Experimental study on chronic toxicity of Guanxinning Injection in rats / 药物评价研究

ABSTRACT

Objective To observe the repeat administration toxicity of Guanxinning Injection in rats.Methods Totally 120 rats (males and females) were randomly divided into vehicle control group and three Guanxinning Injection groups with different dosages (3.40,1.70,and 0.85 g/kg).Rats were administered with Guanxinning Injection by consecutive intravenous injection for 13 weeks.Besides the general conditions were observed,the related indexes were detected,such as body weight,the routine control of blood,hepatic function,renal function,the metabolism condition of lipids,the glycometabolism indexes,and histopathology analysis were determined at 13 weeks of treatments and 4 weeks after the withdrawal,respectively.Results Rats in the Guanxinning Injection group at 3.40,1.70 g/kg apperance shortness of breath,unsteady gait,lying motionless,and other symptoms.There was no obvious abnormal reaction in the 0.85 g/kg dose group.There were two male rats in the Guanxinning Injection group at 3.40 g/kg died at about week 4 of treatments,and there was no death in the 0.85 and 1.70 g/kg dose groups.Compared with vehicle control group,the related indexes of blood,blood biochemistry,organ relative quality,and histopathological showed no obvious abnormalities in Guanxinning Injection 0.85 and 1.70 g/kg group.The levels of urea nitrogen (BUN) and the relative weight of kidney in Guanxinning Injection 3.40 g/kg group were significantly higher than those in vehicle control group at 13 weeks.The change of these parameters regained to normal at 4 weeks after withdrawal and the rest of the detection index showed no obvious abnormality in 3.40 g/kg dase group.Conclusion Intravenous administration of Guanxinning Injection for 13 weeks at high dose could induce reversible damage to kidney.