CAJ | 학술논문

目的制备以B群脑膜炎球菌外膜蛋白(outer membrane protein,OMP)为载体的AC群脑膜炎球菌多糖(polysaccharide,PS)结合疫苗(AC-OMP),并初步研究该制备工艺的稳定性.方法将以溴化氰活化的A、C群PS分别与B群OMP偶联制成AC-OMP.按《中华人民共和国药典》2010年版三部的要求对制备的AC-OMP进行检定.以制备的AC-OMP免疫小鼠,用ELISA法检测小鼠血清抗体阳转率.结果制备的AC-OMP的各项指标均达到质控标准.AC-OMP具有良好的免疫原性,AC-OMP免疫小鼠的血清抗PS抗体阳转率为100％.结论该工艺适用于AC-OMP制备.
목적 제비이B군뇌막염구균외막단백(outer membrane protein,OMP)위재체적AC군뇌막염구균다당(polysaccharide,PS)결합역묘(AC-OMP),병초보연구해제비공예적은정성.방법 장이추화청활화적A、C군PS분별여B군OMP우련제성AC-OMP.안《중화인민공화국약전》2010년판삼부적요구대제비적AC-OMP진행검정.이제비적AC-OMP면역소서,용ELISA법검측소서혈청항체양전솔.결과 제비적AC-OMP적각항지표균체도질공표준.AC-OMP구유량호적면역원성,AC-OMP면역소서적혈청항PS항체양전솔위100％.결론 해공예괄용우AC-OMP제비.
Objective To prepare groups A and C meningococcal polysaccharide (PS) conjugate vaccine with outer membrane protein (OMP) of group B meningococcus as a carrier (AC-OMP),and preliminarily study on stability of the preparation process for AC-OMP.Methods Groups A and C meningococcal polysaccharides activated by cyanogen bromide were coupled with OMP of group B meningococcus respectively to prepare monovalent A-OMP and C-OMP,then AC-OMP was prepared by mixing monovalent A-OMP and C-OMP.The prepared AC-OMP was detected according to the requirements of Chinese Pharmacopoeia 2010 (Volume Ⅲ).Mice were immunized with the prepared AC-OMP,and seroconversion rates of anti-PS in immunized mice were detected by ELISA.Results Each index of the prepared AC-OMP achieved quality control standard.AC-OMP had a good immunogenicity,and seroconversion rates of anti-PS were 100％ in immunized mice.Conclusion The preparation process is suitable for AC-OMP.