【摘要】目的：本实验旨在制备与评价一种新型的半固体过饱和纳米自乳化药物递送系统。方法：采用三相图法，将沉淀抑制剂和吉非替尼(Gefitinib，GEF)加入半固体制剂中，对处方乳化粒径、时间和体外稀释进行评价。结果：过饱和自乳化处方的载药量(90.1mg/g-98.0mg/g)显著提高。稀释后可在5min内完全乳化，粒径为200～400nm。1% (w/w) Soluplus(聚乙烯基己内酰胺-聚乙酸乙烯酯-聚乙二醇接枝共聚物)的加入即可将经稀释产生的过饱和状态延长至6h。结论：总体结果表明，本实验制备的半固体过饱和自乳化体系有利于提高SNEDDS(Self-nanoemulsifying Drug Delivery System)中载药受限的难溶药物的溶解度并维持其体外稀释后的药物过饱和状态。

    【关键词】吉非替尼;半固体过饱和纳米自乳化药物递送系统;Soluplus;Gelucire44/14

    [Abstract] Objective：This study aimed to prepare and evaluate a novel semi-solid supersaturable self-nanoemulsifying drug delivery system. Methods：G-sSNEDDS(GEF-loaded supersaturable self-emulsifying drug delivery system)was prepared by homogenizing precipitation inhibitor and GEF into semisolid SNEDDS. G-sSNEDDS was evaluated for particle size ......