Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (5): 259-262.

• Orginal Article • Previous Articles     Next Articles

A 26 Weeks Oral Toxicity of Extracts of Phyllanthus urinaria L. in Beagle Dogs

JIA Qing-Wen1, XIN Ju-yun2, DAI Xue-dong1   

  1. 1 Shandong Institute of Pharmaceutical Industry, Shandong Jinan 250033 China;
    2 Qingzhou Tranditional Chinese Medical Hospital, Shandong Qingzhou 262500, China
  • Received:2012-03-01 Online:2012-05-10 Published:2015-08-10

Abstract: Objective To observe the long-term toxicity of the extracts of Phyllanthus urinaria L. in dogs by repeated oral administration. MethodDaily doses of extracts at 125 mg·kg-1, 250 mg·kg-1 and 500 mg·kg-1 for 26 weeks were used for low, mid, and high dose group, respectively. Examinations including haematological indexes, biochemical indexes, urinalysis and histopathology were performed at 26 weeks during the administration, and 6 weeks after the withdrawal, respectively. ResultsThe dogs in the high group showed a reduction in the food consumption and appeared interval disgorging during the administration. The levels of ALT, AST, ALP, T-Bil, BUN and γ-GT in high group were significantly higher than those in control group at 26 weeks after administration(P<0.05). Those changed blood biochemistery indexes regained normal at 6 weeks after withdrawal. Hematology data did not show treatment related change in all of the dogs. The high group dogs showed positive protein and bilirubin in the urine at terminal sacrifice. The liver and kidney of dogs in high and mid group appeared reversible pathological changes. ConclusionRepeated oral administration of the extracts of Phyllanthus urinaria L. at high dose could lead to reversible damage to liver and kidney function and pathology in dogs.

Key words: Phyllanthus urinaria L., Beagle dogs, repeat-dose toxicity