元宝枫叶提取物的安全性毒理学研究

About safety assessment of acer truncatum bunge leaves extract in vitro and in vivo

目的评价元宝枫叶提取物的食用安全性。方法采用小鼠急性经口毒性试验、遗传毒性试验（小鼠骨髓细胞微核试验、小鼠精子畸变试验和Ames试验）及亚慢性毒性试验（90 d喂养试验）。结果元宝枫叶提取物对雌、雄性ICR小鼠经口最大耐受量均大于10 g/kg（本文剂量按每千克体质量所摄入受试物的克数计算）,属实际无毒级;Ames试验、小鼠骨髓PCE微核试验和小鼠精子畸变试验结果均为阴性;在本实验剂量范围内摄入（1～2 g/kg）,对实验大鼠的生长发育、食物利用率,血液系统、肝、肾功能、生殖系统,以及蛋白、脂肪、糖的代谢无明显影响。元宝枫叶提取物6 g/kg时对雄性实验大鼠体质量及进食量有影响（P〈0.05）,6 g/kg剂量组在实验中期45 d的血液生物化学指标显示空腹血糖低于阴性对照组（P〈0.05）。结论元宝枫叶提取物在本实验条件下,未显示有急性毒性和遗传毒性;在1～2 g/kg剂量范围内未显示有亚慢性毒性。

Objective To determine the safety of acer truncatum bunge leaves extract（ AT）. Methods Acute oral toxicity testing of AT was performed in mice. Genotoxicity of AT was assessed by bone marrow micronucleus,mice sperm abnormality and bacterial reverse mutation tests. The subchronic toxicity study of AT was used via ninety days feeding test. Results The oral maximum tolerated dose of AT was more than 10 g /kg,which belonged to an actual non-toxicity substance. The results of genotoxicity profiles were all negative.There was no significant difference in toxicity between control and AT treated animals with respect to general condition,body weight,food efficiency,food consumption and clinical chemistry parameters throughout the treatment at dose 1-2g /kg. But compared with the control group,body weight and food consumption were significantly lower in 6g /kg group male rats. And compared with the control group,hypoglycemic effect was indicated in 6g /kg group male rats after 45 days treatment. Conclusion The AT is safe and shows no evidence of observed adverse effect up to the 2g /kg dose.