YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

A Repeated-dose 28-Day Oral Toxicity Test of Aconitum jaluense Extract in Sprague-Dawley Rats

초오 추출물의 Sprague-Dawley 랫드를 이용한 28일 반복 경구투여독성시험

  • Lee, Jong Suk (Acupuncture, Moxibustion and Meridian Research Group, Medical Research Division, Korean Institute of Oriental Medicine) ;
  • Lee, Ji Sun (GLP Center, Catholic University of Daegu) ;
  • Park, Yeong-Chul (GLP Center, Catholic University of Daegu) ;
  • Choi, Sun Mi (Acupuncture, Moxibustion and Meridian Research Group, Medical Research Division, Korean Institute of Oriental Medicine) ;
  • Lee, Sanghun (Acupuncture, Moxibustion and Meridian Research Group, Medical Research Division, Korean Institute of Oriental Medicine)
  • 이종숙 (한국한의학연구원 의료연구본부 침구경락연구그룹) ;
  • 이지선 (대구가톨릭대학교 GLP센터) ;
  • 박영철 (대구가톨릭대학교 GLP센터) ;
  • 최선미 (한국한의학연구원 의료연구본부 침구경락연구그룹) ;
  • 이상훈 (한국한의학연구원 의료연구본부 침구경락연구그룹)
  • Received : 2013.10.18
  • Accepted : 2014.01.17
  • Published : 2014.02.28
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Abstract

A 28-day repeated-dose oral toxicity test was performed to determine the no-observed-effect level (NOEL) and establish an optimum dose of the highly toxic Aconiti Ciliare Tuber (ACT) used as a folk remedy. Repeated oral doses of 1,250, 2,500, and 5,000 mg/kg/day of the hot water extract of ACT were administered to five male and five female Sprague-Dawley rats in each group for 4 weeks. The indicators for toxicity included results of examination of common symptoms and changes in weight and feed intake, eye test, urinalysis, hematological and serum biochemical analyses, and post-mortem weight measurement of organs, and visual inspections. All animals survived at the end of the experiment; in addition, we observed no specific test substance-mediated symptoms. We observed no test substance-mediated changes in body weight and feed intake. We observed statistically significant changes in male OB and pH levels (p<0.05). Further, the biochemical test showed statistically significant changes in the IP value of male rats and $CL^-$valueoffemalerats (p<0.05). However, all changes were within historical data. The post-mortem examinations showed no test substance-mediated changes. Moreover, statistically significant changes under the test conditions were confirmed to have been caused by factors other than the test substance. Thus, the maximum NOEL of ACT extract in rats was estimated to be 5,000 mg/kg/day.

Keywords

References

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