尼莫地平固体分散体的制备及评价

Preparation and Evaluation of Nimodipine Solid Dispersions

采用喷雾冷凝法制备了三批固体分散体,并对其质量进行考察,结果表明:该法制备的固体分散体,呈规则的粒径小于10μm的球形,绝大部分药物以无定型态分散在载体材料中;含量杂质符合现行版药典要求,60 min的溶出度能达到90%。因此,采用喷雾冷凝法制备固体分散体,能够解决尼莫地平溶出度低,生物利用度不高的问题,具有很好的应用前景。

Three batches nimodipine solid dispersions were prepared by spray congealing, and then evaluate their qualities, results showing： solid dispersions were prepared by spray congealing, and their particle size was spherical and less than 10 microns; the vast majority of API was dispersed in carrier material with amorphous type; the impurity and assay were conform to the requirements of the current pharmacopoeia; dissolution could reach 90% in 60 min. Therefore, the method of spray congealing of preparing solid dispersions, can solve the problem of low dissolution and bioavailability of nimodipine, which has very vast potential for application prospect.