摘要
目的为国产辅料聚氧乙烯应用于难溶性药物双层渗透泵片的制备提供依据。方法用HPLC法测定格列吡嗪双层渗透泵片的体外释放度;采用相似因子法(f2)对不同处方药物释放曲线的相似性进行评价;考察含药层促渗聚合物、乳糖用量、助推层聚氧乙烯用量、助推层氯化钠用量及包衣液中含水量、醋酸纤维素浓度对释放度的影响,并对处方进行优化。结果成功制备了格列吡嗪双层渗透泵片,最佳处方在2~16h内释药基本恒定,呈现零级释放特征(r=0.9946),与进口产品Glucotrol XL体外释放行为相似(f2=69.7)。结论应用国产辅料聚氧乙烯成功制备了格列吡嗪双层渗透泵片,释药平稳,控释可达24h。
Objective To provide evidence for judgment of preparing glipizide two-layer osmotic pump tablets with polyethylene oxide. Methods HPLC method was used to measure drug content in dissolution media, the factor f2 was used to evaluate the similarity of different dissolution profiles. Effects of formulation of drug layer, push layer and membrane on the release behavior of controlled release tablets were investigated and the optimal formulation was obtained. Results The optimal formulation had excellent zero-order release characteristics in the time period of 2-16 h (r=0.994 6) and no significant difference in release behavior was found compared to the reference product (f2=69.7).Conclusions Glipizide two-layer osmotic pump tablets were prepared successfully with polyethylene oxide and drug release could be controlled up to 24 h.
出处
《中国药剂学杂志（网络版）》
2009年第6期417-424,共8页
Chinese Journal of Pharmaceutics：Online Edition
基金
十五攻关课题(2004AA2Z3100)
