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The Journal of Internal Korean Medicine > Volume 35(3); 2014 > Article
The Journal of Internal Korean Medicine 2014;35(3): 223-243.
GST 추출물의 Sprague-Dawley Rat를 이용한 13주 반복 경구투여 독성시험 및 4주 회복시험
김윤하1, 김준영1, 한종민1, 이혜영2, 정인철3, 진미림4,5, 김승형5, 박양춘1,5
1대전대학교 한의과대학 내과학교실
2(주)바이오톡스텍
3대전대학교 한의과대학 신경정신과학교실
4대전대학교 한의과대학 약리학교실
5대전대학교 동서생명과학연구원
A Thirteen Week Repeated Oral Dose Toxicity Test and A Four Week Recovery Test of GST in Sprague-Dawley Rats
Yoon-ha Kim1, Jun-young Kim1, Jong-min Han1, Hye-yeong Lee2, In-chul Jung3, Mi-rim Jin4,5, Seong-hyeong Kim5, Yang-chun Park1,5
1Dept. of Internal Medicine, College of Korean Medicine, Dae-Jeon University
2Biotoxtech
3Dept. of Neuropsychology, College of Korean Medicine, Dae-Jeon University
4Dept. of Pharmacology, College of Korean Medicine, Dae-Jeon University
5Institute of Traditional Medicine and Bioscience, Dae-Jeon University
Correspondence  Yang-chun Park ,Tel: 042-229-6919, Fax: 042-254-3403, Email: omdpyc@dju.kr
  Published online: September 30, 2014.
ABSTRACT
Objectives:
To provide information on the safety of GST (GamiSasangja-tang; CnidiiFructus, Sophora Root, Angelica Gigas Root, Clematidis Radix, Stemonae Radix, Spirodelae Herba), we carried out a 13-week repeated oral dose toxicity and a 4-week recovery test of GST in Sprague-Dawley rats.

Methods:
Female and male rats were treated with GST at oral doses of 1,250, 2,500, and 5000 mg/kg. The GST was administered for 13 weeks. Mortality, clinical signs, body weight changes, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights and histological markers were monitored during the study period. The rats were then monitored for 4 extra weeks to determine recovery time after the study period.

Results:
We found no mortality or abnormalities among clinical signs, body weight, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights or histological markers in any of the rats tested.

Conclusions:
The no-observed adverse effects level (NOAEL) is considered as over 5000 mg/kg for male and female rats.
Key words: GST, safety, 13 week repeated oral dose toxicity test, 4 week recovery test, SD rats
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