• Herbal Formula Science
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• v.16 no.1
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• pp.109-115
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• 2008

Objectives : This study was to assessment the toxicity of Sipjeondaebo-tang(Shiquan dabu-decoction) by micronucleus test. Methods : Sipjeondaebo-tang(Shiquan dabu-decoction) water-extract in vivo micronucleus test was performed using 7 weeks ICR mice. At 24 hours after with Sipjeondaebo-tang extract at the doses of 0, 500, 1000 and 2000 mg/kg/day by peritoneal route mice were sacrificed and bone marrow cells were prepared for smear slides. Results : As a result of counting the micronucleus polychromate erythrocyte of 2000 polychromate erythrocyte, all treatment groups did not show statistically significant increase than negative control group. and there was no clinical sign and body weight connected with injection of Sipjeondaebo-tang(Shiquan dabu-decoction) extract. Conclusions: It was concluded that Sipjeondaebo-tang extract did not induce micronucleus in the bone marrow cells of ICR mice

• Herbal Formula Science
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• v.16 no.2
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• pp.145-153
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• 2008

Objectives : This study was to assessment the toxicity of Sipjeondaebo-tang(Shiquan dabu-decoction) by Chromosomalanomaly test. Methods : Sipjeondaebo-tang(Shiquan dabu-decoction) water-extract in vivo Chromosomalanomaly test was performed using chiness hamster lung cell line. Results : Sipjeondaebo-tang water extract was negative in Chromosomalanomaly test at the doses of 0, 625, 1250 and $2500{\mu}g/m\ell$ at 6h and 24h.(S9- fraction). Chromosomalanomaly test(S+fraction) was also negative at the doses of 0, 1250, 2500 and $5000{\mu}g/m\ell$. Conclusions : It was concluded that Sipjeondaebo-tang extract did not induce Chromosomalanomaly in the chiness hamster lung cell.

• The Journal of Internal Korean Medicine
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• v.32 no.3
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• pp.334-344
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• 2011

Objectives : Sipjeondaebo-tang is a medicine traditionally prescribed as a restorative. The aim of this study was to investigate the single oral dose toxicity and safety of extract of fermented Sipjeondaebo-tang in ICR mice. Methods : In single oral dose toxicity study, non-fermented or fermented Sipjeondaebo-tang were administered by oral gavage to ICR mice (5 males, 5 females) at single doses of varying concentrations: 1250, 2500 and 5000 mg/kg. Changes of body weight, general behavior, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There were no mortality or signs of toxicity in single oral dose toxicity studies. There were also no significant differences in body weight, organ weight, or hematological parameters between the treatment and control groups. Conclusions : Fermented Sipjeondaebo-tang did not cause remarkable adverse effects in ICR mice. The oral lethal dose of fermented Sipjeondaebo-tang is more than 5000 mg/kg and no-observed-adverse-effect level (NOAEL) of the extract for both male and female mice is 5000 mg/kg.

• The Journal of Korean Medicine
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• v.29 no.3
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• pp.1-10
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• 2008

Objectives: This study was to assess the toxicity of Sipjeondaebo-tang by bacterial reverse mutation test. Methods: In this study, to evaluate the bacterial reverse mutation of Sipjeondaebo-tang water-extract, the in vitro Ames test using Salmonella typhimurium (TA98, TA100, TA1,535, TA1,537) and Escherichia coli(WP2uvrA) were performed with Sipjeondaebo-tang water extract at the concentrations 0, 312, 625, 1250, 2500 and 5000 ${\mu}g/plate$. Results: Sipjeondaebo-tang water extract was negative in Ames test with both Salmonella typhimurium or Escherichia coli with and without rat liver microsomal enzyme (S9- fraction and S+ fraction). Conclusions: According to these results, we concluded that a Sipjeondaebo-tang water extract did not cause bacterial reverse mutation.