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KMID : 0895820150250030001
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Journal of Oriental Rehabilitation Medicine
2015 Volume.25 No. 3 p.1 ~ p.9
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Study on Single-dose Intramuscular Toxicity of Shinbaro Pharmacopuncture in Sprague-Dawley (SD) Rats and Beagle Dogs
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Lee Jin-Ho
Chung Hwa-Jin
Lee In-Hee
Lee Jae-Woong
Kim Eun-Ji
Kim Min-Jeong
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Abstract
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Objectives : To evaluate Shinbaro Pharmacopuncture safety through analysis of potential single-dose intramuscular toxicity of Sinbaro Pharmacopucture in SD rats and Beagle dogs.
Methods : Single-dose intramuscular toxicity of Shinbaro Pharmacopuncture was assessed in accordance with Korea Food and Drug Administration Guidelines for toxicity testing of Medicinal Products. The SD rats were treated intramuscularly with Shinbaro Pharmacopuncture at doses of 0, 4.6, 9.2, and 18.5 mg/kg, respectively. The Beagle dogs were treated intramuscularly with Shinbaro Pharmacopuncture at doses of 2.3, and 4.6 mg/kg, respectively, and after 3 days, the procedure was repeated a second time at doses of 0.6, and 1.2 mg/kg, respectively, for toxicity testing. Mortality, change in body weight, and necropsy findings were examined for the study period.
Results : There were no mortalities, general symptoms, or body weight changes in the SD rats. While pyelectasis of the left kidney was observed in a male rat in the 4.6 mg/kg administration group, natural occurrence is common, and does not appear to be related with the test substance. No mortalities were observed in the Beagle dogs. In assessment of general symptoms, a female dog in the 9.2 mg/kg group displayed body weight decrease due to leftover food, but the change in body weight was within the normal range seen at 6~7 months, and the necropsy findings were not significant. The toxicity of the test substance appears to be minimal.
Conclusions : The results suggest that the lethal dose 50 (LD50) and approximate lethaldose (ALD) value in single intramuscular administration of Shinbaro Pharmacopuncture in SD rats and Beagle dogs are higher than 18.5 mg/kg.
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KEYWORD
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Single-dose intramuscular toxicity, Shinbaro Pharmacopuncture, SD rat, Beagle dog
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