目的 對我國2014—2016年A群C群腦膜炎球菌多糖疫苗有效組分進行質量趨勢分析研究。方法 收集2014—2016年國內兩家企業(yè)的送檢A群C群腦膜炎球菌多糖疫苗批簽發(fā)資料，對疫苗有效組分A群和C群多糖含量檢測結果進行趨勢分析，同時按規(guī)定隨機抽取一定批次疫苗進行多糖含量測定，并與企業(yè)自檢結果進行統計學比較分析。結果 2014—2016年所有送檢疫苗批次的生產及檢驗記錄摘要審查符合標準要求；趨勢分析結果顯示，各企業(yè)的A群和C群多糖含量測定結果均在警戒限（平均值±2SD）以內，環(huán)比年度統計學比較分析也未發(fā)現顯著性差異，趨勢平穩(wěn)，一致性較好；中國食品藥品檢定研究院對不同批次疫苗多糖含量檢測結果與企業(yè)自檢結果無顯著性差異。結論 我國的A群C群腦膜炎球菌多糖疫苗產品中多糖含量穩(wěn)定，批間一致性較好，檢驗方法可靠，從而確保了上市產品的質量。

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 ±2SD). 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.

R927.11

國家重點研發(fā)計劃項目（2018YFC1603900）和醫(yī)學微生物資源子平臺運行與服務（NIMR-2019）