病毒性疫苗渗透压摩尔浓度的质量控制

目的  通过检测6种病毒性疫苗成品的渗透压摩尔浓度，比较不同疫苗检测均值的差异，并观察同种疫苗检测值的批间稳定性，为增加病毒性疫苗质量控制手段提供依据。方法  采用冰点下降法检测麻疹减毒活疫苗、风疹减毒活疫苗、麻疹腮腺炎联合减毒活疫苗、麻疹腮腺炎风疹联合减毒活疫苗、水痘减毒活疫苗、流感病毒裂解疫苗的渗透压摩尔浓度，对检测值进行统计学处理，计算变异系数。以麻疹腮腺炎风疹联合减毒活疫苗的渗透压摩尔浓度检测均值作为对照，进行方差齐性检验及假设检验，比较各疫苗检测均值的差异。结果  麻疹腮腺炎联合减毒活疫苗与对照相比，均值差异无统计学意义（t=1.66，P>0.05）；麻疹减毒活疫苗、风疹减毒活疫苗、水痘减毒活疫苗及流感病毒裂解疫苗与对照相比，均值差异均有统计学意义（Z>1.96，P<0.001）。同种疫苗批间渗透压摩尔浓度较为稳定，变异系数均<3%，变化幅度能控制在90%~110%均值范围内。结论  6种病毒性疫苗渗透压摩尔浓度存在一定差异，但同种疫苗检测值批间稳定性较好，因此，应根据不同疫苗的渗透压摩尔浓度，分别制定质量控制标准。

Quality control of osmolality of viral vaccines

Objective To compare the difference of mean osmolalities among 6 viral vaccines and observe lot-to-lot stability of a single vaccine,and provide a basis for increasing an approach of quality control of viral vaccines.Methods The osmolalities of 5 live attenuated viral vaccines （measles,mumps and rubella combined vaccine,measles and mumps combined vaccine,measles vaccine,rubella vaccine,varicella vaccine） and influenza vaccine （split virion） were determined by a method of freezing point depression.Coefficient of variation was calculated.The mean osmolality of measles,mumps and rubella combined vaccine was used as a control and mean osmolalities of the remaining 5 vaccines were compared with the control by homogeneity test of variance and hypothesis test.Results There was no significant difference of mean osmolalities between measles and mumps combined vaccine and the control （t =1.66,P ＞ 0.05）.The mean osmolalities of measles vaccine,rubella vaccine,varicella vaccine,and influenza vaccine were significantly different from that of the control （Z ＞ 1.96,P ＜0.001）.The lot-to-lot stability of a single vaccine was good.None of the coefficients of variation were more than 3％,and the measurements ranged between 90％ and 110％ of the mean values.Conclusions There are some differences of the osmolalities among 6 viral vaccines,but lot-to-lot stability of a single vaccine is satisfactory.Therefore,corresponding criteria should be set for different vaccines.