DOI QR코드

DOI QR Code

Single Oral Dose Toxicity Test of Kong-Jin-Dan, a Polyherbal Formula in ICR Mice

  • Park, Mee-Yeon (College of Oriental Medicine, Daegu Haany University) ;
  • Choi, Hae-Yun (College of Oriental Medicine, Daegu Haany University) ;
  • Kim, Jong-Dae (College of Oriental Medicine, Daegu Haany University) ;
  • Lee, Hyeung-Sik (Department of Herbal Biotechnology, Daegu Haany University) ;
  • Ku, Sae-Kwang (College of Oriental Medicine, Daegu Haany University)
  • Published : 2007.12.31

Abstract

The object of this study was to evaluate the single dose toxicity of Kong-Jin-Dan (KJD), a polyherbal formula in male and female mice. KJD was administered to female and male ICR mice as an oral dose of 2000, 1000 and 500 mg/kg (body wt.) according to the recommendation of KFDA Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy, organ weight and histopathology of 12 principle organs were examined. As results, we could not find any mortality, clinical signs, and changes in the body and organ weight except for increases of lymphoid organ weights in KJD-dosing groups. These increases of lymphoid organ weights considered that related to the immune modulate effect of KJD not toxicological signs. In addition, no KJD-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. The results obtained in this study suggest that the KJD does not cause any toxicological signs. The $LD_{50}$ and approximate LD of KJD extracts in both female and male mice were considered as over 2000 mg/kg.

Keywords

References

  1. Dourish, C.T. (1987). Effects of drugs on spontaneous motor activity. In Experimental Psychopharmacology (A.J. Greenshaw and C.T. Dourish, Ed.), pp. 325-334. Humana Press, Clifton
  2. Hodge, H.C. and Sterner, J.H. (1949). Tabulation of toxicity classes. Am. Ind. Hyg. Q. 10, 93
  3. Iqbal, M.P., Sultana, F., Mehboobali, N. and Pervez, S. (2001). Folinic acid protects against suppression of growth by methotrexate in mice. Biopharm. Drug Dispos. 22, 169-178 https://doi.org/10.1002/bdd.271
  4. Irwin, S. (1968). Comprehensive observational assessment: Ia. A systemic, quantitative procedure for assessing the behavioral and physiological state of the mouse. Psychopharmacology 13, 222-257 https://doi.org/10.1007/BF00401402
  5. Kim, Y.H. and Bae, M.J. (2001). The effect of Kong Jin Dan on the lipid metabolism in rats fed high fat-diet. J. East-West Med. 14, 61-78
  6. Kim, Y.S., Lee, J.D., Kim, C.H., Choi, D.Y., Park, D.S., Nam, S.S. and Kang, S.K. (1999). The Effect of Kongjindan Aquaacupuncture on the CD4+ T cell count at al. in rats were administered with MTX. J. Korean Acup. Moxi. Soc. 16, 179- 202
  7. Klein, H.O., Kreysch, H.G., Coerper, C., Voigt, P. and Ruff, I. (1987). Preclinical and early clinical trial with mafosfamide as immune modulator. Methods Find Exp. Clin. Pharmacol. 9, 627-640
  8. Korea Food and Drug Administration (2005): Testing Guidelines for Safety Evaluation of Drugs (Notification No. 2005-60, issued by the Korea Food and Drug Administration on October 21, 2005)
  9. Lee, H.S., Lee I.G. and Ku S.K. (2006). Single oral dose toxicity study of water extracts of Picrorrhiza Rhizoma in mice. J. Toxicol. Pub. Health 22, 117-126
  10. Lee, J.E., Kim, H.J., Choi, E.K, Chai, H.Y., Yun, Y.W., Kim, D.J., Nam, S.Y., Lee, B.J., Ahn, B.W., Kang, H.G. and Kim, Y.B. (2003). Four-week repeated-dose toxicity study on Pinellia Extract. Korean J. Lab. Anim. Sci. 19, 127-141
  11. Lee, J.H, Yang, K.J., Shin, H.D., Park, B.R., Son, C.W., Jang, H.J., Park, D.C., Lee, H.S. and Ku, S.K. (2005). Single subcutaneous dose toxicity of $Polycan^{\circledR}$/TEX>, a ${\beta}-glucan$ originated from Aureobasidium in mice. Lab. Anim. Res. 21, 299-305
  12. US Environmental Protection Agency (1998). Health Effects Test Guidelines OPPTS 870.100, Acute Toxicity Testing Background. US EPA August, Washington, USA

Cited by

  1. A Patient With Minimal Change Disease and Acute Focal Tubulointerstitial Nephritis Due To Traditional Medicine: A Case Report and Small Literature Review vol.10, pp.5, 2014, https://doi.org/10.1016/j.explore.2014.06.001