【摘要】 目的：基于质量源于设计（QbD）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。更多还原

【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 BoxBehnken 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.更多还原