基于质量源于设计理念优化柳叶蜡梅挥发油包合物制备工艺
Optimization of the preparation process of volatile oil inclusion compound of Chimonanthus salicifolius S.Y.Hu based on quality by design concept
张聪 1金唯唯 1曾结林 1刘剑忠 2张慧 1颜继忠1
作者信息
- 1. 浙江工业大学药学院中药研究所,湖州 313000
- 2. 浙江贝尼菲特药业有限公司,丽水 323000
- 折叠
摘要
目的:基于质量源于设计(QhD)理念优化柳叶蜡梅挥发油包合物制备工艺.方法:以挥发油包合物的收率和包合率为关键质量属性(CQAs),选取了7个高风险因素设计Plackett-Burman试验,筛选出关键工艺参数;采用Box-Behnken试验设计分析CQAs与关键工艺参数的相关性;构建设计空间,选取最优操作空间.同时利用显微镜对包合物进行物理表征.结果:柳叶蜡梅挥发油包合物制备工艺优化出的操作空间为包合时间2.6～3.0 h,包合温度41～44 ℃,投料比(β-环糊精:挥发油)7.7∶1～8.3∶1.该操作空间下包合物的收率＞56％,包合率＞73％,包合物形态均一稳定.结论:该包合工艺操作空间可行,为柳叶蜡梅挥发油包合物制备工艺的质量控制提供参考.
Abstract
Objective:Optimize the preparation process of volatile oil inclusion compound of Chimonanthus salicifolius S.Y.Hu based on the concept of quality by design(QbD).Methods:The yield and inclusion rate of the volatile oil inclusion compound were selected as critical quality attributes(CQAs).Plackett-Burman experimental design was carried out to screen the investigation factors as the critical process parameters(CPPs).The correlation between CQAs and CPPs was analyzed by Box-Behnken experimental design.Then,the design space was constructed,and the optimal operation space was selected.Meanwhile,the inclusion compound was physically characterized using microscopy.Results:The operation space optimized for the preparation process of Chimonanthus salicifolius S.Y.Hu volatile oil inclusion compound was the inclusion time 2.6-3.0 h;the inclusion temperature was 41-44 ℃;the material ratio(β-cyclodextrin:volatile oil)was 7.7∶1～8.3∶1.The yield of the inclusion compound at this operating space was＞56％,and the inclusion ratio was＞73％.The morphology of the inclusion compound was homogeneous and stable.Conclusion:The inclusion process is feasible in operation space,and it provides a reference for the quality control of the preparation process of volatile oil inclusion of Chimonanthus salicifolius S.Y.Hu.
关键词
质量源于设计/柳叶蜡梅/挥发油/包合物/设计空间Key words
Quality by design/Chimonanthus salicifolius S.Y.Hu/Volatile oil/Inclusion compound/Design space引用本文复制引用
基金项目
浙江省基础公益研究计划项目(LBY22H280003)
浙江工业大学研究生实践基地建设项目(GZ21231160006)
浙江工业大学研究生实践基地建设项目(GZ21881160011)
出版年
2024
国家科技期刊平台
NSTL
万方数据