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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 develop famotidine effervescent tablets and establish a quality control method. Methods Single factor screening prescription, direct powder tablet preparation of famotidine effervescent tablets, and its traits, weight differences, disintegration time, acidity, content were checked. The results confirmed that the prescription of effervescent tablets, that is, tartaric acid - sodium bicarbonate = 1: 1, 60% disintegrating agent, lactose filler, lubricant PEG6000 3%, magnesium stearate 0.3% Complete disintegration within 5 min. Conclusion This product is reasonable prescription, preparation process is simple, can promote the development.