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麻黃潤肺湯 추출물의 수컷 ICR 마우스에서 경구 단회투여 독성 평가

Single Dose Toxicity Test of “Mahwangyounpae-tang” Extractin Male ICR Mouse

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주제분류한의학

초록

Abstract

To obtain the 50% lethal dose (LD50), approximated lethal dose (ALD) and approximated target organs of “Mahwangyounpae-tang” for further study like repeat dose toxicity, genotoxicity and reproductive toxicity, single dose toxicity was tested in male ICR mouse according to KFDA Guideline 1999-61 [KFDA, 1999] at a dosage level of 2,000, 1,000, 500, 250 and 125 ㎎/㎏/10㎖. In this study, mortalities, clinical signs, body weight changes and body weight gains, gross findings and weight of principal organs were detected during and/or after 14 days of single dosing. After 2 or 3 days of dosing, 1 or 2 animals in 2,000 and 1,000 ㎎/㎏-dosing groups were died. Excitation and leaping response were observed as test article-treatment related clinical signs. These abnormal signs were restricted to 2,000 and 1,000 ㎎/㎏-dosing groups and they were recovered to normal within 4 days after dosing in case of survivors. A significant decrease of body weight were observed in some periods of observation in 2,000 and 1,000 ㎎/㎏-dosing group from 1 days after dosing compared to those of vehicle control group. A significant decrease of body weight gains were observed in observation periods in 2,000 and 1,000 ㎎/㎏-dosing group compared to those of vehicle control group. Hypertrophy of heart and decoloration of kidney were observed as test article-treatment related gross findings. These abnormal findings were restricted to 2,000 and 1,000 ㎎/㎏-dosing groups. A significant increase of absolute and relative heart and kidney weight were demonstrated in 2,000 ㎎/㎏-dosing groups. LD50 in this study was detected as 2,242.42 ㎎/㎏. ALD in this study was detected as 1,000 ㎎/㎏ and the target organ was considered as the heart and kidney.

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