牛樟椴木栽培之牛樟芝子實體的大鼠90天重複劑量亞慢性毒性評估

A 90-day Subchronic Oral Toxicity Evaluation of the Fruiting Body Extraction from Antrodia cinnamomea

王志源(Chih-Yuan Wang) ； 楊長青(Chang-Ching Yang) ； 王千眉(Chien-Mei Wang) ； 蔡慶龍(Ching-Lung Tsai) ； 蔡岳廷(Yueh-Ting Tsai)

《檢驗及品保雜誌》 5卷3期 (2016/08) Pp. 99-110

https://doi.org/10.6573/JTQA.201608_5(3).04

摘要

本試驗係依據衛生署公告之健康食品安全性評估方法，評估牛樟椴木栽培之牛樟芝子實體萃取物，經連續餵食大鼠90天後對大鼠體內可能產生之毒性變化進行評估，以作為重複使用安全性的參考。本試驗共設置4組試驗組，分別為對照組、低、中及高劑量組。低、中及高劑量組試驗物質投予劑量分別為50mg/kg B.W.、100mg/kg B.W.及150mg/kg B.W.，分別為人體每日建議口服劑量（人體每日30、60及90mg/60Kg B.W.）之100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，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。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檢查、血液學檢查、血清生化檢查結果顯示各劑量組與對照組間均無明顯差異。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。綜合以上實驗結果，「牛樟芝子實體(牛樟椴木栽培)」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-obse rved-adverse-effect level, NOAEL)為大於150mg/kg B.W.，此劑量為人體建議攝取量（每日90mg/60kg B.W.）之100倍。

關鍵字

牛樟芝子實體萃取物 ； 大鼠90天重複劑量亞慢性毒性試驗 ； NOAEL

並列摘要

According to the guidelines of the ＂Health Food Safety Assessment Methods＂ promulgated by the Ministry of Health and Welfare, a 90- day oral toxicity evaluation was conducted in rats to evaluate the safety of fruiting body extraction from Antrodia cinnamomea. The rats used in this study were divided into four groups, including the control, low- (50 mg/kg body weight), medium- (100 mg/kg body weight) and high-dose (150 mg/kg body weight) groups. In each group, which consisted of 10 male and 10 female Sprague-Dawley (SD) rats, the doses were admininstered by gavage for 90 days. The rats were observed daily for any clinical signs, and their body weight and food consumption were also measured daily. At the end of the study, all the rats were sacrificed and subjected to hematology, serum biochemistry, and pathological examinations. The results indicated that no doserelated toxic effects were found in terms of the clinical signs, body weight, eye examination, uninary analyses, hematology examination, o r serum biochemistry examination. An evaluation of the histopathology data also revealed no significant change related to the test article. According to the results of the 90-day oral toxicity evaluation, the no observed adverse effect level (NOAEL) of fruiting body extraction from Antrodia cinnamomea is greater than 150 mg/ kg body weight. This NOAEL dose is equivalent to 100 times the recommended daily intake dose for humans.

並列關鍵字

Rat sub-chronic 90-day oral toxicity ； fruiting body extraction from Antrodia cinnamomea