辛伐他汀口腔崩解片崩解评价方法的考察

目的:对3种体外崩解方法进行评价.方法:利用固态溶液技术制备辛伐他汀口腔崩解片,采用3种方法测定口腔崩解片的体外崩解,并且考查体内外相关性.结果:自行设计的试管倒置法有较好的重现性和体内外崩解时间相关性,滴定管滴液法和冻干测定法效果不是很好.结论:试管倒置法适用于冻干型口腔崩解片的体外崩解检测.

Study on disintegrating method for simvastatin orally disintegrating tablets

Objective: To evaluate three disintegrating equipments for simvastatin orally disintegrating tablet. Methods: Simvastatin orally disintegrating tablets were prepared by solid-states-dissolution technology, and three disintegrating equipments were used to detect the disintegration of orally disintegrating tablets in vitro, and also the relationship between disintegrating results :in vivo and in vitro was studied. Results:Tube inverted method has good reproducibility, in vivo -in vitro relationship and effective control of particle size, but the results of the other two methods were not so good. Conclusion: Tube inverted method is suitable for testing the disintegration of freeze-dreled orally disintegrating tablets in vitro.