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目的制备盐酸普拉克索缓释微丸片。方法采用流化床包衣法制备盐酸普勒克索微丸,再将微丸与一定的辅料混合后压制成片。利用正交试验确定了微丸的最终处方。结果最优处方为10%碳酸氢钙用量、3%包衣增重率、25%柠檬酸三乙酯用量。自制缓释微丸片在分割后其释放行为与整片相似。结论自制缓释微丸片与市售缓释片的释放行为相似。
Objective To prepare pramipexole hydrochloride sustained-release pellets. Methods Pulpril hydrochloride pellets were prepared by fluidized bed coating method. The pellets were mixed with certain excipients and then compressed into tablets. Orthogonal experiments were used to determine the final formulation of pellets. Results The optimal prescription was 10% calcium bicarbonate dosage, 3% coating weight gain rate, 25% triethyl citrate dosage. Homemade sustained-release pellets after release in the release of its behavior similar to the whole piece. Conclusion The self-made sustained-release pellets have similar release behavior to the commercially available sustained-release tablets.