麻疹、腮腺炎、风疹(人二倍体细胞)减毒活疫苗病毒滴度质控品长期稳定性评价  

Long-Term Stability Evaluation of Viral Titer Quality Controls for Live Attenuated Vaccines for Measles,Mumps,and Rubella(Human Diploid Cells)

作　　者：果丽曼 贺胤博 白杨 刘辉 王笑巍 张怡 简哲 邱梅 王刚 陆梦溪 GUO Liman;HE Yinbo;BAI Yang;LIU Hui;WANG Xiaowei;ZHANG Yi;JIAN Zhe;QIU Mei;WANG Gang;LU Mengxi(Beijing Institute of Biological Products Co.,Ltd.,Beijing 100176,China)

机构地区：[1]北京生物制品研究所有限责任公司,北京100176

出　　处：《生物化工》2025年第1期89-94,共6页Biological Chemical Engineering

摘　　要：目的:评价冻干麻疹、腮腺炎、风疹(人二倍体细胞)减毒活疫苗病毒滴度质控品效期内稳定性。方法:分别对效期内3年(2020—2023年)和效期后1年(2024年)保存于-40℃的冻干麻疹、腮腺炎、风疹(人二倍体细胞)减毒活疫苗病毒滴度质控品进行外观、水分含量、病毒滴度检定,汇总3种冻干质控品数据资料,并对病毒滴度结果进行统计学分析;对2020—2024年病毒滴度结果进行整体趋势分析,同时对3种冻干质控品病毒滴度结果进行稳定性分析。结果:冻干麻疹、腮腺炎、风疹(人二倍体细胞)减毒活疫苗病毒滴度质控品外观均符合企业规定;2020—2024年质控品水分含量均不高于3.0%,符合企业要求。病毒滴度结果显示,2020—2023年冻干麻疹、腮腺炎、风疹(人二倍体细胞)减毒活疫苗病毒滴度质控品病毒滴度均值分别为(4.46±0.13)lgCCID_(50)/mL(S_(R)=2.91%)、(5.41±0.12)lgCCID_(50)/mL(S_(R)=2.22%)、(4.59±0.12)lgCCID_(50)/mL(S_(R)=2.61%),2024年各冻干质控品病毒滴度均值分别为(4.42±0.11)lgCCID_(50)/mL(S_(R)=2.49%)、(5.38±0.12)lgCCID_(50)/mL(S_(R)=2.23%)、(4.52±0.12)lgCCID_(50)/mL(S_(R)=2.65%),以上病毒滴度结果均在质控品允许范围内。对病毒滴度进行单因素方差分析、独立样本t检验,发现p值均大于0.05,无统计学意义。结论:冻干麻疹、腮腺炎、风疹(人二倍体细胞)减毒活疫苗病毒滴度质控品在3年效期内具有良好的稳定性。本研究可为疫苗的质量控制、检测方法校准和监管提供可靠的依据,有利于确保疫苗质量的稳定性和一致性。Objective:To evaluate the stability of viral titers and quality control products of freeze-dried live attenuated measles,mumps and rubella(human diploid cells)during the validity period.Methods:The viral titer of the lyophilized live attenuated measles,mumps and rubella(human diploid cell)vaccines stored at-40℃for 3 years(2020—2023)and 1 year(2024)within the validity period are evaluated,and the data of the three lyophilized controls are summarized,and the viral titer results are statistically analyzed.The overall trend analysis of the viral titer results from 2020 to 2024 is carried out,and the stability analysis of the viral titer results of the three lyophilized quality controls is carried out.Results:The appearance of the viral titer control of freeze-dried live attenuated vaccine for measles,mumps and rubella(human diploid cell)all met the requirements of the enterprise.From 2020 to 2024,the moisture content of quality control products will not be higher than 3.0%,which meets the requirements of enterprises.The results of viral titer show that the mean viral titers of the live attenuated measles,mumps,and rubella(human diploid cells)live attenuated vaccines from 2020 to 2023 are(4.46±0.13)lgCCID_(50)/mL(S_(R)=2.91%),(5.41±0.12)lgCCID_(50)/mL(S_(R)=2.22%),and(4.59±0.12)lgCCID_(50)/mL(S_(R)=2.61%),respectively.In 2024,the mean viral titers of each lyophilized control are(4.42±0.11)lgCCID_(50)/mL(S_(R)=2.49%),(5.38±0.12)lgCCID_(50)/mL(S_(R)=2.23%),and(4.52±0.12)lgCCID_(50)/mL(S_(R)=2.65%),respectively.One-way ANOVA and independent sample t-test are used to test the viral titers,and the p values are all greater than 0.05,which is not statistically significant.Conclusion:The viral titer control of freeze-dried live attenuated vaccine for measles,mumps and rubella(human diploid cell)has good stability within 3 years of validity.This study can provide a reliable basis for the quality control,calibration and supervision of vaccines,and help ensure the stability and consistency of vaccine quality.

关 键 词：病毒滴度质控品 外观 水分含量 病毒滴度 效期稳定性监测 

分 类 号：R511.1[医药卫生—内科学] R181.3[医药卫生—临床医学]