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

中文关键词:  刺五加  肉苁蓉  西洋参  丹参  安全性  抗疲劳

英文关键词:Acanthopanax senticosus  Cistanche deserticola  American ginseng  Salvia miltiorrhiza  safety  alleviating physical fatigue

中文摘要:

      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、30 d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5000 μg/皿为最高剂量, 不论加S9与否, 该样品对TA97a、TA98、TA100和TA102 4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0.46 g/(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、1.38 g/(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)。

英文摘要:

      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 5000 μg/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 physical fatigue, without acute toxicity or genetic toxicity; the no observed adverse effect level of male and female SD rats in sub-acute dietary toxicity study for the compound Acanthopanax senticosus tablets for 30 days are 5.29, 5.14 g/(kg·BW) respectively (as 115 and 112 times as the recommended dose in adults).