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Single-Dose Oral Toxicity Test of Woohwangchungshim-won in Mice  

Lee, Je Won (Department of Cardiovascular and Neurologic Diseases, College of Korean Medicine, Daegu Haany University)
Baek, Kyung Min (Department of Cardiovascular and Neurologic Diseases, College of Korean Medicine, Daegu Haany University)
Chang, Woo Seok (Department of Cardiovascular and Neurologic Diseases, College of Korean Medicine, Daegu Haany University)
Publication Information
Journal of Physiology & Pathology in Korean Medicine / v.28, no.2, 2014 , pp. 186-194 More about this Journal
Abstract
The object of this study was to obtain acute toxicity information (single-dose oral toxicity) of Woohwangchungshim-won (WHCSW), a pill type herbal medicine used in Korean Medicine (KM) for treating stroke. In order to obtain the 50% lethal dose (LD50), approximate lethal dosage (ALD) and target organs, WHCSW powders were once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 and 0 (control) mg/kg (body weight.) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines (Notification No. 2009-116). The mortality and changes in the body weight, clinical signs and gross observation were monitored for 14 days after single-dose oral administration of WHCSW according to KFDA Guidelines with organ weights and histopathological changes were observed in 12 principle organs. After single-dose oral administration of WHCSW, we could not find any mortality and toxicological evidences up to 2,000 mg/kg-administered group, except for some accidental findings and dose-independent increases of body weight gains in female 1,000 and 500 mg/kg-administered female mice. The results obtained in this study suggest that the LD50 and ALD of WHCSW in both female and male mice after single-dose oral administration were considered as over 2,000 mg/kg because no mortalities were detected up to 2,000 mg/kg that was the highest dose recommended by KFDA and Organization for Economic Co-Operation and Development (OECD), and can be safely used in clinics.
Keywords
Woohwangchungshim-won; single-dose oral toxicity;
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Times Cited By KSCI : 6  (Citation Analysis)
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