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目的 :制备非洛地平口腔粘膜粘附片 ,并对其进行性能评价。方法 :以HPMCK4M和Carbopol 974P为生物粘附聚合物 ,加入碳酸氢钠采用直接压片法制备非洛地平口腔粘膜粘附片。以鸡嗉囊为模型测定其粘附力 ,采用改进的桨法测定粘附片的体外释放行为 ,并测定了粘附片的表面pH值 ,对粘附片的体内粘附行为和刺激性也进行了评价。结果 :粘附片的表面pH值为 7 0 1± 0 11。非洛地平从粘附片中以SuperCase Ⅱ机制释放 ,表观释放速率常数k为 3 3 %h-1 。粘附片与鸡嗉囊接触后产生的粘附力平均为 181 3 5± 3 1 0 8g ,经体内验证与口腔粘附性较为合适 ,且对口腔粘膜刺激性较小。结论 :此给药系统可用于模型药物非洛地平的口腔粘膜给药
OBJECTIVE: To prepare felodipine oral mucoadhesive tablets and evaluate its performance. Methods: HPMCK4M and Carbopol 974P were used as bioadhesive polymers, and sodium bicarbonate was used to prepare felodipine oral mucoadhesive tablets by direct compression. The chicken gizzard capsule was used as a model to determine its adhesion. The modified paddle method was used to determine the in vitro release behavior of the adhesive sheet. The surface pH of the adhesive sheet, the adhesion behavior and irritation of the adhesive sheet were also determined did an evaluation. Results: The surface pH of the adhesive patch was 7011 ± 011. Felodipine was released from the adherent sheet by SuperCase II mechanism with an apparent release rate constant k of 33% h-1. The adhesive force produced by the adhesion of the adhesive sheet to the chicken head capsule was 181 3 5 ± 3 1 0 8g, which was proved to be more suitable for oral cavity adhesion in vivo and less irritating to the oral mucosa. Conclusion: This drug delivery system can be used for oral mucosal administration of model drug felodipine