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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。
OBJECTIVE: To statistically analyze five quantitative test indexes of 140 batches of 23-valent pneumococcal polysaccharide vaccine produced in 2006-2011, and provide basis for quality evaluation and quality control of the vaccine. Methods: The test results of the five batches of polysaccharide content, phenol content, sodium chloride content, pH value and bacterial endotoxin test of 140 batches of 23-valent pneumococcal polysaccharide vaccine produced in 2006-2011 were statistically analyzed. Type polysaccharides content of mobile standard deviation analysis; on the phenol content, sodium chloride content, pH value, bacterial endotoxin test indicators for moving average of the overall trend analysis. Results: In the past 6 years, the difference of polysaccharide content of 23-valent pneumococcal polysaccharide vaccine gradually decreased. The mean of phenol content, sodium chloride content and bacterial endotoxin decreased gradually and stabilized, and the pH value was stable. Conclusion: The quality of 23-valent pneumococcal polysaccharide vaccine produced in 2006-2011 gradually increased and remained stable.