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The Journal of Internal Korean Medicine > Volume 34(4); 2013 > Article
The Journal of Internal Korean Medicine 2013;34(4): 349-361.
GST의 Sprague-Dawley Rat를 이용한 단회 경구투여 독성시험 및 4주 반복 경구투여 용량결정시험
한종민1, 홍지희2, 이혜영3, 정인철4, 진미림5,6, 김승형6, 박양춘1,6
1대전대학교 한의과대학 폐계내과학교실
2대전대학교 한의과대학 안이비인후피부과학교실
3(주) 바이오톡스텍
4대전대학교 한의과대학 신경정신과학교실
5대전대학교 한의과대학 약리학교실
6대전대학교 동서생명과학연구원
Single Oral Dose Toxicity Test and Four Weeks Repeated Oral Dose Determination Test of GST in Sprague-Dawley Rats
Jong-min Han1, Jee-hee Hong2, Hye-yeong Lee3, In-chul Jung4, Mi-rim Jin5,6, Seong-hyeong Kim6, Yang-chun Park1,6
11Division of Respiratory System, Dept. of Internal Medicine, College of Oriental Medicine, Dae-Jeon University
2Dept. of Ophthalmology & Otolaryngology & Dermatology, College of Oriental Medicine, Dae-Jeon University
3Biotoxtech
4Dept. of Neuropsychology, College of Oriental Medicine, Dae-Jeon University
5Dept. of Pharmacology, College of Oriental Medicine, Dae-Jeon University
6Institute 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: December 30, 2013.
ABSTRACT
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.
Key words: Sasangja-tang (Shechuangzi-tang), safety, single dose toxicity, 4-weeks repeated dose determinating, LD50
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