枸橼酸莫沙必利口腔崩解片的制备及评价

• 作 者: 孙运栋 张向荣 付杰超 石晓磊 施路 李三鸣
• 机 构: 沈阳药科大学药学院,沈阳药科大学中药学院,上海卡乐康包衣技术有限公司,
• 出 处: 沈阳药科大学学报
• 发表日期: 2009年03期
• 关键词: 枸橼酸莫沙必利 口腔崩解片 口腔中崩解时间 效应面图 等高线图 溶出度 崩解时间 富马酸钠 直接压片法 处方

目的制备枸橼酸莫沙必利口腔崩解片并对其进行评价。方法在预实验的基础上选择处方中所用辅料,以口腔中崩解时间为考察指标,综合运用效应面图和等高线图对口腔崩解片处方进行优化,直接压片法压片,并对枸橼酸莫沙必利口腔崩解片溶出度进行了考察。结果枸橼酸莫沙必利口腔崩解片的最佳处方为枸橼酸莫沙必利5 mg、微晶纤维素76 mg、甘露醇97 mg、低取代羟丙基纤维素20 mg、橘子香精1 mg、硬脂酸富马酸钠1 mg。口腔中崩解时间为19.4 s,溶出度为99.7%。结论采用直接压片法制备枸橼酸莫沙必利口腔崩解片,崩解时间短、溶出速度快、口感好。

Objective To prepare and evaluate mosapride citrate orally disintegrating tablets. Methods The excipients used in the prescription were selected on the basis of the pre-experiment. The disintegration time in the oral cavity was taken as the index. The prescription of the orally disintegrating tablets was optimized by using the effect surface diagram and the contour map. Dissolution of mosapride citrate orally disintegrating tablets was investigated. Results The best prescription for mosapride citrate orally disintegrating tablets was mosapride citrate 5 mg, microcrystalline cellulose 76 mg, mannitol 97 mg, low-substituted hydroxypropylcellulose 20 mg, oranges Flavor 1 mg, Sodium stearyl fumarate 1 mg. The oral disintegration time was 19.4 s, dissolution was 99.7%. Conclusion The direct tabletting method of mosapride citrate orally disintegrating tablets, disintegration time is short, dissolution speed, good taste.