金线莲植物叶提取物毒理学安全性评价的实验研究

目的 对金线莲植物叶提取物的安全性进行研究。 方法 根据《食品安全性毒理学评价程序和方法(GB 15193-2003)》进行小鼠急性经口毒性试验、Ames试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验、大鼠致畸试验、大鼠90 d喂养试验。 结果 小鼠急性经口毒性试验最大耐受剂量(maximum tolerated dose,MTD)大于35.00 g/(kg·bw),属无毒级;8～5 000 μg/皿剂量Ames试验结果为阴性、2.50～10.00 g/(kg·bw)剂量小鼠骨髓嗜多染红细胞微核试验及小鼠精子畸形试验结果均为阴性,2.92～8.75 g/(kg·bw)剂量对大鼠不具母体毒性、胚胎毒性和致畸作用;5.83～17.50 g/(kg·bw)剂量大鼠 90 d喂养试验对大鼠的体重增长、进食量、食物利用率、血常规指标、血生化指标、脏器重量、脏器/体重比值均无异常变化,大体解剖和组织病理检查均未见与金线莲植物叶提取物有关的异常改变。 结论 在本实验条件下,金线莲植物叶提取物未见明显毒副作用。

Experimental study on toxicological safety evaluation of extractive from Anoectochilus roxburghii leaves

Objective To study the toxicological safety of extractive from Anoectochilus roxburghii leaves. Methods According to the Food Safety Toxicology Evaluation Procedures and Methods, we conducted the tests like acute oral toxicity test in mice, genetic toxicity test in mice (Ames test, bone marrow cell micronucleus test and sperm abnormality test), teratogenic test and 90-day feeding test in rats. Results The maximum tolerated dose of mice treated with Anoectochilus roxburghii leaves was more than 35.00 g/(kg·bw), which belonged to an actual non-toxicity substance. The result of Ames test was negative under 8-5,000 μg/plate dosage. No positive results were found in micronuclear test and sperm abnormality test under 2.50-10.0 g/(kg·bw)dosage of extractive fromAnoectochilus roxburghii leaves. There was no toxicity in pregnant rats and embryo, and no teratogenicity was found in rat embryo treated with 2.92-8.75 g/(kg·bw) dosage of extractive from Anoectochilus roxburghii leaves. There were no related adverse effects on body weight, food intake, food consumption, hematology, serum biochemistry and histopathology in rats under 5.83-17.50 g/kg·bwdosage of extractive from Anoectochilus roxburghii leaves. Conclusions Under these experimental conditions, no obvious toxic and side effects were observed in extractive from Anoectochilus roxburghii leaves.