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KMID : 1123920090230051145
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Korean Journal of Oriental Physiology and Pathology
2009 Volume.23 No. 5 p.1145 ~ p.1153
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Mouse Single Oral Dose Toxicity Test and Bone Marrow Micronucleus Test of Samyo-tang Extractsts
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Sung Ik-Jae
Park Mee-Yeon
Cheon Woo-Hyun
Kim Jong-Dae
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Abstract
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The object of this study was to obtain acute information single oral dose toxicity of Samyo-tang (三拗湯) aqueous extracts, with mouse bone marrow cell micronucleus test for detecting possible genotoxicity. In order to observe the 50% lethal dose (LD50), approximate lethal dosage (ALD), maximum tolerance dosage (MTD) and target organs, test articles were once orally administered to ICR mice at dose levels of 2000, 1000, 500 ㎎/㎏ according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines with organ weights of 12 types of principle organs. In addition, after twice oral treatment of Samyo-tang extracts 2000, 1000 and 500 ㎎/㎏, we checked the changes on the number of polychromatic erythrocyte with one or more nuclei (MNPCE). We could not find any mortality and toxicological evidences upto 2000 ㎎/㎏ treated group. Except for decreases of adrenal glands as pharmacological effects of Samyo-tang extracts as cortisol inhalation effects, increases of body weights, lymphoid organ weights and hypertrophy encounted as results from pharmacological effects as immune modulator effects with some sporadic accidental findings not toxicological signs. No evidence of increases of MNPCE numbers were also detected all three different dosages of Samyo-tang extracts treated mice. The results obtained in this study suggest that the LD50 and ALD of Samyo-tang extracts mice were considered as over 2000 ㎎/㎏ because no mortalities were detected upto 2000 ㎎/㎏ that was the highest dose recommended by KFDA. And the results of mouse bone marrow micronucleus test of Samyo-tang extracts is also negative results.
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KEYWORD
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Samyo-tang(三拗湯), single oral dose toxicity, genotoxicity
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