铝吸附流感疫苗中血凝素含量检测方法的建立

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。

Development of A Method for Determination of Hemagglutinin Content in Pandemic Influenza Vaccine Containing Aluminium Adjuvant

Objective To develop a method for determination of hemagglutinin (HA) content in pandemic influenza vaccine containing aluminium adjuvant.Methods Dissociate pandemic influenza vaccine containing aluminium adjuvant with various dissociation buffers under different conditions and determine the HA content in the vaccine by single radial immunodiffusion (SRID) method.Compare the recovery results and verify the selected dissociation method.Results The recovery rates of HA by using dissociation buffers A and B were 71%～80% and 96%～110% respectively.The condition for determination of HA in vaccine by SRID was optimized as dissociation with buffer B at room temperature for 2 h.Both the inter- and intra-coefficients of variation of the method were less than 20%.Conclusion The dissociation combined with traditional SRID was of good reproducibility and high accuracy in determination of HA content in pandemic influenza vaccine containing aluminium adjuvant,and might substitute for animal potency test.