2015—2020年口服轮状病毒活疫苗的趋势分析和质量评价  

Trend analysis and quality evaluation of oral rotavirus(live)vaccine from 2015 to 2020

作　　者：张丽君 石岩 刘东梅 刘晨鸣 刘晓凡 Zhang Lijun;Shi Yan;Liu Dongmei;Liu Chenming;Liu Xiaofan(Quality Assurance Department,Lanzhou Institute of Biological Products Co.,Ltd.,Lanzhou 730046,China)

机构地区：[1]兰州生物制品研究所有限责任公司质量保证部,730046

出　　处：《国际生物制品学杂志》2021年第5期259-262,共4页International Journal of Biologicals

摘　　要：目的统计分析我国2015—2020年口服轮状病毒活疫苗质量属性检测数据,评价其质量可控性和工艺稳定性。方法根据口服轮状病毒活疫苗注册标准和中国药典(2010、2015、2020年版)规定的方法对634批口服轮状病毒活疫苗的病毒滴度、热稳定性、抗生素残留量、渗透压以及pH进行检测,应用Minitab和GraphPad数据软件对检测结果进行单值移动极差控制图分析、方差分析和箱线图分析。结果2015—2020年634批口服轮状病毒活疫苗的病毒滴度均在每毫升5.5~7.0 lg半数细胞培养物感染量(50%cell culture infectious does,CCID_(50)),热稳定性试验病毒滴度均不低于5.5 lgCCID_(50)/ml、滴度下降不大于1.0 lg CCID_(50)/ml、抗生素残留量、渗透压以及pH均在国家标准范围及企业内控标准范围内。结论2015—2020年的口服轮状病毒活疫苗产品有较好的质量可控性,生产工艺稳定。Objective To analyze the quality attribute data of oral rotavirus(live)vaccine from 2015 to 2020 and evaluate its quality controllability and process stability.Methods According to the registration standard of oral rotavirus(live)vaccine and Chinese pharmacopoeia(versions 2010,2015,2020),634 batches of oral rotavirus(live)vaccine were tested for virus titer,thermal stability,antibiotic residues,osmotic pressure and pH,then the test results was analyzed by individual and moving range charts,variance analysis and box-plot analysis with Minitab and GraphPad.Results The virus titer,thermal stability,antibiotic residue,osmotic pressure and pH of 634 batches oral rotavirus(live)vaccine from 2015 to 2020 were all within the range of national standard and enterprise internal control standard.The virus titer was in the range of 5.5-7.0 lg 50%cell culture infectious dose(CCID_(50))per ml.The thermal stability titers were no less than 5.5 lgCCID_(50)/ml and virus titer decline was no less than 1.0 lgCCID_(50)/ml.Conclusion Oral rotavirus(live)vaccines from 2015 to 2020 show good quality controllability and stable production process.

关 键 词：轮状病毒疫苗 方差分析 箱线分析 趋势分析 

分 类 号：R373.2[医药卫生—病原生物学]