摘要
目的对复合玛咖片进行食用安全性评价。方法急性毒性实验选用ICR小鼠雌、雄各半,共20只,24小时内两次经口灌胃给予受试物,观察小鼠14d的中毒表现及死亡情况。Ames实验采用经鉴定符合要求的组氨酸缺陷型鼠伤寒沙门氏菌TA97a、TA98、TA100、TA102四个菌株进行实验,整个实验在相同条件下重复一次。骨髓细胞微核实验选ICR小鼠,雌、雄各半,共50只,实验设3个剂量组,分别为6.0g/(kg·BW)、3.0g/(kg·BW)、1.5g/(kg·BW),另设阴性对照组及阳性对照组。小鼠精子畸形实验选ICR小鼠,雄性,共25只,实验设3个剂量组,分别为6.0g/(kg·BW)、3.0g/(kg·BW)、1.5g/(kg·BW),另设阴性对照组及阳性对照组。30天喂养实验选SD大鼠,雌、雄各半,共80只,分为对照组及3个实验组。灌胃30天后采血,进行血液学指标检测及血液生化指标检测,并进行解剖,取对照组和高剂量组进行组织病理学检查。结果小鼠急性毒性实验经口最大耐受剂量(MTD)均>18.0g/(kg·BW)。三项遗传毒性实验(Ames实验、骨髓细胞微核实验、小鼠精子畸形实验)结果均为阴性,30天喂养实验,实验期间雌、雄性动物生长状况良好,未见受试物对动物体重、增重及食物利用率产生不良影响;未见受试物对动物血液学、血生化相关指标产生不良影响;大体解剖检查,各剂量组动物均未见脏器明显异常,脏器湿重、脏体比未见异常;组织病理学检查,未见被检脏器存在与受试物相关的组织病理学改变。结论复合玛咖片在本实验剂量范围内具有食用安全性。
Objective To evaluate the edible safety of mixed Maca(Lepidium meyenii)tablet.Methods 20 ICR mice,half female and half male,were selected for acute toxicity test.The test substance was administered orally twice within 24 hours.The poisoning performance and death of mice were observed for 14 days.Four strains of histidine deficient Salmonella typhimurium ta97a,TA98,TA100 and TA102 were used for Ames test.Two experiments were done under the same conditions.50 ICR mice,half female and half male,were selected for bone marrow cell micronucleus test.Three dose groups were set,which were 6.0g/(kg·BW),3.0g/(kg·BW)and 1.5g/(kg·BW)respectively,negative and positive control group were aslo set.25 male ICR mice were selected for mouse sperm malformation test.Three dose groups were set,which were 6.0g/(kg·BW),3.0g/(kg·BW)and 1.5g/(kg·BW)respectively,negative and positive control group were aslo set.In the 30 day feeding experiment,80 SD rats,half female and half male,were divided into control group and 3 experimental groups.After 30 days of intragastric administration,blood was collected for test.All animals were dissected The control group and high-dose group were taken for histopathological examination.Results The maximum tolerated oral dose(MTD)of acute toxicity test in mice was more than 18.0g/(kg·BW).The results of three genotoxicity tests(Ames test,bone marrow cell micronucleus test and mouse sperm malformation test)were negative.During the 30 day feeding test,all animals grew well,and no adverse effects of the test substance on animal weight,weight gain and food utilization were observed;There was no adverse effect of the test substance on animal blood;no obvious abnormalities of organs,wet weight of organs and visceral body ratio were observed;Histopathological examination showed that no histopathological changes related to the test substance were observed in the tested organs.Conclusion Mixed Maca(Lepidium meyenii)tablet was safey to eat within the dose of this experiment.
作者
张悦
张朋朋
孟庆金
董鹏
杨彩玲
王学南
张鹏
田世民
ZHANG Yue;ZHANG Pengpeng;MENG Qingjin;DONG Peng;YANG Cailing;WANG Xuenan;ZHANG Peng;TIAN Shimin(Zhongjianke(Beijing)Testing Technology Co.,Ltd.Beijing 100176;Comprehensive testing center of China Academy of inspection and quarantine,Beijing 100176,China)
出处
《中国老年保健医学》
2021年第5期59-63,共5页
Chinese Journal of Geriatric Care
关键词
复合玛咖片
保健食品
毒理
安全性
Mixed Maca(Lepidium meyenii)tablet
Health food
Toxicological safety
