关键词: 注射用右旋雷贝拉唑钠, 注射用雷贝拉唑钠, 重复给药毒性, 毒代动力学

Abstract: Objective To observe the toxicity damage of dexrabeprazole sodium injection in rats for 13 Weeks. Methods One hundred and ninety rats(female half)were randomly divided into vehicle control group, rabeprazole sodium injection control group, three dexrabeprazole sodium injection groups with different dosages (80, 20 and 5 mg·kg^-1), in addition, rabeprazole sodium injection and dexrabeprazole sodium injection satellite group. Then the group should be given the injection once a day for 13 weeks, after that, stopped to recovery for 4 weeks. During the test, all the animals should weigh weight and food intake. When stopped injection and finishing recovery, blood taken from abdominal aorta, organ coefficient and histopathology were measured for the overall toxicity assessment. Respectively, Satellite animals were taken the blood at first and last injection for toxicokinetics. Results The rats in the dexrabeprazole sodium injection group at 80, 20 mg·kg^-1 apperanced shortness of breath, unsteady gait, prone motionless and other symptoms. The levels of RBC,HGB,HCT in the dexrabeprazole sodium injection group at 80, 20 mg·kg^-1 were significantly lower than those in vehicle control group at 13 weeks (P<0.05). The change of these parameters regained to normal at 4 weeks after withdrawal. The amount of small follicular in the thyroid gland increased at 13 weeks, and failed to fully recover at 4 weeks after the withdrawal. Conclusion Repeated administration of dexrabeprazole Sodium injection (80, 20 mg·kg^-1) for 13 weeks could lead to abnormal indicators related erythrocyte and pathological lesions of thyroid in rats.

Key words: dexrabeprazole sodium injection, rabeprazole sodium injection, repeated dose toxicity, toxicokinetic