论文部分内容阅读
目的制备复方非洛地平/酒石酸美托洛尔渗透泵控释片,并优选最佳处方。方法采用高效液相色谱法测定不同处方制剂累积释药百分率,建立体外评价方法,并通过相似因子和正交设计筛选出最佳处方。结果 渗透泵片的片芯处方、包衣增重是影响释药的主要因素。优化的处方为15 mg聚氧乙烯、45 mg NaCl、11%包衣增重。结论按优化处方制备的渗透泵控释片符合零级释放特征,且两种药物释放同步。
Objective To prepare metoprolol tartrate-controlled osmotic pump controlled-release tablets and optimize the formulation. Methods The cumulative drug release percentage of different prescriptions was determined by high performance liquid chromatography (HPLC) and the method of in vitro evaluation was established. The optimal prescription was screened by similarity factor and orthogonal design. Results osmotic pump chip core prescription, coating weight gain is the main factor affecting drug release. The optimal formulation is 15 mg polyoxyethylene, 45 mg NaCl, 11% coating weight gain. CONCLUSION: The osmotic pump controlled release tablets prepared according to the optimized prescription meet the zero-order release characteristics, and the release of the two drugs is synchronized.