雲芝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 Trametes versicolor mycelium in a 28-day oral feeding study in SD rats

陳彥博(Yen-Po Chen) ； 盛莉莎(Lee-Sar Sheng) ； 蔡岳廷(Yueh-Ting Tsai) ； 陳勁初(Chin-Chu Chen)

《檢驗及品保雜誌》 4卷4期 (2015/10) Pp. 173-184

https://doi.org/10.6573/JTQA.201510_4(4).04

摘要

雲芝(學名：Trametes versicolor)是一種療效十分顯著的藥用菇菌，在中國已有悠久的食用歷史。其經液體培養後的菌絲以熱水提取的抽出液多醣多肽(polysaccharide krestin, PSK）以抗腫瘤藥物的功效於1977 年在日本核准上市，然而未純化前之雲芝菌絲體則可以保健食品方式開發。本研究目的即是依據行政院衛福部公告之健康食品安全性評估方法，利用Spraque-Dawley 大鼠以28 天亞急毒性試驗評估模式初步探討雲芝菌絲體發酵液凍乾粉的安全性，動物安全性試驗係以雲芝菌絲體1、2 及5 g/kg B.W.3 種劑量分別連續28 天以口服方式投予試驗物質，每日進行試驗動物的臨床觀察，且每週測量試驗動物之體重及攝食量。試驗結束後，犧牲大鼠並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，而眼睛檢查結果亦顯示各組大鼠均無異常。試驗結束時之血液學檢查、血清生化檢查結果顯示各劑量組與對照組間並無明顯差異。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。綜合上述的發現，雲芝菌絲體發酵液凍乾粉對大鼠28 天亞急毒性試驗無毒性顯示劑量(NOAEL)為大於5 g/kgB.W.，且能提供膳食纖維。

關鍵字

雲芝 ； 大鼠28 天亞急性毒性試驗

並列摘要

Trametes versicolor, an ideal culinarymedicinal mushroom, has a long history of medicinal usage in China. In particular, hot water extracted polysaccharopeptide Krestin (PSK) from these mushrooms was approved for use in Japan in 1977 and ranked as the world’ s most commercially successful anti-cancer drug. In addition to clinically tested PSK, there is potential in developing extract preparations of T. versicolor as an ingredient in functional foods. This study was conducted to assess the 28-day repeated oral administration of T. versicolor mycelium according to the safety assessment guideline of Health Food promulgated by Department of Health, Executive Yuan of Taiwan. Three doses of 1,000 (low), 2,000 (intermediate) and 5,000 (high) mg/kg body weight/day were administrated to the rats for 28 consecutive days by oral gavage. The clinical observation and the body weight as well as feed intake of the rats were carried out daily and recorded weekly, respectively. At the end of the stipulated experimental period, all animals were autopsied and observed in parameters such as 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 was founded during the ophthalmological examination. There were no significant differences of the urinalysis, hematology and clinical biochemistry parameters between the treatment and control group. Necropsy and histopathological examination indicated that no treatment-related change was found. Based on the above findings, we may conclude that the NOAEL of the toxicological safety of Trametes versicolor mycelium in a 28-day oral feeding study in SD rats is ＞ 5 g/kg B.W.

並列關鍵字

Trametes versicolor ； 28-day oral feeding study in SD rats