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[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。
[Key word]
[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.
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