The Korea Journal of Herbology (대한본초학회지)

The Korea Association of Herbology (대한본초학회)
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Dose range finding study of KOB03, a new polyherbal medicine for the treatment of allergic rhinitis, by oral administration for four weeks in Sprague-Dawley rats

한약제제 KOB03의 랫드에서의 4주 반복 경구투여에 의한 독성 연구

  • Jung, Jin-Ki (Department of Herbology, College of Oriental Medicine, Dongguk University) ;
  • Park, Yong-Ki (Department of Herbology, College of Oriental Medicine, Dongguk University)
  • 정진기 (동국대학교 한의과대학 본초학교실) ;
  • 박용기 (동국대학교 한의과대학 본초학교실)
  • Received : 2012.04.18
  • Accepted : 2012.04.23
  • Published : 2012.05.30
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Abstract

Objectives : To evaluate the toxicity of KOB03, polyherbal medicine for the treatment of allergic rhinitis, we performed the dose-range finding test of KOB03 by oral supplementation for 4 weeks in Sprague-Dawley rats. Methods : The water extract of KOB03 consisting of five different herbs was supplied from GLP company. KOB03 was supplemented by gavage at 0, 500, 2,500 and 5,000 mg/kg/day for 4-week consecutive days. We recorded the clinical signs of toxicity, body weight, organ weights, hematology, gross and histological changes in target organs of rats, and clinical chemistry analysis. Results : KOB03 at all doses was shown no mortality or abnormal clinical signs in rats during at the observation period. Furthermore, there was no difference in body weight and food-take consumption, organ weight, gross pathological findings, and urine analysis among the groups of rats treated with different doses of KOB03. The hematological analysis and clinical blood chemistry data were revealed no toxic effects from KOB03-supplemented rats. Conclusions : The results suggest that KOB03 is a wide margin of safety on dose-range toxicity in rats. The no observable adverse effect level (NOAEL) of the test, KOB03 in rats is no less than 5,000 mg/kg/day.

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