狂犬病疫苗细胞培养灭活验证实验方法的建立

Validation Test on Inactivation of Rabies Vaccine:Development of Cell Culture Method

目的建立狂犬病疫苗细胞培养灭活验证实验方法。方法将9批狂犬病疫苗样品及含有不同病毒量的CTN病毒悬液在Vero细胞上培养21d,丙酮固定细胞后,采用免疫荧光法检测,同时与小鼠法进行比较;并验证细胞培养法的重复性和灵敏度。结果细胞培养免疫荧光法检测的9批狂犬病疫苗样品结果均为阴性,CTN病毒液均为阳性,与小鼠法检测结果一致。细胞培养法的检测灵敏度可达3.3FFU/ml,重复性良好。结论已建立了狂犬病疫苗细胞培养灭活验证实验方法 ,该法具有良好的灵敏度和重复性,可用于狂犬病疫苗的灭活验证。

Objective To develop a cell culture method for validation of inactivation of rabies vaccine.Methods Nine batches of rabies vaccine samples and CTN virus suspension at various contents were cultured in Vero cells for 21 d then,after fixation of cells with acetone,determined by IFA,and the results were compared with those by mouse method.The reproducibility and sensitivity of the developed cell culture method were verified.Results All the determination results of nine batches of vaccine samples by the developed cell culture method were negative,while all those of CTN virus suspension were positive,which were consistent with the determination results by mouse method.Cell culture method reached a sensitivity of 3.3 FFU /ml and showed high reproducibility.Conclusion A cell culture method was developed,which showed high sensitivity and reproducibility and was suitable for the validation of inactivation of rabies vaccine.