Establishment of antigen reference material for inactivated tick-borne encephalitis vaccine
10.13200/j.cnki.cjb.004326
- VernacularTitle:森林脑炎灭活疫苗抗原参考品的建立
- Author:
LIANG Jiaqi
- Publication Type:Journal Article
- Keywords:
Inactivated tick-borne encephalitis vaccine;
Antigen content;
Reference materials;
Quality control
- From:
Chinese Journal of Biologicals
2024;37(11):1281-1285+1293
- CountryChina
- Language:Chinese
-
Abstract:
目的 建立森林脑炎灭活疫苗抗原参考品，以期准确定量检测疫苗的抗原含量。方法 将森林脑炎灭活疫苗原液与冻干保护剂按1∶1的体积分数混合，经冻干，制备为候选参考品，并检测其装量均匀性及抗原均匀性。经3个实验室协作标定，对抗原定量检测结果进行统计并赋值，验证参考品的稳定性及适用性。结果 24瓶候选参考品装量均值为0.497 g/瓶，分装精度为0.48%;7瓶候选参考品抗原含量均值为50.990 EU/支，CV为7.3%。3个实验室协作标定候选参考品抗原含量均值为52.464 EU/支[95%CI:(52.464±3.807)EU/支]，同一实验室CV为7.3%～13.3%，不同实验室之间CV为14.1%。候选参考品赋值为50 EU/支。参考品具有良好的加速稳定性、复溶稳定性及冻融稳定性。以该参考品为标准品，检测森林脑炎灭活疫苗病毒收获液、原液、解析附后疫苗均显示较好的平行性和线性关系（R~2均> 0.99）。结论 建立的森林脑炎灭活疫苗抗原参考品具有良好的稳定性，可用于森林脑炎灭活疫苗的质量控制。
Objective To establish an antigen reference material for the inactivated tick-borne encephalitis vaccine, in order to quantitatively detect the antigen content of vaccines accurately. Methods The inactivated tick-borne encephalitis vaccine stock solution was mixed with lyophilized protective agent in equal volume, and prepared as a candidate reference after lyophilized, which was detected for the loading uniformity and antigen uniformity. After the cooperative calibration of three laboratories, the results of antigen detection were statistically analyzed and assigned, and the stability and applicability of the reference material were verified. Results The average loading capacity of 24 pieces of candidate reference material was0. 497 g/piece, with the sub-packaging accuracy of 0. 48%. The average antigen content of 7 pieces of candidate reference material was 50. 990 EU/piece, with the CV of 7. 3%. The average antigen content calibrated by the three laboratories was52. 464 EU/piece [95% CI:(52. 464 ± 3. 807) EU/piece], the intra-assay CVs were 7. 3%-13. 3%, and the inter-assay CV of different laboratories was 14. 1%. The candidate reference was assigned a value of 50 EU/piece. The reference material had good accelerated stability, resolvation stability and freeze-thaw stability. Using the reference material as the standard, the results showed good parallelism and linear relationship(each R~2> 0. 99) in the virus harvested solution, stock solution and unattached vaccine of inactivated tick-borne encephalitis vaccine. Conclusion The established antigen reference material of inactivated tick-borne encephalitis vaccine has good stability and can be used for the quality control of inactivated tickborne encephalitis vaccine.
