中国现代中药2024，Vol.26Issue(2)：348-356,9.DOI:10.13313/j.issn.1673-4890.20230222002
基于QbD理念的散偏汤提取工艺设计空间预测
Prediction of Extraction Process Design Space of Sanpian Decoction based on Quality by Design
摘要
Abstract
Objective:To predict the design space of the extraction process of Sanpian Decoction.Methods:Based on the theory of quality by design and design space,the failure model of fishbone diagram combined with risk priority number was used to determine the number of extractions,extraction time,and amount of water added as the critical parameters of the extraction process of Sanpian Decoction,and the content of ferulic acid,sinapine thiocyanate,liquiritin and glycyrrhizic acid and extraction yields as the critical quality attributes.Box-Behnken response surface method was used to design an experimental fitting mathematical model.The relationship between them was investigated and the design space of the extraction process of Sanpian Decoction was established.Results:The design space of the extraction process of Sanpian Decoction was established according to the mathematical model.The verification test results showed that the mass fractionof ferulic acid,sinapine thiocyanate,liquiritin,and glycyrrhizic acid in the single prescription were 0.450‰,0.787‰,0.248‰ and 0.451‰,respectively.The extract yield was 23.83%,which met the requirements of critical quality attributes.Conclusion:The established design space provides a reference for the scale-up production and quality control of Sanpian Decoction.关键词
质量源于设计/设计空间/散偏汤/提取工艺Key words
quality by design/design space/Sanpian Decoction/extraction process分类
医药卫生引用本文复制引用
孙萌,陆洋,刘雪纯,赵玥瑛,张晴,席铖,董爽,张馨雨,杜守颖,白洁..基于QbD理念的散偏汤提取工艺设计空间预测[J].中国现代中药,2024,26(2):348-356,9.基金项目
国家自然科学基金项目(82173989) （82173989）
