法莫替丁泡腾片的制备与质量考察

Preparation and Quality Control of Famotidine Effervescent Tablets

目的研制法莫替丁泡腾片并建立质量控制方法。方法单因素筛选处方,粉末直接压片制备法莫替丁泡腾片,并对其性状、重量差异、崩解时限、酸度、含量等进行检查。结果确定了泡腾片的处方,即酒石酸-碳酸氢钠=1∶1,崩解剂用量为60%,乳糖为填充剂,润滑剂为PEG6000 3%,硬脂酸镁0.3%,本品在5 min内可完全崩解。结论本品处方合理,制备工艺简单,可进行推广开发。

OBJECTIVE To prepare the effervescent tablets of famotidine and establish its quality standards.METHODS The formulation was optimized by single factor screening experiments.Famotidine effervescent tablets were prepared using direct compression method,with poloxamer 188 as material carriers of solid dispersion of famotidine.Then the character,weight difference,disintegration time,acidity and the content were tested.RESULTS The optimal formulation was as follows： tartaric acid-sodium bicarbonate=1∶1,the percentage of disintegrant,PEG6000 and magnesium stearate was 60%,3%,0.3%,respectively.The tablets disintegrated entirely in 5 minutes.CONCLUSION The optimal formulation is feasible,the preparation techniques is simple,and can be widely used.