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目的制备头孢曲松钠自动微输注贴剂,对渗透泵处方进行优化并考察贴剂的体外释放。方法采用高效液相色谱法测定不同处方制剂初始释放时间、持续释放时间、累积释放率,通过体外释放对渗透泵处方进行优化。结果渗透泵系统中增渗剂的种类及用量、衣膜中致孔剂的种类及用量、增塑剂的用量以及包衣增重对贴剂的释放行为有一定程度的影响,以致孔剂用量、增塑剂用量以及包衣增重为主要因素对其进行正交试验优化,结果表明,最优处方为葡萄糖300 mg、聚乙二醇1500 1.5 g、邻苯二甲酸二乙酯0.5 ml、包衣增重为11%。结论初步体外释放研究表明,头孢曲松钠自动微输注贴剂初始释放时间为15 min,可持续释放6 h,而且体外释放呈良好的零级释放特征。
Objective To prepare ceftriaxone sodium auto-transdermal patch for the optimization of osmotic pump formulation and to investigate the in vitro release of patch preparation. Methods The initial release time, sustained release time and cumulative release rate of different prescription preparations were determined by high performance liquid chromatography (HPLC). The formulation of osmotic pump was optimized by in vitro release. Results The types and amount of penetration enhancers, the type and amount of porogen in the membrane, the amount of plasticizer and the weight gain of the coating had a certain degree of influence on the release behavior of the patch, , Dosage of plasticizer and weight gain of coating were optimized by orthogonal test. The results showed that the optimal prescription was glucose 300 mg, polyethylene glycol 1500 1.5 g, diethyl phthalate 0.5 ml, Coating weight gain of 11%. Conclusion The initial in vitro release studies showed that the initial release time of ceftriaxone sodium auto-transdermal patch was 15 min and sustained release was 6 h, and the release characteristics in vitro were good.