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采用挤出-滚圆法制备盐酸文拉法辛丸芯,并以单因素试验和Box-Behnken设计优化处方及工艺参数。所得最佳工艺为:挤出速度35 r/min、润湿剂用量25%、滚圆速度1 050 r/min、滚圆时间8 min。按此工艺制得的含药丸芯收率及圆整度实测值均与模型预测值较接近。采用流化床包衣法对所得含药丸芯包隔离衣层及缓释衣层,填充入胶囊后得到仅需日服1次的水溶性药物缓释制剂。以市售缓释胶囊(怡诺思)作参比制剂进行体外释放度考察,结果 3批自制品与参比制剂释放曲线的相似因子(f2)均大于50,提示两种制剂的体外释放行为基本一致。
The venlafaxine hydrochloride pellets were prepared by extrusion-spheronization method. The formulation and process parameters were optimized by single factor test and Box-Behnken design. The optimum process was: extrusion speed of 35 r / min, wetting agent dosage of 25%, rolling speed of 1 050 r / min, spheronization time of 8 min. According to this process, the drug-containing pellets yield and circularity measured values are close to the model predictions. The fluidized bed coating method is adopted to obtain the drug-containing pellets with the separation clothes layer and the slow-release clothes layer, and the water-soluble drug sustained-release preparation which only needs to be taken once a day is filled into the capsules. In vitro release test was conducted with the commercially available extended release capsules (Inositol) as reference formulation. The results showed that the similarities (f2) of the release profiles of three batches of homemade and reference formulations were both greater than 50, suggesting that the in vitro release behavior of the two formulations Basically the same.