重组人干扰素α1b注射剂评价性抽验结果与质量分析.PDFVIP

Drug Evaluation Research 第40 卷 第3 期 2017 年3 月 • 341 • 重组人干扰素 α1b 注射剂评价性抽验结果与质量分析 裴德宁，丁有学，郭 莹，史新昌，毕 华，秦 玺，饶春明* 中国食品药品检定研究院 重组药物室，北京 100050 摘 要：目的 评价重组人干扰素α1b 注射剂的质量现状及存在问题。方法 抽取2 个企业生产的31 批注射用重组人干扰 素α1b 和11 批重组人干扰素α1b 注射液，按照 《中国药典》2010 年版三部标准进行检验，统计分析生物学活性、渗透压摩 尔浓度、水分、pH 值等检验结果，对国产重组人干扰素α1b 注射剂的质量现状进行评价。结果 42 批样品检验全部合格， 各生产企业生产工艺比较稳定。结论 该品种总体质量状况良好，现行质量标准能够保证产品的安全有效，渗透压摩尔浓度 项目的标准规定应进一步完善。 关键词：重组人干扰素α1b ；注射用重组人干扰素α1b ；重组人干扰素α1b 注射液；评价性抽验；质量分析 中图分类号：R927.11 文献标志码：A 文章编号：1674-6376 (2017) 03 - 0341 - 04 DOI: 10.7501/j.issn.1674-6376.2017.03.010 Sampling results and quality assessment of recombinant human interferon α1b injection PEI De-ning, DING You-xue, GUO Ying, SHI Xin-chang, BI Hua, QIN Xi, RAO Chun-ming Division of Recombinant Biological Products, National Institutes for Food and Drug Control, Beijing 100050, China Abstract: Objective To evaluate the quality status of recombinant human interferon α1b injection and find out some quality problems. Methods Totally 31 batches of recombinant human interferon α1b for injection and 11 batches of recombinant human interferon α1b injection from two enterprises were examined according to Chinese Pharmacopoeia Volume Ⅲ (2010), and the quality status of recombinant human interferon α1b injection was evaluated by statistical analysis of the results. Results All 42 batches of samples were qualified. The production process of each enterprise was steady. Conclusion At present the quality of recombinant human interferon α1b injection is generally good. The current standards are feasible, but the specified standard of osmolality needs to be improved. Key words: recombinant human interferon α1b; recombinant human interferon α1b for injection; recombinant human interferon α1b injection; evaluative testing; quality evaluation 重组人干扰素α1b 注射剂是中国第一个基因工