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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 flupirtine maleate orally disintegrating tablets and evaluate its quality. Methods Orthogonal experiments were optimized and prescriptions were prepared. Fludipine maleate orally disintegrating tablets were prepared by using tablet disintegration time and dissolution rate as evaluation indexes. The self-made filter paper method was used to determine the in vitro disintegration time of orally disintegrating tablets. The data were compared with the disintegration time of tablets in vivo and the currently used in vitro disintegration time determination method. Results The obtained tablets had good mouthfeel, with an in vivo disintegration time of 34 s, a disintegration time of 31 s measured by the filter paper method and a disintegration time of 8.5 s by a common method. The results showed that the results obtained by the filter paper method were comparable with those obtained by the in vivo The test results are more similar. Conclusion Flupdine maleate orally disintegrating tablets prescription reasonable to meet the design requirements, in vitro disintegration time design method is reasonable.