【作者】 邵铭； 袁力勇； 刘书珍； 方捍华； 李凤祥； 李长贵； 王军志；

【Author】 SHAO Ming,YUAN Li-yong,LIU Shu-zhen,et al. (National Institute for the Control of Pharmaceutical and Biological Products,Beijing,100050,China)

【机构】 中国药品生物制品检定所；

【摘要】 目的在2009年甲型H1N1流感爆发后,血凝素(HA)含量测定参考品成为疫苗研发的关键制约环节。本研究采用替代方法,以解决这一制约瓶颈,促进我国疫苗及早进入临床研究。方法在前期研究的基础上,各企业采用改良SDS-PAGE方法,测定HA在总蛋白中比例,结合总蛋白含量,计算出疫苗原液中HA含量,用以配制疫苗。之后,以WHO提供的国际参考品对成品疫苗进行复测。结果各企业采用该方法,检测疫苗原液,各原液中总蛋白在372~770μg/ml间,HA比例在32.0～44.3%间,HA含量在105～303μg/ml间。各企业以HA含量指导配制成品疫苗,之后的复测结果证明临床剂量准确。结论本研究成功采用HA含量测定替代方法,促进了我国甲流疫苗的研发,为我国在全球最早批准该疫苗奠定了关键基础。更多还原

【Abstract】 Objective After the outbreak of 2009 pandemic A (H1N1) influenza, vaccine development process was limited by the unavailability of reference materials from WHO. In this study, the alternative methods were used to resolve this problem, hence to boost the development of this vaccine. Methods Manufacturers in China used the established SDS-PAGE method to measure the Haemagglutinin (HA) percentage in vaccine bulks, thus, the HA content can be calculated based on the total protein contents. The exact HA contents of final products were re-tested by SRID using the references materials from WHO. Results For various vaccines bulks, the total protein content are 372~770μg/ml, the ratio of HA in total proteins are 32.0～44.3%, the HA content are 105～303μg/ml, facilitating the formulation of final products for clinical trials. The re-test results proved that the HA content measured by SDS-PAGE were relative accurate. Conclusion The alternative method was successfully applied during the development of 2009 pandemic A (H1N1) influenza vaccine, and consequentially, China approved this vaccines first in the world.更多还原