Prediction of Extraction Process Design Space of Sanpian Decoction based on Quality by Design
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.
quality by designdesign spaceSanpian Decoctionextraction process
国家科技期刊平台
NSTL
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