三七参芪胶囊安全性评价及缓解体力疲劳功能的研究  

The Safety Evaluation and Function of Alleviating Physical Fatigue of SanQiShenQi Capsule

作　　者：范治云 谭会萍[2] 李志坤 陈峰 祝清芬 FAN Zhi-yun;TAN Hui-ping;LI Zhi-kun;CHEN Feng;ZHU Qing-fen(Shandong Institute of Food and Drug Control,Jinan 250101,Shandong,China;The Third Hospital of Jinan,Jinan 250132,Shandong,China)

机构地区：[1]山东省食品药品检验研究院,山东济南250101 [2]济南市第三人民医院,山东济南250132

出　　处：《食品研究与开发》2018年第19期180-184,共5页Food Research and Development

摘　　要：评价三七参芪胶囊的安全性及研究其缓解体力疲劳的作用,采用小鼠急性经口毒性试验、小鼠骨髓细胞微核试验、精子畸形试验、Ames试验对其安全性进行评价;通过负重游泳实验及测定小鼠血清尿素氮含量、肝糖原含量及全血乳酸含量考察三七参芪胶囊的缓解体力疲劳作用。结果表明:三七参芪胶囊经口最大耐受量(the maximum tolerated dose,MTD)均大于20 g/kg bw,属无毒级;对鼠伤寒沙门氏菌TA97、TA98、TA100和TA102菌株无致突变作用;对小鼠骨髓嗜多染红细胞未见致突变作用;对小鼠精子未显示损伤作用;经口给予小鼠0.45、0.9、2.7 g/kg bw剂量的三七参芪胶囊30 d,0.9、2.7 g/kg bw剂量能显著延长小鼠的负重游泳时间、显著提高小鼠肝糖原水平,2.7 g/kg bw剂量显著降低小鼠运动后血清尿素含量,对小鼠的血乳酸曲线下面积未见明显影响;表明三七参芪胶囊毒理学安全,根据《保健食品检验与评价技术规范》判定标准,其具有缓解体力疲劳功能。To evaluate the safety of SanQiShenQi capsule and study effects of its alleviating physical fatigue in mice,the safety of SanQiShenQi capsule were evaluated by the acute toxicity test in mice,the mutation of salmonella test(Ames test),the micronucleus test of mice bone marrow polychromatic erythrocytes and the experiment of mouse sperm deformity;effects of alleviating physical fatigue of mice were researched via the swimming test and the determination of serum urea nitrogen,liver glycogen content and blood lactic acid content of mice.The results showed that the maximum tolerated dose(MTD)of SanQiShenQi capsule was more than 20 g/kg bw,and it was nontoxic;it had no mutagenic effect on salmonella typhimurium TA97,TA98,TA100 and TA102,and had no mutagenic effect on mouse bone marrow polychromatic erythrocytes,and showed no damage to mouse sperm.The mice were administered with the SanQiShenQi capsule at the doses of 0.45,0.9 and 2.7 g/kg bw for 30 days by intragastric infusion respectively,the doses of 0.9 g/kg bw and 2.7 g/kg bw can significantly prolong the weight loading swimming time,increase the level of mice hepatic glycogen and the dose of 2.7g/kg bw significantly decrease the level of mice serum urea after movement.SanQiShenQi capsule had no obvious effect on the area behind mice blood lactate curve.It was concluded that the toxicology of SanQiShenQi capsule was toxicologically safe and had the function of alleviating physical fatigue according to the standard of“health food inspection and evaluation technical specification”.

关 键 词：三七参芪胶囊 安全性评价 小鼠 缓解 体力疲劳 

分 类 号：R285.5[医药卫生—中药学]