胰岛素自复乳化给药系统的制备与质量评价
Preparation and quality evaluation of insulin-loaded self-double-emulsifing drug delivery systems
作者：王晓娜;王歆悦;姜思凡;廖杰;尹宗宁;
Author：
收稿日期： 年卷（期）页码：2016,31(05):-456-458
期刊名称：华西药学杂志
Journal Name：WEST CHINA JOURNAL OF PHARMACEUTICAL SCIENCES
关键字：自复乳化给药系统;乳化剂;油相;胰岛素;稳定性;体外释放:蛋白多肽;口服给药
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基金项目：
中文摘要
目的制备胰岛素自复乳化给药系统并评价其质量。方法以自复乳的微观结构、体积平均粒径和自乳化速率为评价指标筛选较优处方,并考察其稳定性及体外释放特性。结果优选的处方组成为内水相-中链甘油三酸酯-亲脂乳化剂-亲水乳化剂(21∶24∶6∶9),平均粒径为6.74±0.55μm,包裹进入复乳的胰岛素为86.8%±8.2%;于25℃静置30 d后,其显微形态及平均粒径等指标均未见明显变化;8 h后胰岛素在体外的累计释放量达约80%,具一定缓释作用。结论成功制备了胰岛素自复乳化给药系统,可为蛋白多肽类药物的口服给药提供新的方法。
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