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冻干粉末的安全性评估:对Sprague-Dawley大鼠的慢性毒性(26周)评估

Safety assessment of freeze-dried powdered : evaluation of chronic toxicity (26-week) in Sprague-Dawley rats.

作者信息

Pei Yanyu, Wei Ruoyao, Sun Jingjiang, Gao Hong

机构信息

Institute of Laboratory Animal Sciences, Chinese Academy of Medical Sciences (CAMS) & Comparative Medicine Center, Peking Union Medical College (PUMC), Beijing 100021, PR China.

出版信息

Toxicol Rep. 2017 Feb 24;4:143-150. doi: 10.1016/j.toxrep.2017.02.003. eCollection 2017.

DOI:10.1016/j.toxrep.2017.02.003
PMID:28959634
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5615089/
Abstract

There is a lack of safety assessment data regarding the long-term consumption of (Leguminosae, the seeds of L. and L.). Thus, we evaluated the toxicity of freeze-dried powdered in male and female Sprague-Dawley rats. Rats were intragastrically administered freeze-dried powdered at a dose of 0.5, 2.2, or 10.0 g/kg body weight/day for 26 weeks; several variables were assessed after 13 and 26 weeks as well as after a 4-week recovery period. No mortality was observed in the treated animals, and body weight increased in a dose-dependent manner. The total bilirubin (TBIL) levels also displayed a dose-dependent relationship. In males, at 26 weeks, there were significant increases in relative kidney weights in the 2.2 and 10.0 g/kg groups compared with that in the negative control group (p < 0.05 or p < 0.01). Pigment deposition in the epithelial cells of the renal proximal convoluted tubules and atrophy or regeneration of renal tubules were observed in the 10.0 g/kg group after 26 weeks, and these changes were not fully reversed after the 4-week recovery period. Under the studied conditions, the primary toxicity organs for freeze-dried powdered in the 10.0 g/kg group were the kidneys.

摘要

关于长期食用(豆科植物,L.和L.的种子)缺乏安全性评估数据。因此,我们评估了冻干的粉末在雄性和雌性Sprague-Dawley大鼠中的毒性。大鼠以0.5、2.2或10.0克/千克体重/天的剂量灌胃给予冻干的粉末,持续26周;在13周和26周后以及4周恢复期后评估了几个变量。在接受治疗的动物中未观察到死亡,体重呈剂量依赖性增加。总胆红素(TBIL)水平也呈现剂量依赖性关系。在雄性大鼠中,在26周时,2.2克/千克和10.0克/千克组的相对肾重量与阴性对照组相比显著增加(p < 0.05或p < 0.01)。在26周后,10.0克/千克组观察到肾近端曲管上皮细胞色素沉着以及肾小管萎缩或再生,并且在4周恢复期后这些变化未完全逆转。在所研究的条件下,10.0克/千克组中冻干粉末的主要毒性器官是肾脏。

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