肉苁蓉尿囊素提取物安全性毒理学评价

Safety and Toxicological Assessment of Allantoin Extract from Cistanches Herba

目的:研究肉苁蓉尿囊素提取物的食用安全性,为其后续开发利用提供科学依据。方法:根据《保健食品检验与评价技术规范》,对肉苁蓉尿囊素提取物进行细菌回复突变(Ames)实验、小鼠骨髓微核实验、小鼠精子畸变实验、大鼠30 d喂养实验。结果:Ames实验中,尿囊素提取物剂量分别40,200,1 000,5 000μg/皿,无论加或不加哺乳动物肝脏微粒体酶(S9),各剂量组的回复突变菌落数均未出现剂量依赖性的增加,结果为阴性;小鼠骨髓嗜多染红细胞微核实验中,与正常组比较,尿囊素提取物各剂量组中的微核率均无显著性差异;小鼠精子畸变实验中,尿囊素提取物各剂量组小鼠精子畸变率与正常组比较无显著性差异,结果为阴性。3项遗传毒性实验结果均为阴性,表明尿囊素提取物无遗传毒性。大鼠30 d喂养实验结果显示,采用不同浓度尿囊素提取物(1.100,0.550,0.275 g·kg^(-1))分别对大鼠连续喂养30 d,大鼠未见中毒症状和死亡,各剂量组大鼠体质量、摄食量、增重、周食物利用率、总食物利用率、脏体比、血常规指标及生化指标与正常组均无显著性差异,脏器病理组织学检查也未发现病理改变。结论:肉苁蓉尿囊素提取物属无毒级物质,未见遗传毒性,具有较高的食用安全性,为其安全性提供了科学实验依据。

Objective: To evaluate the safety of allantoin extract from Cistanches Herba,so as to provide scientific support for subsequent utilization and development of allantoin extract from Cistanches Herba. Method:According to the national standard procedures and methods in food safety and toxicological evaluation,a series of toxicological studies on allantoin extract from Cistanches Herba were conducted,including genetic toxicity and subacute toxicity tests. Result: In the Ames test,with or without mammalina liver microsomal enzymes(S9),allantoin extract from Cistanches Herba in 40,200,1 000,5 000 μg·dish-1 dose range for four bacteria showed no dose-dependent increase. In the micronucleus test,there was no statistically significant difference among each dose group and the negative control group. In the test of mouse sperm aberration,there was no significant difference in the sperm aberration rate among the allantoin extract group and the negative control group. The results of three genotoxicity tests were all negative,indicating no genotoxicity in allantoin extract. The results of 30 days test showed no death and abnormal clinical sign in rats of control group and each dose group( 1. 100,0. 550,0. 275 g·kg^-1). The body weight,food intake,weekly and total food utilization,weight increment,organ/body ratios,blood biochemical indexes and blood routine indexes had no significant difference among the control group and dose groups. There was no abnormal pathological change in heart,liver,spleen,lung,kidney and testicle of rats in treatment group.Conclusion: Allantoin extract from Cistanches Herba is a non-toxic substance without any genetic toxicity but with a high edible safety. This study provides scientific experimental basis for its safety.