Carcinogenesis, Teratogenesis & Mutagenesis ›› 1999, Vol. 11 ›› Issue (5): 275-276.doi: 10.3969/j.issn.1004-616x.1999.05.026

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THE STUDY ON MUTAGENICITY OF rhEPO INJECTIONS

Hu Yanping , Li Yanhong   

  1. National Instit ute f or the Control of Pharmaceutical and Biological Products , Beijing  100050
  • Received:1999-07-30 Revised:1999-09-15 Online:1999-09-30 Published:1999-09-30

Abstract: Three batches of rhEPO injections were studied on mutagenicity by Ames test and micronucleus test of PCE in mouse bone marrow. The Ames test result s showed that the reversion mutation f requencies of three batches of rhEPO injections with five doses ( 18. 75~300. 00 IU/ plate) didn’t increase in st rain TA97 , TA98 ,TA100 and TA102 with or without S9mix ; In 15000~60000 IU/ kg doses , the f requencies of micronucleus in bone marrow PCE cells of mice didn’tincrease. It showed three batches of rhEPO injections had no mutagenicity.

Key words: rhEPO Injections, Ames test, micronuclues test of PCE in mouse bone marrow, mutagenicity