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永达三加汤水提取物的非临床安全性评价:在斯普拉格-道利大鼠中进行的为期13周的亚慢性口服毒性研究。

Non-clinical safety evaluation of Yongdamsagan-tang water extract: A 13-week subchronic oral toxicity study in Sprague Dawley rats.

作者信息

Jeon Woo-Young, Seo Chang-Seob, Ha Hyekyung, Shin Hyeun-Kyoo, Cho Jae-Woo, Lee Mee-Young

机构信息

KM Convergence Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.

KM Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.

出版信息

J Appl Toxicol. 2025 Feb;45(2):322-338. doi: 10.1002/jat.4703. Epub 2024 Oct 4.

Abstract

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.

摘要

尽管传统草药仍在临床中持续应用,但关于勇丹三加汤水提取物(YSTW)的毒理学安全性等科学证据尚未确立。本研究的目的是调查YSTW以不同浓度对Sprague Dawley大鼠进行13周重复口服给药后的潜在毒性情况。YSTW以0、1000、2000和5000mg/kg体重/天的剂量,每日一次口服给予大鼠,持续13周。在实验期间,未观察到与YSTW治疗相关的显著毒理学变化。这些结果表明,在大鼠中给予YSTW 13周,在高达5000mg/kg体重/天的剂量下未出现毒性迹象,该剂量被认为是未观察到不良反应水平。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd71/11738534/382ac5431d5d/JAT-45-322-g004.jpg

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