依托度酸渗透泵型控释片的研制及其体外释药影响因素  

Preparation of etodolac osmotic pump controlled release tablets and factors influencing the in vitro drug release

作　　者：李兴凯[1] 高峦 吴爽 杨星钢[1] 潘卫三[1] 

机构地区：[1]沈阳药科大学药学院 [2]东北制药总厂

出　　处：《中国药剂学杂志（网络版）》2008年第6期317-325,共9页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：目的以大剂量难溶性药物依托度酸为模型,制备单室单层渗透泵型控释片,考察其释药影响因素,并对处方进行优化。方法采用单因素法考察片芯处方、膜增重及工艺过程对渗透泵控释片释药行为的影响;利用正交设计法进行处方优化。结果确定最佳片芯组成为氯化钠(NaCl)120mg、聚氧乙烯(PEO)50mg、碱性物质50mg。NaCl、PEO、碱性物质、致孔剂的用量及衣膜厚度是影响药物释放的主要因素。结论依托度酸单室单层渗透泵型控释片工艺稳定,在12h内零级释药明显。Objective To prepare etodolac oral osmotic pump controlled release tablets, study factors influencing the in vitro drug release and optimize the formulation. Methods Factors influencing the in vitro drug release were studied by a series single factor experiments and the optimal formulation was selected based on the orthogonal experimental design. Results The optimized core formulation contained NaCl 120 mg, PEO 50 mg and base 50 mg. Amounts of NaCl, PEO, base and PEG 4000 in the formulation and coating thickness were the main factors influencing the in vitro release of etodolac. Conclusions In vitro release of etodolac from the oral osmotic pump controlled release tablets was constant during the first 12 h and conformed to zero order release kinetics.

关 键 词：药剂学 依托度酸 渗透泵片 零级释药 

分 类 号：R94[医药卫生—药剂学]