龙胆泻肝汤水提取物的非临床安全性评价:在 Sprague Dawley 大鼠中进行的为期 13 周的亚慢性口服毒性研究。

IF 2.7 4区 医学 Q3 TOXICOLOGY Journal of Applied Toxicology Pub Date : 2024-10-04 DOI:10.1002/jat.4703
Woo-Young Jeon, Chang-Seob Seo, Hyekyung Ha, Hyeun-Kyoo Shin, Jae-Woo Cho, Mee-Young Lee
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引用次数: 0

摘要

尽管传统草药在临床上的应用仍在继续,但龙胆泻肝汤水提取物(YSTW)的毒理学安全性等科学证据尚未确立。本研究的目的是对 Sprague Dawley 大鼠重复口服不同浓度的龙胆泻肝汤水提取物 13 周后的潜在毒性进行调查。大鼠每天口服一次 YSTW,剂量分别为 0、1000、2000 和 5000 毫克/千克体重/天,持续 13 周。在实验期间,大鼠的毒理学变化与 YSTW 处理无关。这些结果表明,对大鼠连续 13 周施用 YSTW 后,在最高剂量为 5,000 毫克/千克体重/天(这一剂量被认为是无观测不良效应水平)时,没有出现任何毒性迹象。
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Non-clinical safety evaluation of Yongdamsagan-tang water extract: A 13-week subchronic oral toxicity study in Sprague Dawley rats.

Despite the continued clinical application of traditional herbal medicines, scientific evidence such as toxicological safety profile of Yongdamsagan-tang water extract (YSTW) has not yet been established. The purpose of this study was to investigate the potential toxicity profile of YSTW following a 13-week repeated oral administration at various concentrations to Sprague Dawley rats. YSTW was administered orally to rats once daily at doses of 0, 1000, 2000, and 5000 mg/kg bw/day for 13 weeks. During the experimental period, there were no significant toxicological changes related to YSTW treatment. These results indicate that the administration of YSTW for 13 weeks in the rat resulted in no signs of toxicity at up to 5000 mg/kg bw/day, which was considered the no-observed-adverse-effect level.

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来源期刊
CiteScore
7.00
自引率
6.10%
发文量
145
审稿时长
1 months
期刊介绍: Journal of Applied Toxicology publishes peer-reviewed original reviews and hypothesis-driven research articles on mechanistic, fundamental and applied research relating to the toxicity of drugs and chemicals at the molecular, cellular, tissue, target organ and whole body level in vivo (by all relevant routes of exposure) and in vitro / ex vivo. All aspects of toxicology are covered (including but not limited to nanotoxicology, genomics and proteomics, teratogenesis, carcinogenesis, mutagenesis, reproductive and endocrine toxicology, toxicopathology, target organ toxicity, systems toxicity (eg immunotoxicity), neurobehavioral toxicology, mechanistic studies, biochemical and molecular toxicology, novel biomarkers, pharmacokinetics/PBPK, risk assessment and environmental health studies) and emphasis is given to papers of clear application to human health, and/or advance mechanistic understanding and/or provide significant contributions and impact to their field.
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