目的制备与参比制剂生物等效的磷酸卡维地洛缓释微丸。方法采用流化床制备磷酸卡维地洛载药微丸,进一步制备缓释微丸,采用正交实验优化处方工艺。结果载药微丸的最佳处方为:丸芯粒径0.35~0.5 mm,崩解剂用量15%,黏合剂用量10%,增溶剂用量15%;缓释微丸的最佳处方为:包衣增重7%,包衣液浓度50%,致孔剂用量5%,二氧化硅用量10%。结论自研制剂与参比制剂生物等效。 Objective To prepare bioequivalent carvedilol phosphate sustained-release pellets with reference formulation. Methods Carvedilol phosphate-loaded drug-loaded pellets were prepared by fluidized bed. The sustained-release pellets were further prepared. The orthogonal experiment was used to optimize the formulation. Results The optimal prescription of drug-loaded pellets was as follows: the diameter of pellet was 0.35-0.5 mm, the amount of disintegrant was 15%, the amount of binder was 10% and the amount of solubilizer was 15% Clothing weight gain 7%, 50% concentration of coating solution, porogen dosage 5%, silica dosage 10%. Conclusion Self-developed formulations and reference formulations bioequivalence.