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새로운 Anthracycline계 항암성 항생물질 DA-125의 랫드에 대한 4주 용량설정시험(DRF)과 13주 아급성 독성시험
Four-Week Dose-Range Finding and 13-Week Repeated Dose Intravenous Toxicity Studies in Rats with DA-125, a New Anthracycline Antitumor Antibiotic

백남기    (동아제약(주) 연구소   ); 안병옥    (동아제약(주) 연구소   ); 이순복    (동아제약(주) 연구소   ); 이상득    (동아제약(주) 연구소   ); 김원배    (동아제약(주) 연구소   ); 양중익    (동아제약(주) 연구소  );
  • 초록

    This study was conducted to investigate the repeated dose toxicity of DA-125, a new anthracycline antitumor antibiotic, in rats. Before the 13-week main study, a 4-week dose-range finding (DRF) study was carried out. The administration of DA-125 intravenously at dosage levels of 0, 0.125, 0.5, 2.0, and 8.0 mg/kg/day to rats for 4 weeks resulted in premature deaths of all animals in the 8.0 mg/kg/day group and in the deaths of 4 males and 4 females at 2.0 mg/kg/day. Body weights were markedly reduced in the 8.0 mg/kg/day group and showed dose-related decreases in all treatment groups when compared with the control group. Reductions in weight gain were slight and not significantly different at 0.125 mg/kg/day but animals receiving 0.5 mg/kg/day showed more marked decreases in gain in a clear dose-related manner Based On the results of the above DRF study, a 13-week repeated dose intravenous toxicity study in rats with DA-125 was performed at a dose level of 0, 0.012, 0.08 and 0.3 mg/kg/day. No treatment related effects were noted in behavior or body weight in all treatment groups. One male at the highest dose level died on study day 26, but the death could not be related to test article toxicity. Swelling and scabbing of the ears was present in all of the groups, including the control group. There were no treatment related changes in the hematological, biochemical or urinalysis values in all treatment groups. Thymus weights were significantly reduced ill males receiving 0.3 mg/kg/day and they were sligltly, and not significantly, reduced in females of the same group. While there were no associated histological changes. Treatment related necrosis was found in the tail vein (injection site) at 0.08 and 0.3 mg/kg/day. On the basis of these results, the no observed effect level (NOEL) was 0.012 mg/kg/day and the maximum tolerated dose (MTD) was estimated to be more than 0.3 mg/kg/day under the conditions tested.


  • 주제어

    DA-125 .   repeated dose toxicity.  

 저자의 다른 논문

  • 백남기 (15)

    1. 1990 "돼지 췌장 유래 엘라스타제의 변이원성 시험" Environmental mutagens and carcinogens = 한국 환경성돌연변이·발암원학회지 10 (2): 107~112    
    2. 1990 "돼지 췌장 유래 엘라스타제의 항원성 시험" Environmental mutagens and carcinogens = 한국 환경성돌연변이·발암원학회지 10 (2): 113~118    
    3. 1990 "엘라스타제의 토끼에 대한 최기형시험" Environmental mutagens and carcinogens = 한국 환경성돌연변이·발암원학회지 10 (2): 119~126    
    4. 1993 "새로운 항암성 항생물질 DA-125의 심장독성에 대한 평가" The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology 1 (1): 9~19    
    5. 1993 "DA-125의 국소자극성" The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology 1 (1): 20~25    
    6. 1993 "새로운 Anthracycline 항암제 DA-125의 랫드에서의 아급성독성연구" The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology 1 (2): 226~235    
    7. 1993 "새로운 Anthracycline 항암제 DA-125의 항원성 및 면역독성에 대한 연구" The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology 1 (2): 236~243    
    8. 1993 "새로운 Anthracycline 항암제 DA-125의 조혈기독성 및 혈관장해성" The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology 1 (2): 244~250    
    9. 1994 "천연형 인성장호르몬 DA-3002의 단회 및 13주 반복투여독성연구" The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology 2 (2): 161~172    
    10. 1994 "재조합 인 과립구 콜로니 자극인자 DA-3030의 랫드에 대한 4주 정맥내 반복투여 독성연구" The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology 2 (3): 270~280    
  • 안병옥 (22)

  • 이순복 (12)

  • 이상득 (7)

  • 김원배 (46)

  • 양중익 (42)

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