SPH3261微丸胶囊的工艺筛选

Process Screening of SPH3261 Pellet Capsules

目的对SPH3261微丸胶囊的制备工艺进行筛选。方法以单因素考察试验为基础,对包衣过程中的工艺参数进行考察,以包衣增重、微丸的粒径分布、微丸载药量为指标,对微丸的制备工艺进行筛选。结果通过对流化床的导流筒和空气分布板间距离、进风风量、进风温度、喷液速度、物料温度等参数的考察,最终确定了SPH3261微丸胶囊的制备工艺。结论确定了SPH3261微丸胶囊的制备工艺,该工艺制得的产品依据拟定的质量标准检验合格,溶出曲线一致,制备工艺合理,简单易行,适合于工业化生产。

Objective To screen the preparation technology of SPH3261 pellets capsules.Methods Based on the single factor test,the process parameters in the coating process were investigated,and the preparation process of the pellets was screened by taking the tartaric acid content,particle size distribution and drug loading of the pellets as indicators.Result The preparation process of SPH3261 pellets capsule was determined by investigating the parameters such as the distance between the guide cylinder and the air distribution plate of the fluidized bed,the inlet air volume,the inlet air temperature,the injection velocity,and the material temperature.Conclusion The preparation process of SPH3261 pellets capsule is determined.The product prepared by this process is qua lified according to the proposed quality standard.The cumulative dissolution curve is consistent.The preparation process is reasonable,simple and feasible,and suitable for industrial production.