为观察大豆异黄酮复合软胶囊（SIC）的增强免疫力效果及安全性。按照人体推荐用量的30、20、10倍，经口给予小鼠340、670、1000 mg/kg•bw剂量的SIC干预。通过测定脏器/体重比值、细胞免疫、体液免疫、单核-巨噬细胞吞噬功能指标和NK细胞活性，评估SIC对免疫功能的影响，结果发现：高剂量SIC干预小鼠的足跖肿胀度、淋巴细胞增殖OD差值、溶血空斑数分别比对照组提高了34.87%（p<0.05）、36.07%（p<0.05）、15.85%（p<0.05），血清溶血素值比对照组升高了12.66%（p<0.01）。说明SIC具有增强细胞免疫和体液免疫的功能。通过急性毒性试验、Ames试验、小鼠骨髓细胞微核试验和小鼠精子畸形试验评价SIC的安全性，结果表明：在30 d观察期内，各剂量组的SIC对实验鼠体重、进食量、食物利用率、血液生化学指标、脏器系数均无影响，其大鼠急性毒性MTD大于19.76 g/kg•bw，NOAEL大于3.33 g/kg•bw。以上结果表明，SIC无急性毒性和遗传毒性，具有增强免疫力的功能。

The immune enhancement effect and safety of soybean isoflavone compound capsules (SIC) were evaluated. Mice were intragastrically administered SIC at doses of 340, 670 and 1000 mg/kg•bw for 30 days, in accordance with 30-, 20-, and 10-fold the recommended dosage for humans, respectively. Immune function was evaluated by measuring the organ/body weight ratio, cellular immunity, humoral immunity, mononuclear macrophage phagocytosis index, and natural killer cell activity. The degree of paw swelling, optical density difference of lymphocyte proliferation, and number of hemolytic plaques in the high-dose SIC intervention group were suppressed by 34.87% (p<0.05), 36.07% (p<0.05), and 15.85% (p<0.05), respectively, compared to the control group, and serum hemolysin levels were increased by 12.66% (p<0.01). Cellular and humoral immune functions were enhanced by SIC. The safety of SIC was evaluated through acute toxicity testing, the Ames test, mouse bone marrow cell micronucleus testing, and mouse sperm abnormality testing. During the 30-day observation period, there were no effects on the body weight, food intake, food utilization rate, hematological indexes, hematological biochemical indices, or organ coefficient in the experimental rats treated with the different doses of SIC. The acute toxicity in rats was greater than 19.76 g/kg•bw, and the no-observed-adverse-effect level was greater than 3.33 g/kg•bw. These results demonstrate that SIC has no acute toxicity or genotoxicity and effectively enhances immunity.

大学生创新创业训练项目（S202010712132）