公开(公告)号：KR101258652B1

公开(公告)日：2013-04-29

申请号：KR1020110018962

申请日：2011-03-03

Applicant: 대한민국 (식품의약품안전처장)

Inventor： 김승희 ,  김동섭 ,  안치영 ,  박윤주 ,  최미라 ,  노항식

IPC: G01N33/68 ,  G01N33/53 ,  G01N30/88

Abstract: 본 발명은 크기 배제 크로마토그래피 방법(size exclusion high performance liquid chromatography, SE-HPLC)을 이용하여 표준항원과 표준항체가 없어도 인플루엔자 백신의 헤마글루티닌의 정량을 가능하게 한 방법으로, 기존에 인플루엔자 백신의 헤마글루티닌을 정량하는 방법인 방사면역확산법(single radial immunodiffusion technique, SRID)보다 헤마글루티닌의 농도를 확인하는 시간이 현저하게 단축되었으면서도 정량 정확도는 더 높아진 헤마글루티닌의 정량 방법이다.

公开(公告)号：KR1020120100214A

公开(公告)日：2012-09-12

申请号：KR1020110018962

申请日：2011-03-03

Applicant: 대한민국 (식품의약품안전처장)

Inventor： 김승희 ,  김동섭 ,  안치영 ,  박윤주 ,  최미라 ,  노항식

IPC: G01N33/68 ,  G01N33/53 ,  G01N30/88

Abstract: PURPOSE: A quantitative analysis of hemagglutinin of influenza vaccine is provided to quantifying the hemagglutinin of influenza vaccine without standard antigen and standard antibody. CONSTITUTION: A quantitative analysis of hemagglutinin of influenza vaccine comprises the following steps: separating a standard antigen the concentration in which hemagglutinin concentration is known by using the size exclusion chromatography; separating influenza vaccines in which the hemagglutinin concentration is not know by using the size exclusion chromatography under the same condition as the first step; calculating area of peaks which show the antigen-antibody reactions by using the result of the size exclusion chromatography of the standard antigen in the first step; calculating the area of peaks corresponding to the peaks in the third step by using the size exclusion chromatography result of the influenza vaccine; multiplying by the hemagglutinin return concentration of the standard antigen in the first step after dividing the outcome of the fourth step into the outcome of the third step; and calculating concentration correcting value which is the difference of converted value of each peak area, in which the antigen-antibody reaction is displayed based on 1 micro gram of hemagglutinin performing the size exclusion chromatography is using the standard antigen provided in the first step and performing the size exclusion chromatography by using the influenza vaccine which can checks the concentration of the hemagglutinin; and dividing the result of the fifth step by the concentration correction value of the hemagglutinin of the influenza vaccine in the sixth step.

Abstract translation: 目的：提供流感疫苗血凝素的定量分析，以量化没有标准抗原和标准抗体的流感疫苗血凝素。 构成：流感疫苗血凝素的定量分析包括以下步骤：使用尺寸排阻色谱法分离标准抗原血凝素浓度的浓度; 通过在与第一步相同的条件下使用尺寸排阻色谱法分离其中血凝素浓度不知道的流感疫苗; 通过使用第一步中标准抗原的大小排阻色谱的结果计算显示抗原 - 抗体反应的峰的面积; 通过使用流感疫苗的大小排阻色谱结果计算与第三步骤中的峰对应的峰的面积; 在将第四步骤的结果除以第三步骤的结果之后，将标准抗原的血凝素返回浓度乘以第一步骤; 并且基于进行大小排阻色谱的1微克血凝素显示出其中显示抗原 - 抗体反应的每个峰面积的转化值的差异的浓度校正值是使用第一步中提供的标准抗原，并进行 通过使用可以检查血凝素浓度的流感疫苗的大小排阻色谱法; 并且将第五步骤的结果除以流感疫苗的血细胞凝集素的浓度校正值。