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台灣道地牛樟椴木牛樟芝子實體油萃取物SN3-OE1之亞慢性毒性安全性評估

Safety assessment of subchronic toxicity of SN3-OE1, oil extraction from fruit body of Antrodia cinnamomea

摘要


牛樟椴木牛樟芝子實體(Antrodia cinnamomea,牛樟椴木),是台灣特有種具有多樣化生物活活性的菇類,萃取技術和溶劑是否會影響其生物活性和毒理。本試驗材料是使用油萃取物(SN3-OE1),混合飼料每日投與ICR小鼠90天後,分析鼠體內可能產生之毒性變化。試驗分組為對照組、低中高劑量試驗組(0、208.3、500.0、1249.5 mg/Kg B.W./day)等四組。方法是依據衛生福利部公告之健康食品安全性評估方法進行試驗。分析每週測量試驗動物之體重及攝食量,試驗期間鼠的生理活動狀況及外觀,與對照組無統計上差異(p>0.05)。試驗結束後,犧牲小鼠採集尿液、血液及臟器進行,血清生化及組織病理上分析顯示,三劑量各試驗組與對照組小鼠均無明顯組織病理變化。綜合上述實驗數據,本試驗材料對小鼠90天餵食毒性試驗之無毒性顯示之劑量1249.5 mg/kg B.W./day。

並列摘要


Fruit body of Antrodia cinnamomea, a medicinal mushroom indigenous to Taiwan, grows only in the inner cavity of Cinnamomum kanehirai Hayata basswood. The biological activity of the components in Antrodia cinnamomea depends on the different solvents and extraction techniques. To evaluate the toxicity of the oil extracts, we treated ICR mice with SN3-OE1, oil extraction from fruit body of Antrodia cinnamomea. Animals were daily treated with SN3-OE1 administered in the diet at dosage levels of 0 (reverse osmosis water), 208.3, 500.0, 1249.5 mg/kg B.W./day) for 90 days, respectively. The evaluation method is according to OECD Guidelines for the Testing of Chemicals No. 408 (Repeated Dose 90-day Oral Toxicity Study in Rodents), suggesting from Ministry of health and welfare. Body weight, food consumption, activity and physical appearance were measured weekly. At the end of the study, urinary test, hematological analysis and biochemical parameters were determined and the major organs, including liver, brain, heart, adrenals, kidneys, and gonads were also evaluated. There was no significant difference (p> 0.05), in pathophysiological effects, observed in the three different groups, compared to the control. Together, 90-days repeated oral dose toxicity tests shows the NOAEL (No-Observed-Adverse- Effect Level) of oral administration of SN3-OE1 at doses up to 1249.5 mg/kg B.W./day in mice.

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