摘要:
目的:本实验以咖啡因为模型药物,优化及研制咖啡因口腔崩解片。方法:采用低取代羟丙基纤维素、微晶纤维素(MCC)作为崩解剂,用干粉直接压片法制备咖啡因口腔崩解片。采用正交实验优化处方组成,以达到最短的崩解时间。通过质量研究,建立了初步的质量标准。结果:处方中主药咖啡因的含量固定为100 mg,MCC为40 mg,L-HPC为25 mg,甘露醇为105 mg,硬度固定在3 kg/cm2。按拟定的质量标准对咖啡因口崩片质量检查结果表明,咖啡因口崩片质量可控。结论:咖啡因口崩片的制剂简单、质量可控。
Abstract:
Objective :To optimize the formula of caffeine orally disintegrating tablet and to investigate the related indexes. Methods :Taking the contents of L-HPC,MCC(disintegrating agent)as disintegrants and the disintegrating time(td)as evaluation indexes to carry out the orthogonal experiment to optimize the formula.The dissolution curve of the optimized formula was drawn. Results :The optimized formula for caffeine orally disintegrating tablet was as follows:the contents of caffeine,MCC,L-HPC,and mannitol were 100,40,25,and 105 mg,respectively.The prepared orally disintegrating tablets disintegrated completely within 30 s and dissolved basically within 2 min. Conclusion :This preparation method of oralhy disintegranting tablet of caffeine is simple and available.Determination method has high accuracy and recovery.It is a suitable method for the preparation and content determination of caffeine orally disintegranting tablet.
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