Single Dose Oral Toxicity Study of Fermented Soshiho-tang Extract in Mice

발효소시호탕의 마우스에 대한 단회투여 경구독성시험

  • Seo, Sang-Hee (Center for Herbal Medicine Improvement Research, Korea Institute of Oriental Medicine) ;
  • Hwang, Youn-Hwan (Center for Herbal Medicine Improvement Research, Korea Institute of Oriental Medicine) ;
  • Lee, Ji-Hye (Center for Herbal Medicine Improvement Research, Korea Institute of Oriental Medicine) ;
  • Oh, Su-Young (Center for Herbal Medicine Improvement Research, Korea Institute of Oriental Medicine) ;
  • Kim, Tae-Soo (Center for Herbal Medicine Improvement Research, Korea Institute of Oriental Medicine) ;
  • Ma, Jin-Yeul (Center for Herbal Medicine Improvement Research, Korea Institute of Oriental Medicine)
  • Received : 2011.11.08
  • Accepted : 2011.12.12
  • Published : 2012.02.25

Abstract

The aim of this study was to investigate the acute toxicity and safety of fermented Soshiho-tang extract using male and female ICR mice. Mice were treated with fermented Soshiho-tang extract once orally at 1250, 2500 or 5000 mg/kg and observed for two weeks. At the doses used, no mortality or abnormal clinical signs in animals were shown during at the observation period. In addition, no differences were found between control and treated groups in body weight, hematology and biochemical analysis, and other findings. Above data strongly suggest that no observed adverse effect level of fermented Soshiho-tang extract might be over 5000 mg/kg/day in this study.

Keywords

References

  1. 韓藥調劑指針解說. 大韓藥師會, 1995.
  2. Hirayama, C., Okumura, M., Tanikawa, K., Yano, M., Mizuta, M., Ogawa, N. A multicenter randomized controlled clinical trial of Shosaiko-to in chronic active hepatitis. Gastroenterol Jpn. 24(6):715-719, 1989.
  3. Tajiri, H., Kozaiwa, K., Ozaki, Y., Miki, K., Shimuzu, K., Okada, S. Effect of sho-saiko-to(xiao-chai-hu-tang) on HBeAg clearance in children with chronic hepatitis B virus infection and with sustained liver disease. Am J Chin Med. 19(2):121-129, 1991. https://doi.org/10.1142/S0192415X91000193
  4. 김덕현, 윤수홍. 소시호탕이 사염화탄소에 의해 유도된 흰쥐의 간장해에 미치는 영향. J. Korean Soc. Hygienic Sciences. 4(2):1-6, 1998.
  5. 김동현. 성분대사연구. 최신고려인삼연구. 1: 71-88, 2007.
  6. Bae, E.A., Han, M.J., Kim, E.J., Kim, D.H. Transformation of ginseng saponins to ginsenoside Rh2 by acids and human intestinal bacteria and biological activities of their transformants. Arch Pharm Res. 27: 61-67, 2004. https://doi.org/10.1007/BF02980048
  7. 박성진, 성동호, 박동식, 김승섭, 고징유, 안주희 등. 발효더덕의 화학성분. 한국식품영양학회지 38(3):396-400, 2009.
  8. 함성호, 임병락, 유가화, 가선오, 박병현. 발효에 의한 오가피의 항당뇨 활성 촉진. 대한동의생리병리학회지 22(2):340-345, 2008.
  9. 서성숙, 정승기. 발효 금은화의 인플루엔자 바이러스 A형에 대한 저해효과. 대한한방내과학회지 30(3):465-480, 2009.
  10. Heo, Y.H. Studies on the fermentable properties of isolated B. subtilis from fermented soybean. Annual Belletin Seoul Health. 18: 181-192, 1998.
  11. Oka, H., Yamamoto, S., Kuroki, T., Harihara, S., Marumo, T., Kim, S.R., Monna, T., Kobayashi, K., Tango, T. Prospective study of chemoprevention of hepatocellular carcinoma with Sho-saiko-to (TJ-9). Cancer. 76(5):743-749, 1995. https://doi.org/10.1002/1097-0142(19950901)76:5<743::AID-CNCR2820760506>3.0.CO;2-V
  12. Amagaya, S., Umeda, M., Ogihara, Y. Inhibitory action of shosaikoto and daisaikoto (traditional Chinese medicine) on collagen-induced platelet aggregation and prostaglandin biosynthesis. Planta Med. 5: 345-349, 1986.
  13. Sakaguchi, S., Tsutsumi, E., Yokota, K. Preventive effects of a traditional Chinese medicine (sho-saiko-to) against oxygen toxicity and membrane damage during endotoxemia. Biol Pharm Bull. 16: 782-786, 1996.
  14. Fujiwara, K., Mochida, S., Nagoshi, S. Regulation of hepatic macrophage function by oral administration of xiao-chai-hu-tang (sho-saiko-to, TJ-9) in rats. J Ethnopharmacol. 46: 107-114, 1995. https://doi.org/10.1016/0378-8741(95)01235-6
  15. Amagaya, S., Hayagawa, M., Ogihara, Y., Fujiwara, K. Effect of Syo-saiko-to and Dai-saiko-to on carbon tetrachlorideinduced hepatic injury in rats. J Med Pharm Soc Wakan Yaku. 5: 129-136, 1988.
  16. Amagaya, S., Miyake, A., Ogihara, Y., Fujiwara, K. Effect of Syo-saiko-to on liver regeneration in partially hepatectomized rats. J Med Pharm Soc Wakan Yaku. 5: 137-145, 1988.
  17. Haranaka, K., Satomi, N., Sakurai, A., et al. Antitumor activities and tumor necrosis factor producibility of traditional Chinese medicines and crude drugs. Cancer Immunol Immunother. 20: 1-5, 1985.