人用狂犬病疫苗原代地鼠肾细胞蛋白质国家对照品的建立

Establishment of national control for protein of primary hamster kidney cells used for rabies vaccine for human use

目的建立用于人用狂犬病疫苗(地鼠肾细胞)中地鼠肾细胞蛋白质残留量检测(ELISA法)的国家对照品。方法采用ELISA法,用原代地鼠肾细胞蛋白质标准品(量值为4.0μg/mL)对原代地鼠肾细胞蛋白质对照品进行协作标定赋值,并进行均匀性和稳定性分析。结果协作标定的数据经统计学分析后,原代地鼠肾细胞蛋白质对照品量值为34.7 ng/mL,95%参考范围为(34.7±10.1)ng/mL,该对照品的均匀性和稳定性考察也符合要求。结论建立了人用狂犬病疫苗(地鼠肾细胞)原代地鼠肾细胞蛋白质国家对照品(批号为:250025-201901),以确保检测体系的准确、可靠。

Objective To establish the national control for determination of host cell protein residues in rabies vaccine(hamster kidney cells)for human use(ELISA method). Methods The primary hamster kidney cell protein control was collaboratively calibrated and assigned by ELISA using the standard for primary hamster kidney cell protein of which the measurement was 4. 0 μg/mL,and evaluated for uniformity and stability. Results The primary hamster kidney cell protein control was assigned as 34. 7 ng/mL,of which the 95% reference range was(34. 7 ± 10. 1) ng/mL after statistical processing of the collaboratively calibrated data. The uniformity and stability of the control also met the relevant requirements. Conclusion National primary hamster kidney cell protein control with a lot number of 250025-201901 was established,which ensured the accuracy and reliability of detection system.