye buyi formula. The fishbone diagram combined with the failure model and effect analysis method was adopted to determine the water addition， extraction time and extraction times as critical process parameters （CPPs）. High-performance liquid chromatography was employed to detect the contents of rutin， nuciferine， sinapine thiocyanate， liquiritin， and glycyrrhizic acid ammonium salt. The analytic hierarchy process-entropy weight method was used to comprehensively assign weights to the content of the five components including rutin and the extract yield. The Box-Behnken response surface method was employed to fit the mathematical model between CQAs and CPPs， screen the operational space of the extraction process， and validate it. RESULTS The optimal operational space of the extraction process was 9.5 to 12 times the amount of water added， the extraction time was 1 to 1.7 hours， and the extraction times were 3. Upon verification，the comprehensive scores of the optimal extraction process within the operational space were 89.79 and 84.93， respectively. CONCLUSIONS The extraction process of the Shenye buyi formula can be applied to the development and production of its granule preparations.
