香杉芝液态发酵菌丝体粉末及其萃取物之口服急性毒性分析

Acute Oral Toxicity Test of Antrodia salmonea Powder Derived from Submerged Fermented Mycelia

摘要: 香杉芝(Antrodia salmonea)为台湾特有种真菌，经液态发酵培养可大量生产香杉芝菌丝体发酵液粉末，目前投入研究指出具有抗癌、抗发炎和保护肝脏机能等良好功效，极适合开发成为健康食品之素材。本研究为首次针对香杉芝液态发酵菌丝体粉末及其萃取物进行单一剂量口服急性毒性试验，以香杉芝液态发酵菌丝体粉末(AS)和其水萃取物(AS-W)及酒精萃取物(AS-E)，经由口服投予Institute of Cancer Research (ICR)小鼠单一极限剂量，AS-E为3 ml/kg bw外，AS及AS-W皆为9 mg/kg bw，观察2周；以及经由口服投予Sprague-Dawley (SD)大鼠单一极限剂量皆为2000 mg/kg，观察1周，以测试可能产生的毒性变化。结果显示不论在ICR小鼠或是SD大鼠的试验中，在分别投予AS、AS-W及AS-E或对照溶液后，全部动物均存活，并在试验期间皆无发现任何临床症状，而各试验物质处理组在试验期间之体重生长情形均正常及无不良反应，于血清生化分析亦未发现相关异常。试验终结进行解剖肉眼检查及组织病理学检查，所有动物皆未发现任何与试验物质处理相关之病变。综观以上香杉芝液态发酵菌丝体粉末及其萃取物的研究试验结果，在喂食ICR小鼠之口服急性毒性的2周试验期间，其AS-E的LD50为大于3 ml/kg bw，AS及AS-W则皆大于9 g/kg bw；在SD大鼠之口服急性毒性剂量投予至2000 mg/kg，在1周试验期间未发现不良反应，此结果将作为人体使用此产品之安全性参考。

Abstract: Antrodia salmonea (AS) is a type of fungus that is found only in Taiwan. By using liquid fermentation culture, large quantities of AS mycelium fermentation liquid powder can be produced. Current research suggests that it has beneficial effects in fighting cancer, reducing inflammation, and protecting the liver. It is highly suitable for use as an ingredient in healthy food products. This study is the first to conduct a test on the oral toxicity of the liquid fermented mycelium powder and its extract from AS. The alcohol extract (AS-E) was orally administered to Crl:CD1 (ICR) mice at a maximum single dose of 3 ml/kg bw, while mycelium powder (AS) and AS-W were both adminis-tered at a maximum single dose of 9 mg/kg bw. The mice were observed for 2 weeks. In addition, the extract was orally administered to Sprague-Dawley (SD) rats at a maximum single dose of 2000 mg/kg, and these rats were observed for 1 week to check for any potential toxic changes. The re-sults showed that no abnormalities were found in the ICR mice or SD rats during the tests. All ani-mals survived after being given AS, AS-W, AS-E, or the control solution, and no clinical symptoms were observed. The weight gain of each test substance treatment group was normal, with no ad-verse reactions. Furthermore, the serum biochemical analysis did not reveal any relevant abnor-malities. Macroscopic anatomical examination and histopathological examination were conducted after the experiment, and no impairment related to the handling of the test substances was found in any of the animals. Based on the above research and test results on the liquid fermentation myce-lium powder and its extract, a 2-week oral acute toxicity test was conducted on ICR mice, and the LD50 of AS-E was found to be greater than 3 ml/kg body weight. The LD50 of AS and AS-W were both found to be greater than 9 g/kg body weight. The acute oral toxicity dose in SD rats was 2000 mg/kg, and no adverse reactions were observed during the 1-week test. These results can serve as a safety reference for future human consumption.