带状疱疹减毒活疫苗原液制备过程温度参数的比较

Comparison of Temperature Parameters in the Preparation of Live Vaccine of Live Attenuated Herpes Zoster

目的:确定带状疱疹减毒活疫苗原液制备的冻融温度参数。方法:将制备的带状疱疹减毒活疫苗病毒收获物分别置于2~8℃及室温(26℃)条件下融化,两组样品共同经冻撞破碎、滤过,抽样备检,然后进行分装冻干。按2015版《药典三部》水痘减毒活疫苗的检测项目及本企业拟定的《带状疱疹生产及检定规程》进行原液、成品、病毒滴度及热稳定性进行检定。结果经2~8℃冻融样品结果与室温条件下冻融的样品结果相比较,2~8℃冻融时间为室温冻融的3倍,原液滴度、热稳定性及成品稳定性检测显示,均未见差异。结论:带状疱疹减毒活疫苗制备工艺中,原液样品收获后,在置室温温度冻融的条件下,病毒滴度及热稳定性结果不受影响。

Objective: To determine the freezing and thawing temperature parameters of the preparation of live attenuated herpes simplex vaccine. Methods: The prepared shrimp attenuated live virus virus was melted at 2 ~ 8℃ and room temperature(26℃) respectively. The two groups were crushed by crushing, filtering, sampling and then packing Lyophilized. According to the 2015 version of 'Pharmacopoeia three' varicella live attenuated vaccine test project and the enterprise to develop the 'herpes zoster production and verification procedures' for the liquid, finished product, virus titer and thermal stability test. Result: the results of freezing and thawing at 2 ~ 8℃ were compared with the results of freeze-thawing at room temperature. The freezing-thawing time at 2 ~ 8℃ was 3 times of freezing and thawing at room temperature, and the titer, thermal stability and finished product stability Show, no difference. Conclusion: In the preparation process of live attenuated herpes simplex vaccine, the results of freezing and thawing at room temperature, virus titer and thermal stability were not affected.