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KMID : 0895820150250020073
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Journal of Oriental Rehabilitation Medicine
2015 Volume.25 No. 2 p.73 ~ p.80
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Single-dose Intramuscular Toxicity Studies of Shinbaro3 Pharmacopunture in Sprague-Dawley Rats and Beagle Dogs
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Lee Jin-Ho
Lee In-Hee
Lee Jae-Woong
Kim Eun-Ji
Kim Min-Jeong
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Abstract
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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 (LD50) and approximate lethal dose (ALD) value of the test substance Shinbaro3 Pharmacopuncture are higher than 1.2mg/kg in SD rats and Beagle dogs.
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KEYWORD
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Single-dose intramuscular toxicity, Harpagophytum procumbens, Shinbaro3 Pharmacopuncture, Spraque-Dawley rat, Beagle dog
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