Journal of Physiology & Pathology in Korean Medicine (동의생리병리학회지)

The Physiological Society of Korean Medicine and The Society of Pathology in Korean Medicine (대한동의생리학회·한의병리학회)
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Single Oral Dose Toxicity Study of Water Extracts of Polygalae Radix in ICR Mice

  • Kang, Byung Hoon (Department of Herbology, College of Korean Medicine, Daegu Haany University) ;
  • Ku, Sae Kwang (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University) ;
  • Seo, Bu Il (Department of Herbology, College of Korean Medicine, Daegu Haany University) ;
  • Roh, Seong Soo (Department of Herbology, College of Korean Medicine, Daegu Haany University) ;
  • Park, Soo Jin (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University) ;
  • Park, Ji Ha (Department of Herbology, College of Korean Medicine, Daegu Haany University)
  • Received : 2013.07.11
  • Accepted : 2013.07.29
  • Published : 2013.08.25
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Abstract

The objective of this study was to evaluate the single oral dose toxicity of Polygalae Radix (PR) in male and female mice. PR extract (yield = 18.6%) was administered to ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines (2009-116, 2009). Animals were monitored for the mortality and the changes in body weight, clinical signs and gross observation during 14 days after dosing. Upon necropsy, organ weight and histopathology of 14 principal organs were examined. It was observed that there were no mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principal organs related to PR extract up to 2,000 mg/kg. Therefore, 50% lethal dose ($LD_{50}$) and approximate LD of PR aqueous extracts after single oral treatment in female and male mice were considered over 2000 mg/kg the limited dosages recommended by KFDA Guidelines, respectively.

Keywords

References

  1. Lee, B.J., Ahn, B.W., Kang, H.G., Kim, Y.B. Four-week repeated-dose toxicity study on Pinellia Extract. Korean J Lab Anim Sci 19: 127-141, 2003.
  2. Roh, S.S., Ku, S.K. Mouse single oral dose toxicity study of DHU001, a polyherbal formula. Toxicol Res 26: 53-59,2010. https://doi.org/10.5487/TR.2010.26.1.053
  3. Cheong, M.H., Lee, S.R., Yoo, H.S., Jeong, J.W., Kim, G.Y., Kim, W.J., Jung, I.C., Choi, Y.H. Anti-inflammatory effects of Polygala tenuifolia root through inhibition of NF-B activation in lipopolysaccharide-induced BV2 microglial cells. J Ethnopharmacol 137: 1402-1408, 2011. https://doi.org/10.1016/j.jep.2011.08.008
  4. Choi, J.G., Kim, H.G., Kim, M.C., Yang, W.M., Huh, Y., Kim, S.Y., Oh, M.S. Polygalae radix inhibits toxin-induced neuronal death in the Parkinson's disease models. J Ethnopharmacol 134: 414-421, 2011. https://doi.org/10.1016/j.jep.2010.12.030
  5. Liang, Z., Shi, F., Wang, Y., Lu, L., Zhang, Z., Wang, X., Wang, X. Neuroprotective effects of tenuigenin in a SH-SY5Y cell model with 6-OHDA-induced injury. Neurosci Lett 497: 104-109, 2011. https://doi.org/10.1016/j.neulet.2011.04.041
  6. Lee, S.B., Seong, N.S., Lee, Y.J. A study on the protective effects of Polygalae Radix on neurotoxicity induced by N-methyl-D-aspartic acid (NMDA). Kor. J. Herbology 20(2):115-125, 2005
  7. Hu, Y., Liu, M., Liu, P., Guo, D.H., Wei, R.B., Rahman, K. Possible mechanism of the antidepressant effect of 3,6'-disinapoyl sucrose from Polygala tenuifolia Willd. J Pharm Pharmacol 63: 869-874, 2011. https://doi.org/10.1111/j.2042-7158.2011.01281.x
  8. Hu, Y., Liu, P., Guo, D.H., Rahman, K., Wang, D.X., Xie, T.T. Antidepressant effects of the extract YZ-50 from Polygala tenuifolia in chronic mild stress treated rats and its possible mechanisms. Pharm Biol 48: 794-800, 2010. https://doi.org/10.3109/13880200903280034
  9. Ikeya, Y., Takeda, S., Tunakawa, M., Karakida, H., Toda, K., Yamaguchi, T., Aburada, M. Cognitive improving and cerebral protective effects of acylated oligosaccharides in Polygala tenuifolia. Biol Pharm Bull 27: 1081-1085, 2004. https://doi.org/10.1248/bpb.27.1081
  10. Karakida, F., Ikeya, Y., Tsunakawa, M., Yamaguchi, T., Ikarashi, Y., Takeda, S., Aburada, M. Cerebral protective and cognition-improving effects of sinapic acid in rodents. Biol Pharm Bull 30: 514-519, 2007. https://doi.org/10.1248/bpb.30.514
  11. Xu, S.P., Yang, Y.Y., Xue, D., Liu, J.X., Liu, X.M., Fan, T.P., le Pan, R., Li, P. Cognitive-enhancing effects of polygalasaponin hydrolysate in a(25-35)-induced amnesic mice. Evid Based Complement Alternat Med 2011: 839720, 2011.
  12. Kawashima, K., Miyako, D., Ishino, Y., Makino, T., Saito, K., Kano, Y. Anti-stress effects of 3,4,5-trimethoxycinnamic acid, an active constituent of roots of Polygala tenuifolia (Onji). Biol Pharm Bull 27: 1317-1319, 2004. https://doi.org/10.1248/bpb.27.1317
  13. Hu, Y., Liao, H.B., Liu, P., Guo, D.H., Rahman, K. A bioactive compound from Polygala tenuifolia regulates efficiency of chronic stress on hypothalamic-pituitary-adrenal axis. Pharmazie 64: 605-608, 2009.
  14. Yao, Y., Jia, M., Wu, J.G., Zhang, H., Sun, L.N., Chen, W.S., Rahman, K. Anxiolytic and sedative-hypnotic activities of polygalasaponins from Polygala tenuifolia in mice. Pharm Biol 48: 801-807, 2010. https://doi.org/10.3109/13880200903280042
  15. Lee, T.H. The research on the pharmacological concept of sedative effect of Polygalae Radix. Kor. J. Herbology 12(1):1-6, 1997.
  16. Kim, K.H., Jeong, H.W., Lee, D.W., Kim, J.S., Kim, Y.G., Cho, S.I. Effects of Radix Polygalae extract on sociopsychological stress. Kor. J. Herbology 18(1):99-108, 2003.
  17. Park, H.J., Lee, K., Heo, H., Lee, M., Kim, J.W., Whang, W.W., Kwon, Y.K., Kwon, H. Effects of Polygala tenuifolia root extract on proliferation of neural stem cells in the hippocampal CA1 region. Phytother Res 22: 1324-1329, 2008. https://doi.org/10.1002/ptr.2488
  18. Spelman, K., Burns, J., Nichols, D., Winters, N., Ottersberg, S., Tenborg, M. Modulation of cytokine expression by traditional medicines: a review of herbal immunomodulators. Altern Med Rev 11: 128-150, 2006.
  19. Park, J.H., Kim, J.S., Jang, D.S., Lee, S.M. Effect of Polygala tenuifolia root extract on cerebral ischemia and reperfusion. Am J Chin Med 34: 115-123, 2006. https://doi.org/10.1142/S0192415X06003680
  20. Zhu, Y.P. Chinese Materia Medica Chemistry. Pharmacology and Applications. The Netherlands, Harwood Academic Publishers, pp 516-519, 1998.
  21. Park, H.K., Jeon, S.G., Kim, T.B., Kang. H.R., Chang, Y.S., Kim, Y.K., Cho, S.H., Min, K.U., Kim, Y.Y. Occupational asthma and rhinitis induced by a herbal medicine, Wonji (Polygala tenuifolia). J Korean Med Sci 20: 46-49, 2005. https://doi.org/10.3346/jkms.2005.20.1.46
  22. Korea Food and Drug Administration. Testing Guidelines for Safety Evaluation of Drugs (Notification No. 2009-116, issued by the Korea Food and Drug Administration on August 24, 2009). 2009.
  23. Irwin, S. Comprehensive observational assessment: Ia. A systemic, quantitative procedure for assessing the behavioral and physiological state of the mouse. Psychopharmacology 13: 222-257, 1968. https://doi.org/10.1007/BF00401402
  24. Dourish, C.T. Effects of drugs on spontaneous motor activity in Experimental psychopharmacology (Greenshaw, A.J. and Dourish, C.T., Eds.), Clifton, Humana Press.325-334, 1987.
  25. Levene, A. Pathological factors influencing excision of tumours in the head and neck. Part I. Clin Otalary. 6: 145-151, 1981. https://doi.org/10.1111/j.1365-2273.1981.tb01800.x
  26. Ludbrook, J. Update: microcomputer statistics packages. A personal view. Clin Exp Pharmacol Physiol 24: 294-296, 1997. https://doi.org/10.1111/j.1440-1681.1997.tb01823.x
  27. Lee, W.H., Gam, C.O., Ku, S.K., Choi, S.H. Single oral dose toxicity test of platycodin D, a saponin from platycodin radix in mice. Toxicol Res 27: 217-224, 2011. https://doi.org/10.5487/TR.2011.27.4.217
  28. Flecknell, P. Laboratory Animal Anesthesia. 2nd Ed., New York, Harcourt Brace & Company, 269, 1996.
  29. Plata, E.J., Murphy, W.H. Growth and haematologic properties of the BALB/wm strain of inbred mice. Lab Anim Sci 22: 712-720, 1972.
  30. Yamaguchi, C., Fujita, S., Obara, T., Ueda, T. Effects of room temperature on reproduction, body weight and organ weights, food and water intakes, and hematology in mice. Exp Anim 32: 1-11, 1983.
  31. Banks, W.J. Female reproductive system in Applied veterinary histology (Banks WJ, Ed). Baltimore, Williams & Wilkins. pp 506-526, 1986.
  32. Pineda, M.H. Female reproductive system in Veterinary endocrinology and reproduction (McDonald LE, Pineda MH, Eds.). Philadelphia, Lea & Febiger, pp 303-354, 1989.