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目的提高难溶性药物马来酸罗格列酮的体外溶出速率 ,满足脉冲制剂的设计要求。方法选用PVPK3 0为载体 ,用溶剂法制备了马来酸罗格列酮固体分散体 ,比较考察了原料药及其物理混合物和固体分散体的溶出差别 ,并通过红外光谱及X 射线粉末衍射对固体分散体进行了鉴定。结果体外溶出结果表明固体分散体能显著增加药物在水中及人工肠液中的溶出速率 ;红外光谱分析结果表明药物与载体之间没有发生化学反应 ;X 射线粉末衍射图谱表明药物以无定形状态分散于载体PVPK3 0中。结论固体分散体体外溶出速率的提高可以满足脉冲制剂的设计要求。
Objective To improve dissolution rate of rosiglitazone maleate in vitro and to meet the design requirements of pulse preparation. Methods The solid dispersion of rosiglitazone maleate was prepared by solvent method using PVPK30 as carrier. The difference of dissolution of the drug substance, its physical mixture and solid dispersion was investigated. Solid dispersions were identified. Results The results of in vitro dissolution showed that the solid dispersion could significantly increase the dissolution rate of the drug in water and artificial intestinal juice. Infrared spectroscopy analysis showed no chemical reaction between the drug and the carrier. The X-ray powder diffraction pattern showed that the drug dispersed in the amorphous state in the carrier PVPK3 0. Conclusion The improvement of in vitro dissolution rate of solid dispersion can meet the design requirements of pulse preparation.