Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (8): 453-456.

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13 Weeks Intravenous Repeated Dose Toxicity Study of Dexrabeprazole Sodium for Injection in Beagle Dogs

LIU Cui-ling1, DAI Xiao-li2, MA Yu-kui2, SUN Rong3   

  1. 1.People's Hospital of Linqu County, Linqu 262600, China;
    2. Shandong Academy of Pharmaceutical Sciences, Jinan 250100, China;
    3. Shandong Academy of Chinese Medicine, Jinan 250014, China
  • Received:2017-05-11 Revised:2017-09-26 Online:2017-08-20 Published:2017-09-26

Abstract: Objective To reach the repeated dose toxicity of dexrabeprazole sodium for injection in Beagle dogs and compare the toxicity with rabeprazole sodium for injection. Methods Fifty normal Beagle dogs were divided into five groups: solvent control group, rabeprazole sodium for injection group (40 mg·kg-1) and dexrabeprazole sodium injection group (2.5, 10 and 40 mg·kg-1). The dogs were administered intravenously with corresponding drug for 13 weeks continuously. The body weights were detected every week and body temperature, ECG, ophthalmology, urine and stool were examined before and after administration period and recovery for 4 weeks. The serum and plasma of dogs were collected to detect hematology and blood biochemistry index, and dogs were autopsied to detect viscera index and histopathology at the end of administration and recovery for 4 weeks. Results The main toxicity symptoms of some dogs administered with dexrabeprazole sodium for injection (40mg·kg-1) are decreased voluntary activity, shortness of breath, salivation and prone. Abnormal reduction of the levels of RBC, HGB, HCT, TP, ALB and escalation of the levels of TC, TG, BUN and kidney index were found after administration for 13 wk. Pathological changes of thyroid was also found by histopathological examination. Conclusion Major toxic target organs of Beagle dogs after administration with dexrabeprazole sodium for injection (40mg·kg-1) for 13 wk are liver, kidney and thyroid. The toxicity level is similar in dexrabeprazole sodium for injection group and rabeprazole sodium for injection group with same dose. No observed adverse effect level (NOAEL) in Beagle dogs is 2.5 mg·kg-1.

Key words: dexrabeprazole sodium for injection, repeated dose toxicity, thyroid, Beagle dog

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