中国医疗设备2017，Vol.32Issue(5)：32-34,39,4.DOI:10.3969/j.issn.1674-1633.2017.05.008
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
Study on BSA as a Positive Control for Humoral Immunity Evaluation of Medical Biomaterial
杜晓丹 1方玉 1王春仁 1陈鸿波 1杨昭鹏1
作者信息
- 1. 中国食品药品检定研究院医疗器械检定所,北京 100050
- 折叠
摘要
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. MethodsA group of8 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.ResultsThe Mouse immuned by BSA alone did not show signiifcant 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 signiifcant 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 signiifcant difference with the negative control group. ConclusionThe experiment indicated that BSA could be used as a humoral immunity positive control of the immunogenic evaluation of the medical biomaterial.关键词
牛血清白蛋白/体液免疫/阳性对照物/生物医用材料/免疫刺激Key words
bovine serum albumin/humoral immunity/positive control/medical biomaterial/immunostimulation分类
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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):32-34,39,4.
