口腔崩解片崩解时限测定方法对比实验考察

Study on the disintegration test method for oral disintegrated tablets

目的:考察不同方法测定3种不同崩解原理的口腔崩解片(oraldisintegratedtablets,ODT)的体外崩解时限,为国家药品标准制定部门制定口腔崩解片的质量标准提供参考。方法:采用溶出仪小杯法、量筒法、表面皿法、溶出仪改进法、崩解仪改进法对速崩型、速溶型、融蚀型口腔崩解片进行体外崩解时间测定,并与口腔内崩解行为对照,同时以结果判定难易、装置是否简单、分辨率高低、重复性、体内外相关性为考察指标筛选出不同崩解行为ODT体外评价方法。结果:速崩型、速溶型、融蚀型ODT的体内崩解时间分别为19.8,13.4,30.1s,不同方法测定同一类型的ODT具有不同的崩解时间,融蚀型ODT的体外崩解时间大于4min。相关性研究中,表面皿法测得4个处方的速溶型ODT体外崩解时间为12.5,19.7,24.0,30.7s,相应的体内崩解时间为13.6,21.0,25.4,31.3s;崩解仪器改进法测定速崩型ODT的体外崩解时间为19.5,26.5,14.3,37.0s,相应的体内崩解时间为20.2,28.4,15.2,39.5s。结论:表面皿法和崩解仪改进法可分别作为速溶型和速崩型ODT体外崩解时限的测定方法,目前尚无适宜的方法可准确测定融蚀型ODT的体外崩解时限。

OBJECTIVE To measure the disintegration time of three types of ODT by methods. METHODS Five methods were used to measure the disintegration time of three types of ODT, and the results were evaluated. RESULTS In vivo disintegration times of three types of ODT were 19. 8, 13.4,30. 1 s, but there were various disintegration times for the same tables measured by 5 methods and the thawing ODT did not disintegrate in 4 minutes. The disintegration time of fast dissolving tablets measured by glass Petri dish were 12. 5,19. 7,24. 0,30. 7 s the in vivo disintegrating times were 13. 6,21.0,25. 4,31.3 s. The disintegration times of rapidly disintegration tablets measured by modified disintegration apparatus were： 19. 5,26. 5, 14. 3, 37.0 s the in vivo disintegrating times were 20. 2,28. 4,15. 2,39. 5 s. CONCLUSION The disintegration time of fast dissolving tablets and rapidly disintegration tablets can be measured respectively by glass Petri dish method and modified disintegration apparatus,but there is no way to evaluate the thawing ODT.