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
孙萌 1刘雪纯 1赵玥瑛 1张晴 1席铖 1董爽 1张馨雨 1杜守颖 1白洁 1陆洋1
作者信息
- 1. 北京中医药大学 中药学院,北京 102488
- 折叠
摘要
目的:预测散偏汤提取工艺的设计空间.方法:基于质量源于设计和设计空间理念,采用鱼骨图结合失效模型与效应分析的方法确定提取次数、提取时间、加水倍量为散偏汤提取工艺的关键工艺参数,以阿魏酸、芥子碱硫氰酸盐、甘草苷、甘草酸的含量及出膏率为关键质量属性,采用Box-Behnken响应面法试验设计拟合数学模型,考察其相互关系,建立散偏汤提取工艺设计空间.结果:依据数学模型建立了散偏汤提取工艺设计空间,在此空间内取点验证,发现单个处方阿魏酸、芥子碱硫氰酸盐、甘草苷、甘草酸的质量分数分别为 0.450‰、0.787‰、0.248‰、0.451‰,出膏率为 23.83%,符合关键质量属性的要求.结论:建立的设计空间可为散偏汤放大生产和质量控制提供参考.
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引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据