摘要
目的以牛蒡提取物为研究对象,初步对牛蒡的安全性进行毒理学评价。方法根据卫生部《保健食品检验与评价技术规范》(2003年版)要求,选择急性经口毒性试验、鼠伤寒沙门菌回复突变(Salmonella typhimurium/reverse mutation,Ames)试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验和30d灌胃试验对牛蒡提取物进行毒性评价。结果急性经口毒性试验动物灌胃后未见明显中毒反应,牛蒡提取物小鼠急性经口半数致死量(median lethal dose,LD50)>15.0g/kg·bw,毒性分级属无毒级;Ames试验牛蒡提取物回变菌落数未超过溶剂对照的2倍且无剂量-反应关系,提示牛蒡提取物致突变试验结果为阴性;牛蒡提取物各剂量组骨髓细胞微核率和精子畸形率与溶剂对照组比较,差异无统计学意义(χ^(2)=7.035、4.216,P>0.05);牛蒡提取物大鼠30d经口灌胃试验期间,动物生长发育良好,体质量、食物利用率、血液学、血液生化学、脏器系数和组织病理学等相关指标均未见明显特异性毒理学变化,最大未观察到有害作用剂量(no-observed-adverse-effect level,NOAEL)8.0g/kg·bw。结论牛蒡提取物急性毒性分级属无毒级,无遗传毒性,在本研究实验条件和试验剂量下,可初步认定其作为中药材及保健食品是安全的。
Objective To preliminarily evaluate the toxicology on the safety of edible burdock using burdock extract as the study object.Methods According to the requirements of Technology Standard for Testing&Assessment of Health Food(2003)of the Ministry of Health,the acute oral toxicity test,Salmonella typhimurium/reverse mutation(Ames)assay,mouse bone marrow cell micronucleus test,mouse sperm aberration test and 30d gavage test were performed to evaluate the toxicity of burdock extract.Results In the acute oral toxicity test,no obvious toxic reaction was observed in animals after gavage.The acute oral median lethal dose(LD50)of edible burdock extract in mice was>15.0g/kg·bw,and the toxicity grade was non-toxic.In the Ames test,the number of retroactive colonies of edible burdock extract did not exceed twice that of the solvent control and there was no dose-response relationship,suggesting that the mutagenic test results of edible burdock extract was negative.There was no statistically significant difference in the rates of bone marrow cell micronucleus and sperm aberration in each dose group of edible burdock extract(χ^(2)=7.035,4.216,P>0.05),compared with the solvent control group.During the 30d oral gavage test of edible burdock extract in rats,the growth and development of rats were good,and no obvious specific toxicological changes were observed in weight change,food utilization rate,hematology,blood biochemistry,organ coefficient,histopathology and other related indexes.The maximum no-observant-adverse effect level(NOAEL)of edible burdock extract was 8.0g/kg·bw.Conclusion Under the experimental conditions and dosage of this study,edible burdock extract has no acute toxicity and no genetic toxicity,can be preliminarily identified as a safe Chinese medicine and health food.
作者
李晓华
聂文强
吴宝剑
李军涛
李文学
杨光宇
LI Xiaohua;NIE Wenqiang;WU Baojian;LI Juntao;LI Wenxue;YANG Guangyu(Department of Family Medicine,The First Affiliated Hospital of Guangdong Pharmaceutical University,Guangzhou,Guangdong 510440,China;不详)
出处
《医学动物防制》
2024年第6期596-601,605,共7页
Journal of Medical Pest Control
基金
广东省自然科学基金项目(2021A1515011291)
广东省中医药管理局项目(20201232)
广州市医药卫生科技项目(20141A010050)。
关键词
牛蒡
提取物
保健食品
中药材
毒性研究
安全性评价
Edible burdock
Extract
Health food
Traditional Chinese medicine
Toxicity study
Safety evaluation
