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The acute toxicity of STB-HO-BM was evaluated in Sprague Dawley (SD) rats and beagle dogs. STB-HO-BM was administered orally to rats at dose levels of 0 and 2,000 ㎎/㎏/day and to dogs at dose levels of 0, 500, 1,000 and 2,000 ㎎/㎏/day. In these experiments, there were no death and clinical changes which were related to STB-HO-BM administration. In addition, there were no significant changes between control and treated groups in body weights and autopsy findings. In conclusion, the administration of STB-HO-BM 2,000 ㎎/㎏ in SD rats and up to 2,000 ㎎/㎏ in beagle dogs was proved to be safe, and it is thought that STB-HO-BM may not show any toxicity in its clinical use.
We have investigated the genotoxicity of STB-HO-BM using in vitro and in vivo system such as Ames reverse mutation test, chromosomal aberration test and micronucleus test. in Ames reverse mutation test, STB-HO-BM treatment at the dose range up to 5,000 ug/plate did not induce mutagenicity in Salmonella typhimurium TA98, TA100, TA102, TA1535, TA1537 and in Escherichia coli WP2 uvrA with and without metabolic activation. Any significant aberration wasn't observed in chinese hamster lung (CHL) fibroblast cells treated with STB-HO-BM at the concentration of 12.5, 2.5, 5 ㎎/㎖ both in the absense and presence of metabolic activation system. In mouse micrnucleus test, no significant increase in the occurrence of micronucleated polychromatic erythrocytes was observed in ICR male mice orally administered with STB-HO-BM at the doses of 0.5, 1.0, 2.0 g/㎏. These results indicate that STB-HO-BM has no mutagenic potential under the condition in this study.
This study was performed to evaluate repeated-dose toxicities of STB-HO-BM in Sprague-Dawley rats. STB-HO-BM was administered orally to rats at dose levels of 0, 100, 300 and 1,000 mg/kg/day for 13 weeks. In recent study, there were no dose related changes in mortality, clinical signs, body weight changes, food and water consumption, opthalmoscopy, organ weights, urine analysis, hematological findings, and biochemical examination of all animals treated with STB-HO-BM. Gross and histopathological findings revealed no evidence of specific toxicity related to STB-HO-BM. These results suggest that the oral no observed adverse effect level (NOAEL) of STB-HO-BM may be over 1,000 mg/kg in rats.
To investigate the mutant induction of wild ginseng culture extract, we performed chromosomal aberration assay with chinese hamster lung cell in vitro. The test concentration of the extract was decided for the standard with the 50% suppression of cell propagation in the cell. The concentrations for the chromosome test were 1,250, 2,500 and 5,000 ㎍/ml with metabolic activation (+S, 6 hours treatment), 1,100, 2,200 and 4,400 μg/ml without metabolic activation (-S, 6 hours treatment) 800, 1,600 and 3,200 ㎍/ml without metabolic activation (-S, 24 hours treatment). No significant increase in chromosome aberrations was observed at any of these concentrations both in the absence and presence of metabolic activation system. Cyclophosphamide monohydrate (CPA) and ethylmethanesulfonate (EMS) caused a significant increase in chromosome aberration. These results may be concluded that wild ginseng culture extract is not capable of inducing chromosome aberration in cultured chinese hamster lung cell regardless of metabolic activation and genotoxicity of that is negative under the present experimental condition.
To investigate the acute toxicity of adventitious roots extract derived from wild ginseng, it was orally administered to beagle dogs with a single dose. In acute toxicity test, three groups (9 beagle dogs of male) were administered with different dosages of adventitious roots extract (prepared by Biopia Corp.) 500 mg/kg (G2), 1,000 mg/kg (G3), 2,000 mg/kg (G4) and one group (G1, 2 beagle dogs of male) were received by only capsule without the extract according to the Regulation on Korea Food and Drug Administration (1999. 12. 22). There were vomitus for a time and mucous stool at the day, and anorexia and mucous stool at the first day in the group of 2,000 mg/kg administration. There were mucous stool in one and anorexia for a while in two beagle dogs at the first day in the 1,000 mg/kg administration. But no death or abnormal clinical sign was observed through the study period. Therefore, the adventitious roots extract derived from wild ginseng is considered not to have the acute toxicity in the beagle dogs. These results suggest that LD_(50) value of the test substance was considered to be more than 2,000 mg/kg in the beagle dogs.
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Germanium is found in a range of minerals and ores and is present in foods including beans, tomato juice, oysters, tuna and garlic. Germanium is a non-metallic element, which can exist in valence states of 2 and 4. Clinical trials and use in private practices for more than a decade have demonstrated organic germanium's efficacy in treating serious disease including cancer, arthritis and senile osteoporosis. But it was rarely reported that inorganic germanium has biological properties. STB-BM contains mineral complex, rare earth elements and a little amount of inorganic germanium. The experiment was carride out the anti-obesity effect. To investigate anti-obesity effect of STB-BM, we measured the effect of body weight, fat weight (subcutaneous fat, epididymal fat, visceral fat, kidney fat and total fat) and serum biochemical level in rats fed high fat diets. STB-BM 35mg/kg suppressed the increasing ratio of body weight, epididymal fat weight, visceral fat weight, total fat weight, triglyceride and LDL-cholesterol (p<0.05).
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Daily oral administration to Sprague Dawly rats for 4 weeks of DWP-301, at doses of 0, 500, 1000, 2000mg/kg presented following results; 1) No animals died and there were no significant differences in general signs, body weight, food consumption, urinalysis haematological, biochemical, gross pathological and histopathological examination between control and treated rats. 2) Water consumption, pH-, protein- urobilinogen-, ketone-values in urine were significantly increased in the treated male and female rats. It is supposed that these differences in animals are a consistent feature of repeated overdosage with test suspensions. The results indicate that the non toxic dose of test compounds in rats is over 2000mg/kg in this test system.