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菇類菌絲複合性飲品之大鼠90天重複劑量亞慢性毒性試驗

A 90-day Oral Gavage Toxicity Study of a Mushroom Mycelia Complex Drink in Rats

摘要


菇類菌絲複合性飲品係以樟芝(Antrodia cinnamomea)菌絲體發酵液為主體,另外添加1% (v/v)舞茸(Grifola frondosa)子實體濃縮萃取液、40倍濃縮巴西蘑菇(Agaricus blazei)菌絲體發酵濾液、100倍桑黃(Phellinus linteus)子實體萃取液及40倍濃縮雲芝(Coriolus versicolor)菌絲體發酵濾液,再經調和糖酸比而成之複合性飲品。本試驗共設置4組試驗組,分別為對照組、低、中及高劑量組。低、中及高劑量組試驗物質投予劑量分別為180 mL/kg B.W.、360 mL/kg B.W.及720 mL/kg B.W.,這些劑量分別為人體每日建議口服劑量(人體每日360 mL/60kg B.W.)之30倍、60倍及120倍。每組各使用10隻雄性及雌性Sprague-Dawley (SD)品系大鼠,以口服管餵方式連續90天投予試驗物質,然後犧牲大鼠採集血液及臟器進行血液、血清生化分析及病理學檢查。試驗結果顯示,試驗期間所有試驗大鼠均無出現異常之臨床症狀,各劑量組大鼠均能正常增重,而眼睛檢查結果顯示各組大鼠均無異常。試驗結束時之尿液學、血液學、血清生化檢查結果均顯示各劑量組與對照組間無顯著差異。病理解剖、肉眼病變檢查以及組織病理學檢查結果顯示,各劑量組與對照組大鼠均無明顯組織病理變化。綜合上述實驗結果,此試驗物質對大鼠90天重複劑量亞慢性毒性試驗之無毒性顯示劑量為大於720 mL/kg B.W.,此劑量為人體建議攝取量(360 mL/60 kg B.W.)的120倍。

並列摘要


Concentrated aqueous extract from Grifola frondosa fruit body (1% v/v), Agaricus blazai mycelia (40x), Phellinus linteus fruit body (50x) and Coriolus versicolor mycelia (40x) was added to the mycelium fermentation broth of Antrodia cinnamomea to produce a mushroom mycelia complex drink after the adjustment of the sweet and sour ratio. In this study, four groups were used. Dose levels of the mushroom mycelia complex drink at 180 mL/kg B.W., 360 mL/kg B.W. and 720 mL/kg B.W. were administered to the low-, medium and high-dose groups, respectively. The dose level of the treated groups were 30 times, 60 times and 120 times as much as the daily recommended intake for human (360 mL/60 kg B.W./day). Each group consisted of ten male and ten female Sprague-Dawley (SD) rats were fed with the drink by oral gavage for 90 days. After the sacrifice, 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. All rats gained weight normally and no abnormality were found during the ophthalmological examination. There were no significant differences in the urinalysis, hematology and clinical biochemistry parameters between the treatment and control group. Necropsy and histopathological examination showed that no treatment-related change was found. According to the results, the no-observed-adverse-effect level of this mushroom mycelia complex drink for the rats was greater than 720 mL/kg B.W., which was 120 times as much as the recommended daily intake for human (360 mL/60 kg B.W./day).

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