中国现代中药2026，Vol.28Issue(5)：1010-1019,10.DOI:10.13313/j.issn.1673-4890.20250914001
基于设计空间的巴赫蜜膏提取工艺优化与多指标成分含量测定
Extraction Process Optimization and Multi-component Determination of Bakh Paste Based on Design Space
摘要
Abstract
Objective:To optimize the extraction process for the preparation of Bakh Paste based on the Quality by Design(QbD)concept and establish a method for multi-component determination.Methods:The contents of caffeic acid,rutin,rosmarinic acid,quercetin,and luteolin,together with extract yield,were defined as critical quality attributes(CQAs).Failure mode and effects analysis(FMEA)was employed to screen potential critical process parameters(CPPs).A high-performance liquid chromatography(HPLC)method was established for the determination of these components.A Box-Behnken response surface design was adopted to construct a mathematical model for analyzing the interactions between CPPs and CQAs,and then the design space was established and optimized for the extraction process.Results:The CPPs affecting the extraction process were extraction time,water volume,and extraction cycles.The established method showed good accuracy and reproducibility.The extraction conditions were optimized as three extraction cycles,extraction for 1.5 h,and a 12-fold water volume.Conclusion:The optimized extraction process of Bakh Paste is stable and reliable,which can provide a reference for the development and quality control of this preparation.关键词
巴赫蜜膏/提取工艺/设计空间/Box-Behnken设计Key words
Bakh Paste/extraction process/design space/Box-Behnken design分类
医药卫生引用本文复制引用
朱金媛,阿衣努尔·热合曼,何雨峻,阿地力江·伊明..基于设计空间的巴赫蜜膏提取工艺优化与多指标成分含量测定[J].中国现代中药,2026,28(5):1010-1019,10.基金项目
国家自然科学基金项目(82260873) （82260873）
