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삼정환의 랫드를 이용한 90일 반복 경구투여 독성시험
Repeated Dose 90-Day Oral Toxicity Study of Modified Samjung-Hwan in Sprague-Dawley Rats
J Korean Med Obes Res 2018;18:36-49
Published online June 30, 2018;  https://doi.org/10.15429/jkomor.2018.18.1.36
Copyright © 2018 The Society of Korean Medicine for Obesity Research.

김민지, 이명종, 김호준
Min-Jee Kim, Myeong-Jong Lee, Hojun Kim

동국대학교 한의과대학 한방재활의학교실

Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Dongguk University
Hojun Kim
Department of Rehabilitation Medicine of Korean Medicine, Dongguk University Ilsan Oriental Hospital, 27 Dongguk-ro, Ilsandong-gu, Goyang 10326, Korea
Tel: +82-31-961-9111
Fax: +82-31-961-9009
E-mail: kimklar@dongguk.ac.kr
Received May 13, 2018; Revised June 5, 2018; Accepted June 14, 2018.
cc This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Objectives: The study is aimed at evaluating the possible toxicity in 90-day repeated oral administration of modified Samjung-hwan (mSJH) in Sprague-Dawley (SD) rats. This study was conducted to detect the no-observed adverse effect level (NOAEL).
Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 0, 1,000, 2,000, 4,000 mg/kg. Each group consisted of 10 rats of each gender. The modified SJH extract was given once a day for 90 days. We monitored the changes of mortalities, clinical signs, body weight changes, food consumption, ophthalmologic findings, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histological markers of all animals treated with modified SJH extract during the study period.
Results: There were no toxicologically significant changes in mortalities, clinical signs, body weight gains, food consumption, ophthalmologic findings, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histological markers in any of rats tested.
Conclusions: The NOAEL of the modified SJH extract in male rats and no observed effect level (NOEL) in female rats are considered 4,000 mg/kg.
Keywords : No-observed-adverse-effect Level, Safety, Toxicity tests


June 2018, 18 (1)
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