摘要
目的对中国独创的基因重组戊型肝炎(hepatitis E,HE)疫苗Hecolin~?上市后质量的一致性进行评价。方法比较了Hecolin~?批签发疫苗与III期临床试验疫苗的效力试验检测结果,进而通过趋势分析评价Hecolin~?疫苗上市5年来的批间质量一致性。结果批签发疫苗与Ⅲ期临床试验疫苗的体内效力试验结果一致。批签发疫苗体内效力、铝含量、硫柳汞含量、p H等关键指标,中国食品药品检定研究院与企业的趋势分析结果均显示具有较好的一致性。结论趋势分析结果表明,上市后Hecolin~?疫苗批间质量一致性较好,质量稳定。
Objective The objective of this study is to monitor the quality control of global origination-recombinant hepatitis E vaccine （ Hecolin ） after the relevant lieensure. Methods Potency of each released lot from Hecolin was compared with the vaccine reference evaluated in Phase Ⅲ clinical trial. Trend analysis was then applied to evaluate the quality and batch-to-batch consistency of released lots from Hecolin during the past five years after the licensure. Results Efficacy of released lots from Hecolin was consistent with that from Phase Ⅲ clinical trial. Trend analysis with critical quality indexes showed a good consistency including ED50, aluminum hydroxide, thiomersalate, pH in released lots from Hecolin measured both by NIFDC and the vaccine manufacture. Conclusion This retrospective study on quality management of Hecolin showed batch-to-batch consistency in released lots from Hecolin and confirmed the reliability of manufacturing process for Hecolin.
出处
《微生物学免疫学进展》
2017年第2期49-52,共4页
Progress In Microbiology and Immunology
关键词
戊型肝炎
疫苗
批签发
质量控制
Hepatitis E
Vaccine
Lot release
Quality control
