铁皮石斛叶的安全性毒理学评价试验研究  

Toxicological Evaluation of Dendrobium Officinale Leaves

作　　者：卢礼平 王欢 熊玲 杨桃 潘婷 唐靖雯 潘梅 LU Liping;WANG Huan;XIONG Ling;YANG Tao;PAN Ting;TANG Jingwen;PAN Mei(Guizhou Warmen Pharmaceutical Co.,Ltd.,Guiyang 550018,China;Center for Analysis and Assay,Huaxi School of Public Health,Sichuan University,Chengdu 610041,China)

机构地区：[1]贵州威门药业股份有限公司,贵州贵阳550018 [2]四川大学华西公共卫生学院分析测试中心,四川成都610041

出　　处：《中国民族民间医药》2022年第19期12-16,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：贵州省科技重大专项(黔科合重大专项字[2019] 3002)。

摘　　要：目的:系统评价铁皮石斛叶的食用安全性。方法:经过急性经口毒性试验、遗传毒性试验(细菌回复突变试验、哺乳动物红细胞微核试验、体外哺乳细胞染色体畸变试验)、 90 d经口毒性试验和大鼠致畸试验,综合评价铁皮石斛叶的食用安全性。结果:铁皮石斛叶急性经口毒性试验表明,该物质属实际无毒级别;三项遗传毒性试验结果均为阴性;90 d经口毒性试验未观察到有害作用剂量雄鼠为8.37 g/(kg·bw),雌鼠为8.73 g/(kg·bw);致畸试验结果显示试验剂量下铁皮石斛叶对大鼠无致畸作用。结论:铁皮石斛叶作为食品原料对人体健康造成的潜在风险较低。Objective To systematically evaluate the edible safety of Dendrobium officinale leaves.Methods Through acute oral toxicity test, genetic toxicity test(Ames test, mammalian erythocyte micronucleus test, in vitro mammalian cell chromosome aberration test), 90 days oral toxicity test and rat teratogenicity test, the edible safety of Dendrobium officinale leaf.Results The acute oral toxicity test of Dendrobium officinale leaves showed that the substance belonged to the actual non-toxic level;The results of three genotoxicity tests were negative;No harmful effect was observed in 90 days oral toxicity test, and the dose was 8. 37 g/(kg·bw) for male rats and 8. 73 g/(kg·bw) for female rats;The results of teratogenic test showed that Dendrobium officinale leaves had no teratogenic effect on rats.Conclusion Dendrobium officinale leaf as food raw material has low potential risk to human health.

关 键 词：铁皮石斛叶 毒理学评价 食品原料 地方标准 

分 类 号：R285.5[医药卫生—中药学]