CAJ | 학술논문

按照国家一级标准物质要求和禽流感病毒（ H5亚型）血凝抑制试验抗原制造及检验规程规定的抗原制备方法，研制了一批禽流感病毒（ H5亚型）血凝抑制抗原国家参考品，用于检测禽流感病毒（ H5亚型）制品生物效价和血凝抑制操作过程中的校验。该批抗原经过8家单位对其协作标定后对结果进行统计学分析，确定该批禽流感抗原的血凝效价为1∶80。另对所研制的禽流感抗原均一性、稳定性、无菌检验、剩余水分测定、真空度测定等各项指标进行检测，结果均符合禽流感病毒（ H5亚型）血凝抑制试验抗原制造及检验规程和国家一级标准物质要求，说明该禽流感病毒（ H5亚型）血凝抑制抗原可以作为国家参考品。
안조국가일급표준물질요구화금류감병독（ H5아형）혈응억제시험항원제조급검험규정규정적항원제비방법，연제료일비금류감병독（ H5아형）혈응억제항원국가삼고품，용우검측금류감병독（ H5아형）제품생물효개화혈응억제조작과정중적교험。해비항원경과8가단위대기협작표정후대결과진행통계학분석，학정해비금류감항원적혈응효개위1∶80。령대소연제적금류감항원균일성、은정성、무균검험、잉여수분측정、진공도측정등각항지표진행검측，결과균부합금류감병독（ H5아형）혈응억제시험항원제조급검험규정화국가일급표준물질요구，설명해금류감병독（ H5아형）혈응억제항원가이작위국가삼고품。
According to the related national standards and the rules of the avian influenza virus ( AIV, H5 subtype) hemagglutination inhibition test antigen, national reference material for AIV ( H5 subtype ) HI test antigen was prepared. The reference product is used for detecting AIV ( H5 subtype) products biological titer and calibration in the process of HI test. The HA titer of the reference product was studied collaboratively by 8 laboratories and the result was estimated by the statistical methods. The HA titer of this preparation was confirmed as 1 ∶ 80. Appearance, sterility, specificity, residual moisture, vacuum degree, uniformity and stability were detected, and the results conformed to the rules. The reference product can be used as national reference material.