Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (2): 65-69.

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Experimental Study on the Long-term Toxicity of Shendanxiong Injection in Rats

WU Xiao-fei, HU Yu-chi*, CAO Chun-ran, SUN Yuan-yuan, LV Jing   

  1. Drug Safety Evaluation Center, Beijing Institute for Drug Control, Beijing 100035, China
  • Received:2013-08-15 Revised:2016-02-03 Online:2014-02-08 Published:2016-02-03

Abstract: ObjectiveTo observe the long-term toxicity of shendanxiong injection in rats by intravenous injection. MethodsDaily doses of shendanxiong injection at 342、228、152 mg crude drug·kg-1 for 30 days were used for high, mid, and low dose group, respectively. Clinical observations, examinations of body weight and feed consumption were performed during whole experimental stage. Rats examinations including haematological indexes, biochemical indexes, organ coefficient, and histopathology were performed on the 30th day, and on the 14th day after withdrawal, respectively. ResultsNo abnormity was found in all rats in terms of clinical observation, body weight increase and food consumption. The levels of WBC, GR%, Urea, CR, TBIL and liver coefficient, kidney coefficient, adrenal gland coefficient in high dose group were significantly higher than those in control group, and the levels of GR%, CR, TBIL in mid dose group were significantly higher than those in control group, and LY% level in mid dose group was significantly lower than those in control group on 30th day (P<0.05). Those changed indexes of hematology, blood biochemistry and organ coefficient in high dose group regained normal except CR level and kidney coefficient on the 14th day after withdrawal, and above indexes in mid dose group all regained normal. The kidney of rats in high dose group appeared irreversible pathological changes, but the kidney of rats in mid dose group appeared reversible pathological changes. ConclusionRepeated intravenous injection administration of the shendanxiong injection at mid dose could lead to reversible damage to kidney function and pathology

Key words: shendanxiong injection, long-term toxicity, rat

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