选用聚乳酸(PLA)为骨架基体,聚乙二醇(PEG) 6000为致孔剂,用热熔挤出技术(HME)制备了难溶性药物双氯芬酸钠(DS)的固体分散物.通过改变PEG6000与DS含量,比较了对DS体外溶出速率的影响.结果发现,DS的溶出速率随着PEG6000与DS含量的增加而增加,且呈现良好的线性关系.当PLA、PEG6000、DS质量分数为67%、30%、3%时,体系18d药物溶出度为76.5%,若将DS质量分数提高到5%或将PEG6000质量分数提高到40%,则体系分别在4d和3d即达到最大溶出度.文中还对体系中DS的分散机制进行了研究,发现DS主要分散于PEG6000中,而PLA作为骨架材料有效稀释了药物浓度,并延长了药物的释放时间.
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