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首页> 外文期刊>Natural product sciences >A 14-Day Repeated Dose Toxicity of Epimedii Herba Aqueous Extract Administered by Oral Gavage in F344 Rats
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A 14-Day Repeated Dose Toxicity of Epimedii Herba Aqueous Extract Administered by Oral Gavage in F344 Rats

机译：F344大鼠经口灌胃给予淫羊Epi提取液的14天重复剂量毒性

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摘要

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.
机译：这项研究的目的是表征淫羊Epi（EH）对F344大鼠的毒性，并确定13周毒性研究的剂量水平。 EH在许多亚洲国家被公认为是具有抗细菌和抗病毒作用，雌激素和抗雌激素作用的传统药物以及用于治疗骨质疏松症，降压药，疲劳，肾脏疾病和相关并发症的草药。但是，EH提取物的毒理学评估必不​​可少的基本信息不足以支持其安全使用。因此，我们在本研究中按照OECD和MFDS指南对该药物进行了毒理学评估。将EH提取物以0、500、1000、2000、3500和5000 mg / kg / day的剂量水平口服给予F344大鼠2周。每组由5只雄性和雌性大鼠组成。在这项研究中，在临床观察，死亡率，体重，食物消耗，尿液分析，尸检和器官重量检查中没有发现与EH相关的不良变化。与对照动物相比，雄性和雌性的总红细胞计数，血细胞比容，平均红细胞血红蛋白浓度，总胆固醇和磷脂均以5000 mg / kg / day的比例下降。与对照动物相比，雄性和雌性的平均红细胞体积和网织红细胞计数以5000 mg / kg / day的比例增加。因此，我们建议在为期13周的EH提取物接触研究中，将5000 mg / kg /天的剂量水平作为最高治疗组，以进行进一步的毒性评估。

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