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目的:评价国产重组人干扰素α2a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α2a注射剂的质量现状进行评价。结果:法定检验显示28批成品全部合格,7批原液全部合格(部分检验)。探索性研究显示若在成品中增加比活性测定,则合格率为87.0%,若在原液中增加相关蛋白含量测定,则合格率为57.1%。结论:该品种总体质量状况良好,现行检验标准基本可行,但有待提高,建议在成品中增加比活性检测,在原液中增加相关蛋白含量检测。
Objective: To evaluate the quality status and existing problems of domestic recombinant human interferon α2a injection. Methods: The statistic test method combined with exploratory research was used to test the samples. The statistical analysis of the test results was carried out to evaluate the quality status of domestic recombinant human interferon α2a injection. Results: The statutory test showed that all 28 batches of finished products were qualified and all of the 7 batches of liquid products were qualified (partial inspection). Exploratory studies showed that if the specific activity was increased in the finished product, the pass rate was 87.0%. If the relative protein content was increased in the stock solution, the pass rate was 57.1%. Conclusion: The overall quality of this variety is good. The current test standard is basically feasible, but it needs to be improved. It is suggested to increase the specific activity in the finished product and increase the detection of related protein content in the stock solution.