某种黄芪丹参胶囊的毒理学安全性评价

目的]了解某品牌黄芪丹参胶囊作为保健食品长期食用的安全性。方法]2011年1月,依照《保健食品检验与评价技术规范》(2003年版)对某品牌黄芪丹参胶囊采用小鼠急性经口毒性试验、遗传毒性试验(Ames试验、小鼠骨髓微核试验、小鼠精子畸形试验)和30d喂养试验进行检测评价。结果]按照2.5、5.0、10.0g/kg.bw经口给小鼠某品牌黄芪丹参液,3项遗传毒性试验结果均为阴性;30d喂养试验结果,各实验组大鼠生长发育良好,体重增重、食物利用率、脏器系数、血常规、血液生化指标均在本实验室值正常范围内;病理组织学检查,实验组各脏器未见异常改变。结论]某品牌黄芪丹参胶囊急性毒性分级属无毒级,无遗传毒性,按推荐量食用是安全的。

Evaluation on Toxicological Safety of Astragalus Mongholicus and Salvia Miltiorrhiza Soft Capsule

Objective]To understand the safety of long-term consumption of a certain brand of Astragalus Mongholicus and Salvia Miltiorrhiza soft capsule as a healthcare food.Methods]In January 2011,in accordance with technical specifications for health food inspection and evaluation(2003),acute oral toxicity test on a certain brand of Astragalus Mongholicus and Salvia Miltiorrhiza soft capsule,genotoxicity test(Ames test,mouse bone marrow micronucleus test,sperm shape abnormality test)and detection evaluation and 30-day feeding study.Results]According to a brand of Astragalus Mongholicus and Salvia Miltiorrhiza fluid 2.5,5.0,10.0 g/kg·bw was given orally to mice.Three genotoxicity tests were negative;30 days feeding trial results showed that the experimental groups’ growth and development,body weight gain,food utilization,organ coefficient,blood,blood biochemical parameters were within the normal range values in the laboratory;Histopathological examination of various organs of the experimental group,no abnormal changes were observed.Conclusion]The acute toxicity classification of a certain brand of Astragalus Mongholicus and Salvia Miltiorrhiza soft capsule is a non-toxic level,without genetic toxicity,the recommended amount of consumption is safe.