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目的:制备联苯双酯胃漂浮缓释胶囊,进行体外释放度的考察。方法:采用聚乙二醇6 000为联苯双酯固体分散体的载体、羟丙甲纤维素(HPMCK4M)等为胃漂浮材料制成缓释胶囊,以体外释放度和漂浮时间为指标优选最佳处方,并与普通滴丸进行对比。利用差示扫描量热法(DSC)考察药物在载体中的存在状态。结果:所得优化处方在0.3%十二烷基硫酸钠(SDS)的盐酸(0.1mol.L-1)溶液中释放符合一级动力学方程,漂浮时间达6h以上。结论:所制备的胶囊体外漂浮性能良好,释药行为具有良好的缓释特征。
OBJECTIVE: To prepare bifendate gastric floating sustained-release capsules for in vitro release. Methods: Polyethylene glycol 6000 was used as carrier of solid dispersion of bifendate, hypromellose (HPMCK4M) as a sustained-release capsule made of gastric floating material, the best in vitro release and floating time Good prescription, and compared with ordinary dripping pills. The presence of the drug in the carrier was examined using differential scanning calorimetry (DSC). Results: The optimized formulation was in accordance with the first-order kinetic equation in 0.1 mol·L-1 hydrochloric acid (0.1 mol·L-1) solution of 0.3% sodium dodecyl sulfate (SDS) and the floating time was more than 6 h. Conclusion: The prepared capsules have good floating performance in vitro and good sustained release characteristics.