我国A群C群脑膜炎球菌多糖疫苗有效组分质量趋势分析研究  

Quality trend analysis for effective components of group A and C meningococcal polysaccharide vaccine in China

作　　者：王珊珊[1] 李亚南[1] 赵丹[1] 毛琦琦[1] 陈苏京 李茂光[1] 徐颖华[1] 叶强[1] WANG shanshan;LI Yanan;ZHAO Dan;MAO Qiqi;CHEN Sujing;LI Maoguang;XU Yinghua;YE Qiang(Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,National Institute for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院卫生部生物技术产业检定方法及其标准化重点实验室,北京102629

出　　处：《药物评价研究》2021年第9期1897-1901,共5页Drug Evaluation Research

基　　金：国家重点研发计划项目(2018YFC1603900);医学微生物资源子平台运行与服务(NIMR-2019)。

摘　　要：目的对我国2014—2016年A群C群脑膜炎球菌多糖疫苗有效组分进行质量趋势分析研究。方法收集2014—2016年国内两家企业的送检A群C群脑膜炎球菌多糖疫苗批签发资料,对疫苗有效组分A群和C群多糖含量检测结果进行趋势分析,同时按规定随机抽取一定批次疫苗进行多糖含量测定,并与企业自检结果进行统计学比较分析。结果2014—2016年所有送检疫苗批次的生产及检验记录摘要审查符合标准要求;趋势分析结果显示,各企业的A群和C群多糖含量测定结果均在警戒限(平均值±2SD)以内,环比年度统计学比较分析也未发现显著性差异,趋势平稳,一致性较好;中国食品药品检定研究院对不同批次疫苗多糖含量检测结果与企业自检结果无显著性差异。结论我国的A群C群脑膜炎球菌多糖疫苗产品中多糖含量稳定,批间一致性较好,检验方法可靠,从而确保了上市产品的质量。Object Quality trend analysis for the effective components of group A and C meningococcal polysaccharide vaccine during 2014-2016 in China.Methods The data from group A and C meningococcal polysaccharide vaccine sent to lot release by two domestic manufactories were collected,and the trend analysis for the effective components group A and C polysaccharide content were performed.Meanwhile,some vaccine batches randomly selected,were determined for group A and C polysaccharide content,of which were compared with that of the manufactories for the statistical analysis.Result It was found that all batches of vaccine production and inspection records were in accordance with the standard requirements.The trend analysis showed that almost all results of the group A and group C polysaccharide content from its manufactories were within the alert limit(mean±2 SD).No significant differences were observed in the year-on-year statistical comparison of the group A and group C polysaccharide.The trend was smooth and consistency was better.No significant difference were found in the group A and group C polysaccharide content of different lots determined by NIFDC in comparison with that of manufactories.Conclusion These findings indicate that the polysaccharide content from domestic group A group C meningococcal polysaccharide vaccine is stable and has good consistency between different batches.The test methods are reliable.These should ensure the quality of the vaccine products entered into the markets.

关 键 词：A群C群脑膜炎球菌多糖疫苗 多糖含量 质量 批签发 趋势分析 

分 类 号：R927.11[医药卫生—药学]