变异白色红花总黄酮提取物安全性毒理学评价

Toxicological Safety Evaluation of Total Flavones Extract from White Safflower Variety

本文通过急性毒性试验、三项遗传毒性试验和30 d喂养试验,对变异白色红花总黄酮提取物(TFES)进行安全性毒理评价。结果表明,TFES对小鼠急性毒性试验,LD50>10.0 g/kg·BW,按急性毒性剂量分级,属实际无毒物质;三项遗传毒性试验即Ames试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验结果均为阴性;TFES对大鼠30 d喂养试验,动物未见明显的中毒症状和死亡,TFES各剂量组大鼠体重、总食物利用率、血清生化指标、血液学指标、脏器系数指标以及病理组织学等指标与对照组比较,无显著性差异。TFES在本实验条件下,未观察到明显毒性作用,为其进一步开发应用提供了安全依据。

Acute toxicity test ,three genetic toxicity tests and 30 days oral toxicity test were carried out to evaluate the toxicological safety of total flavones extract from white safflower variety （TFES）. Mice acute toxicity test showed the LDso of TFES was higher than 10.0 g/kg · BW. TFES belonged to actually non-toxic substances according to the acute toxicity dosage classification. Three genetic toxicity tests including Ames, Mice Bone Marrow Cell Micronucleus and Mice Sperm Abnormality showed negative results. Rats 30 days oral toxicity test of TFES showed no evident poisoning symptom and no death. There was no significant difference between different dosage groups of TFES and control group on animal weight, food utility, hematology, bio-chemistry, organ/body weight ratio and several indexes of pathological organization. Therefore ,TFES had no toxicity which provided a secure basis for its further development and application.