Browse > Article

Thirteen Weeks Repeated Oral Dose Toxicity Study of Oplopanax elatus (Nakai) Nakai Hydrothermal Extract Powder in Sprague-Dawley Rats  

Yoo, Nam Ho (College of Agriculture and Life Science, Kangwon National University)
Kwon, Yongsoo (College of Pharmacy, Kangwon National University)
Chun, Hyeon Soo (HtO Life Incorporated)
An, Kyu Sup (Korea Conformity Laboratories)
Kim, Hye Jin (Korea Conformity Laboratories)
Ryu, Hyeon Yeol (Korea Conformity Laboratories)
Lee, So Min (Korea Conformity Laboratories)
Song, Kyung Seuk (Korea Conformity Laboratories)
Park, Byung Jun (College of Agriculture and Life Science, Kangwon National University)
Kim, Myong Jo (College of Agriculture and Life Science, Kangwon National University)
Publication Information
Korean Journal of Pharmacognosy / v.50, no.4, 2019 , pp. 260-271 More about this Journal
Abstract
This study aimed to evaluate the safety of Oplopanax elatus (Nakai) Nakai hydrothermal extract powder. It was conducted using male and female Sprague-Dawley (SD) rats. The test group was established with dose of 500 (low-dosage group), 1,000 (medium- dosage group), and 2,000 (high- dosage group) mg/day. These are investigated that number of dead animals, general symptoms, weight changes, food consumption, ophthalmological examination, urinalysis, urine volume, hematological values, plasma coagulation time values, serum biochemical values, absolute organ weight, relative organ weight and histopathological finding during the experiment. As a result of the above, toxicological changes were not observed. Therefore, the non-toxic content of Oplopanax elatus (Nakai) Nakai hydrothermal extract powder is determined to be 2,000 mg/kg/day, and target organ was not observed.
Keywords
Dose; Oplopanax elatus (Nakai) Nakai; Oral; Rat; Toxicity;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
연도 인용수 순위
1 Kim, H. Y. and Sung, Y. K. (2018) Pharmacological treatment of osteoarthritis. J Korean Med Assoc. 61: 623-629.   DOI
2 Wolf, B. W. and Weisbrode, S. E. (2003) Safety evaluation of an extract from Salacia oblonga. Food Chem. Toxicol. 41: 867-874.   DOI
3 Mei, N., Arlt, V. M., Phillips, D. H., Heflich, R. H. and Chen, T. (2006) DNA adduct formation and mutation induction by aristolochic acid in rat kidney and liver. Mutat. Res. 602: 83-91.   DOI
4 이우철 (1996) 원색한국기준식물도감, 251, 아카데미서적, 서울.
5 Shikov, A. N., Pozharitskaya, O. N., Makarov, V. G., Yang, W. Z. and Guo, A. D. (2014) Oplopanax elatus (Nakai) Nakai: chemistry, traditional use and pharmacology, Chin. J. Nat. Med. 12: 721-729.   DOI
6 Kwon, Y. S., Yoo, J. H., Yoo, N. H., Kim, M. J., Kim H. P., Yang, H. J. and Chun. W. J. (2018) Chemical constituents of Oplopanax elatus stem, Kor. J. Pharmacogn. 49: 23-27.
7 식품의약품 안천청 (2017) 비임상시험관리기준, 식품의약품안전처 고시 제 2017-32 호.
8 식품의약품 안천청 (2017) 의약품등의 독성시험기준, 식품의약품안전처 고시 제 2017-71 호.
9 Organization for Economic Cooperation and Development (1998) Repeated Dose 90-day Oral Toxicity Study in Rodents, OECD Guideline for Testing of Chemicals No. 408.
10 Gary, A. Boorman., Scot, L. Eustis., Michael, R. Elwell. and William, F. M. (1990) Pathology of the Fischer rat; Reference and Atlas, 4th edit. Academic Press, UK.
11 Lewis, R.W., Billingtion, R. Debryune, E. Gamer, A. Lang, B. and Carpanini, F. (2002) Recognition of adverse and nonadverse effects in toxicity studies, Toxicol. Pathol. 30: 66-4.   DOI
12 Sahota, P. (2013) Toxicologic pathology: nonclinical safety assessment, CRC press, USA.
13 Kuzutani, K. (2012) Spontaneous mammary adenocarcinoma in a twelve-week-old female Sprague-Dawley rat, J. Toxicol Pathol. 25: 221-224.   DOI
14 추상규 (2001) 요 검사학, 1st ed. 고려의학, 서울.
15 Greaves, P. (2007) Histopathology of preclinical toxicity studies; Interpretation and relevance in drug safety evaluation, 3rd edit., Elsevier science, USA.
16 Prejean, J. D. (1973) Spontaneous tumors in Sprague-Dawley rats and Swiss mice, Cancer Research 33: 2768-2773.