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자료유형
학술저널
저자정보
저널정보
한국독성학회 Toxicological Research Journal of Toxicology and Public Health Vol.23 No.1
발행연도
2007.3
수록면
87 - 96 (10page)

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Single and repeated-dose toxicity of anti-diabetic herb extract microcapsule (ADHEM) were evaluated according to Toxicity Test Guidelines of Korea Food and Drug Administration using Sprague-Dawley rats. For single-dose toxicity test, kneading ADHEM with sterilized water were administered orally once at dose levels of 0 and 2,000 ㎎/㎏ and examined for 14 days. No dead animals, clinical signs and abnormal necropsy findings were observed and also no significant difference in body weights was found. Therefore, the LD?? of ADHEM was considered to be higher than 2,000 ㎎/㎏ in both male and female rats. For repeated-dose toxicity test, ADHEM were mixed with powder fodder and administerd orally for 28 days at dose levels of 0, 500, 1000 and 2000 ㎎/㎏/day. No dead animals, clinical signs and significant difference in body weights were found. In hematology and serum biochemistry, all values were included within the normal ranges. In relative organ weights, kidney or liver were significantly increased in the 500, 1000 or 2000 ㎎/㎏/day male groups, uterus was significantly increased in the 500 ㎎/㎏/day female group and left adrenal glands were significantly decreased in the 2000 ㎎/㎏/day female group. In histopathological examinations, vacuolation and microgranuloma in the liver, chronic progressive nephropathy and inflammation in the kidney were observed in the 500, 1000 or 2000 ㎎/㎏/day both male and female groups. Therefore, the no observed adverse effect level (NOAEL) of ADHEM was considered to be lower than 500 ㎎/㎏/day in both male and female rats.

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