乳酸左氧氟沙星胃漂浮缓释片的制备及体外评价

PREPARATION AND IN VITRO RELEASE OF LEVOFLOXACIN LACTATE INTRA-GASTRIC FLOATING SUSTAINED RELEASE TABLETS

目的制备乳酸左氧氟沙星胃漂浮缓释片,考察其漂浮性和体外释放行为。方法以湿法制粒压片法制备乳酸左氧氟沙星胃漂浮缓释片,分别考察处方中各辅料对制剂漂浮性和体外释放行为的影响。结果处方中羟丙基甲基纤维素(hypromellose cellulose,HPMC)黏度规格、用量及十八醇、碳酸氢钠用量对制剂的漂浮性或体外释放行为均有影响,处方中HPMC K_(100M)量为100mg/片、十八醇用量为40mg/片、碳酸氢钠用量为40mg/片时其漂浮性能和释放行为较好。结论本制剂具有良好的胃漂浮和缓释效果,且工艺稳定性好。

Objective To investigate the preparation of levofloxacin floating sustained release tablets and study their in vitro release.Methods The tablets were prepared by wet granulation tabletting,and effect of different excipients on the tablets＇ floating and release property was evaluated.Results The viscosity and amount of Hypromellose Cellulose,amount of octadecanol and sodium bicarbonate could influence the tablets＇ floating or release property.The tablets showed a good sustainedrelease and floating property with HPMC K100M 100mg/tablet,sodium bicarbonate 40mg/tablet,octadecanol 40mg/tablet.Conclusion The tablets had good floating and release charactiristics,and showed good process stability.