CAJ | 학술논문

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。
목적：：평개국산중조인간우소α2a주사제적질량현상급존재문제。방법：채용법정검험방법결합탐색성연구진행양품검험,통계분석검험결과,대국산중조인간우소α2a주사제적질량현상진행평개。결과：법정검험현시28비성품전부합격,7비원액전부합격(부분검험)。탐색성연구현시약재성품중증가비활성측정,칙합격솔위87.0%,약재원액중증가상관단백함량측정,칙합격솔위57.1%。결론：해품충총체질량상황량호,현행검험표준기본가행,단유대제고,건의재성품중증가비활성검측,재원액중증가상관단백함량검측。
Objective: To evaluate the quality status of recombinant human interferon α2a injections and find out some quality problems. Methods:The statutory testing methods combining with the exploratory studies were used to examine the samples, and the quality status of recombinant human interferon α2a injections was evaluated by statistical analysis of the results. Results: All 28 bat-ches of the injections were qualified using the statutory testing methods. The exploratory studies showed that if the specific activity was determined, the qualified rate was only 87. 0%. All 7 batches of drug substances were qualified using the statutory testing methods. The exploratory studies showed that if the related protein was determined, the qualified rate was 57. 1%. Conclusion:At present the quality of recombinant human interferonα2a injections is generally good. The current standards are feasible;however, improvement is still needed. Specific activity determination should be supplemented the standards for drug products and related protein determination should be supplemented the standards of drug substances.