星点设计—效应面法优选贝马喷膜剂的制剂处方

Optimization of the formulation of Beima spraying-film preparation by the central composite design-response surface methodology

目的:优化贝马喷膜剂的制剂处方,提高制剂使用的顺应性。方法:以成膜时间、制剂的稳定性及土贝母苷甲含量为评价指标,对3种指标进行归一法处理,采用星点设计-效应面法优化贝马喷膜剂的制剂处方。结果:优化的贝马喷膜剂的制剂处方为:溶剂乙醇的质量分数为74.8%,聚乙烯吡咯烷酮(PVP)质量分数为15%,药液比例8.2%。3批验证性试验表明实际值与预测值基本一致。结论:应用星点设计-效应面法优化贝马喷膜剂的制剂处方,实验值与预测值吻合度高,所建立的模型预测性良好。

OBJECTIVE To optimize the formulation of Beima spraying-film preparation, and improve the using compliance of preparation. METHODS Applying overall desirability to handling the three indexes of film-forming time, preparation stabili- ty, the content of tubeimoside, the optimized formulation was obtained by the central composite design-response surface method- ology. RESULTS The optimum formulation was composed of 74. 8% ethanol, 15% PVP,and the 8. 2~ extraction. Results of the three batch of confirmatory test were accord with the predicted values. CONCLUSION The observed and predicted values were closed to each other, it proved that the optimum formulation by CCD-RSM was successful. The set ting model had a relia- ble predictability.