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肉苁蓉保健品 Memoregain 的安全性评估:遗传毒性和 28 天重复剂量毒性试验。

Safety assessment of the Cistanche tubulosa health food product Memoregain: Genotoxicity and 28-day repeated dose toxicity test.

机构信息

Institute of Food Safety and Health Risk Assessment, School of Pharmaceutical Sciences, National Yang-Ming University, Taipei, Taiwan, ROC; School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan, ROC.

Department of Physiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan, ROC; Graduate Institute of Medical Sciences, College of Medicine, Taipei Medical University, Taipei, Taiwan, ROC.

出版信息

Food Chem Toxicol. 2018 Aug;118:581-588. doi: 10.1016/j.fct.2018.06.012. Epub 2018 Jun 7.

DOI:10.1016/j.fct.2018.06.012
PMID:29886232
Abstract

The pharmacological effects of Cistanches Herba, known as "Ginseng of the desert", have been extensively studied. In this study, we aimed to assess the genotoxic and oral toxic effects of the Cistanche tubulosa health food product Memoregain using in vitro and in vivo tests. Ames tests using five strains of Salmonella typhimurium showed no signs of increased reverse mutation upon exposure to Memoregain up to a concentration of 5 mg/plate. Exposure of Chinese hamster ovary (CHO-K1) cells to Memoregain did not increase the frequency of chromosomal aberrations in vitro. Moreover, Memoregain treatment did not affect the proportions of immature to total erythrocytes or the number of micronuclei in the immature erythrocytes of ICR mice. Additionally, after 28-day repeated oral dose toxicity tests (0, 0.15, 0.3, and 0.5g/kg body weight) in rats, no observable adverse effects were found. These toxicological assessments supported the safety of Memoregain for human consumption.

摘要

素有“沙漠人参”之称的肉苁蓉的药理学作用已得到广泛研究。在这项研究中,我们旨在通过体外和体内试验评估 Memoregain 这种管花肉苁蓉保健食品的遗传毒性和口服毒性作用。使用五种鼠伤寒沙门氏菌菌株进行的 Ames 试验表明,Memoregain 在高达 5mg/平板的浓度下,没有出现逆转突变增加的迹象。管花肉苁蓉在体外暴露于中国仓鼠卵巢(CHO-K1)细胞中,并未增加染色体畸变的频率。此外,Memoregain 处理并未影响 ICR 小鼠未成熟红细胞与总红细胞的比例,或未成熟红细胞中的微核数量。另外,在大鼠中进行 28 天重复口服剂量毒性试验(0、0.15、0.3 和 0.5g/kg 体重)后,未发现可观察到的不良影响。这些毒理学评估支持 Memoregain 可安全供人类食用。

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