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舞茸菌絲體發酵液凍乾粉於Spraque-Dawley大鼠之28天口服重複劑量亞急毒性試驗分析

Evaluation of the Toxicological Safety of Grifola frondosa Myceliumin a 28-day Oral Feeding Study in SD Rats

摘要


舞茸(學名Grifola frondosa)為一種多孔菌,生長在北半球溫帶森林中,普遍用作為傳統醫藥和營養補充品,在台灣市場上亦可見其蹤跡。本試驗之目的即是依據衛福部公告之健康食品安全評估方式,檢驗試驗物質舞茸菌絲體發酵液凍乾粉連續經口服給予Spraque-Dawley大鼠28天後,是否引起不良反應及毒性症狀。以舞茸菌絲體1,000、2,000、3,000 mg/kg B.W.三種劑量連續28天以口服方式投予試驗物質,每日進行試驗動物之臨床觀察,且每週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,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檢查、血液學檢查、血清生化檢查雖有少數項目與對照組間具顯著差異,但均未超過正常生理值範圍。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。綜合上述試驗結果,試驗組皆與陰性對照組無顯著差異,指出舞茸菌絲體發酵液凍乾粉之NOAEL (no-observedadverse-effect level)為3,000 mg/kg/day。

並列摘要


Grifola frondosa, belonging to the family Polyporaceae, is usually distributed in temperate rainforests of northern hemisphere. They are also seen in Taiwan. Grifola frondosa is one of the traditional Chinese medicines and dietary supplements. The present study was conducted to investigate the 28-day oral toxicity of freeze dried Grifola frondosa mycelium powder in Spague-Dawley (SD) rats according to the safety assessment guideline of Health Food announced by Ministry of Health and Welfare (Taiwan). Rats were orally administrated with reverse osmosis water (control) or 1,000, 2,000 and 3,000 mg/kg BW/day Grifola frondosa mycelium for 28 consecutive days. Clinical observation of the rats was carried out daily. The body weight and feed intake of the rats were recorded weekly. At the end of the study, all rats were sacrificed and the blood and organs were collected for urinalysis, hematology, clinical chemistry and histopathological examination. During the study period, no abnormality occurred in clinical signs, body weight and ophthalmological examination. A few parameters in urinalysis, hematology and clinical biochemistry analysis showed significant differences between the treatment and control group, but these parameters were all within the normal range. Necropsy and histopathological examination indicated that no treatment-related change was found. According to the results, the no-observed-adverse-effect level (NOAEL) of Grifola frondosa mycelium was greater than 3,000 mg/kg BW/day in SD rats.

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