(57(3):183-192)Risk Assessment of the Bioproduct of Anoectochilus formosanus Hayata I. Acute Toxicity of the Taiwan Jin-Yuan Wine in Rats

台灣金線連萃取物已知具有保肝、鎮痛、利尿、降血糖及降血壓等作用，唯以其萃取物爲主要成分，或是配伍其他原料製成如「台灣金圓酒」之類的保健飲品，在上市販售前仍應進行對哺乳動物之安全性評估。本研究係依據安全性評估規範進行台灣金圓酒對大鼠（SD品系）之口服急毒性試驗。供試酒樣品先以逆滲透水配製成溶液濃度，依體重最終經口投予大鼠的劑量總計爲5g/kg，投予後連續觀察14天。結果全部鼠隻無中毒症狀或死亡，故其對大鼠之口服急毒性LD50值應大於5g/kg；另外，調查處理組雄、雌鼠第0、7及14天時體重及增重並無影響。檢查白血球及紅血球總數、血紅素、血球容積比、平均紅血球體積、平均血紅素及平均血紅素濃度、血小板及白血球分類等血液值均無與試驗物質有關之影響。血清肝腎酵素值天門冬酸轉氨酶(AST)、氨基丙酸轉氨酶(ALT)、尿素氮(BUN)及肌氨酸(creatinine)等項目亦無與試驗物質有關之影響。檢視體內臟器重量包括腦、心、肝臟、腎臟、脾臟、胸腺、腎上腺、睪丸及卵巢及等重量及百分比與對照組比較皆無明顯差異，切片鏡檢體內重要臟器均無因試驗物質引起之肉眼及組織病理變化。由本試驗結果推論，每日以5g/kg體重的台灣金圓酒劑量，經口持續餵食大鼠14日後，應未產生毒害作用。Ethanol extracts of Anoectochilus formosanus Hayata (AF) have been known to protect liver injury, ease pain, diuretic, decrease hyperglycemia and hypertension. However, the safety of AF extracts along or in combination with other materials, such as Taiwan Jin-Yuan wine, is still needed to elucidate before marketing. The objective of this study was conducted to evaluate the acute oral toxicity of Taiwan Jin-Yuan wine in Sprague Dawely (SD) rats. Rats were single given with Taiwan Jin-Yuan wine at a limited dose of 5g/kg body weight and consecutively observed for 14 days. Results revealed no poison symptom or death in the control and treated rats. The acute oral LD50 of Taiwan Jin-Yuan wine inferred greater than 5 g/kg body weight in rats. No significant changes of body weight at intervals on day 0, 7 and 14 post-treatment. The hematological parameters of white and red blood cell counts, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets and white blood differentiation were normal. Furthermore, serum biochemistry showed no alteration in liver and renal function of aspartate aminotransferase, alanine aminotransferase, blood urea nitrogen and creatinine. The organ weights of brain, heart, liver, kidney, spleen, adrenal, testis and ovary had no significant changes between control and treatment groups. No gross and histopathological changes of rats after treated with Jin-Yuan wine was found in the acute oral toxicity test. This study concludes that there are no harmful effects on rats fed orally with AF-containing Taiwan Jin-Yuan wine at a daily dose of 5 g/kg body weight for 14 days