A 90-day subchronic toxicity study with sodium formononetin-3′-sulphonate (Sul-F) delivered to dogs via intravenous administration
A 90-day subchronic toxicity study with sodium formononetin-3′-sulphonate (Sul-F) delivered to dogs via intravenous administration
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DOI：
10.1016/j.yrtph.2016.02.016
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发表时间：
2016-06-01
影响因子：
3.4
通讯作者：
Wang, Xiaoyan
中科院分区：
文献类型：
--
作者：
Li, Chunmei;Li, Guisheng;Wang, Xiaoyan
刺芒柄花素-3 '-磺酸钠（Sodium formonononetin-3'-sulfonate，Sul-F）是刺芒柄花素的水溶性衍生物，越来越多的研究表明，Sul-F不仅具有良好的水溶性，而且具有良好的降血脂和生物活性。在本研究中，在犬中评价了90天静脉输注后Sul-F的毒性。以0、33.3、100和300 mg/kg剂量的Sul-F处理狗，观察90天，然后是28天的恢复期。每周测量体重、体温和摄食量。在试验前、第45天和第90天以及28天恢复期后进行检眼镜检查、ECG检查、尿分析、血清生化和血液学检查。在第90天和第28天恢复期进行组织学检查。未检测到死亡、眼科异常或体重、临床化学、血液学和组织病理学检查的给药相关结果。然而，在300 mg/kg/天Sul-F给药犬中观察到白色晶体（非代谢性Sul-F）、一过性呕吐和可恢复的血管刺激。在此条件下，Sul-F在犬中的无明显不良作用水平（NOAEL）为100 mg/kg。(C)2016 Elsevier Inc. All rights reserved.
Sodium formononetin-3'-sulphonate (Sul-F) is a water-soluble derivate of formononetin, and an increasing number of studies have shown that Sul-F not only possesses favorable water solubility but also exhibits good lipid-lowering and bioactivities. In the current study, the toxicity of Sul-F was evaluated in dogs after 90-day intravenous infusion. Dogs were treated with Sul-F at dose of 0, 33.3,100, and 300 mg/kg, and observed for 90-day followed by 28-day recovery period. Weekly measurement of body weight, temperature and food consumption were conducted. Ophthalmoscopy, ECG examination, urinalysis, serum biochemistry and hematology examination were performed at pre-test, on days 45 and 90, and following by 28-day recovery period. Histological examination was performed on day 90 and 28-day recovery period. No mortality, ophthalmic abnormalities or treatment-related findings in body weight, clinical chemistry, hematology, and histopathological examination were detected. However, a white crystal (non-metabolic Sul-F), transient vomiting and recoverable vascular stimulation were observed in 300 mg/kg/day Sul-F treated dogs. Under the conditions, the no-observed-adverse-effect-level (NOAEL) for Sul-F was 100 mg/kg in dogs. (C) 2016 Elsevier Inc. All rights reserved.