2013年重组人干扰素_2b注射剂评价性抽验质量分析.pdfVIP

7160 · · 现代生物医学进展 Progress in Modern Biomedicine Vol.14 NO.36 DEC.2014 doi: 10.13241/ki.pmb.2014.36.042 2013 年重组人干扰素α2b 注射剂评价性抽验质量分析* 丁有学 裴德 宁 李永红 郭 莹 韩春梅 李 响 饶春 明△ ( 中国食品药品检定研究院重组药物室卫生部生物技术产品检定方法及其标准化重点实验室 北京 100050) 摘要 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 20 83.3% ； 批原液 批合格（部分检验），合格率 ；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 。 关键词：重组人干扰素 α2b ；评价性抽验 ；质量分析 R917 A 1673-6273 2014 36-7160-05 中图分类号： 文献标识码： 文章编号： （ ） Sampling Results and Quality Assessment of Recombinant Human Interferon α2b Injection in 2013* DING You-xue, PEI De-ning, LI Yong-hong, GUO Ying, HAN Chun-mei, LI Xiang, RAO Chun-ming △ (Department of Recombinant Drug Products , National Institute for Food and Drug Control, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Beijing, 100050, China) ABSTRACT Objective: To evaluate the quality status of recombinant human interferon α2b 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 α2b 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 ad