中文摘要：

目的：优化醒脑静固体制剂中挥发性成分艾片、人工麝香的β-环糊精包合工艺。方法：以球磨法包合艾片和人工麝香;以艾片中龙脑和人工麝香中麝香酮包合率作为评价指标,采用Box-Behnken响应面设计考察环糊精用量、加水量及包合时间对包合物制备工艺的影响,运用Design-Expert软件对工艺参数拟合优化并进行验证。结果：最佳工艺为龙脑和麝香酮质量-环糊精质量比为1∶8,环糊精-水质量比为1∶4,包合时间为53 min,龙脑和麝香酮理论包合率分别为98.82%,83.33%;经验证,龙脑及麝香酮包合率分别为97.41%,82.59%。结论：采用球磨法包合,结合Box-Behnken响应面法优选的艾片、人工麝香-β-环糊精包合物制备工艺稳定可行,包合率高,适用于生产。

英文摘要：

Objective：To optimize the preparation process of the aipian,artficial moschus-β-cyclodextrin inclusion compound from the oral solid preparation of Xingnaojing.Method： Aipian and artficial moschus were included by ball grinding method;Box-Behnken response surface method was used to investigate the amount of β-cyclodextrin,inclusion time,the amount of water which effect the preparation process of β-cyclodextrin inclusion compound with the entrapment efficiency of borneol in aipian and muscone in artficial moschus as the index.Design-Expert software was applied to imitate,optimize and verify the process parameter.Result： The optimal process was as follows： the weight rate of borneol-muscon to β-cyclodextrin was 1∶8;the weight rate of β-cyclodextrin to water was 1∶4;inclusion time was 53 min;the theoretical entrapment efficiency of borneol and muscone was 98.82% and 83.33% respectively.The entrapment efficiency of borneol and muscone was 97.41% and 82.59% respectively by verification.Conclusion： The optimized preparation process of aipian,artficial moschus-β-cyclodextrin inclusion compound by ball grinding method and Box-Behnken response surface method is stable and feasible.The entrapment efficiency is high.It can be used for production.