Toxicological Research

  • 제22권4호
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  • Pages.431-438
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  • 2006
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  • 1976-8257(pISSN)
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  • 2234-2753(eISSN)
한국독성학회 (Korean Society of Toxicology & Korea Environmental Mutagen Society)
권호 표지

Single Oral Dose Toxicity Test of Water Extracts of Puerariae Radix in ICR Mice

  • Seong, Seung-Kyoo (Department of Veterinary Pathology, Seoul National University) ;
  • Kim, Dae-Yong (Department of Veterinary Pathology, Seoul National University) ;
  • Rhee, Jung-Woo (Central Research Laboratories, Dong Wha Pharm. Ind. Co. Ltd.) ;
  • Leem, Moon-Jeong (Central Research Laboratories, Dong Wha Pharm. Ind. Co. Ltd.) ;
  • Rho, Yang-Kook (Central Research Laboratories, Dong Wha Pharm. Ind. Co. Ltd.) ;
  • Lee, Hyun-Yong (Central Research Laboratories, Dong Wha Pharm. Ind. Co. Ltd.) ;
  • Ryu, Jei-Man (Central Research Laboratories, Dong Wha Pharm. Ind. Co. Ltd.) ;
  • Ku, Sae-Kwang (Central Research Laboratories, Dong Wha Pharm. Ind. Co. Ltd.)
  • 발행 : 2006.12.30
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초록

The object of this study was to obtain acute toxicity information (single oral dose toxicity) of lyophilized water extract of Puerariae Radix (PR) in both male and female mice. In order to investigate the 50% lethal dose $(LD_{50})$, approximate lethal dosage (ALD), test substances were once orally administered to female and male ICR mice at dose levels of 2000 and 0 (control) mg/kg (body wt.) according to the recommendation of KFDA Guidelines [2005-60, 2005]. The mortality and body weight changes, clinical signs and gross observation were monitored during 14 days after dosing. Organ weight and histopathology of 12 principal organs were measured. As the results, we could not find any mortality, clinical signs, body weight changes and gross findings except for PR extracts unrelated sporadic findings. In addition, no abnormal changes related PR extracts treatment on the organ weight and histopathology of principal organs were detected except for some sporadic findings including hyperplasia of lymphoid follicles in the popliteal lymph nodes and spleen as pharmacological effects of PR extracts. The results obtained in this study suggest that the PR extracts does not cause any toxicological signs except for pharmacological effects of enhancement of Immune system. The $LD_{50}$ and ALD of PR extracts in both female and male mice were considered as over 2000 mg/kg because no mortalities were detected up to 2000mg/kg that was the highest dose recommended by KFDA and Organization for Economic Co-Operation and Development.

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참고문헌

  1. Arao, T., Udayama, M., Kinjo, J., Nohara, T., Funakoshi, T. and Kojima, S. (1997): Preventive effects of saponins from puerariae radix (the root of Pueraria lobata Ohwi) on in vitro immunological injury of rat primary hepatocytes cultures. Biol. Pharm. Bull., 20, 988-991 https://doi.org/10.1248/bpb.20.988
  2. Banks, W.J. (1986): Female reproductive system. In Applied veterinary histology (W.J. Banks Ed.), Williams & Wilkins: Baltimore, pp. 506-526
  3. Hodge, H.C. and Sterner, J.H. (1949): Tabulation of toxicity classes. Am. Ind. Hyg. Q., 10, 93
  4. Huh, J.E., Yang, H.R., Park, D.S., Choi, D.Y., Baek, Y.H., Cho, E.M., Cho, Y.J., Kang, I.K., Kim, D.Y. and Lee, J.D. (2006): Puerariae radix promotes differentiation and mineralization in human osteoblast-like SaOS-2 cells. J. Ethnopharmacol., 104, 345-350 https://doi.org/10.1016/j.jep.2005.09.041
  5. 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
  6. Kang, K.A., Chae, S., Koh, Y.S., Kim, J.S., Lee, J.H., You, H.J. and Hyun, J.W. (2005): Protective effect of puerariae radix on oxidative stress induced by hydrogen peroxide and streptozotocin. Biol. Pharm. Bull., 28, 1154-1160 https://doi.org/10.1248/bpb.28.1154
  7. Keung, W.M. and Vallee, B.L. (1998a): Daidzin and its antidipsotropic analogs inhibit serotonin and dopamine metabolism in isolated mitochondria. Proc. Natl. Acad. Sci. USA, 95, 2198-2203
  8. Keung, W.M. and Vallee, B.L. (1998b): Kudzu root: an ancient Chinese source of modern antidipsotropic agents. Phytochemistry, 47, 499-506 https://doi.org/10.1016/S0031-9422(97)00723-1
  9. Kim, S. and Fung, D.Y. (2004): Antibacterial effect of watersoluble arrowroot (Puerariae radix) tea extracts on foodborne pathogens in ground beef and mushroom soup. J. Food Prot., 67, 1953-1956 https://doi.org/10.4315/0362-028X-67.9.1953
  10. Kim, T.J. (1996): Korean Resource Plants, Seoul National University Press, Seoul, pp. 232-236
  11. 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
  12. 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)
  13. 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
  14. 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 $Polycan^{\circledR}$, a $\beta$-Glucan originated from Aureobasidium in mice. Lab. Anim. Res., 21, 299-305
  15. Lee, J.S. (2004): Supplementation of Pueraria radix water extract on changes of antioxidant enzymes and lipid profile in ethanol-treated rats. Clin. Chim. Acta, 347, 121-128 https://doi.org/10.1016/j.cccn.2004.04.002
  16. Organization for Economic Co-Operation and Development (Ed.). (1987): OECD guideline (401) for testing of chemicals, acute oral toxicity (deleted 2002)
  17. Organization for Economic Co-Operation and Development (Ed.). (2001): OECD guideline (423) for testing of chemicals- acute oral toxicity-acute toxic class method
  18. Pineda, M.H. (1989): Female reproductive system. In Veterinary endocrinology and reproduction (L.E. McDonald and M.H. Pineda Eds.), Lea & Febiger: Philadelphia, pp. 303-354
  19. Plata, E.J. and Murphy, W.H. (1972): Growth and haematologic properties of the BALB/wm strain of inbred mice. Lab. Anim. Sci., 22, 712-720
  20. US Environmental Protection Agency (1998): Health Effects Test Guidelines OPPTS 870.100, Acute Toxicity Testing Background. US EPA August, Washington, USA
  21. Wang, J.F., Guo, Y.X., Niu, J.Z., Liu, J., Wang, L.Q. and Li, P.H. (2004): Effects of Radix Puerariae flavones on liver lipid metabolism in ovariectomized rats. World J. Gastroenterol., 10, 1967-1970 https://doi.org/10.3748/wjg.v10.i13.1967
  22. Yamaguchi, C., Fujita, S., Obara, T. and Ueda, T. (1983): Effects of room temperature on reproduction, body weight and organ weights, food and water intakes, and hematology in mice. Exp. Anim., 32, 1-11 https://doi.org/10.1538/expanim1978.32.1_1
  23. Yan, B., Wang, D.Y., Xing, D.M., Ding, Y., Wang, R.F., Lei, F. and Du, L.J. (2004): The antidepressant effect of ethanol extract of radix puerariae in mice exposed to cerebral ischemia reperfusion. Pharmacol. Biochem. Behav., 78, 319-325 https://doi.org/10.1016/j.pbb.2004.04.010