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Single-dose Intramuscular Toxicity Studies of Shinbaro3 Pharmacopunture in Sprague-Dawley Rats and Beagle Dogs

  • Journal of Korean Medicine Rehabilitation
  • Abbr : JKMR
  • 2015, 25(2), pp.73-80
  • Publisher : The Korean Academy Of Oriental Rehabilitation Medicine
  • Research Area : Medicine and Pharmacy > Korean Medicine

김민정 1 이진호 1 Lee In Hee 1 이재웅 1 김은지 1

1자생의료재단 척추관절연구소

Accredited

ABSTRACT

ObjectivesTo 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.MethodsFor 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.ResultsThere 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.ConclusionsThere results suggest that the lethal dose 50 (LD50) 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. (J Korean Med Rehab 2015;25(2):73-80)

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