亚单位流感疫苗中裂解剂壬苯醇醚-9含量两种检测方法的比较

目的比较高效液相色谱法(HPLC)和紫外分光光度法检测亚单位流感疫苗中裂解剂壬苯醇醚-9含量的效果。方法分别采用HPLC法和紫外分光度法检测亚单位流感疫苗中间体和成品中壬苯醇醚-9的含量,并取中间体进行SDS-PAGE分析。结果紫外分光光度法测定亚单位流感疫苗成品和中间体的壬苯醇醚-9含量比HPLC法高10%以上,测定中间体3壬苯醇醚-9含量的结果差异更显著;SDS-PAGE分析显示中间体1、2、3的核蛋白(NP)含量差异显著,大多数存在于中间体3中。结论 HPLC法可代替紫外分光光度法检测亚单位流感疫苗中裂解剂壬苯醇醚-9的含量。

Determination of content of nonoxynol-9 as a cleavage reagent in influenza virus subunit vaccine by two methods

Objective To compare the determination results of content of nonoxynol-9 as a cleavage reagent in influenza virus subunit vaccine by HPLC and UV spectrophotometry.Methods The nonoxynol-9 contents in intermediate and final product of influenza virus subunit vaccine were determined by HPLC and UV spectrophotometry separately,and the intermediate was analyzed by SDS-PAGE.Results The nonoxynol-9 contents in intermediate and final product,especially in intermediate,of influenza virus subunit vaccine determined by UV spectrophotometry increased by more than 10% as compared with those by HPLC.SDS-PAGE showed the nucleoprotein(NP) contents were significantly different in intermediates 1,2 and 3,which was the highest in intermediate 3.Conclusion HPLC may be used for determination of nonoxynol-9 content in influenza virus subunit vaccine instead of UV spectrophotometry.