乙型脑炎减毒活疫苗检定用BHK21工作细胞库的质量控制

摘要

Objective To comprehensively control quality of BHK21 working cell bank used for Japanese encephalitis vaccine (JEV) to ensure their quality.Methods According to Chinese Pharmacopoeia 2010 edition (Volume Ⅲ),related quality tests were performed for BHK21 working cell bank,including the identification test for cell,tests for bacteria,fungi,mycoplasma and adventitious virus contamination,and virus sensitivity test.Results The isozyme electrophotograms of BHK21 cell sample were consistent with those of standard BHK21 cell.The test results of bacteria,fungi,mycoplasma and adventitious virus contamination were all in accord with related requirements.The detection result of virus sensitivity showed that viral titer of JEV cultured by BHK21 cell sample was 6.93 lgPDF/ml,similar to qualitied BHK21 cell (viral titer of JEV was 6.89 lgPDF/ml),both were in accord with related requirement (6.48-7.12 lgPDF/ml).Conclusion The tested BHK21 cell can be used for detection of JEV to ensure JEV quality.%目的 对乙型脑炎减毒活疫苗(乙脑疫苗)检定用BHK21工作细胞库进行全面质量控制以确保其质量.方法 按照《中华人民共和国药典》2010年版三部收录的细胞鉴别试验、无菌检查、支原体检查、外源病毒污染检查和病毒敏感性检查方法,对检定用BHK21工作细胞库进行全面质量检定.结果 待检BHK21细胞的同工酶电泳图谱与BHK21细胞标准图谱一致.细菌、真菌、支原体、外源病毒检测结果均符合规定要求.病毒敏感性检测显示,待检BHK21细胞培养的乙脑疫苗病毒滴度为6.93 lgPDF/ml,与合格BHK21细胞培养的乙脑疫苗(病毒滴度为6.89 lgPDF/ml)相似,均达到质量标准要求(6.48～7.12 lgPDF/ml).结论 检测合格的BHK21工作细胞库可用于乙脑疫苗的质量检定来保证乙脑疫苗质量.