戊型肝炎疫苗抗原国家标准品的建立  

Establishing national standard for hepatitis E vaccine antigen content

作　　者：高帆[1] 卞莲莲[1] 么山山[1] 毛群颖[1] 梁争论[1] 吴星[1] GAO Fan;BIAN Lian-lian;YAO Shan-shan;MAO Qun-ying;LIANG Zheng-lun;WU Xing(National Institute for Food and Drug Control,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院、国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室、国家药品监督管理局生物制品质量研究与评价重点实验室,北京102629

出　　处：《中国病毒病杂志》2022年第6期433-436,共4页Chinese Journal of Viral Diseases

基　　金：中国医学科学院医学与健康科技创新工程(2021-I2M-5-005)。

摘　　要：目的建立戊型肝炎疫苗抗原国家标准品,用于我国戊型肝炎疫苗质量控制。方法选取一批戊型肝炎疫苗原液为标准品原料制备候选标准品(编号CS),进行均匀性和稳定性检测,并分发给3个实验室进行协作标定和适用性研究。结果CS均匀性结果显示分装精度为0.7%;抗原含量均匀性CV值为6.8%;水分含量为0.4%。稳定性结果显示CS具有较好的加速稳定性和复溶稳定性。协作标定共获得16个有效数据,结果显示CS平均值为259271 YU/支[95%CI:(259271±5768)YU/支],实验室内CV值为2.8%~6.9%,实验室间CV值为4.5%。依据3个实验室完成的协作标定结果,将CS赋值260000 U/支。以CS为标准检测企业自制样品均显示较好的平行性和线性。结论本研究建立了首个戊型肝炎疫苗抗原国家标准品(300051-202101),可用于我国戊型肝炎疫苗质量控制。Objective To establish the hepatitis E vaccine antigen content national standard for the quality control of hepatitis E vaccine.Methods One lot of hepatitis E vaccine bulk was selected as the raw material to produce the candidate standard(CS),the homogeneity and stability of CS were tested.Meanwhile,CS was distributed to three laboratories for collaborative calibration and applicability study.Results The results of homogeneity assessment showed that the aliquot accuracy was 0.7%,the antigen content homogeneity CV was 6.8%and the moisture content was 0.4%.The stability results showed decent acceleration stability and reconstitution stability of CS.A total of 16 valid parameters were obtained from the collaborative calibration.The results showed that the average value of CS was 259271 YU/ampoule[95%CI:(259271±5768)YU/ampoule]with 2.8%—6.9%of intra-laboratory CV and 4.5%of inter-laboratory CV.Based on the collaborative calibration results provided by three laboratories,the assigned value of CS was 260000 U/ampoule.When using CS as reference material to test samples prepared by manufactures,good parallelism and linearity were observed.Conclusions The first Chinese national standard for hepatitis E vaccine antigen content(300051-202101)has been established,which can be used for quality control of hepatitis E vaccine in China.

关 键 词：戊型肝炎 疫苗 抗原含量 国家标准品 

分 类 号：R512.6[医药卫生—内科学]