熊去氧胆酸固体分散体片剂的制备及其质量评价

Preparation of Ursodeoxycholic Acid SD Tablet and Quality Evaluation

目的制备熊去氧胆酸固体分散体片,考察其溶出度。方法将熊去氧胆酸与辅料混合均匀,加入适当浓度的乙醇溶液溶解,采用流化床喷雾包衣技术包载于空白丸芯表面,制得固体分散体小丸,再粉碎后与MCC、PVPP和微粉硅胶混合压片,制得固体分散体片剂,溶出度仪测定固体分散体粉末、固体分散体小丸、固体分散体片的溶出曲线。结果溶出度测定表明,固体分散体片剂的溶出速度显著增大,甚至比相应的粉末还大。结论可以采用将固体分散体小丸粉碎后压片的方式制备熊去氧胆酸固体分散体片。

Objective To prepare Ursodeoxycholic Acid SD tablet and observe it’s dissolution rate. Methods Homogeneously mix Ursodeoxycholic Acid and accessories,put ethanol to dissolve,use the technology of fluidized bed spraying to be warped with empty pellets to make solid disperse pel ets,which blend with Mcc、PVPP and Gum Acacia after break into pieces. Make solid disperse pel ets,dissolution of solid disperse powder and solid disperse balls,stripping curve of solid disperse slab. Rseults Dissolution rate shows that the speed of solid disperse pellets increased remarkably,even larger than compared powder. Conclusion The method of pulverizing and tabletting solid disperse bal s could be use to prepare Ursodeoxycholic solid disperse pel ets.