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综合性基因毒性和28天口服毒性评估揭示了标准化Anisomeles indica含有粉末的安全性

Yng-Tay Chen^1,2,3, Yu-Ru Chen¹, Fuu-Jen Tsai^4,5

¹Graduate Institute of Food Safety, College of Agriculture and Natural Resources, National Chung Hsing University, Taichung City, Taiwan, nchu.edu.tw.

BioMed research international

|March 14, 2026

概括

评估了Anisomeles indica健康粉 (AIHP) 的安全性. 研究在老鼠中没有发现基因毒性或不良影响,确定高无观察不良影响水平 (NOAEL) 为8000 mg/kg/day.

科学领域:

药理学和毒理学药理学和毒理学
自然产品安全自然产品安全
监管科学监管科学

背景情况:

安尼索梅利斯印尼卡在传统医学和功能性食品中使用.
缺乏对Anisomeles indica健康粉 (AIHP) 的系统毒理学评估.
确保植物成分的安全性对于公共健康至关重要.

研究的目的:

通过使用国际公认的指南来评估AIHP的基因毒性.
在动物模型中确定AIHP的亚急性口服毒性.
为AIHP建立一个没有观察到的不良影响水平 (NOAEL).

主要方法:

基因毒性测试包括细菌逆变异 (OECD 471),体外染色体异常 (OECD 473) 和体内微核测试 (OECD 474).
一项为期28天的重复剂量口服毒性研究 (OECD 407) 在Sprague-Dawley大鼠身上进行,剂量高达8000 mg/kg/day.
综合评估包括血液学,血清生物化学,器官重量,尿液分析和组织病理学.

主要成果:

AIHP 没有表现出任何基因毒性潜力,在所有变异性和结晶性测定中显示出负结果.
在老鼠中没有观察到与治疗相关的不良反应,包括死亡率,临床症状或生理参数的变化.
没有观察到副作用的水平 (NOAEL) 确定为8000 mg/kg/天,这是测试的最高剂量.

结论:

在基因毒性和亚急性口服毒性方面,AIHP被认为是安全的.
建立的NOAEL支持AIHP在健康食品中使用的安全性.
这项研究为AIHP的监管接受提供了必要的毒理学数据.

关键词:

它们是Anisomeles indica的植物.诺亚尔·诺亚尔 (NOAEL) 是一个遗传毒性遗传毒性遗传毒性重复剂量28天的口服毒性

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