《中国药典》重组人干扰素注射剂质量标准浅析

Analysis of specification of recombinant human interferon for injection published in《Chinese Pharmacopoeia》

本文剖析了现行版《中国药典》收载的重组人干扰素注射剂质量标准相关方法、检测限度和历史沿革;对比研究了与国外先进药典如欧洲药典的差距,包括相关物质、相关杂质分析、生物学活性测定结果的统计分析、比活性等方面;介绍了2015年版《中国药典》拟增修订主要内容,如增订报告基因法检测干扰素生物学活性、增订定量PCR法检测外源DNA残留量,加强"理化对照品"的管理,相关检定机构对国内生产企业的理化对照品进行了标定。本文还探讨了提高该类制品质量标准的主要方向。

In this paper ,the specification and its history of recombinant human interferon for injection published in current version of 《 Chinese Pharmacopoeia》 were analysed .The comparative study was carried out with the davanced Pharmaco-poeia, such as 《European Pharmacopoeia》, it showed some differences between《Chinese Pharmacopoeia》and 《European Pharmacopoeia》including analysis of related substances , statistical analysis of bioassay and potency per millilitre .The dis-ired revisions added to《Chinese Pharmacopoeia 》2015 edition （ draft） was introduced ,including adding reporter gene meth-od for interferon potency assay and Q-PCR method for detection of residual extraneous DNA .National regulatory laboratory has calibrated the reference substances in strengthening the standard substances .Here the major developing direction of biotech products was investigated too .