贻贝黏蛋白在BALB/c小鼠中的免疫原性研究  

Study on the immunogenicity of MAP in BALB/c mice

作　　者：焦菲菲 谢月 康瑞娟 马立翠 董谦 母瑞红[2] JIAO Fei-fei;XIE Yue;KANG Rui-juan(Jiangyin USUN Biochemical Technology Co.,Ltd.,Jiangyin 214400,China;不详)

机构地区：[1]江阴贝瑞森生化技术有限公司,江苏江阴214400 [2]中国食品药品检定研究院(医疗器械标准管理中心),北京102629

出　　处：《中国医学装备》2021年第8期191-197,共7页China Medical Equipment

基　　金：国家重点研发计划(2016YFC1103200)“新型动物源性材料——贻贝黏蛋白材料和产品的标准化研究”。

摘　　要：目的:评估贻贝黏蛋白(MAP)注射入小鼠体内时的免疫原性,并为其临床应用提供安全性依据。方法:选择BALB/c小鼠72只,采用随机数表法将小鼠分为试验样品组(S组)、阴性对照组(N组)、阳性对照组(P组)、阳性抑制组(D组)、阳性促进组(P*组)及空白对照组(C组)6组,每组小鼠根据不同实验选取不同数量。通过免疫学实验评估MAP对小鼠免疫系统的影响,对T淋巴细胞转化功能、巨噬细胞吞噬功能、体液免疫应答、体重和脏器系数以及血液学和脾淋巴细胞总数对免疫器官组织学的影响进行评估。结果:注射高剂量MAP时,小鼠产生免疫应答;但S组与N组比较,临床等效剂量MAP产生的免疫原性未产生显著差别。S组与N组对淋巴细胞表面CD4、CD8和CD3、CD19标志的表达差异无统计学意义(t=0.171,t=0.995,t=0.240,t=0.163;P>0.05);MAP对小鼠腹腔巨噬细胞吞噬鸡红细胞的能力无明显的促进或抑制作用,S组与N组之间的差异无统计学意义(t=1.14,P>0.05)。MAP对小鼠的体液免疫应答和免疫因子水平、小鼠的体重和免疫器官(胸腺和脾脏)和小鼠的白细胞计数未产生显著影响,且未表现出刺激小鼠脾淋巴细胞增长的迹象,S组脾淋巴细胞总数虽低于N组,但差异无统计学意义(t=1.85,P>0.05)。结论:临床等效剂量MAP对BALB/c小鼠的体液免疫和细胞免疫未产生影响,应用于小鼠时安全性良好。Objective:To assess the immunogenicity of mussel adhesive protein(MAP)when it was injected into mice,and to provide basis of safety of mussel adhesive protein in clinical application.Methods:72 BALB/c mice were selected and were randomly divided into test sample group(S group),negative control group(N group),positive control group(P group),positive inhibition group(D group),positive promotion group(P*group)and blank control group(C group)according to random number table method.The number of mice in each group was allocated according to the experimental arrangement.The impact of MAP on the immune system of mice was assessed through immunology experiment.The influences of T lymphocyte transformation function,macrophage phagocytic function,humoral immune response,coefficient of body weight and organ,hematology and total number of splenic lymphocytes on histology of immune organ were further assessed.Results:Mice produced an immune response when injected with high dose of MAP.At the clinically equivalent dose,there was no significant difference in the immunogenicity that was generated by MAP between S group and N group.MAP did not significantly affect the expression of CD4,CD8,CD3 and CD19 on the surface of lymphocytes between S group and N group(t=0.171,t=0.995,t=0.240,t=0.163,P>0.05).And MAP had no obvious promotion or inhibition on the ability that peritoneal macrophages of mice swallowed chicken red blood cells,and the difference of that between S group and N group was not significant(t=1.14,P>0.05).MAP also did not generate significant effects on the humoral immune response,immune factor levels,body weight and immune organs(thymus and spleen),and white blood cell count of mice.And it didn’t show signs that MAP stimulated the growth of splenic lymphocytes of mouse.Although the total number of splenic lymphocytes in S group was lower than that in N group,the difference was not statistically significant(t=1.85,P>0.05).Conclusion:MAP with the clinically equivalent dose doesn’t generate effects on the humoral and

关 键 词：贻贝黏蛋白(MAP) 免疫原性 安全性 小鼠 

分 类 号：R-332[医药卫生]