樟芝发酵菌丝体及活性成分Antrosterol纯化物之大鼠急性毒性分析

An Acute Toxicity Study of Antrosterol and Antrosterol-Enriched Antrodia cinnamomea Myceliumin SD Rats

本实验试验物质为葡萄王生技股份有限公司之樟芝纯化物Antrosterol (AST)及樟芝发酵菌丝体冻干品(AC-1)(AST含量3.0 mg/g)、富含活性成分Antrosterol之樟芝发酵菌丝体冻干品(AC-2)(AST含量8.8 mg/g),经单次口服投予大鼠后,评估可能产生之急性毒性反应,系参考卫生福利部食品药物管理署:健康食品安全性评估方法(1999)。试验共设置7组,分别为逆渗透水对照组、橄榄油对照组、试验组I (8 mg/kg bw AST)、试验组II (16 mg/kg bw AST)、试验组III (24 mg/kg bw AST)、试验组IV (2 g/kg bw AC-1)、试验组V (2 g/kg bw AC-2),以上试验组为AST建议剂量依序之17、34、52、17及42倍,每组各使用5只雌性Sprague-Dawley (SD)品系大鼠,以口服管喂方式单次投予试验物质或对照物质,并进行7天临床观察。试验结束后,牺牲大鼠并采集血液、肝脏与肾脏进行血清生化分析及病理学检查。临床症状部分,各组别所有大鼠均无出现异常之症状。动物体重部分,血清生化结果显示,对照组与其对应试验组均无显着差异。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。综合以上实验结果,试验物质AC-1、AC-2及AST在本试验条件下,大鼠均无发现任何与试验物质相关之急性毒性反应,AC-1及AC-2其LD50皆大于2 g/kgbw,AST则大于24 mg/kg bw,此结果将作为人体使用此产品之安全性参考。

This study was conducted to a single limit dose of acutetoxicity assessment in SD rats according to thesafety assessment guideline of Health Food announced by Ministry of Health andWelfare, Executive Yuan of Taiwan. The test substances in thisexperiment are Antrosterol (AST), Antrodiacinnamomea (A. cinnamomea)mycelium (AC-1) (AST content 3.0 mg/g) and Antrosterol-Enriched A. cinnamomea mycelium (AC-2) (ASTcontent 8.8 mg/g) is provided by the Biotechnology Center of Grape King Inc. SDrats were divided into seven groups and were fed with RO water, olive oil, AST8 (Group I), 16 (Group II), 24 (Group III)mg/kg bw, 2 g/kg bw A. cinnamomea powder (AST content 3.0 mg/g) (Group IV) and 2 g/kg bw Antrosterol-Enriched A. cinnamomea powder (AST content 8.8mg/g) (Group V). The above test group is 17, 34, 52, 17 and 42 times therecommended dose of AST. Each group has 5 experiment animals. During the study period, no abnormalityoccurred in clinical signs and body weight. There was no significant differencein biochemistry parameters between the treatment and control group. Necropsyand histopathological examination showed no treatment-related change.The results of this study provide evidences for the use of A. cinnamomea fermentation product as a safe agent in functionalfood: The LD50 of A. cinnamomea powder, its Antrosterol, A. cinnamomea powder and Antrosterol-Enriched A.cinnamomea powder than 24 mg/kg bw, 2 g/kg bw and 2 g/kg bw in SD ratsrespectively.