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目的制备盐酸文拉法辛缓释胶囊并考察其体外释药特性。方法采用挤出-滚圆法制备盐酸文拉法辛素丸,采用Eudragit NE30D水分散体作为成膜材料,流化床底喷法对素丸进行包衣,单因素考察对处方和工艺进行筛选和优化。结果挤出-滚圆法制备的丸芯粒度分布16～30目,缓释包衣增重为22%～30%时,与上市品(怡诺思)释放速率基本一致,4种包衣增重的f2值分别为68、78、71和50。结论该方法制备的盐酸文拉法辛缓释胶囊处方和制备工艺可靠,重现性好。
Objective To prepare venlafaxine hydrochloride sustained-release capsules and study its in vitro release characteristics. Methods Venlafaxine hydrochloride pellets were prepared by extrusion-spheronization method. Eudragit NE30D water dispersions were used as film-forming materials. The pellets were coated with fluidized bed bottom spray method. The formulation and process were screened by single factor test and optimization. Results The particle size distribution of the pellets prepared by extrusion-spheronization method was 16-30 mesh, and the sustained release coating weight gain was 22% -30% Heavy f2 values were 68, 78, 71 and 50, respectively. Conclusion The venlafaxine hydrochloride sustained-release capsules prepared by this method have good prescription and reproducibility and good reproducibility.