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J Ethnopharmacol. 2014 Mar 28;152(3):457-63. doi: 10.1016/j.jep.2014.01.011. Epub 2014 Jan 30.

Subchronic toxicity study of Coptidis rhizoma in rats.

Author information

1
Department of Pathology, Biotoxtech Co., Ltd, 686-2 Yangcheong-ri, Ochang-eup, Cheongwon-gun 363-883, Chungbuk, Republic of Korea.
2
Department of Pathology, Biotoxtech Co., Ltd, 686-2 Yangcheong-ri, Ochang-eup, Cheongwon-gun 363-883, Chungbuk, Republic of Korea; Department of Biomedical Laboratory Science, Namseoul University, 21 Maeju-ri, Seonghwan-eup, Cheonan 331-707, Chungnam, Republic of Korea.
3
Division of Toxicopathology, Hoseo Toxicology Research Center, Hoseo University, 79 Hoseo-ro, BaeBang-Myeon, Asan 336-795, Chungnam, Republic of Korea.
4
Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Republic of Korea.
5
Toxicological Research Divison, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Osong Health Technology Administration Complex, 187 Osongsaengmyeong2-ro, Osong, Cheongwon 363-700, Chungbuk, Republic of Korea.
6
Department of Biomedical Laboratory Science, Namseoul University, 21 Maeju-ri, Seonghwan-eup, Cheonan 331-707, Chungnam, Republic of Korea. Electronic address: kang@nsu.ac.kr.
7
Department of Pathology, Biotoxtech Co., Ltd, 686-2 Yangcheong-ri, Ochang-eup, Cheongwon-gun 363-883, Chungbuk, Republic of Korea; Department of Laboratory Animal Medicine, College of Veterinary Medicine, Chungbuk National University, 410 Naesudong-ro, Heungdeok-gu, Cheongju 361-763, Chungbuk, Republic of Korea. Electronic address: jkkang@cbu.ac.kr.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE:

Coptidis Rhizoma (CR) is a medical herb from the family Ranunculacease that has been used to treat gastroenteritis, dysentery, diabetes mellitus, and severe skin diseases.

AIM OF THE STUDY:

To evaluate the no-observed-adverse-effect level (NOAEL) and the toxicity of CR, following repeat oral administration to rats for 13 weeks.

MATERIALS AND METHODS:

CR was administered by oral gavage to groups of rats (n=10/group, each sex) at dose levels of 0 (control), 25, 74, 222, 667 or 2000 mg/kg/day 5 times per week for 13 weeks. Mortality, clinical signs, body weights, food consumption, hematology, serum chemistry, urinalysis, vaginal cytology and sperm morphology, organ weights, gross and histopathological findings were compared between control and CR groups.

RESULTS:

Urinalysis showed a significant increase in N-acety1-β-glucosaminidase in males in the 2000 mg/kg/day group (P<0.01). However, no mortality or remarkable clinical signs were observed during this 13-week study. No adverse effects on body weight, food consumption, hematology, serum chemistry, organ weights, gross lesion, histopathology, vaginal cytology, sperm motility, or deformity were observed in the males or female rats treated with CR.

CONCLUSIONS:

On the basis of these results, the NOAEL of CR is determined to be 667 mg/kg/day for males and 2000 mg/kg/day for females.

KEYWORDS:

Coptidis Rhizoma; Fischer 344 rat; GLP; NOAEL; Subchronic toxicity

PMID:
24486210
DOI:
10.1016/j.jep.2014.01.011
[Indexed for MEDLINE]
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