摘要:目的制备落新妇苷(AT)纳米混悬剂(AT-NS)冻干粉,并考察其体外溶出行为。方法采用介质研磨法制备AT-NS,单因素试验优化其处方和工艺,并进一步冷冻干燥获得AT-NS冻干粉;扫描电镜(SEM)观察AT-NS冻干粉形态,并考察其体外溶出行为。结果优化所得AT-NS平均粒径为(332±21)nm,多分散度指数(PDI)为0.298±0.019;冷冻干燥后,AT-NS冻干粉粒径增长约50nm;SEM显示AT-NS冻干粉有片层状和圆球状2种形态;体外溶出结果显示,与AT原料药相比,AT-NS冻干粉60min累积溶出率增长了约1.25倍。结论介质研磨法联合冷冻干燥技术制备AT-NS冻干粉,工艺稳定可行;AT-NS冻干粉能够显著改善AT的体外溶出度。
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