丁卡因口腔粘附片的研究

Investigation of tetracaine buccal adhesive tablets

目的:研制丁卡因口腔粘附片,并考察不同辅料的体外膨胀情况及释药性能。方法:采用聚乙烯吡咯烷酮(PVP)、羟丙甲基纤维素(HPMC)、低取代羟丙基纤维素(L-HPC)及卡波普(CP934)为生物粘附材料,以不同配比制备丁卡因口腔粘附片,照中国药典2000年版附录浆板法用HPLC测定其释放度。结果:用CP与HPC(或HPMC)以12的比率制备的丁卡因口腔粘附片在1～2分钟内起效,口腔内的粘附时间大于3小时,夜间使用可达10小时以上。结论:CP与HPC(或HPMC)作为粘附材料制备丁卡因口腔粘附片能获得良好效果。

Objective:To investigate the buccal adhesive tablets of tetracaine and to observe the swelling behavior and drug release performance on various excipients. Methods:The buccal adhesive tablets of tetracaine were prepared using PVP, HPMC, L-HPC, CP 934 with different proportion, its release rate was determined by HPLC according to the paddle method described in the 2000 edition of China Pharmacopoeia ( the edition of 2000).Results:The buccal adhesive tablets of tetracaine prepared by CP and HPC(or HPMC)with 12 produced effect within 1～2min. The adhesive time in oral cavity was more than 3h, and above 10h at night. Conclusion:The good effect can be obtained on the buccal adhesive tablets when using CP and HPC(or HPMC)as the adhesive materials.