以大鼠28天餵食毒性試驗評估「芝麻精華膠囊」之安全性

Safety Evaluation of Supamin® by A 28-day Feeding Toxicity in Rats

陳文南(Wen-Nan Chen) ； 李敏雄(Min-Hsiung Lee) ； 藍文傑(Mun-Kit Nam) ； 黃振鋒(Chen-Feng Huang) ； 蔡岳廷(Yueh-Ting Tsai)

《檢驗及品保雜誌》 1卷3期 (2012/08) Pp. 111-119

https://doi.org/10.6573/JTQA.201208_1(3).02

摘要

依據衛生署公告之健康食品安全性評估方法，利用大鼠28天餵食毒性試驗評估富味鄉食品股份有限公司所提供之試驗物質「芝麻菁華膠囊」之安全性。試驗設計共設置4組試驗組，分別為對照組、低、中及高劑量組。低、中及高劑量組投予大鼠試驗物質的量分別為450 mg/kg、900 mg/kg及1,800 mg/kg（body weight, B.W.），分別為人體每日建議口服劑量（人體每日420 mg/ 60 kg B.W.）之64倍、128倍及256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28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、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，且各劑量組大鼠均能正常增重；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、血液學及血清生化學檢查之結果顯示各劑量組和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之結果顯示各劑量組和對照組大鼠均無顯現任何與試驗物質有關之病變。綜合以上的發現，富味鄉食品股份有限公司所提供之「芝麻菁華膠囊」對大鼠28天重複劑量亞急性毒性試驗之無毒性顯示劑量（No-Observed-Adverse-Effect Level, NOAEL）為大於1,800 mg/kg/day，此劑量為人類建議攝取量（每日420 mg/ 60 kg）之256倍。

關鍵字

芝麻菁華膠囊 ； 28天餵食毒性試驗

並列摘要

According to the guidelines of ＂Health Food Safety Assessment Methods＂ announced by the Department of Health, Executive Yuan, ROC, a rat 28-day feeding toxicity test was conducted to evaluate the security of test article ＂Supamin®＂ provided by FLAVOR FULL FOODS INC. There were four groups including control group, low dose, medium dose and high dose group in the experimental design. The rats of test groups were administrated at different doses of 450, 900 and 1,800 mg/kg body weight (B. W.), were 64 times, 128 times and 256 times the dose of the human daily intake, respectively. In each group, 10 male and 10 female Sprague- Dawley (SD) rats were administrated by gavage for 28 days. Rats were observed daily for clinical sign, body weight and food consumption measured weekly. At termination of test, all rats were sacrificed and subjected to hematology, serum biochemistry and pathological examination. The test result showed that no dose-related toxic effect was found in clinical sign, body weight, eye examination, urinary analyses, hematology, serum biochemistry. Evaluation of gross and histopathology data revealed no significant change related to the test article. According to the results, the no observed adverse effect level (NOAEL) of Supamin® in the 28-day feeding toxicity was greater than 1,800 mg/kg. This dose of NOAEL was 256 times the dose of the human daily intake (420 mg/ 60 kg B.W./day).

並列關鍵字

Supamin® ； 28-day feeding toxicity ； NOAEL