Safety assessment of the standardized aqueous extract from solid-state cultured Xylaria nigripes (Wuling Shen) in rats

Springer Science and Business Media LLC - Tập 7 - Trang 1-10 - 2021
Ming-Nan Lai1, Hui-Chen Hsu2, Lean-Teik Ng3
1Kang Jian Biotech Co., Ltd., Nantou County, Taiwan
2Department of Biotechnology and Animal Science, National Ilan University, Ilan County, Taiwan
3Department of Agricultural Chemistry, National Taiwan University, Taipei, Taiwan

Tóm tắt

Xylaria nigripes (Koltz.) Cooke, also known as Wuling Shen, is a high-value medicinal mushroom. It is a herbal medicine traditionally used for treating insomnia, trauma and depression. However, its toxicity has never been systematically evaluated. This study aimed to evaluate the safety of a standardized aqueous extract (XNE), an ingredient of commercial products, prepared from solid-state cultured X. nigripes in rats. A 90-day subchronic toxicity study was conducted by oral administration of XNE at daily doses of 20, 1000 and 2000 mg/kg body weight to Sprague-Dawley rats of both sexes, and the control group was given distilled water (vehicle). All animals were checked daily for general behavior, body weight changes and signs of toxicity. At the end of the treatment period, hematological analysis, biochemical analysis and histopathological examination of organs were conducted. At tested concentrations, oral XNE administration caused no treatment-induced adverse effects on general health, body weight gain, relative organ weights, and hematological and biochemical parameters. Histopathological results also showed no significant structural changes in organs even in high-dose XNE-treated animals. This study suggests that treatment with XNE for 90 days does not produce significant toxicity, even up to 100 fold (2000 mg/kg body weight/day) of the recommended daily intakes. Therefore, the use of XNE as herbal medicines is considered to be relatively safe.

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