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Study on Single-dose Intramuscular Toxicity of Shinbaro Pharmacopuncture in Sprague-Dawley (SD) Rats and Beagle Dogs

  • Journal of Korean Medicine Rehabilitation
  • Abbr : JKMR
  • 2015, 25(3), pp.1-9
  • Publisher : The Korean Academy Of Oriental Rehabilitation Medicine
  • Research Area : Medicine and Pharmacy > Korean Medicine

이진호 1 정화진 1 Lee In Hee 1 이재웅 1 김은지 1 김민정 1

1자생의료재단 척추관절연구소

Accredited

ABSTRACT

ObjectivesTo evaluate Shinbaro Pharmacopuncture safety through analysis of potential single-dose intramuscular toxicity of Sinbaro Pharmacopucture in SD rats and Beagle dogs.MethodsSingle-dose intramuscular toxicity of Shinbaro Pharmacopuncture was as-sessed in accordance with Korea Food and Drug Administration Guidelines for toxicity test-ing 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.ResultsThere 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 admin-istration 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.ConclusionsThe results suggest that the lethal dose 50 (LD50) and approximate lethal-dose (ALD) value in single intramuscular administration of Shinbaro Pharmacopuncture in SD rats and Beagle dogs are higher than 18.5 mg/kg. (J Korean Med Rehab 2015;25(3):1-9)

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