Abstract：Objective This text was aimed to search a valid humoral immunity positive control based
on the tentative exploration analysis of the immunogenic evaluative method of medical biomaterial.
Meanwhile, the recommended dosage, immune method and immune effect was aimed to explore.
Methods A group of 8 weeks’ female Balb/c mice were randomized assigned into groups. Different
doses of bovine serum albumin (BSA) were used to immune the mouses 3 times, each time spaced for 2
weeks. The eyeball blood were separately gained and the serum were segregate to detect the serum total
IgG antibody concentration. The experimental results were analyzed by statistical methods. Results The
Mouse immuned by BSA alone did not show significant humoral immunity stimulative effect in all the
dosages. The mouse that BSA mixed adjuvant, serum IgG of the middle dose and the high dose were
much higher than the negative control, and the ability of high dose was higher than the middle dose.
It was significant different between the serum IgG of the group executed 2 weeks after immuned for 2
times and the negative control group, as well as the group executed 2 weeks after immuned for 3 times
and the negative control group. Serum IgG of the group executed 2 weeks after immuned for 3 times was
higher than the group executed 2 weeks after immuned for 2 times. The adjuvant control group did not
show significant difference with the negative control group. Conclusion The experiment indicated that
BSA could be used as a humoral immunity positive control of the immunogenic evaluation of the medical
biomaterial.
杜晓丹，方玉，王春仁，
陈鸿波，杨昭鹏. 牛血清白蛋白作为生物医用材料产品体液免疫评价阳性对照物的研究[J]. 中国医疗设备, 2017, 32(5): 32-34.
DU Xiao-dan, FANG Yu,
WANG Chun-ren,
CHEN Hong-bo,
YANG Zhao-peng. Study on BSA as a Positive Control for Humoral Immunity Evaluation
of Medical Biomaterial. China Medical Devices, 2017, 32(5): 32-34.
