非诺贝特缓释微丸的制备

【目的】制备非诺贝特缓释微丸。【方法】用挤出滚圆法制备非诺贝特缓释微丸,以释放度为指标,分别对微丸制备过程中的处方和工艺因素进行考察。【结果】经处方筛选和工艺因素考察,优化配方及操作参数,结果目标粒径为18～24目的药物含量约59%,微丸累积释放度1 h为25.2%,4 h为25.2%,7 h为94.6%,主药含量和微丸的累积释放度均达到预期效果。【结论】微丸制备工艺稳定,适于产业化放大。

Preparation of fenofibrate sustained release pellets

Objective ] To prepare fenofibrate sustained-release pellet. Methods] Fenofibrate pellets were prepared by means of extrusion-spheronization, and the main technological factors and formulation factors during the preparation of sustained release pellets were studied. Results] Through the formulation and process observation, it was discovered that the objective pellets were 18-24 mesh cut, The cumulative release of the pellets were 25.2%, 25.2% and 94.6% for 1, 4 and 7 h, respectively. Drug content and the pellets cumulative release were having the desired effect. Conclusion ]The process was stable and easy to amplify.