The Korea Journal of Herbology (대한본초학회지)

The Korea Association of Herbology (대한본초학회)
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Single Dose Acute Toxicity of Ssanghwa-tang in Crl : CD (SD) Rats

랫드에서 쌍화탕의 급성독성에 관한 연구

  • Kim, Su-Jeong (Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine) ;
  • Lee, Mee-Young (Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine) ;
  • Shin, In-Sik (Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine) ;
  • Seo, Chang-Seob (Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine) ;
  • Ha, Hye-Kyung (Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine) ;
  • Huh, Jung-Im (Division of Toxicology, Korea Institute of Toxicology) ;
  • Shin, Hyeun-Kyoo (Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine)
  • 김수정 (한국한의학 연구원 한약 EBM 연구센터) ;
  • 이미영 (한국한의학 연구원 한약 EBM 연구센터) ;
  • 신인식 (한국한의학 연구원 한약 EBM 연구센터) ;
  • 서창섭 (한국한의학 연구원 한약 EBM 연구센터) ;
  • 하혜경 (한국한의학 연구원 한약 EBM 연구센터) ;
  • 허정임 (한국 안전성 평가 연구소) ;
  • 신현규 (한국한의학 연구원 한약 EBM 연구센터)
  • Received : 2011.04.27
  • Accepted : 2011.06.10
  • Published : 2011.06.30
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Abstract

Objectives : This study was conducted to evaluate the acute toxicity and safety of Ssanghwa-tang (Shuanhetang in Chinese, Sou-wa-to in Japanese) in Crl : CD Sprague-Dawley (SD) rat though the current regulatory guideline. Methods : In this study, 10 rats of each sex were randomly assigned to two groups of 5 rats each and were administrated singly by gavage at dose levels of 0 and 2000 mg/kg/day of ssanghwa-tang water extract (SHT). After single administration of SHT, mortalities, clinical signs, body weight changes, gross findings were observed for the 15-day period. Results : Acute toxicity tests revealed that a single oral administration of SHT at dose levels of 2000 mg/kg did not affect clinical signs, body weight, and gross findings, evaluating the safety of SHT. The SHT treatment did not result in any toxicologically significant changes in mortality, clinical signs, body weight changes. Conclusions : These results showed that the single oral administration of SHT did not cause any toxic effect at the dose levels of 2000 mg/kg/day in rats. In conclusion, the median lethal dose (LD50) of SHT was considered to be over 2000 mg/kg/day body for both sexes.

Keywords

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