Department of Life Science, College of Science, National Taiwan University, Taipei, Taiwan.
Glytheron Inc., 5 Holland, Unit 109, Irvine, CA 92618, USA.
Regul Toxicol Pharmacol. 2018 Feb;92:429-438. doi: 10.1016/j.yrtph.2017.12.022. Epub 2017 Dec 27.
Antrodia cinnamomea is one of the most highly valued mushrooms utilized in traditional Taiwanese therapeutic practices. Its neutral monosaccharides (mannose, glucose and xylose) linked by a β-D-glucan chain have been claimed to be responsible for its health benefits. The objective of the present study was to investigate adverse effects, if any, of β-glucan (∼65% pure) from A. cinnamomea in subchronic toxicity and mutagenicity studies. In the subchronic toxicity study, Sprague Dawley rats (12/sex/group) were followed Organization for Economic Cooperation and Development (OECD) test guideline with Good Laboratory Practice (GLP) application, and were administered (gavage) Antrodia mushroom β-glucan preparation at dose levels of 0, 500, 1000 and 2000 mg/kg body weight (bw)/day for 90 days. Treatment with β-glucan preparation did not result in any toxicologically significant treatment-related changes in clinical observations, ophthalmic examinations, body weights, body weight gains, feed consumption, and organ weights. The clinical pathology as studied by hematology, serum chemistry, urinalysis or terminal necropsy (gross or histopathology findings) did not reveal any treatment-related adverse effects. The results of mutagenicity studies as evaluated by gene mutations in Salmonella typhimurium, in vitro chromosome aberrations and in vivo micronucleus test in mice did not reveal any genotoxicity of β-glucan preparation. Based on the subchronic study, the no observed-adverse-effect level (NOAEL) for β-glucan preparation from Antrodia mushroom was determined as 2000 mg/kg bw/day, the highest dose tested.
樟芝是一种在传统台湾治疗实践中被高度重视的药用蘑菇。其通过β-D-葡聚糖链连接的中性单糖（甘露糖、葡萄糖和木糖）被认为是其具有健康益处的原因。本研究的目的是调查樟芝β-葡聚糖（约 65%纯）在亚慢性毒性和致突变性研究中的任何不良反应。在亚慢性毒性研究中，Sprague Dawley 大鼠（每组 12 只，雌雄各半）按照经济合作与发展组织（OECD）测试指南和良好实验室规范（GLP）应用进行研究，并以 0、500、1000 和 2000mg/kg 体重（bw）/天的剂量（灌胃）给予樟芝β-葡聚糖制剂，共 90 天。β-葡聚糖制剂处理未导致临床观察、眼科检查、体重、体重增加、饲料消耗和器官重量出现任何与毒性相关的、有意义的治疗相关变化。通过血液学、血清化学、尿液分析或终端尸检（大体或组织病理学发现）研究的临床病理学未显示任何与治疗相关的不良反应。通过沙门氏菌突变试验、体外染色体畸变试验和体内微核试验评价的致突变性研究结果未显示β-葡聚糖制剂具有遗传毒性。基于亚慢性研究，确定樟芝β-葡聚糖制剂的无观察到不良效应水平（NOAEL）为 2000mg/kg bw/天，即最高测试剂量。
