Objective: To evaluate the quality of the Japanese encephalitis inactivated vaccine strain adapted in human diploid cells (ZFB-3). Methods: The virus strain was identified by identification test to determine whether it was Japanese encephalitis virus strain, the virus titer was tested in mice brain to evaluate the adaptability and proliferation ability of the virus seed on human diploid cells (ZFB-3), the sterility test, mycoplasma test, and external virus factor test was conducted for any external contamination. Results: The virus strain was proved as Japanese encephalitis virus and had been well adapted to human diploid cells (ZFB-3) with high virus titer. The virus strain was free from contamination by bacteria, fungi, mycoplasma or exogenous viral factors. Conclusion: The quality of Japanese encephalitis inactivated vaccine strain adapted in human diploid cells (ZFB-3) meets the requirements and can be applied to vaccine production.
XU Hong-shan, SHEN Hui-li, FU Rui, LIU Xin-yu, LI Yu-hua, YE Qiang
. Quality evaluation of Japanese encephalitis inactivated vaccine strain in human diploid cells[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(3)
: 542
-546
.
DOI: 10.16155/j.0254-1793.2024.03.20
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