Dissolution Characteristics of Trepibutone Tablets
10.3870/j.issn.1004-0781.2016.04.018
- VernacularTitle:曲匹布通片的溶出特性
- Author:
Mingfeng XU
;
Hong JIANG
;
Chenxi LIU
;
Shi BAO
;
Chundi HU
- Publication Type:Journal Article
- Keywords:
Trepibutone tablet;
Dissolution medium;
Dissolution curve;
f2 factor
- From:
Herald of Medicine
2016;35(4):397-400
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the dissolution behavior between domestic trepibutone tablets and original reference product, and provide a basis for evaluating the quality consistency of generic drugs. Methods Four dissolution media recommended by Japanese Orange Book and a domestic standard dissolution media were selected to determined the dissolution profile,and f2 factor was calculated to investigate the consistency of stripping curves. Results In water,pH 4.0 and pH 1.2,the f2 of domestic formulation and reference formulation was under 50,and the dissolution profile was inconsistent.Dissolution behavior of domestic preparations of different manufacturers was dissimilar.In water,the f2 of domestic preparations of different batches of the same manufacturer was over 99.9,and the dissolution behavior was similar. Conclusion The dissolution method of existing domestic standard can not distinguish the dissolution behavior of different products,and it should be revised and completed.There is still great difference in quality between the domestic preparations and reference preparations.
