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.
ABSTRACT
Objective To investigate effect of trepibutone tablet combined with ursodeoxycholic acid in treatment of patients with gallstone. Methods 200 cases with gallstone were diagnosed and randomly divided into observation group and control group from February 2013 to February 2014.100 cases in control group were given ursodeoxycholic acid treatment 50 mg/(kg? d),two times per day for six month.On the basis of control group observation group were treated with trepibutone one tablet per day,three times per day,4 weeks for 1 course, 2 weeks of treatment interval between 4 courses, totally for four courses.After treatment, patients were followed up and recorded gallbladder wall thickness, gallbladder functional status. Results After 6 months of treatment in patients with gallbladder wall thickness of observation group ( 2.77 ±0.38 ) mm was superior to control group (3.24 ±0.36)mm(P<0.05).After 6 months of treatment in patients with gallbladder function score of observation group (58.75 ±4.79) was better than control group (53.11 ±5.02) ( P<0.05).Recurrence rate of observation group was 9% better than that of control group 18%(χ2 =3.468,P<0.05)after treatment for 6 months.Conclusion Effect of trepibutone tablet combined with ursodeoxycholic acid in treatment of patients with gallstone is well.There is no obvious side effects during the treatment.