枸橼酸莫沙必利口腔崩解片的制备及评价

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。

Preparation and evaluation of mosapride citrate oral disintegrating tablet

Objective To prepare and evaluate the mosapride citrate oral disintegrating tablet. Methods The basic excipients of the formulation were selected on the base of preliminary test. With the oral disintegration time as index, the formulation was optimized by response surface and contour plot, then the tablet was prepared by a direct compression method and the dissolution was investigated. Results The optimal formulation consisted of mosapride citrate 5mg, MCC 76 mg, Man 97 mg, L-HPC 20 mg, orange essence 1 mg, SSF 1 mg. Oral disintegrating time of the tablet was 19.4 s, and dissolution percent reached 99.7%. Conclusions The tablets with short disintegrating time, fast dissolution and palatability are obtained by a direct compression method.