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目的研制法莫替丁胃内漂浮型双层缓释片并考察其体外释药行为。方法分别以湿法制粒的方法制备速释层和缓释层,压制胃内漂浮型双层片,紫外分光光度法测定法莫替丁的释放度,并记录起漂时间和持续漂浮时间。结果法莫替丁胃内漂浮型双层缓释片的释药曲线用Higuchi方程拟合,可维持24 h持续释放,起漂时间<5 min,持续漂浮时间>8 h。结论研制的法莫替丁胃内漂浮型双层缓释片制备工艺简单,质量稳定,释药速度平稳,达到设计要求。
Objective To develop famotidine floating intragastric sustained-release tablets and study its in vitro release behavior. Methods The immediate release layer and the sustained release layer were prepared by wet granulation. The floating double layer tablets were compressed and the release of famotidine was determined by ultraviolet spectrophotometry. The time of starting and the sustained floating were recorded. Results The releasing curve of famotidine floating double-layered sustained-release tablets was fitted by Higuchi equation and sustained release was maintained for 24 h. The time to start floating was less than 5 min and the duration of floating was longer than 8 h. Conclusion The preparation of famotidine floating sustained-release double-layered sustained-release tablets in the stomach has the advantages of simple process, stable quality, stable drug release rate and meeting the design requirements.