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目的建立铝吸附流感疫苗中血凝素(HA)含量的检测方法。方法选用不同的解离液,在不同的条件下对铝吸附疫苗进行解离,以单向免疫扩散法(SRID)检测血凝素含量,比较回收效果,并对选取的解离方法进行初步验证。结果经解离液A处理后,测定HA的回收率为71%～80%,而解离液B的回收率在96%～110%之间。对不同温度、作用时间等考察,最终确定以解离液B在室温解离2h后进行检测。该方法试验内和试验间变异系数均小于20%。结论采用解吸附结合传统SRD方法测定铝吸附流感疫苗中HA含量,重复性好,准确度高,可代替动物接种法。
Objective To establish a method for the determination of hemagglutinin (HA) in aluminum-adsorbed influenza vaccine. Methods Different dissociation solutions were used to dissociate the aluminum-adsorbed vaccine under different conditions. The hemagglutinin content was detected by one-way immunodiffusion (SRID), and the recovery effect was compared. The selected dissociation method was preliminarily verified . Results After dissociation solution A treatment, the recovery of HA was 71% -80%, while the recovery of dissociation solution B was between 96% and 110%. For different temperatures, the role of time and other investigations, and ultimately determine the dissociation solution B dissociation at room temperature 2h after the test. The coefficient of variation (CV) between the method and the experiment was less than 20%. Conclusion The method of desorption combined with the traditional SRD method for determination of HA content in aluminum-adsorbed influenza vaccine has good repeatability and high accuracy, which can replace the animal vaccination method.