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。
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.
作者
孙萌
刘雪纯
赵玥瑛
张晴
席铖
董爽
张馨雨
杜守颖
白洁
陆洋
SUN Meng;LIU Xue-chun;ZHAO Yue-ying;ZHANG Qing;XI Cheng;DONG Shuang;ZHANG Xin-yu;DU Shou-ying;BAI Jie;LU Yang(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China)
出处
《中国现代中药》
CAS
2024年第2期348-356,共9页
Modern Chinese Medicine
基金
国家自然科学基金项目(82173989)。
关键词
质量源于设计
设计空间
散偏汤
提取工艺
quality by design
design space
Sanpian Decoction
extraction process
作者简介
通信作者:陆洋,教授,研究方向:中药新剂型与新技术,Tel:010-83912123,E-mail:luyang@bucm.edu.cn;白洁,教授,研究方向:中药新剂型与新技术,Tel:010-84738657,E-mail:baijie22811@163.com。
