Immune Function and Food Safety Evaluation of Soybean Isoflavone Composite Capsule
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Abstract:
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.
