ACM의 비글견을 이용한 단회 경구투여 용량증가 독성 시험 및 4주 반복 경구투여 용량 결정 시험
분야
의약학 > 기초한의학
저자
임정화 ( Jung Hwa Lim ) , 이상룡 ( Sang Ryong Lee ) , 정인철 ( In Chul Jung )
발행기관
대한한방신경정신과학회
간행물정보
동의신경정신과학회지 2013년, 제24권 제1호, 131~144페이지(총14페이지)
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38600828.pdf [무료 PDF 뷰어 다운로드]
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    영문초록
    Objectives: To provide information on the safety of ACM, we carried out a single oral dose-increasing toxicity and 4-weeks repeated oral dose determining test of ACM in beagle dogs. Methods: In a single oral dose-increasing toxicity test, beagles were treated with ACM orally increasing dose level (1,000, 2,000, 5,000 mg/㎏) at interval of 3 days. After administration, signs of toxicity were observed for two weeks. In 4-weeks repeated oral dose determinating test, beagles were treated with ACM with oral dose 500, 1,000, 2,000 mg/kg for 4 weeks. Mortality, clinical signs, body weight changes, food consumption, urinalysis, hematological and biochemical parameters, organ weights, necropsy findings, and histological findings were monitored during the study period. Results: In a single oral dose-increasing toxicity test, we found no mortality, abnormalities in clinical signs, body weight, and necropsy findings during the study period. In 4-weeks repeated oral dose determinating test, we found no mortality, abnormalities in clinical signs, body weight, food consumption, urinalysis, hematological and biological parameters, gross findings, organ weights, necropsy findings, and histopathological findings in any of the beagles tested. Conclusions: The results obtained in these studies suggest that maximum tolerated dose (MTD) of ACM in male and female beagle dogs was supposed to be over 5,000 mg/kg. For the future studies of toxicity, it is advisable that high dose and low dose are set at 2000 mg/kg and 500 mg/kg, respectively.
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