• Biomolecules & Therapeutics
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• 제5권2호
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• pp.179-186
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• 1997

The pharmacokinetics and tissue distribution of DWP20373, a novel fluoroquinolone, were examined in rats and beagle dogs after a single intravenous and oral administration. Analysis of DWP20373 in plasma, tissue, and urine was performed by both HPLC and microbiological assay. The plasma drug concentration declined biexponentially both rats and beagle dogs. In the rats, the terminal drug elimination half-life (t$_{1}$2$\beta$/) was 64 min (IV) and 57 min (PO) by bioassay, and 76 min (IV) and 77 min (PO) by HPLC. Whereas in beagle dogs, t$_{1}$2$\beta$/ was 196 min (IV) and 350 min (PO). The volume of distribution at steady-state (Vd$_{ss}$ ) was 811 ml/kg (bioassay) and 2061 ml/kg (HPLC) in rats, and 2738 ml/kg (bioassay) in beagle dogs. The total body clearance (Cl$_{t}$) of DWP20373 was 10 ml/min/kg (bioassay) and 7 ml/min/kg (HPLC) in rats, and 11 m1/min/kg (bioassay) in beagle dogs. The extent of bioavailability after oral administration was 49% (bioassay) and 67% (HPLC) in rats, and 84% (bioassay) in beagle dogs. The 24-h urinary recovery, measured by bioassay, was 2.7% after oral dosing and 5.5% after intravenous dosing in rats. Serum protein binding ratio determined at 27g/ml was 78%. This drug was also distributed in tissues in the decreasing order of liver, kidney, spleen, lung, heart, and muscle determined at 30 min after oral administration.on.

• Toxicological Research
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• 제13권1_2호
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• pp.127-130
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• 1997

Acute toxicity of EPO(Erythropoietin) was investigated using rats and beagle dogs according to Established Regulation of Korean National Institute of Safety Research (1994. 4. 14). Rats and beagle dogs were injected intravenously with dosages of 20000 IU/kg, 2000 IU/kg, 200 IU/kg, 20 IU/kg and 2 IU/kg. In animals injected with EPO, there were neither dead animals nor significant changes of body weights. In addition, no differences were found between control and treated groups in clinical signs and autopsy findings. Therefore $LD_50$ of EPO was considered to be higher than 20000 IU/ kg B. W. in rats and beagle dogs.

• Toxicological Research
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• 제14권2호
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• pp.217-226
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• 1998

SDK (skin decontamination kit) is new skin decontaminant which is developed by ADD (Agency for defence development). In this study, four-week toxicity of SDK was investigated using beagle dogs and Sprague-Dawley rats. The beagle dogs and Sprague-Dawley rats were dressed topically seven days per week for 28 days, with dosage of 0, 0.25, 0.8 and 1 g/kg/day. respectively. Animals treated with SDK did not cause any death and show any clinical signs. They did not show any significant changes of body weight, feed uptake and water consumption. They were not significantly different from the control group in urinalysis, ocular examination and histopathological examination. In hematological and serum biochemical assay, there were no-dose-defendent changes. Therefore, SDK was not indicated to have any toxic effect in the beagle dogs and Sprague-Dawley rats when it was dressed topically below the dosage 1 g/kg/day for four weeks.

• Toxicological Research
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• 제15권1호
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• pp.69-73
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• 1999

Acute toxicity of typhoid vaccine was investigated using Sprague-Dawley (SD) rats and beagle dogs. SD rats and beagle dogs were administered intramuscularly with dosages of 0,. 0.2, 0.1, 0.05 and 0.025 mg/kg, respectively. In animals administered with typhoid vaccine, there were neither dead animals nor significant changes of body weights. In addition, no differences were found between control and treated groups in clinical signs and autopsy findings. Therefore, LD50 of typhoid vaccine was considered to be higher than 0.2 mg/kg in SD rats and beagle dogs.

• Biomolecules & Therapeutics
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• 제5권3호
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• pp.284-291
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• 1997

The pharmacokinetics and tissue distribution of DWP20367 (1-cyclopropyl-6-fluoro-8-chloro-7-(2, 7-diazabicyclo[3,3,0]tract-4-ene-7-yl)-1,4-dihydro-4-oxoquinoline-3-carboxylic acid), a novel fluoroquinolone, were examined in rats and beagle dogs after a single intravenous and oral administration. Analysis of DWP20367 in plasma, tissue, and urine was determined by both HPLC and microbiological assay (bioassay). The plasma concentration-time curves of the drug in rats and beagle dogs were biexponentially declined. The terminal half-life (t$_{1}$2$\beta$/) of the drug in rats was about 60.1 $\pm$7.3 min (i.v.) and 61.3 $\pm$ 12.4 min (p.o.) in bioassay, and 86.3 $\pm$19.8 min (i.v.) and 50.9$\pm$ 14.9 min (p.o.) in HPLC. In beagle dogs, half-life of the drug determined by bioassay was about 121.8$\pm$6.2 min (i.v.) and 111.0$\pm$7.6 min (p.o.). The volume of distribution at steady-state (Vd$_{ss}$ ) was 243.8$\pm$74.1 ml/kg (bioassay) and 339.2$\pm$84.3 ml/kg (HPLC) in rats, and 1587.5 $\pm$536.9 ml/kg (bioassay) in beagle dogs. The total body clearance (Cl$_{t}$) of DWP20367 was 3.4 $\pm$ 0.4 ml/min/kg (bioassay) and 2.4$\pm$0.4 ml/min/kg (HPLC) in rats, and 12.3$\pm$ 1.0 ml/min/kg (bioassay) in beagle dogs, respectively. The extent of bioavailability after oral administration was 89.1%(bioassay) and 79.9% (HPLC) in rats, and 78.7% (bioassay) in beagle dogs. Urinary recovery (24-h) assayed by bioassay was 0.7% (p.o.) and 1.2% (i.v.) in rats, and 0.8% (p.o.) and 1.0% (i.v.) in beagle dogs. In rats, 24-h fecal recovery determined by bioassay was 11.2% (p.o.) and 0.1% (i.v.). Rat and human serum protein binding ratios at 2$\mu$g/ml were about 90~91%. This drug determined by bioassay was also distributed by the order of liver, kidney, lung, heart, spleen and muscle 30 min after oral administration.on.

• 한방재활의학과학회지
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• 제25권2호
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• pp.73-80
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• 2015

Objectives To assess the safety of Shinbaro3 Pharmacopuncture by analyzing the potential single-dose intramuscular toxicity of Shinbaro3 Pharmacopuncture at various dose levels in SD (Spraque-Dawley) rats and Beagle dogs. Methods For evaluation of single-dose intramuscular toxicity of Shinbaro3 Pharmacopuncture, 40 SD rats (20 male and 20 famale) and 4 Beagle dogs (2 male and 2 female) were used. The rats were divided in four groups of 10 each, and treated intramuscularly with Shinbaro3 Pharmacopuncture at doses of 0.3, 0.6 and 1.2 mg/kg in distilled water, and distilled water as a vehicle control group, respectively. The Beagle dogs were divided into two groups of 2 each, and treated intramuscularly with Shinbaro3 Pharmacopuncture at doses of 0.15, and 0.3 mg/kg in distilled water, respectively, and signs of toxicity were observed. After a wash-out period of 3 days, the procedure was repeated with Shinbaro3 Pharmacopuncture at doses of 0.6, and 1.2 mg/kg in distilled water, respectively. Mortality, body weight changes, and necropsy findings were examined during the study period. Results There were no mortalities in either the SD rats or Beagle dogs. There were also no significant differences in adverse effects, body weight, or necropsy findings between the Shinbaro3 Pharmacopuncture and control groups. Conclusions There results suggest that the lethal dose 50 ($LD_{50}$) and approximate lethal dose (ALD) value of the test substance Shinbaro3 Pharmacopuncture are higher than 1.2 mg/kg in SD rats and Beagle dogs.

• Toxicological Research
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• 제13권3호
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• pp.293-296
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• 1997

The acute toxicity study of CJ-50001, a recombinant granulocyte-colony stimulating factor (rG-CSF), was performed in Sprague Dawley (SD) rats and beagle dogs. CJ-50001 was administered up to maximum dose 5,000 $\mu\textrm{g}$/kg (i.v.) and 10,000 $\mu\textrm{g}$/kg (p.o.) in SD rats and 5,000 $\mu\textrm{g}$/kg (i.v.) in beagle dogs. In these experiments, there were no death and harmful clinical changes which were related to CJ-50001. In conclusion, $LD_{50}$ of CJ-50001 is over 5,000 $\mu\textrm{g}$/kg, i.v. in SD rats and beagle dogs, and over 10,000 $\mu\textrm{g}$/kg, p.o. in SD rats.

• 한국한의학연구원논문집
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• 제9권2호
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• pp.131-148
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• 2003

This study was performed to evaluate the acute oral toxicity of an oriental medical prescription for obesity treatment, SH21-B, in Sprague-Dawley rats and Beagle dogs. SH21-B was administered in rats at does of 0mg/kg, 2,000mg/kg, and 5,000mg/kg. And also SH21-B was administered in Beagle dogs at does of 150mg/kg, 300mg/kg, and 600mg/kg. The rats and dogs of both sexes were observed daily for 14 days after single oral administration. Two female rats, one administered at 2,000mg/kg and the other administered at 5,000mg/kg, died, but no dead animal was observed among male rats. Therefore LD50 in the female rat is observed to be 8,710mg/kg, and MLD(Minimum Lethal Dose) of the male rat is observed to be more than 5,000mg/kg. Among dogs, no dead animal was observed up to 600mg/kg and MLD is observed to be more than 600mg/kg.

• Biomolecules & Therapeutics
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• 제7권2호
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• pp.185-190
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• 1999

The current study was performed to determine the acute oral toxicity of P55A, a crude extract of 1 : 1 mixture of Phellodendron amurense cortex and Aralia elata cortex, in SD rats and beagle dogs. 5 rats of each sex were treated with a single dose of P55A orally at doses of 0 and 5,000 mg/kg respectively. Also 2 dogs of each sex were treated with a single dose of P55A orally at doses of 0 and 2,000 mgAg, respectively. After the treatment, clinical signs, and body weight change were observed for 14 days. All rats survived during the study and did not show any clinical sign. Body weight gain showed no significant difference between the control and treated rats. Grossly, no lesion was observed in the rats. All dogs survived during the study. In clinical signs, dark stool was observed in the 2,000 mg/kg treated dogs at day 1 after administration. The animals recovered from general signs at day 2 after administration. Body weight gain showed no significant difference between the control and treated dogs. Grossly, no lesion was observed in the dogs. It is suggested that the LD$_{50}$ of P55A by oral administration was estimated to be over 5,000 mg/kg in both sexes of rats and 2,000 mg/kg in both sexes of beagle dogs.s.

• 한국독성학회:학술대회논문집
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• 한국독성학회 2001년도 International Symposium on Dietary and Medicinal Antimutgens and Anticarcinogens
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• pp.173-173
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• 2001

The acute toxicity study of MBRI-98304, a new Hepatitis B virus (HBV) immunotherapeutic agent, was performed in Sprague-Dawley rats (7 weeks old) and Beagle dogs (4 months old). MBRI-98304 was injected intramuscularly at a single dosage of 0, 20, 100, 500, 2, 500, and 12, 500 $\mu\textrm{g}$/kg in rats and 0, 200, 1, 000, and 5, 000 $\mu\textrm{g}$/kg in Beagle dogs for 2 weeks daily. There were no deaths or clinical signs.(omitted)