汝康胶囊毒理学安全性实验研究.pdfVIP

62 北方药学 2011 年第 8 卷第 1 期 汝康胶囊毒理学安全性实验研究 解国梁 王 莉 尹幸念 樊树理 （内蒙古疾病预防控制中心毒理科 呼和浩特 010031） [1] 摘要：检测汝康胶囊作为保健食品的安全性。 方法：依据卫生部《保健食品检验与评价技术规 范》 ，通过小鼠经口急性毒性试 验、致突变试验，大鼠 30 天喂养试验对汝康胶囊进行检测。 结果：小鼠经口 LD50＞21.5g/kg ·bw ，属无毒级物质；致突变试验结果 为阴性；大鼠 30 天喂养试验表明各剂量组体重增长、食物利用率、脏体比、血液学及血清生化指标与对照组比较均无显著性差 异（ P＞0.05 ）。 病理检查主要脏器未发现与实验有关的病理性改变。 结论：汝康胶囊为无毒、无致突变作用的保健食品。 关键词 汝康胶囊 毒性试验 安全评价 ： 中图分类号：R965.33333333333333333文献标识码：B33333333333333333文章编号：1672-8351（2011 ）01-0062-04 Study of toxicologic security assessment on the Rukang capsule Abstract ：Objective ：The study evaluated security of the Rukang capsule as health food.Methords:Accroding to 《Technical standards for testing and assessment of health food 》of health department. （2003 ），the Rukang capsule was detected through rats peroral a－ cute toxicologic experiment ， rats mutagen test and rats thirty-days feeding test.Results:Median lethal dose of rats peroral test was more than 21.5g/kg ·bw ，which indicated that the Rukang capsule was non-toxic material. The result of rats mutagen test was negative; Rats thirty-days feeding test indicated that no significant difference about weight gain ，food utilization rate ，routine blood test ，rate of organ to body （weight to weight ）， and Patho-histological observations between the rats of each group （P 0.05 ）.Pathological exami－ nation of main organs was done that Pathological change were not found.Conclusion:The Rukang capsule is non-toxic and non-muta－ gen health food. Key words ：the Rukang capsule toxicologic experiment security assessment