不同解吸附处理对肺炎球菌结合疫苗各型多糖含量检测结果的影响

目的探讨不同解吸附处理对肺炎球菌结合疫苗各型多糖含量检测结果的影响。方法将七价肺炎球菌结合疫苗分别用胰蛋白酶、NaOH解吸附或未解吸附处理,十三价肺炎球菌结合疫苗(制品1和制品2)分别用胰蛋白酶、NaOH解吸附(10、30、90 s)处理,应用免疫化学分析系统(IMMAGE 800)测定各型多糖含量。结果除14型外,未经解吸附处理的七价肺炎球菌结合疫苗各型多糖含量均显著低于经胰蛋白酶解吸附和NaOH解吸附处理后的多糖含量(P<0.05);除23F型多糖外,经胰蛋白酶解吸附处理后的七价肺炎球菌结合疫苗各型多糖含量均低于经NaOH解吸附处理后的多糖含量。经胰蛋白酶解吸附处理后,制品1中的14型和制品2中的1型多糖含量低于经NaOH解吸附处理后的50%;随着NaOH解吸附处理时间的增加,制品1和制品2中19A型多糖含量急剧下降。结论肺炎球菌结合疫苗进行各型多糖含量检测之前需进行解吸附处理,胰蛋白酶解吸附和NaOH解吸附处理对多糖含量检测结果均有影响。

Effect of various desorption treatments on determination result of polysaccharide content in pneumococcal conjugate vaccine

Objective To investigate the effect of various desorption treatments on determination results of contents of various types of polysaccharide in pneumococcal conjugate vaccine.Methods Heptavalent pneumococcal conjugate vaccine was desorbed by trypsin and sodium hydroxide respectively using that untreated as control.In addition,13-valant pneumococcal conjugate vaccines(products 1 and 2)were desorbed by trypsin and sodium hydroxide for 10,30 and 90 s separately,and determined for contents of various types of polysaccharide by immunochemical assay system(IMMAGE 800).Results Except that of polysaccharide of type 14,all the polysaccharide contents of various types in heptavalent vaccine untreated was significantly lower than those trypsin-and sodium hydroxide-desorbed vaccine(P < 0.05).Except that of type 23F,all the polysaccharide contents of various types in heptavalent vaccine desorbed with trypsin were significantly lower than those with sodium hydroxide.After desorption with trypsin,the polysaccharide contents of type 14 in product 1 and type 1 in product 2 were lower than the 50% of those after desorption with sodium hydroxide.However,the polysaccharide contents of type 19A in products 1 and 9 decreased remarkably with the increasing time for desorption with sodium hydroxide.Conclusion It is necessary to desorb the samples before determination of various types of polysaccharide content in pneumococcal conjugate vaccine.The desorption by either trypsin or sodium hydroxide impacts the determination result of polysaccharide content.