纳豆软胶囊功效成分安全性及免疫功能研究

Study on Safety and Immune Function of Functional Ingredients of Natto Soft Capsules

该研究对自主研制的纳豆软胶囊功效成分进行安全性评价与免疫功能研究,利用SPF级ICF小鼠进行急性毒性、遗传毒性(骨髓细胞微核、精子畸变、Ames)与免疫功能研究,利用SPF级Wistar大鼠进行30 d喂养试验。结果:小鼠经口急性毒性MTD均大于24.8 g/kg BW,属于实际无毒物;小鼠微核、精子畸变、Ames试验均为阴性;大鼠灌胃试验30 d内,血常规与生化指标正常,各脏器未见有意义的病理改变。经口给予小鼠不同剂量受试物30 d,小鼠迟发性变态反应与单核-巨噬细胞功能增强,小鼠半数溶血值等指标正常。结论:在该试验条件下,纳豆软胶囊功效成分安全性好,对动物健康无损害和毒副作用,具有增强免疫力功能。

The safety and immune function of the self-developed natto soft capsules are evaluated in this study.Acute toxicity,genetic toxicity(bone marrow micronucleus,sperm aberration,Ames)and immune function are studied on SPF-grade ICF mice,and 30-day feeding test is conducted on SPF-grade Wistar rats.Results:MTD in the oral acute toxicity test of mice is more than 24.8 g/kg BW,which belongs to actual non-toxic substance;the micronucleus,sperm aberration and Ames tests of mice are all negative;the blood routine parameters and biochemical indexes of rats are normal within 30 days of intragastric injection test,and there's no significant pathological change observed in each organ.After oral injection of different doses of test substances for 30 days,delayed allergic reaction and monocyte-macrophage function of mice are enhanced,and half hemolysis value and other indicators of mice are normal.Conclusion:Under such experimental conditions,the functional ingredients of natto soft capsules have good safety,have no harmful effects and toxic side effects on animal health,and can enhance immunity.