基于质量源于设计理念的降脂护肝方提取工艺研究
Extraction of Jiangzhi Hugan prescription based on concept of quality by design
吴作敏 1李恒 1王韵旨 1宁萌 1郭丽 1李宜涵 1金少举 2王瑞3
作者信息
- 1. 漯河市中心医院药学部,河南 漯河 462000
- 2. 漯河医学高等专科学校,河南 漯河 462000
- 3. 漯河市中心医院药学部,河南 漯河 462000;河南省中药制剂与加工中医药重点实验室,河南 漯河 462000;河南省中药制剂现代化技术研发与临床应用工程研究中心,河南 漯河 462000
- 折叠
摘要
目的 基于质量源于设计理念,优化降脂护肝方的提取工艺.方法 以提取次数、提取时间、加水倍量为关键工艺参数(CPPs),应用正交设计从黄芪甲苷、甜菜碱、多糖含量及出膏率4项潜在关键质量属性(CQAs)中筛选CPPs对应的CQAs,通过Box-Behnken设计确定CQAs,并建立数学模型分析CPPs与CQAs之间的交互作用,最后建立设计空间并验证.结果 根据Box-Behnken试验确定甜菜碱的含量与出膏率为CQAs.通过设计空间的优化,得到最佳提取工艺为加10倍量水,提取3次,每次1.5h.结论 本研究优选的提取工艺稳定可靠,可为降脂护肝方的制备及质量控制提供参考.
Abstract
Objective To optimize the extraction of Jiangzhi Hugan prescription(JZHG)based on the concept of quality by design.Methods The number of extractions,extraction time and the times of water addition were used as the critical process parameters(CPPs).The orthogonal design was adopted to screen the critical quality attributes(CQAs)corresponding to CPPs from four potential CQAs,namely the content of astragaloside Ⅳ,betaine,polysaccharide and the extraction amount of solid matter.The CQAs were determined by Box-Behnken design.The mathematical model was established to determine the interaction between CPPs and CQAs.The design space of the JZHG extraction was established and verified.Results The content of betaine and the extraction amount of solid matter were determined as CQAs in the extraction by the variance analysis of Box-Behnken experiment.Through the optimization of the design space,the optimum extraction process was obtained as follows:adding 10 times of water,3 extractions,and each extraction 1.5 h.Conclusion The optimized extraction is stable and reliable,which provides reference for the process development and quality control of JZHG.
关键词
质量源于设计/降脂护肝方/提取工艺/Box-Behnken设计/设计空间Key words
quality by design/Jiangzhi Hugan prescription/extraction process/Box-Behnken design/design space引用本文复制引用
基金项目
河南省中医药科学研究专项(2022ZY1195)
漯河市重大科技创新专项(漯财预指[2022]478号)
漯河医学高等专科学校创新创业发展能力提升工程科技类项目(2021LYZKJXM043)
出版年
2024
NETL
NSTL
万方数据