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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。
Objective To detect the safety of Dragon peptide immune capsule as a health food. Methods Acute oral toxicity, mutagenicity test (mouse bone marrow micronucleus test, mouse sperm abnormality test) and rats 30d feeding test. Results Long peptide immunization capsule acute oral toxicity test of SPF Kunming mice of different genotypes, 24h second intragastric administration of up to 20g / kg (equivalent to the crowd recommended daily intake of 3.0g / 60kg 400 times) No obvious symptoms of poisoning within two weeks, no animal death, according to acute toxicity grading standards, the test substance is non-toxic level. Two mutagenic test results were negative. The results of 30d feeding test showed that the tested samples were added to the basal diet at the rates of 1.25%, 2.50% and 5.00% respectively (corresponding to 25, 50 and 100 times of the daily recommended daily intake of 0.05g / kg) There was no significant difference in body weight, food intake, food utilization rate, hematology, blood biochemistry, organ weight, visceral / body ratio and histopathology of Wistar rats compared with the normal control group , Did not find that the test substance has obvious toxic effects. Conclusion Long peptide immune capsule as a health food is safe and can pass one or two stages of toxicological safety assessment.