中国药典、欧洲药典和WHO草案甲、乙型肝炎疫苗质量控制标准与方法的比较

分析2010年版中国药典甲、乙肝疫苗标准部分修订及新增内容,并与欧洲药典6.0版甲、乙肝疫苗标准(以下简称欧洲药典)和WHO 2010年生物制品标准化专家会议"确保重组乙肝疫苗质量、安全性、效力的建议"草案(以下简称WHO草案)比较,2010年版中国药典甲、乙肝疫苗部分在生产工艺、质量标准、产品稳定性等方面的标准要求较2005年版中国药典有较大的提高,对于残留有害物质的控制进一步加强;欧洲药典和WHO草案对疫苗原液的比活提出了明确要求,对乙肝疫苗要求进行糖、脂成分测定。在今后药典的标准提高方面,应加强疫苗产品的比活及糖、脂质等方面标准和方法的研究,制定相应标准,保证疫苗的质量。

Amendments on the standards of hepatitis A and hepatitis B vaccines in Chinese pharmacopoeia (ChP) 2010 edition were analyzed and compared with corresponding parts in European pharmacopoeia (EP) version 6.0 and WHO Draft of Recommendations to Assure the Quality,Safety and Efficacy of Recombinant Hepatitis B Vaccines for Expert Committee on Biological Standardization (WHO Draft).Major improvements were introduced on the standards of hepatitis A and hepatitis B vaccines for manufacturing process,specifications,stability of products.Controlling of residual hazardous substances was strengthened.Specific requirements on relative activity of bulk were listed in EP and WHO Draft.Tests for the contents of carbohydrates and lipids were required for hepatitis B vaccine.In the future,researches on the standards and methods of relative activity and the contents of carbohydrates and lipids should be strengthened in the improvements on the standards of ChP to insure the qualities of vaccine.