CAJ | 학술논문

目的：对肺炎球菌结合物及其制备过程中间品进行多种方法抗原性监控，以期对肺炎球菌结合物制备过程中多糖抗原性进行差异分析，进而为制备工艺参数的选择提供重要参考指标。方法用已建立的免疫双扩散法、抑制ELISA、速率比浊法对23 F型肺炎球菌结合物制备过程中间品和结合物进行抗原性分析；对不同方法结果比较、综合分析23 F型肺炎球菌结合物制备过程中的多糖抗原性变化。结果建立分析抗原性变化的抑制ELISA和速率比浊法；3种方法均可用于肺炎球菌结合物制备过程中的多糖抗原性分析；其中抑制ELISA可监控制备过程中抗原性的微小改变并可量化。结论用多种方法对23 F型肺炎球菌结合物制备过程中的多糖抗原性进行分析，为结合物制备过程中多糖抗原性的监控提供了多层面的有效方法，并为抗原性监控提供可量化的方法。
목적：대폐염구균결합물급기제비과정중간품진행다충방법항원성감공，이기대폐염구균결합물제비과정중다당항원성진행차이분석，진이위제비공예삼수적선택제공중요삼고지표。방법용이건립적면역쌍확산법、억제ELISA、속솔비탁법대23 F형폐염구균결합물제비과정중간품화결합물진행항원성분석；대불동방법결과비교、종합분석23 F형폐염구균결합물제비과정중적다당항원성변화。결과건립분석항원성변화적억제ELISA화속솔비탁법；3충방법균가용우폐염구균결합물제비과정중적다당항원성분석；기중억제ELISA가감공제비과정중항원성적미소개변병가양화。결론용다충방법대23 F형폐염구균결합물제비과정중적다당항원성진행분석，위결합물제비과정중다당항원성적감공제공료다층면적유효방법，병위항원성감공제공가양화적방법。
Objective To monitor and analyze the antigenicity of Streptococcus pneumonia polysac-charide, its derivatives and conjugates by three immunological assays .Methods Inhibition ELISA and rate nephelometry(RN) were established for this study.Antigenicity of serotype 23F pneumococcal conjugates and their intermediates were analyzed by double immunodiffusion assay , inhibition ELISA and RN .The re-sults derived from three assays were comparatively analyzed to evaluate the changes of antigenicity during the preparing process of serotype 23F conjugate.Results Double immunodiffusion assay, inhibition ELISA and RN were all applicable to antigenicity analysis during the process of conjugate preparation .Inhibition ELISA could quantitatively detect a slight difference of polysaccharide antigenicity during the preparing process . Conclusion The antigenicity of polysaccharide during the preparing process of pneumococcal conjugates could be analytically monitored by using three immunological assays .This study provided evidence for suc-cessfully using immunological assays as the quality control means during the preparing process of pneumococ -cal conjugates .