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目的:研究发酵金耳提取物的急性毒性和遗传毒性。方法:以最大给药体积的发酵金耳提取物(0.4g.mL-1)给予小鼠,1d内灌胃3次后连续观察14d,记录中毒和死亡情况,测定最大耐受量。采用0.1,0.5,1.0,2.5,5.0mg/皿5个剂量组进行鼠伤寒沙门菌回复突变试验(Ames试验);采用2.5,5.0,10.0g.kg-13个剂量组进行小鼠精子畸变试验;采用2.5,5.0,10.0g.kg-13个剂量组进行小鼠骨髓细胞微核试验;采用3.5,7.0,13.5g.kg-13个剂量组进行30d喂养试验。结果:小鼠灌胃发酵金耳提取物的最大耐受量为24.0g.kg-1,为成人推荐每日用量的240倍。发酵金耳提取物的Ames试验阴性、未发现对小鼠精子产生畸变作用、无致小鼠骨髓嗜多染红细胞微核增生作用。30d喂养发酵金耳提取物3个剂量组血液学检查、肝肾功能测定、主要脏器系数等各项指标与对照组比较差异均无显著性,主要脏器病理检查未见异常。结论:发酵金耳提取物属实际无毒物质,在本试验条件下,未发现其有遗传毒性。
OBJECTIVE: To study the acute toxicity and genotoxicity of the extract of Gynostemma pentaphyllum. Methods: Mice were treated with the extract of P. maxium (0.4g.mL-1) with the maximal administration volume. The mice were infused into stomach for three days and then observed continuously for 14 days. The maximum tolerated dose was recorded. Salmonella typhimurium reversion mutation test (Ames test) was carried out with 5 doses of 0.1,0.5,1.0,2.5,5.0mg / dish. The mice sperm aberration test was carried out with 2.5, 5.0 and 10.0g.kg-13 dose groups The micronucleus test of mouse bone marrow cells was carried out with 2.5, 5.0 and 10.0g.kg-13 dose groups, and the 30d feeding experiments with 3.5, 7.0 and 13.5g.kg-13 dose groups. Results: The maximum tolerated dose of Gynostemma extract in mice was 24.0g.kg-1, which is 240 times of the recommended daily dosage for adults. Ames test ferment extract of gold ears negative, did not find the role of mouse sperm distortion, no micronuclei hyperplasia of mouse bone marrow polychromatic erythrocytes. There was no significant difference in the indexes of hematological examination, liver and kidney function test, major organ coefficient and other indexes between the three doses of 30 days feeding fermented Gynulaceae extract and the control group. There was no abnormality in the pathological examination of major organs. Conclusion: The fermented extract of Gynura auantis is an actual non-toxic substance. Under the conditions of this experiment, no genotoxicity was found.