双氯芬酸钠速缓双释口腔膜剂的制备及质量评价

目的制备可用于口腔局部用药的双氯芬酸钠速缓双释膜剂,并考察其质量特性。方法以喷雾干燥法制备速缓双释口腔膜剂,单因素法优化制备工艺条件,评价工艺优化后口腔膜剂的外观、厚度和耐折度,采用紫外分光光度法和桨碟法分别对口腔膜剂的药物含量和药物释放度进行评价。结果双氯芬酸钠速缓双释膜剂光滑透明,无明显气泡,平均厚度为0.09±0.01 mm,平均耐折度为54次,平均药物含量98.63%。在pH 6.8磷酸盐缓冲液中的15 min释放度为52%,3 h内释放剩余的药物。结论双氯芬酸钠速缓双释口腔膜剂预期能达到迅速镇痛和持久镇痛的治疗效果,该口腔膜剂有较好的应用前景。

Preparation and Quality Evaluation of Diclofenac Sodium Oral Film with Fast and Sustained Release Capability

Objective To prepare diclofenac sodium oral film with fast and sustained release capability and investigate its quality characteristics.Methods The functional oral film with fast and sustained release capability was prepared by spray drying method.The preparation conditions were optimized by single factor method.The appearance,thickness and folding endurance of oral film after process optimization was evaluated.The drug content and drug dissolution rate of oral film were evaluated by UV spectrophotometry and paddle over disk method,respectively.Results The appearance of functional oral film for diclofenac sodium was transparent and smooth without obvious bubbles.Its average thickness was 0.09±0.01 mm,average folding strength was 54,and average drug content was 98.63%.In pH 6.8 phosphate buffer,52%of the drug was released in 15 minutes,and the remaining drug was released in 3 hours.Conclusion The functional diclofenac sodium oral film with fast and sustained release capability is expected to achieve rapid analgesia and sustained treatment,and it has good application prospects.