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作 者:杨非[1] 姚文环[1] 李慧[1] 张静[1] 唐慧[1] 吕实波[1] 郭婕[1] 孙劭靖 陆震 程东[1] YANG Fei;YAO Wenhuan;LI Hui;ZHANG Jing;TANG Hui;LYU Shibo;GUO Jie;SUN Shaojing;LU Zhen;CHENG Dong(Shandong Provential Center for Disease Prevention and Control,Jinan 250014,China;Shandong Huaxi Haiyu Biomedical Co.,LTD.,Jinan 250000;Huaxi Biotechnology Co.,LTD.,Jinan 250000)
机构地区:[1]山东省疾病预防控制中心,济南250014 [2]山东华熙海御生物医药有限公司,济南250000 [3]华熙生物科技股份有限公司,济南250000
出 处:《中国比较医学杂志》2022年第12期66-76,102,共12页Chinese Journal of Comparative Medicine
摘 要:目的研究银耳多糖的急性毒性、遗传毒性及亚慢性毒性,为银耳多糖开发利用提供科学数据。方法依据食品安全国家标准,对银耳多糖进行急性经口毒性试验、三项遗传毒性试验和90 d经口毒性试验。结果小鼠急性经口LD50>12.0 g/(kg·bw),属实际无毒级;三项遗传毒性试验结果均为阴性;大鼠90 d经口毒性实验中,各剂量组动物生长发育良好,体重、增重、进食量、食物利用率、血液学、血生化、尿常规、脏器湿重及脏/体比等指标与阴性对照组比较均无显著性差异(P>0.05),组织病理学观察未见与试验因素有关的变化,确定该银耳多糖最大未观察到有害作用剂量(NOAEL)为:雄性动物为7.21 g/(kg·bw),雌性动物为8.18 g/(kg·bw)。结论在本次条件下,银耳多糖未见急性毒性、遗传毒性及亚慢性毒性。Objective To study the acute toxicity,genetic toxicity and subchronic toxicity of Tremella polysaccharide and to provide scientific bases for its safe application.Methods Acute oral toxicity,genetic toxicity,and 90 days oral toxicity tests were performed following the national standards of food safety.Results The LD50of Tremella polysaccharide was more than 12.0 g/(kg·bw),and Tremella polysaccharide was a non-toxic substance.The result of the three genotoxicity tests were negative.In the subchronic toxicity test,compared with the negative control group,there were no significant differences(P>0.05)in bw,weight gain,food intake,food utilization rate,hematological indexes,blood biochemical indexes,urine routine,organ weight,or organ coefficients.Histopathological observations showed no changes related to test factors.The no observed adverse effect level(NOAEL)of Tremella polysaccharide was 7.21 g/(kg·bw)for males and 8.18 g/(kg·bw)for females.Conclusions No evidence for acute toxicity,genetic toxicity,or subchronic toxicity was observed in this Tremella polysaccharide study.
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