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大黄提取物在 Sprague-Dawley 大鼠中的亚慢性经口毒性研究。

Subchronic oral toxicity study of rhubarb extract in Sprague-Dawley rats.

机构信息

Hubei Provincial Key Laboratory for Applied Toxicology, Hubei Provincial Center for Disease Control and Prevention, Wuhan 430079, China.

Center for Food Evaluation, State Administration for Market Regulation, Beijing 10070, China.

出版信息

Regul Toxicol Pharmacol. 2021 Jul;123:104921. doi: 10.1016/j.yrtph.2021.104921. Epub 2021 Apr 21.

DOI:10.1016/j.yrtph.2021.104921
PMID:33894279
Abstract

OBJECTIVE

The study was primarily used to evaluate subchronic oral toxicity of rhubarb extract.

METHODS

The rhubarb extract was orally administered to rats at doses of 0.00, 0.65, 1.62 and 4.05 g/kg BW/day for 13 weeks with a recovery period of 4 weeks. The weight and the relative organ weight of the kidney in the 0.65 g/kg BW group were significantly increased but no significant changes were seen in renal histopathology. When the rats received rhubarb extract at 1.62 g/kg BW or above, the relative weight of the spleen and kidney were significantly increased; the kidney was also swollen and black with hydronephrosis. Histologic examination showed that there was an obvious increase in pigment deposition in renal tubular epithelial cells. No toxic related changes were observed in the 0.65 g/kg BW group, even though organ weight was increased and relative ratio to body weight of kidney were observed at 0.65 g/kg BW dosage, no significant renal histopathologic changes were detected at this dose. Based on the current study conditions and results, the no observed adverse effect level (NOAEL) of rhubarb extract in rats is 0.65 g/kg BW/day.

摘要

目的

本研究主要用于评价大黄提取物的亚慢性经口毒性。

方法

大黄提取物以 0.00、0.65、1.62 和 4.05 g/kg BW/天的剂量经口给予大鼠,为期 13 周,恢复期为 4 周。在 0.65 g/kg BW 组中,体重和肾脏的相对器官重量显著增加,但肾脏组织病理学未见明显变化。当大鼠接受 1.62 g/kg BW 或更高剂量的大黄提取物时,脾脏和肾脏的相对重量显著增加;肾脏肿胀且发黑,伴有肾盂积水。组织学检查显示,肾小管上皮细胞中的色素沉着明显增加。在 0.65 g/kg BW 组中未观察到与毒性相关的变化,即使在 0.65 g/kg BW 剂量下观察到器官重量增加和肾脏与体重的相对比值,在该剂量下也未检测到明显的肾脏组织病理学变化。基于目前的研究条件和结果,大黄提取物在大鼠中的无观察不良效应水平(NOAEL)为 0.65 g/kg BW/天。

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