复方刺五加片毒理学安全性及缓解体力疲劳功效研究  

Study on toxicological safety and alleviating physical fatigue function of compound Acanthopanax senticosus tablets

作　　者：陈耿[1] 陈东亚[1] 刘协[1] 赵荣[1] 施伟庆[1] 吕中明[1] 俞萍[1] 卞倩[1] 陈新霞[1] 奚清丽[1] CHEN Geng;CHEN Dong-Ya;LIU Xie;ZHAO Rong;SHI Wei-Qing;LV Zhong-Ming;YU Ping;BIAN Qian;CHEN Xin-Xia;XI Qing-Li(Institute of Toxicology and Risk Assessment,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,China)

机构地区：[1]江苏省疾病预防控制中心,毒理与风险评估研究所,南京210009

出　　处：《食品安全质量检测学报》2022年第14期4724-4733,共10页Journal of Food Safety and Quality

摘　　要：目的评价一种以刺五加、肉苁蓉、西洋参、丹参为原料的复方保健食品毒理学安全性和缓解体力疲劳功效。方法依据《保健食品检验与评价技术规范(2003年版)》,进行急性经口毒性、遗传毒性、30d亚急性毒性以及缓解体力疲劳动物功能学等试验。结果该复方刺五加片对雌、雄ICR小鼠急性经口最大耐受剂量值均>15.00 g/(kg·BW);鼠伤寒沙门氏菌/哺乳动物微粒体酶试验,以5000μg/皿为最高剂量,不论加S9与否,该样品对TA97a、TA98、TA100和TA1024组标准测试菌株的回复突变数均未超过相应水对照组值的2倍;小鼠骨髓细胞微核试验和小鼠睾丸染色体畸变试验,与溶剂对照相比,样品各剂量组骨髓细胞微核率、睾丸初级精母细胞性染色体单价体率、常染色体单价体率、细胞畸形率均无显著性差异(P>0.05);30 d亚急性毒性试验未发现该样品对SD大鼠生长、活动、体质量、摄食量、食物利用率、血液生理生化指标以及主要组织器官的毒理学病理学效应;小鼠缓解体力疲劳功效试验,该复方刺五加片0.46g/(kg·BW)组负重游泳时间显著延长(P<0.01),运动前后3个时间点血乳酸曲线下面积显著减少(P<0.01),0.46、1.38g/(kg·BW)组血清尿素氮显著降低(P<0.05或P<0.01)。结论该复方刺五加片具有缓解体力疲劳功效,且未见明显急性毒性或遗传毒性,其对雌、雄SD大鼠30 d经口毒性未观察到有害作用的水平分别为5.29、5.14 g/(kg·BW)(相当于成人推荐摄入量的115和112倍)。Objective To evaluate the toxicological safety and alleviating physical fatigue function of compound health food with Acanthopanax senticosus,Cistanche deserticola,American ginseng and Salvia miltiorrhiza as raw materials.Methods According to the“Technical standards for testing&assessment of health food(2003 edition)”,the tests of acute oral toxicity,genetic toxicity,30 days sub-acute dietary toxicity and alleviating physical fatigue function were performed.Results The acute oral maximum tolerable dose values of the compound Acanthopanax senticosus tablets in the female and male ICR mice were>15.00 g/(kg·BW);Salmonella typhimurium/mammals microsomal enzyme test,set 5000μg/plate as the highest concentration,the colony numbers of 4 standard test bacterial strains(TA97a,TA98,TA100 and TA102)in all test article concentrations were less than twice that in corresponding solvent control in the presence or absence of S9 mix;mice tests of bone marrow cells micronucleus and testicle cells chromosome aberration,compared with negative control group,there were no significant differences in the micronucleus rate of bone marrow cells,the monovalent rate of sex-somal and autosomal,as well as the aberration rate of primary spermatocyte from each dose of the sample(P>0.05);no toxicological/pathological effects of the compound Acanthopanax senticosus tablets on growth,behavioral activity,body weight,feed intake,feed utilization rate,blood physiological and biochemical indicators,cardinal tissues and organs in SD rats were found,after 30 days continuous feeding trial.The efficacy test for relieving physical fatigue in mice,the load-bearing swimming time in the 0.46 g/(kg·BW)group was significantly prolonged(P<0.01),the area under the blood lactic acid curve at 3 time points before and after exercise was significantly reduced(P<0.01),and the serum urea nitrogen in the 0.46 and 1.38 g/(kg·BW)groups was significantly reduced(P<0.05 or P<0.01).Conclusion The compound Acanthopanax senticosus tablets has a function on alleviating

关 键 词：刺五加 肉苁蓉 西洋参 丹参 安全性 抗疲劳 

分 类 号：TS218[轻工技术与工程—粮食、油脂及植物蛋白工程] TS201.6[轻工技术与工程—食品科学与工程]