2008—2012年麻疹减毒活疫苗的质量分析

目的对中国2008—2012年连续5年麻疹减毒活疫苗(简称麻疹疫苗)的批签发情况进行总结,评价其麻疹疫苗的总体质量。方法通过对送检样品的资料审查和关键项目的实验室检定,采用趋势分析法对病毒滴度等进行分析和比较,回顾麻疹疫苗质量的整体情况。结果中国麻疹疫苗整体质量较好,批签发通过率为98.6%。疫苗关键指标数据稳定,病毒滴度100%符合国家标准,其中8批疫苗病毒滴度由于超过警戒线企业主动撤检。结论中国麻疹减毒活疫苗的质量稳中有升。国家疫苗批签发程序对确保上市疫苗的质量发挥重要作用,趋势分析在批签发中的应用更加严格保证了上市疫苗的安全性和有效性。

Analysis of quality control for measles vaccine,live, from 2008 to 2012

Objective To summarize results for the quality control and discuss the quality status of measles vaccine, live, applied for lot release from 2008 to 2012. Methods By reviewing the lots summary protocol and testing the crucial items, in combination with trend analysis, the comprehensive quality for measles vaccine ~ live, was analyzed. Results The qual- ity for domestic measles vaccine, live was consistent during the recent 5 years, the ratio of obtained certification of lot re- lease is 98.6%. The virus titers of all lots are satisfied with the acceptance criteria of 2010 Chinese Pharmacopoeia, but eight lots were withdrawn by manufactures because of out of trend. Conclusion The data presented here demonstrate that safety and efficiency for the domestic measles vaccine, live on market are guaranteed by the improvement of the vaccine quality and production process, lot release program and the application of trend analysis.