• Title/Summary/Keyword: 4-weeks repeated oral dose determinating test

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Single Oral Dose-increasing Toxicity Test and Four Weeks Repeated Oral Dose Determinating Test of ACM (Added Chongmyung-tang) in Beagle Dogs (ACM의 비글견을 이용한 단회 경구투여 용량증가 독성 시험 및 4주 반복 경구투여 용량 결정 시험)

  • Lim, Jung-Hwa;Lee, Sang-Ryong;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.24 no.1
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    • pp.131-144
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    • 2013
  • 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.

Single Oral Dose Toxicity Test and Four Weeks Repeated Oral Dose Determination Test of GST in Sprague-Dawley Rats (GST의 Sprague-Dawley Rat를 이용한 단회 경구투여 독성시험 및 4주 반복 경구투여 용량결정시험)

  • Han, Jong-Min;Hong, Jee-Hee;Lee, Hye-Yeong;Jung, In-Chul;Jin, Mi-Rim;Kim, Seong-Hyeong;Park, Yang-Chun
    • The Journal of Internal Korean Medicine
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    • v.34 no.4
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    • pp.349-361
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    • 2013
  • Objectives : This study aimed to evaluate the single oral dose toxicity and four weeks repeated dose determination of Gamisasangja-tang (GST) in male and female Sprague-Dawley rats. Methods : In the single oral toxicity study, rats were orally administered a single dose of 0 and 5,000 mg/kg GST. There were 5 rats in each group. After single administration, mortality, clinical signs, body weight changes and gross pathological finding were observed for 14 days. In the 4-weeks repeated oral dose determination study, rats were orally administered a single dose of 0, 1,250, 2,500 or 5,000 mg/kg GST. There were 5 rats in each group. Mortality, clinical signs, body weight changes, food consumption and gross pathological finding were observed for 28 days. Organ weight, clinical chemistry and hematology were tested after 28 days. Results : There was no mortality in either of the two studies. There were also no significant differences in clinical sign, body weight, organ weights, hematological or serum chemical parameters between the GST and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of GST is over 5,000 mg/kg, so this finding would be expected to provide scientific evidence for the safety of GST.