Sabin株脊髓灰质炎灭活疫苗(Vero细胞)渗透压摩尔浓度的质量分析

Quality analysis on osmol concentration of inactivated poliomyelitis vaccine prepared with Sabin strain(Vero cells)

目的分析Sabin株脊髓灰质炎灭活疫苗(Vero细胞)渗透压的摩尔浓度。方法选取本所2016~2018年1季度生产的92批次Sabin株脊髓灰质炎灭活疫苗(Vero细胞)[inactivated poliomyelitis vaccine made from Sabin strains(Vero cells),sIPV],采用渗透压摩尔浓度测定仪检测其渗透压摩尔浓度,并对检测数据进行正态性检验。结果 2016~2018年生产的92批sIPV渗透压摩尔浓度数据符合正态分布(P> 0. 05),渗透压摩尔浓度均值为330. 38 mOsmol/kg,标准差为9. 38 mOsmol/kg。生产初期(2016年)与现阶段(2017~2018年)生产的sIPV渗透压摩尔浓度差异无统计学意义(P> 0. 05)。结论 sIPV渗透压摩尔浓度变化趋于稳定状态,本研究为该产品渗透压摩尔浓度限度标准的制定提供了实验依据。

Objective To analyze the osmol concentration of inactivated poliomyelitis vaccine prepared with Sabin strain(Vero cells).Methods A total of 92 batches of inactivated poliomyelitis vaccine prepared with Sabin strains(sIPV)by the Institute of Medical Biology from 2016 to the first quarter of 2018 were determined for osmol concentration by osmol concentration analyzer,and the obtained data were subjected to normality test.Results The data on osmol concentration of sIPV showed a normal distribution(P>0.05),of which the mean was 330.38 mOsmol/kg,with a standard deviation of 9.38 mOsmol/kg.However,the osmol concentrations of sIPV manufactured in 2016 and in 2017~2018 showed no significant difference(P>0.05).Conclusion The change of osmol concentration of sIPV showed a static tendency,which provided an experimental basis for the formulation of limit standard of osmol concentration of the product.