球面对称设计筛选盐酸普萘洛尔药物树脂渗透泵控释片

Preparation of osmotic pump tablets containing propranolol hydrochloride-loaded resin complexes by spherical symmetric design

目的:对盐酸普萘洛尔药物树脂渗透泵控释片制备工艺进行研究。方法:采用球面对称设计法对处方进行筛选。结果:最优处方组成为:片心中氯化钠30 mg,包衣液中醋酸纤维素与聚乙二醇的比例为5:1,包衣膜增重8％。最优处方在2～14 h内呈现零级释放特征,24 h累积释放量为94％。结论:经球面对称设计法优化的处方体外释放理论值与试验值吻合良好且符合设计要求。

Objective：To prepare the osmotic pump tablets containing propranolol hydrochlorideloaded resin complexes. Methods：Spherical symmetric design was used for optimization of the formulations. Results：The optimal formulation consisted of 30 mg NaCI as a core material, 5：1 （g/g）ratio of cellulose acetate to PEG4000 as coating materials, and 8% （w/w）of tablet weight gain for membrane coating. The release profile of propranolol hydrochloride from the osmotic pump tablets exhibited a zero order process within 2- 14 h, and the accumulative release rate was 94% at 24 h. Conclusion： The release profile of optimal formulation was consistent with the predicted one of spherical symmetric design.