牛樟菇子實體萃取物於Sprague-Dawley大鼠之90天重複劑量亞慢性毒性試驗

Repeated Dose 90-day Subchronic Toxicological Assessment of Extracts of Antrodia camphorata Fruiting Bodies in Sprague-Dawley rats

古幸宜(Sing-Yi Gu) ； 李彥鵬(Yen-peng Li) ； 蔡慶龍(Ching-lung Tsai) ； 林佳祺(Chia-chi Lin) ； 郭建良(Chien-liang Kuo) ； 翁豐嶽(Feng-yue Weng) ； 劉文煌(Wen-huang Liu) ； 蔡岳廷(Yueh-Ting Tsai)

《檢驗及品保雜誌》 6卷3期 (2017/07) Pp. 147-162

https://doi.org/10.6573/JTQA.201707_6(3).06

摘要

牛樟菇(Antrodia cinnamomea)，為台灣珍貴特有的真菌種，被認為具有抗氧化、抗腫瘤及抗發炎等功效，「牛樟菇子實體萃取物」為此類產品之一，係由恩揚生物科技股份有限公司生產，為了瞭解其食用的安全性，本研究依據衛福部公告之健康食品安全性評估方法，以連續餵食大鼠90天後於大鼠可能產生之反應變化進行評估，作為重複食用之安全性參考。本試驗共設置4組試驗組，分別為對照組、低、中及高劑量組，每組各使用10隻雄性及雌性Sprague-Dawley (SD)品系大鼠，試驗物質以口服管餵方式連續90天投予，劑量分別為50 mg/kg B.W.、100 mg/kg B.W.及200 mg/kg B.W.。試驗結果顯示，所有試驗大鼠於臨床症狀觀察、體重變化、攝食量分析及眼睛檢查，均無顯現異常變化；尿液學檢查、血液學檢查及血清生化檢查，均未顯現出任何與試驗物質有關之臨床毒性反應；病理解剖、肉眼病理學檢查以及組織病理學檢查結果顯示，均無顯現試驗物質相關之病理變化。綜合以上實驗結果，「牛樟菇子實體萃取物」對大鼠90天重複劑量亞慢性毒性試驗之無毒性顯示之劑量(No-Observed-Adverse- Effect Level, NOAEL)為200 mg/kg B.W.，此劑量為人體建議攝取量（每日120 mg/60 kg B.W.）之100倍。

關鍵字

牛樟菇子實體 ； 90天重複劑量亞慢性毒性試驗 ； 無毒性顯示之劑量(NOAEL)

並列摘要

Antrodia cinnamomea is a precious fungus endemic to Taiwan that has been claimed to have significant antioxidant, antitumor activities and immunomodulation. ＂Extracts of Antrodia camphorata fruiting bodies＂ is a newly manufacturing product and supplied by the Balay Biotech Co., Ltd., Taiwan. For the sake of understanding its safety, we conducted this study to assess the 90-day oral toxicity based on the ＂Safety Assessment Guideline of Health Food＂ promulgated by the Department of Health, Executive yuan, Taiwan. There were four testing groups in this study, including the control group and low, medium and high dose groups. There were ten male and ten female Sprague-Dawley (SD) rats in each group. The test article was administered to the low, medium and high dose groups in a dose of 50 mg/kg B.W., 100 mg/kg B.W. and 200 mg/kg B.W. individually by oral gavage for 90 consecutive days. Results showed that no abnormal changes we observed in clinical signs, body weight, food intake and ophthalmological examinations. No clinical changes related to toxicity of the test article were found in urinalysis, hematology and serum biochemistry parameters between the treatment and control groups. Necropsy, gross pathology examination and histopathological examination indicated no test article-related changes. According to the above results, the no-observed-adverse-effect level (NOAEL) of ＂extracts of Antrodia camphorata fruiting bodies＂ for repeated dose 90-day oral toxicity study in rat was 200 mg/kg B.W., which was 120-fold the human recommended daily intake (120 mg/60 kg B.W.).

並列關鍵字

Fruiting bodies of Antrodia camphorate ； repeated dose 90-day subchronic toxicity study ； no-observed-adverse-effect level (NOAEL)