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This study was conducted to investigate the subacute intravenous toxicity of rHu-EPO in Sprague-Dawley rats. rHu-EPO was daily administered to male and female rats for 30 days with different dose levels(100, 500, 2,500 unit/ kg). After the administration period of 30 days, 5 males and 5females rats per each dose group were assigned for recovery period of additional 30 days. There were no clinical signs compared with control group but slight decrease in spontaneous motor activities and locomotions were observed at high dose groups of males and females. In males, feed consumption was reduced at 500 unit/kg and body weight gain was retarded. In the administration sites of tail, focal congestion was observed in a few animals treated with rHu-EPO. No deaths were occurred during the course of study. In hematological examination. a significant increase of hemoglobin and hematocrit was observed in the males and females rats receiving high dose of rHu-EPO. rHu-EPO administration for 30 days showed a marked decrease in glucose concentration. At the highest dose groups, there was a significant incerase in the weights of spleens in both sexes. but this was considered to be related to its pharmacological activity. These results indicate that rHu-EPO does not induce any significant toxic effect on Sprague-Dawley rats for 30 days.

참고문헌 (10)

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  4. Recent advances in erythropoietin research , Fisher,J.W.;Ernst Jucker(ed.) , Progress in Drug Research / v.41,pp.293-311, 1993
  5. Subacute toxicity of recombinant human erythropoietin in rats , Kim,D.H.;Lim,D.M.L.;Cho,H.J.;Park,K.H.;Ha,B.J.;Kim,H.S. , Korean J. Toxicol. / v.10,pp.243-254, 1994
  6. A new approach to practical toxicity testing , Lorke,D. , Arch. Toxicol. / v.54,pp.275-287, 1983
  7. General Pharmacological studies of erythropoietin(TYB-5220) , Mino,T.;Ohmura,T.;Hiraoka,Y.;Sugino,T.;Hayashi,H. , 藥理と治療 / v.18,pp.953-971, 1990
  8. National Institute of Safety Research , Toxicity test guideline for safety evaluation of drugs for human use, No. 94-3 Korea / v.,pp., 1994
  9. Acute subcutaneous and intravenous toxicity studies in rats and monkeys with TYB-5220 , Spicer,E.J.F.;Wisler,J.A. , 藥理と治療 / v.18,pp.973-1034, 1990
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