不同搅拌系统对免疫球蛋白分子大小分布的影响分析

Influences of different agitation systems on the molecule size distribution of immunoglobulin

目的分析在超滤配制过程中不同搅拌系统对破伤风人免疫球蛋白(human tetanus immunoglobulin,HTIG)分子大小分布的影响。方法采用机械搅拌系统(A系统)和磁力搅拌系统(B系统)超滤配制HTIG各5批,比较各生产阶段的HTIG分子大小分布变化。结果用于A、B系统生产的HTIG分子大小分布均符合中国药典2015年版三部的要求,且两者间的差异没有统计学意义(t=-0.95,P=0.398)。在HTIG超滤配制过程中,A系统在超滤浓缩阶段对HTIG分子大小分布的影响小于B系统,两者间的差异有统计学意义(t=2.31,P=0.038)。进一步在同一搅拌系统中比较各生产阶段的HTIG分子大小分布,结果显示,A系统对各生产阶段的HTIG分子大小分布均无影响;当采用B系统生产HTIG时,超滤浓缩阶段(t=20.57,P=0.000)和pH值调节阶段(t=-4.15,P=0.006)与前一生产阶段的分子大小分布差异有统计学意义。结论在HTIG超滤配制过程中,A系统对HTIG分子大小分布的影响比B系统小。

Objective To analyze the influence of different agitation systems on the molecular size distribution of human tetanus immunoglobulin(HTIG)during the ultrafiltration and formulation process.Methods Five batches of HTIG each were ultrafiltered and formulated using mechanical agitation system(A system)or magnetic agitation system(B system),and the molecular size distributions of HTIG at different production stages were compared.Results The molecular size distributions of HTIG for production with A or B system all met the requirements of Chinese pharmacopoeia(2015 edition,volumeⅢ),and the difference had no statistical significance(t=-0.95,P=0.398).During the ultrafiltration and formulation process,the effect of A system was less than that of B system on the molecular size distribution at the ultrafiltration and concentration stage,the difference had statistical significance(t=2.31,P=0.038).The molecular size distributions of HTIG at different production stages were further compared in the same agitation system.The results showed that A system had no effect on the molecule size distribution of HTIG at different production stages.When HTIG was produced using B system,the molecular size distributions of HTIG had significant difference at the ultrafiltration and concentration stage(t=20.57,P=0.000)and the pH adjustment stage(t=-4.15,P=0.006)as compared with those at the previous production stage respectively.Conclusion During the ultrafiltration and formulation process,the effect of A system is less than that of B system on the molecular size distribution.