2013 年重组人干扰素alpha2b 注射剂评价性抽验质量分析

目的:评价国产重组人干扰素α2b注射剂的质量现状及存在问题。方法:采用法定检验方法结合探索性研究进行样品检验,统计分析检验结果,对国产重组人干扰素α2b注射剂的质量现状进行评价。结果:法定检验显示92批成品91批合格,合格率98.9%;24批原液20批合格(部分检验),合格率83.3%;探索性研究表明,按欧洲药典标准在原液中增加相关蛋白含量测定,则有两家企业的产品符合要求。结论:该品种总体质量状况良好,现行检验标准基本可行,建议在原液中增加相关蛋白含量检测。

Sampling Results and Quality Assessment of Recombinant Human Interferon alpha-2b Injection in 2013

Objective:To evaluate the quality status of recombinant human interferon alpha2b injection and find out some quality problems.Methods:Statutory testing methods combined with the exploratory studies were used to examine samples, and the quality status of recombinant human interferon alpha2b injection was evaluated by statistical analysis of the results.Results:91 of 92 batches of drug products were qualified using statutory testing methods, and the passing rate was 98.9%. 20 of 24 batches of bulks were qualified using part of statutory testing methods, and the passing rate was 83.3%. Exploratory studies showed that when related protein content determination was added in stock solution according to the European Pharmacopoeia standards, and products of these two companies may meet the requirements.Conclusion:At present the quality of recombinant human Interferon alpha2b injection is generally good. The current standards are feasible, but they need to be improved. We suggest that the related protein testing should be added into the standards of drug substances.