免疫婴儿乳粉的安全毒理学评定

Assessment of safety and toxicology of immune infant milk formula

以24株人肠道病原菌(包括病原性大肠杆菌12株、沙门氏菌8株、志贺氏菌3株、小肠结肠炎耶尔森氏菌1株)作为抗原,对乳牛进行系统免疫,免疫乳与非免疫乳乳中IgG含量无显著差异。系统免疫并不增加乳中IgG的含量,但IgG的抗体特异性大大增强,所得的免疫初乳中乳抗体对24种不同病原菌的凝集价为28～212,为普通初乳中乳抗体凝集价的32～256倍。以免疫初乳作为原料制备免疫初乳粉并添加到婴儿乳粉中制成免疫婴儿乳粉。婴儿免疫乳粉LD50>10g/kg;Ames试验及小鼠骨髓微核试验和小鼠精子畸变试验表明婴儿免疫乳粉无致畸变作用。大鼠30d喂养试验表明,婴儿免疫乳粉对大鼠生长无不良影响,大鼠血液指标正常,病理学检查未见任何病变。

strains of pathogenic bacteria (including 12 of pathogenic E.coli,8 of Salmonella,3 of Shigella and 1 of Yersinia enterocolitica) originated from human intestinal tract were selected as antigens,and dairy cows were immunized.Vaccination could not increase the concentration of IgG in the immune milk,but significantly highten the specificity of milk antibodies. The antibody titers against 24 pathogenic bacteria in immune colostrum (20 g/L of IgG) were 28～212,32～256 folds of control regular colostrum (20 g/L of IgG). LD50 for mice feeding of immune infant milk formula prepared by adding of immune colostrum powder into infant milk formula was higher than 10 g/kg. No aberration inducing effects of immune infant milk formula were observed resulting from the Ames test,mouse marrow micronucleus test and mouse sperm aberration test. 30 day feeding of immune infant milk formula showed that there is no side effects to mice,blood biochemical examinations were normal. Pathobiological inspection indicated that no pathobiological changes is occurred to the mice.