Nat Prod Sci.  2015 Mar;21(1):34-41. 10.0000/nps.2015.21.1.34.

A 14-Day Repeated Dose Toxicity of Epimedii Herba Aqueous Extract Administered by Oral Gavage in F344 Rats

Affiliations
  • 1Korea Institute Toxicology, 141 Gajeong-ro, Yuseong-gu, Daejeon 305-343, Korea.
  • 2Toxicological Research Division, Toxicological Evaluation and Research Department, National Institute of Food and Drug Safety Evaluation, Chungcheongbuk-do 363-951, Korea.
  • 3College of pharmacy, Research Institute of pharmaceutical Sciences, Kyungpook National University, Daegu 702-701, Korea.
  • 4College of Pharmacy, Catholic University of Daegu, Gyeongsangbuk-do 712-702, Korea. bsmin@cu.ac.kr

Abstract

The objective of this study is to characterize a toxicity of Epimedii Herba (EH) in F344 rats and to find a dose levels for the 13 weeks toxicity study. EH is well known as medicinal herb in many Asian countries for traditional medicines of antibacterial and antiviral effects, estrogenic and antiestrogenic effects, and for treatment of osteoporosis, hypotensives, fatigue, kidney disorders, and related complications. However, the indispensable and basic information of toxicological evaluation of EH extract is insufficient to support its safe use. Therefore, we conducted toxicological evaluation of this drug in compliance with OECD and MFDS guideline in this study. The extract of EH was administered orally to F344 rats at dose levels of 0, 500, 1000, 2000, 3500, and 5000 mg/kg/day for 2 weeks. Each group was composed of 5 male and female rats. In this study, there were no treatment of EH-related adverse changes in clinical observations, mortality, body weights, food consumption, urinalysis, gross finding at necropsy, and organ weight examination. Total red blood cell count, hematocrit, mean corpuscular hemoglobin concentration, total cholesterol, and phospholipid were decreased in males and females at 5000 mg/kg/day compared to the control animals. Mean corpuscular volume and reticulocyte counts were increased in males and females at 5000 mg/kg/day compared to control animals. Therefore, we recommend that dose level of 5000 mg/kg/day is a highest treatment group in 13-week EH extract exposure study for further toxicity assessment.

Keyword

Epimedii Herba; Berberidaceae; Toxicity test; F344 rats; Water extract
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