The Journal of Korean Medicine (대한한의학회지)

The Society of Korean Medicine (대한한의학회)
권호 표지

Safety of a Traditional Korean Medicine, Cheonggan extracts (CGX): A 2-week Single-dose Toxicity Study in SD Rats and Beagle Dogs

  • Shin, Jang-Woo (East-West Immune Center, Institute of Traditional Medicine and Bioscience of Daejeon University) ;
  • Cho, Jung-Hyo (Liver-Immune Center, Daejeon Oriental Hospital of Daejeon University) ;
  • Seo, Dong-Seok (Safety Assessment Center, Korea Testing and Research Institute for Chemical Industry) ;
  • Sung, Nak-Won (Safety Assessment Center, Korea Testing and Research Institute for Chemical Industry) ;
  • Kwon, Min (Safety Assessment Center, Korea Testing and Research Institute for Chemical Industry) ;
  • Son, Chang-Gue (East-West Immune Center, Institute of Traditional Medicine and Bioscience of Daejeon University)
  • Published : 2009.11.30
Download PDF
⟨ Previous Next ⟩

Abstract

Objectives: To evaluate the acute toxic effects and approximate lethal dose of Cheonggan extracts (CGX) in SD rats and beagle dogs. Methods: Male and female rats were divided into 4 groups (Control, CGX 1250, CGX 2500, CGX 5000) respectively and male and female dogs were divided into two groups respectively (Control, CGX 5000) respectively. A single oral dose of CGX was treated to the rats and dogs. Mortality, signs of gross toxicity, and behavioral changes were observed over 14 days. All animals were observed every hour for 4 hours after administration and once a day thereafter for 14 days. Body weights were determined at $0_{th}$, $7_{th}$, and $14_{th}$ days. All surviving animals were sacrificed and necrotized. Major organs were inspected visually for gross findings. Results: No animals died in any of the groups during the experimental period (2 weeks), rats or dogs. Body weights of rats and dogs during the experiment continuously increased in all groups but there was no significant change. No abnormal clinical signs were observed for 2 weeks after a single administration of CGX in any dose group of CGX, rats or dogs. No abnormal findings in major organs were observed in any group of rats or dogs. Conclusion: CGX does not have acute toxic effects in rats or dogs. Therefore, an approximate lethal dose is assumed to exceed 5000 mg/kg in both rats and dogs.

Keywords

References

  1. Fogden E, Neuberger J. Alternative medicines and the liver. Liver Int. 2003; 23:213-20. https://doi.org/10.1034/j.1600-0676.2003.00843.x
  2. Shekelle PG, Morton SC, Suttorp MJ, Buscemi N, Friesen C. Challenges in systematic reviews of complementary and alternative medicine topics. Ann Intern Med. 2005; 21:1042-7.
  3. Wang H, Ye X, Gao Q, Wu C, Qian Y, Luo B, et al. Pharmacovigilance in traditional Chinese medicine safety surveillance. Pharmacoepidemiol. Drug Saf. 2009; 18:357-61. https://doi.org/10.1002/pds.1725
  4. Ernst E. Risks of herbal medicinal products. Pharmacoepidemiol. Drug Saf. 2004; 13:767-71. https://doi.org/10.1002/pds.1014
  5. Tang JL, Liu BY, Ma KW. Traditional Chinese medicine. Lancet. 2008; 372:1938-40. https://doi.org/10.1016/S0140-6736(08)61354-9
  6. Cho JH, Lee YY, Seo SH, Yoo HS, Choi WJ, Lee YW, et al. A clinical report about 57 patients with chronic liver disease. Korean J Oriental Med. 2001; 21:112-21.
  7. Son CG, Choi BL, Shin JW, Choi WJ, Cho JH, Cho CK. Effect of gamichunggantang on alcoholic metabolism and alcoholic liver disease. Korean J Oriental Med. 2001; 2:89-8.
  8. Son CG, Choi WJ, Shin JW, Han SH, Cho JH, Song KC, et al. Effects of gamichunggantang on hyperlipidemia. Acta Pharmacol Sin. 2003; 24:133-9.
  9. Shin JW, Son JY, Oh SM, Han SH, Wang JH, Cho JH, et al. An herbal formula, CGX, exerts hepato-therapeutic effects on dimethylnitrosamine-induced chronic liver injury model in rats. World J Gastroenterol. 2006; 12:6142-8. https://doi.org/10.3748/wjg.v12.i38.6142
  10. Hu XP, Shin JW, Wang, JH, Cho JH, Son JY, Cho CK, et al. Antioxidative and hepatoprotective effect of CGX, an herbal medicine, against toxic acute injury in mice. J Ethnopharmacol. 2008; 120:51-5. https://doi.org/10.1016/j.jep.2008.07.042
  11. KFDA, Guidelines for Toxicity Tests of Drugs and Related Materials. Notification No. 2005-60, 2005.
  12. KFDA, Guidelines for Management for Nonclinical Test, Notification No. 2005-79, 2005.
  13. Seeff LB, Lindsay KL, Bacon BR, Kresina TF, Hoofnagle JH. Complementary and alternative medicine in chronic liver disease. Hepatology. 2001; 34:595-603. https://doi.org/10.1053/jhep.2001.27445
  14. Duke K. A century of CAM in New Zealand: a struggle for recognition. Complement Ther Clin Pract. 2005; 11:11-6. https://doi.org/10.1016/j.ctcp.2004.11.003
  15. Gavin JA, Boon H. CAM in Canada: places, practices, research. Complement Ther Clin Pract. 2005; 11:21-7. https://doi.org/10.1016/j.ctcp.2004.10.004
  16. Sinclair S. Chinese herbs: a clinical review of Astragalus, Ligusticum, and Schizandrae. Altern Med Rev. 1998; 3:338-4.
  17. Ye YN, Liu ES, Li Y, So HL, Cho CC, Sheng HP, et al. Protective effect of polysaccharides-enriched fraction from Angelica sinensis on hepatic injury. Life Sci. 2001; 69:637-46. https://doi.org/10.1016/S0024-3205(01)01153-5
  18. Dhuley JN. Hepatoprotective effect of rhinax on antitubercular drug-induced hepato-toxicity in rats. Hindustan Antibiot Bull. 2002; 44:53-9.
  19. Levy C, Seeff LD, Lindor KD. Use of herbal supplements for chronic liver disease. Clin Gastroenterol Hepatol. 2004;2: 947-56. https://doi.org/10.1016/S1542-3565(04)00455-0
  20. Stickel F, Patsenker E, Schuppan D. Herbal hepatotoxicity. J Hepatol. 2005; 43:901-10. https://doi.org/10.1016/j.jhep.2005.08.002
  21. Firenzuoli F, Gori L. Herbal medicine today: clinical and research issues. Evid Based Complement Alternat Med. 2007; 4:37-40. https://doi.org/10.1093/ecam/nem096
  22. Seeff LB. Herbal hepatotoxicity. Clin Liver Dis. 2007; 11:577-96. https://doi.org/10.1016/j.cld.2007.06.005
  23. Wojcikowski K, Johnson DW, Gobe G. Medicinal herbal extracts-renal friend or foe? Part one: the toxicities of medicinal herbs. Nephrology (Carlton). 2004; 9:313-8. https://doi.org/10.1111/j.1440-1797.2004.00310.x
  24. Stickel F, Schuppan D. Herbal medicine in the treatment of liver diseases. Dig Liver Dis. 2007; 39:293-304. https://doi.org/10.1016/j.dld.2006.11.004
  25. Shayne CG. Animal models in toxicology 2nd edition, CRC Press, Boca Raton, FL, 2007:849-50.
  26. Lehman AJ. Some relations of drug toxicities in experimental animals compared to man. Appraisal of saftey of chemicals in foods, drugs and cosmetics. Association of Food and Drug Officials of the United States. 1959.
  27. Hottendorf GH. Species differences in toxic lesion. Human risk assessment, ed. Roloff, MV. Philadelphia: Taylor & Francis. 1987:87-95