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.

中文翻译：

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固态培养的黑木鼠（乌林申）的标准化水提取物在大鼠中的安全性评估

Xylaria nigripes（Koltz。Cooke），又称五灵沉，是一种高价值的药用蘑菇。它是传统上用于治疗失眠，创伤和抑郁症的草药。但是，其毒性尚未得到系统评价。这项研究旨在评估从固态培养的黑黑线虫（X. nigripes）在大鼠中制备的标准化水提取物（XNE）（商业产品的成分）的安全性。通过口服XNE，按日剂量分别为20、1000和2000 mg / kg体重对男女的Sprague-Dawley大鼠进行90天的亚慢性毒性研究，对照组给予蒸馏水（媒介物）。每天检查所有动物的一般行为，体重变化和毒性迹象。在治疗期结束时，进行血液学分析，进行器官的生化分析和组织病理学检查。在测试浓度下，口服XNE不会对整体健康，体重增加，相对器官重量以及血液和生化指标产生任何治疗引起的不良影响。组织病理学结果也显示，即使在高剂量XNE处理的动物中，器官也没有明显的结构变化。这项研究表明，使用XNE治疗90天不会产生明显的毒性，即使是建议每日摄入量的100倍（2000毫克/千克体重/天）也是如此。因此，使用XNE作为草药被认为是相对安全的。以及血液和生化参数。组织病理学结果也显示，即使在高剂量XNE处理的动物中，器官也没有明显的结构变化。这项研究表明，使用XNE治疗90天不会产生明显的毒性，即使是建议每日摄入量的100倍（2000毫克/千克体重/天）也是如此。因此，使用XNE作为草药被认为是相对安全的。以及血液和生化参数。组织病理学结果也显示，即使在高剂量XNE处理的动物中，器官也没有明显的结构变化。这项研究表明，使用XNE治疗90天不会产生明显的毒性，即使是建议每日摄入量的100倍（2000毫克/千克体重/天）也是如此。因此，使用XNE作为草药被认为是相对安全的。