龙肽免疫胶囊毒理安全性实验研究

目的检测龙肽免疫胶囊作为保健食品的安全性。方法急性经口毒性、二项致突变试验(小鼠骨髓微核试验、小鼠精子畸形试验)以及大鼠30d喂养试验。结果龙肽免疫胶囊对两种性别的SPF级昆明种小鼠急性经口毒性试验,24h二次灌胃量达20g/kg(相当于人群推荐日摄入量3.0g/60kg的400倍),两周内动物未见明显中毒症状,无动物死亡,按急性毒性分级标准规定,该受试物属无毒级。二项致突变试验结果均为阴性。30d喂养试验结果表明:将受试样品按1.25%、2.50%、5.00%的比例加入基础饲料中(分别相当于人群推荐日摄入量0.05g/kg的25、50、100倍),受试样品各剂量组对Wistar大鼠体重、进食量、食物利用率、血液学、血液生化、脏器重量、脏/体比值以及病理组织学等指标与正常对照组比较,均无显著性差异,未发现该受试物有明显的毒性作用。结论龙肽免疫胶囊作为保健食品是安全的,可以通过一、二阶段的毒理学安全性评价。

Toxicological Experimental Research of Long-tai Capsule

Objective To test the safety of Long-tai capsule as functional food. Methods Acute toxicity test, Bone marrow cell micronucleus test, Mice sperm abnormality test and 30 days feeding test were selected to study the toxicity of Long-tai capsule. Results In acute toxicity test, male and female KM mice were given with 20g/kg dose of Long-tai capsule two times within 24h, no toxic symptom were observed and no death. The resuhs of bone marrow cell micronucleus test, mice sperm abnormality test were negative. In the 30 days feeding test, compared with control group, 1.25 %, 2.50 % and 5. 00 % contents of Long-tai capsule in the feed （ as 25,50,100 times of population recommended amount respectively） showed no obvious toxic effects in clinical examination, blood test, biochemical test, organisms weight and pathological observation to Wistar rats. Conclusion Long-tai capsule is safe as a kind of functional food.