挤出滚圆法制备盐酸文拉法辛缓释胶囊

Preparation of Venlafaxine Hydrochloride Sustained-Release Capsules by Extrusion-spheronization

目的制备盐酸文拉法辛缓释胶囊。方法以微晶纤维素作为微丸成型材料,水为黏合剂,Kollicoat SR 30D为缓释材料,采用挤出滚圆法制备盐酸文拉法辛含药微丸,进而采用流化床包衣技术制备盐酸文拉法辛缓释微丸;以释放度结果为指标,考察包衣增重。结果采用挤出滚圆法制备所得的盐酸文拉法辛微丸,表面光滑平整,圆整度好;包衣增重24%-28%时,自制盐酸文拉法辛缓释胶囊体外释放行为与原研产品一致,相似因子f2均大于50。结论采用挤出滚圆及流化床包衣工艺,可制备盐酸文拉法辛缓释胶囊。

Objective To prepare venlafaxine hydrochloride sustained-release capsules. Methods MCC was used as filling substance, water as binder, and Kollicoat SR 30D as sustained-release material. Venlafaxine hydrochloride pellets were prepared by extrusion-spheronization technology, and venlafaxine hydrochloride sustained-release pellets were prepared by fluidized bed coating technology. With drug release result as an indicator, the coating weight gain was investigated. Results The surface of pellets was smooth and good roundness. When the coating weight was between 24%-28%, the in vitro release behavior of homemade venlafaxine hydrochloride sustained-release capsules was consistent with the original research product.The similarity factor f2 was greater than 50 for both. Conclusion Venlafaxine hydrochloride sustained-release capsules can be prepared by extrusion-spheronization technology and fluidized bed coating technology.