【摘要】 目的:统计分析2006-2011年生产的140批23价肺炎球菌多糖疫苗的5项定量检定指标,为疫苗的质量评价和质量监督提供依据。方法:对2006-2011年生产的140批23价肺炎球菌多糖疫苗的多糖含量、苯酚含量、氯化钠含量、pH值、细菌内毒素检查等5项指标的检定结果进行统计分析;对各单型多糖的含量进行移动标准偏差分析;对苯酚含量、氯化钠含量、pH值测定、细菌内毒素检查指标进行移动平均值总体趋势分析。结果:6年来,23价肺炎球菌多糖疫苗的多糖含量批间差异逐渐缩小;苯酚含量、氯化钠含量、细菌内毒素检查均值逐渐下降并趋于稳定;pH值一直较为稳定。结论:2006-2011年生产的23价肺炎球菌多糖疫苗质量逐步提高并保持稳定。更多还原

【Abstract】 Objective: To provide evidence for evaluation and supervision by statistical analysis based quantitative test results of 140 batches of 23-valent pneumococcal polysaccharide vaccines from 2006 to 2011.Methods: We collected and analyzed quantitative test results of 140 batches of 23-valent pneumococcal polysaccharide vaccine′s from 2006 to 2011,including the polysaccharide content,phenol content,sodium chloride content,pH,test of bacterial endotoxin.The moving standard deviation of each single type of polysaccharide content,the moving average trends of phenol content,sodium chloride content,pH,and test of bacterial endotoxin were analyzed.Results: The test differences between the batches in polysaccharide contents of 23-valent pneumococcal polysaccharide vaccine were narrowed during 6 years,the trend of phenol content,sodium chloride content and test of bacterial endotoxin was also diminished and stabilized,and the moving average line of pH had been relatively stable.Conclusion: The quality of 23-valent pneumococcal polysaccharide vaccine during 6 years has been improved and maintained in a stable condition.更多还原