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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 microcrystalline cellulose as a pellet forming material, water as a binder, Kollicoat SR 30D as a sustained release material, the use of extrusion spheronization hydrochloride venlafaxine drug-containing pellets, and then use fluidized bed coating technology Venlafaxine hydrochloride sustained-release pellets; release results as an indicator to examine the weight gain of the coating. Results The venlafaxine hydrochloride pellets prepared by extrusion-spheronization method were smooth and smooth with good roundness. In vitro release behavior of self-made venlafaxine hydrochloride sustained release capsules was Original research products consistent, similar factors f2 are greater than 50. Conclusions Venlafaxine hydrochloride sustained release capsules can be prepared by extrusion spheronization and fluidized bed coating.