星点设计-效应面法优化生地黄低聚糖吸入粉雾剂的制备工艺

Optimized preparation of dry powder inhalation of Rehmannia glutinosa oligosaccharides by central composite design and response surface method

目的:优化生地黄低聚糖吸入粉雾剂(RGOS-DPI)的制备工艺。方法:以喷雾干燥法制备微粉,分别测定收率、吸湿率、排空率和平均粒径,以总评"归一值"为评价指标,采用星点设计考察进口温度、甘露醇在辅料总量中的比例以及待喷液浓度3因素对制备工艺的影响,对结果分别进行多元线性和二项式方程拟合,效应面法优选最佳条件并进行预测分析。结果:从相关系数上看,总评"归一值"用二项式方程拟合较好,根据优化条件制备的RGOS-DPI的得率78.60%,吸湿率5.93%,排空率94.20%,平均粒径2.537μm。结论:星点设计可用于优化制备工艺,优选的RGOS-DPI制备工艺稳定可行,微粉粒径大小适宜,可满足肺部吸入给药的要求。

Objective: To optimize the formulation of dry powder inhalation of Rehmannia glutinosa oligosaccharides(RGOS-DPI) extracted from traditional Chinese medicinal herbs.Method: RGOS-DPI was prepared by spray drying technique.Dependent variables such as yield,moisture absorption rate,emptying rate and mean diameter of micropowder were transformed into desirabilities mathematically by Hassan s method.Overall desirability was calculated from the geometric mean of the four desirabilities of each formulation.The eff...