蜜環菌菌絲體發酵液凍乾粉於Sprague-Dawley大鼠之28天口服亞急毒性試驗分析

Genotoxicity and Acute Oral Toxicity Test of Armillaria mellea Mycelium

江逸敏(Yih-Min Jiang) ； 吳家駒(Jia-Jiu Wu) ； 洪鳴遠(Ming-yuan Hung) ； 陳宜廷(Yi-ting Chen) ； 廖俊旺(Jiunn-Wang Liao) ； 施養佳(Yang-Chia Shih) ； 陳勁初(Chin-Chu Chen)

《檢驗及品保雜誌》 6卷1期 (2017/03) Pp. 40-50

https://doi.org/10.6573/JTQA.201703_6(1).06

摘要

蜜環菌（學名：Armillaria mellea），屬白蘑科(Tricholomataceae)，分布於全球各地區，為藥食兼用菌。本實驗依據衛福部食藥署健康食品安全性評估方法，檢驗試驗物質以蜜環菌菌絲體發酵液凍乾粉0.4 g/kg bw/day（低劑量）、2.0 g/kg bw/day（中劑量）及4.0 g/kg bw/day（高劑量）三種劑量連續經口服給予Sprague-Dawley大鼠28天後，每日進行試驗動物之臨床觀察，且每周測量試驗動物之體重及攝食量。試驗結束後，犧牲大鼠採集血液及臟器進行血液學分析、血清生化分析及病理學檢查。結果顯示各劑量組實驗動物未顯示任何臨床毒性症狀；在平均體重與體重增長百分率(%)以及試驗大鼠的攝食量方面，各處理組均與對照組間無顯著性差異。血液學檢查、血清生化檢查，雖有少數項目與對照組具顯著差異，但無劑量關係。在尿液相關數值及臟器重量與臟器相對重量百分比(%)測定上，各劑量組與對照組間均無顯著性差異。肉眼及組織病理檢查結果，各劑量組均無明顯與試驗物質有關之病理變化。其他非特異性病變及發生率於對照組與處理組間之雌雄鼠並無劑量與病變相關性。綜合以上實驗結果，大鼠經連續管餵28天蜜環菌菌絲體發酵液凍乾粉之無毒害作用劑量(no observed adverse effect level, NOAEL)大於4.0g/kg bw/day。

關鍵字

蜜環菌 ； 28天口服亞急毒性試驗 ； NOAEL

並列摘要

Armillaria mellea belongs to an edible and medicinal mushroom of the Tricholomataceae family that is found worldwide. Following the safety assessment guideline of Health Food announced by Ministry of Health and Welfare, this study was conducted to assess the 28-day oral toxicity of freeze dried Armillaria mellea mycelium powder at doses of 0.4 (low dose), 2.0 (mid dose) and 4.0 (high dose) g/kg b.w./ day in Spague-Dawley (SD) rats. Clinical observation of rats was carried out daily. The body weight and feed intake of the rats were recorded weekly. At the end of the stipulated experiment period, all animals were euthanized and the blood and organs were collected for hematology, clinical, biochemistry and histopathological examination. Results indicated that all rats in the treatment and control group did not show any abnormal clinical signs during the study period. No significant differences in average body weight and body-weight gain (%) were seen between treated and control groups. There was no significant reduction in feed and water intake of the treated rats in either sex through the study. A few parameters in hematology and clinical biochemistry analysis showed significant differences between the treatment and control group, but these parameters were not dose-dependent and therefore not considered treatment-related. Analysis of urinalysis, organ weight and relative organ weight (%) revealed no significant differences between the control and treated groups. Necropsy and histopathological examination indicated that no treatment-related change was found. According to these results, the no-observed-adverse-effect level (NOAEL) of Armillaria mellea mycelium was greater than 4.0 g/kg b.w./day in SD rats.

並列關鍵字

Armillaria mellea ； 28-day oral toxicity study ； NOAEL