马来酸氟吡汀口腔崩解片的制备与处方优化

Preparation and Optimization of the Formulation of Flupirtine Maleate Orally Disintegrating Tablets

目的制备马来酸氟吡汀口腔崩解片,并对其质量进行评价。方法正交实验优化处方,以片剂崩解时限和溶出度作为评价指标制备马来酸氟吡汀口腔崩解片。采用自制滤纸法对口腔崩解片进行体外崩解时限的测定,并且与体内片剂的崩解时限和目前常用的体外崩解时限测定方法进行比较,所得数据进行统计学分析。结果所得片剂口感良好,体内崩解时间为34 s,采用滤纸法测得体外崩解时间为31 s,常用方法测得的崩解时限为8.5 s,结果表明滤纸法测得的结果与体内试验结果较为相似。结论马来酸氟吡汀口腔崩解片处方合理,达到设计要求,体外崩解时间测定方法设计合理。

Objective To prepare and optimize the formulation of fluprhine maleate orally disintegrating tablets. Methods The formulation was optimized with an orthogonal design according to disintegrating time in vitro and dissolution. Filter paper test was designed to evaluate disintegration time of tablets. The disintegration time of the orally disintegrating tablets iri vitro was compared with the disintegration time in mouth and that detected by the common method. Results The taste of tablets were desirable. The tablets were disintegrated within 34 s in mouth ,31 s by the filter paper test and 8.5 s by the common method. Conclusion The formulation of flupritine maleatc orally disintegrating tablets was reasonable. The design can closely estimate the disintegration time of orally disintegrating tablets.