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目的应用星点设计-效应面法优化普萘洛尔传递体的处方工艺。方法采用硫酸铵梯度法制备普萘洛尔传递体。将药物/磷脂摩尔比、Span-80/磷脂摩尔比、探头超声时间作为考察因素,以包封率、载药量、平均粒径及变形性指数为效应指标,求算总评“归一值”并采用Design-Expert 8.0软件进行效应面法优化,确定最佳处方工艺并进行验证。结果确定最优制备工艺为:药物/磷脂摩尔比19.83%、Span-80/磷脂摩尔比21.08%、探头超声时间10.29 min,以该处方工艺制备所得传递体的包封率、载药量、平均粒径及变形性指数分别为76.63%,4.80%,52.82 nm,20.83,且实测值与预测值的偏差均较小。结论星点设计-效应面法适用于普萘洛尔传递体的处方工艺优化,优化所得处方工艺稳定、可行。
Objective To optimize the formulation of propranolol delivery system by using the apices design - response surface method. Methods Propranolol was prepared by ammonium sulfate gradient method. The drug / phospholipid molar ratio, Span-80 / phospholipid molar ratio, probe ultrasonic time as the investigation factor, the encapsulation efficiency, drug loading, average particle size and deformability index as the effect index, "And Design-Expert 8.0 software for response surface methodology to determine and validate the best recipe. The results showed that the optimal preparation process was as follows: drug / phospholipid molar ratio 19.83%, Span-80 / phospholipid molar ratio 21.08%, probe ultrasonic time 10.29 min. The entrapment efficiency, drug loading, The particle size and deformability index were 76.63%, 4.80%, 52.82 nm and 20.83, respectively, and the deviations of the measured values from the predicted values were small. Conclusion The method of star design-response surface method is suitable for the pretreatment process optimization of propranolol delivery system, and the optimized prescription process is stable and feasible.