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目的分析2013~2016年本公司生产的A群C群脑膜炎球菌多糖疫苗关键质量属性的变化趋势,评价产品质量的一致性。方法根据《中国药典》三部(2010及2015版)规定的方法对2013~2016年本公司生产的520批A群C群脑膜炎球菌多糖疫苗的多糖含量(A群磷含量、C群多糖N-乙酰神经氨酸含量)、水分及多糖分子大小等关键质量指标进行检测,应用Minitab数据分析软件对产品关键质量指标的检测结果进行I-MR控制图趋势比较分析、方差分析及工艺能力指数分析。结果 2013~2016年A群C群脑膜炎球菌多糖疫苗的A群磷含量、C群多糖N-乙酰神经氨酸含量、水分及多糖分子大小的检测结果均在国家标准范围内,整体处于稳定状态。结论 A群C群脑膜炎球菌多糖疫苗生产工艺稳定,产品质量一致性良好。
Objective To analyze the trend of the key quality attributes of Group A Group C meningococcal polysaccharide vaccine produced by our company from 2013 to 2016 and evaluate the consistency of product quality. Methods The polysaccharide content of Group A (Group C) C meningococcal polysaccharide vaccine (Group A phosphorus, C group polysaccharide N - acetylneuraminic acid content), water and polysaccharide molecular size and other key quality indicators were detected using Minitab data analysis software product key quality indicators test results I-MR control chart trend comparison analysis, analysis of variance and process capability index . Results The phosphorus content of group A, group C, polysaccharides N-acetylneuraminic acid, the molecular weights of water and polysaccharides of group A meningococcal polysaccharide vaccine between 2013 and 2016 were within the range of national standards, and were in a stable state as a whole . Conclusion Group A meningococcal polysaccharide vaccine production process is stable, consistent product quality.