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  • P-ISSN 1010-0695
  • E-ISSN 2288-3339

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

Journal of Korean Medicine / Journal of Korean Medicine, (P)1010-0695; (E)2288-3339
2009, v.30 no.6, pp.27-34
Jang-Woo Shin (Daejeon University)
Jung-Hyo Cho (Daejeon University)
(Daejeon University)
Dong-Seok Seo (Safety Assessment Center)
Nak-Won Sung (Safety Assessment Center)
Min Kwon (Safety Assessment Center)
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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 0th, 7th, and 14th 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
traditional Korean medicine, herbal medicine, acute toxicity tests


Reference

1

Fogden E, Neuberger J. Alternative medicines and the liver. Liver Int. 2003; 23:213-20.

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.

4

Ernst E. Risks of herbal medicinal products. Pharmacoepidemiol. Drug Saf. 2004; 13:767-71.

5

Tang JL, Liu BY, Ma KW. Traditional Chinese medicine. Lancet. 2008; 372:1938-40.

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 dimethylnitrosamineinduced chronic liver injury model in rats. World J Gastroenterol. 2006; 12:6142-8.

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.

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.

14

Duke K. A century of CAM in New Zealand: a struggle for recognition. Complement Ther Clin Pract. 2005; 11:11-6.

15

Gavin JA, Boon H. CAM in Canada: places, practices, research. Complement Ther Clin Pract. 2005; 11:21-7.

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 polysaccharidesenriched fraction from Angelica sinensis on hepatic injury. Life Sci. 2001; 69:637-46.

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.

20

Stickel F, Patsenker E, Schuppan D. Herbal hepatotoxicity. J Hepatol. 2005; 43:901-10.

21

Firenzuoli F, Gori L. Herbal medicine today: clinical and research issues. Evid Based Complement Alternat Med. 2007; 4:37-40.

22

Seeff LB. Herbal hepatotoxicity. Clin Liver Dis. 2007; 11:577-96.

23

Wojcikowski K, Johnson DW, Gobé G. Medicinal herbal extracts-renal friend or foe? Part one: the toxicities of medicinal herbs. Nephrology (Carlton). 2004; 9:313-8.

24

Stickel F, Schuppan D. Herbal medicine in the treatment of liver diseases. Dig Liver Dis. 2007; 39:293-304.

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

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