右旋酮洛芬氨丁三醇缓释胶囊的研制

摘要

Objective To prepare the Dexketoprofen Trometamol ( DKT ) Sustained-Release Capsule. Methods Three methods were adopted to prepare DKT Sustained-Release Capsule, the final method of preparation was the physical mixing of two kinds of pellets with different drug release rates. The DKT contained pellets were prepared by extrusion-spheronization method, the coated pellets were prepared by using ethanol solution of ethyl cellulose ( EC ) and polyvinylpyrrolidone ( PVP ) as coating solution. The proportion of contained pellets and coated pellets were adjusted. Results The preferred ratio of contained pellets and coated pellets was 4:1 and its corresponding dissolution data was 22. 13%(0. 5 h), 46. 58%(2 h ) and 88. 51%(8 h), respectively. Conclusion The DKT Sustained-Release Capsule can be prepared by combining contained pellets with coated pellets in order to reach the release requirement in vitro. The method is simple and has low requirement for equipment and easy to industrialize.%目的 制备右旋酮洛芬氨丁三醇(DKT)缓释胶囊.方法 采用3种方法 制备DKT缓释胶囊,最终确定的制备方法 是将2种不同释放速度的微丸以物理方式混合.通过挤出-滚圆法制备DKT含药丸芯,以乙基纤维素和聚乙烯吡咯烷酮的乙醇溶液为包衣液制备包衣丸,调节包衣丸和含药丸芯的比例.结果 包衣丸和含药丸芯的比例为4:1时,缓释胶囊的体外释放良好,0.5 h释放22.13%,2 h释放46.58%,8 h释放88.51%.结论 通过将两种微丸混合装胶囊来制备满足体外释放要求的DKT缓释胶囊,该方法 工艺简单,对设备要求低,易于工业化生产.