引用本文: | 李菲,李炳龙,王建筑,曹娟,郝吉福,郭丰广.法莫替丁泡腾片的制备与质量考察[J].中国现代应用药学,2011,28(4):335-337. |
| LI Fei,LI Binglong,WANG Jianzhu,CAO Juan,HAO Jifu,GUO Fengguang.Preparation and Quality Control of Famotidine Effervescent Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2011,28(4):335-337. |
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摘要: |
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。 |
关键词: 法莫替丁 泡腾片 固体分散体 制备 |
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Preparation and Quality Control of Famotidine Effervescent Tablets |
LI Fei, LI Binglong, WANG Jianzhu, CAO Juan, HAO Jifu, GUO Fengguang
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School of Pharmacy, Taishan Medical College, Taian 271016, China
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Abstract: |
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. |
Key words: famotidine effervescent tablets solid dispersion preparation |