高速熔融搅拌法制备双氯芬酸钾缓释微丸的处方工艺考察.pdfVIP

第44卷第5期 应 用 化 工 Vol.44 No.5 2015年5月 Applied Chemical Industry May2015 高速熔融搅拌法制备双氯芬酸钾缓释 微丸的处方工艺考察 刘春憬 （青岛科技大学药学院，山东青岛 266042） 摘 要：采用高速熔融搅拌法制备含药微丸，以微丸体外累积释放度为指标考察工艺因素对微丸体外释放的影响， 并设计正交实验对处方进行筛选。结果表明，确定的最佳的处方为每粒胶囊含有主药60 mg，固体石蜡100 mg，预 胶化淀粉16 mg，柠檬酸8 mg及硫酸钙适量，所制备的双氯芬酸钾缓释微丸的体外释放行为符合 Higuchi方程 Q= 1/ 2 0.2487 t +0.063 1（0.997 6）。采用高速熔融搅拌法制备的双氯芬酸钾缓释微丸表面光滑，圆整度高，具有良好 的缓释效果。 关键词：熔融法；双氯芬酸钾；缓释微丸；处方；工艺 中图分类号：TQ460.6 文献标识码：A 文章编号：1671-3206（2015）05-0918-04 Studies on preparation of diclofenac potassium sustained-release pellets by the melt pelletization in a high-speed mixer LIUChun-iing （Department of Pharmacy，Qingdao University of Science and Technology，Qingdao266042，China） Abstract：Drug contained pelletswere prepared by the melt pelletization in a high speed mixer，and the influencingfactorsofformulationandtechniqueonpelletsreleasingprofilewereinvestigatedusedcumula tive release as the indicator，and an orthogonal test was designed to optimize the prescription. Results shows that thebestprescriptionfor each capsulecontainsmain drug60 mg，paraffinwax 100 mg，pregela tinized starch 16 mg，citric acid 8 mg and the amount of calcium sulfate，and the release of the drugfrom pelletwasinaccordancewithHiguchiequation 1/ 2 ：Q=0.2487t +0.063 1（0.9976）.Thediclofenacpo tassium sustained releasepelletsmadeby thistechniquewassmooth surface，highroundnessandprovided a rather good sustained release profile. Key words：melt agglomeration；diclofenac potassium；sustained release pellets；prescription；prepara tion technology 双氯芬酸钾（DP）为新一代强效