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

신바로 약침의 SD 랫드와 비글견에 대한 단회 근육투여 독성시험

  • Lee, Jin-Ho (Jaseng Spine and Joint Research Institute Jaseng Medical Foundation) ;
  • Chung, Hwa-Jin (Jaseng Spine and Joint Research Institute Jaseng Medical Foundation) ;
  • Lee, In-Hee (Jaseng Spine and Joint Research Institute Jaseng Medical Foundation) ;
  • Lee, Jae-Woong (Jaseng Spine and Joint Research Institute Jaseng Medical Foundation) ;
  • Kim, Eun-Jee (Jaseng Spine and Joint Research Institute Jaseng Medical Foundation) ;
  • Kim, Min-Jeong (Jaseng Spine and Joint Research Institute Jaseng Medical Foundation)
  • 이진호 (자생의료재단 척추관절연구소) ;
  • 정화진 (자생의료재단 척추관절연구소) ;
  • 이인희 (자생의료재단 척추관절연구소) ;
  • 이재웅 (자생의료재단 척추관절연구소) ;
  • 김은지 (자생의료재단 척추관절연구소) ;
  • 김민정 (자생의료재단 척추관절연구소)
  • Received : 2015.06.18
  • Accepted : 2015.07.08
  • Published : 2015.07.31


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 ($LD_{50}$) 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.


Supported by : 자생의료재단


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