摘要
目的:对用于重组人干扰素α-2b相关蛋白分析的欧洲药典方法和自建方法进行实际应用效果的比较。方法:采用欧洲药典和自建2种分析方法对今年在国家药品评价性抽验工作中获取的8个企业生产的24批重组人干扰素α-2b产品分别进行分析,对二者的分离效果和得到的相关蛋白含量等进行比较。结果:自建方法能分离出欧洲药典方法不能分离的N端甲硫氨酸化蛋白,在24批产品中有15批产品检测出N端甲硫氨酸化蛋白,其含量为(23.15±8.50)%。用欧洲药典7.0版所载方法分析,24批产品的相关蛋白总含量为(11.53±8.31)%,相关蛋白峰数量为(6.1±1.9)个;用自建方法分析,相关蛋白总含量为(30.99±17.84)%,相关蛋白峰数量为(12.8±2.6)个。结论:自建方法对重组人干扰素α-2b的相关蛋白的分离效果更好,能对产品的质量进行更好的控制。
Objective： To compare the European Pharmacopeia（ EP） method with the method established in our laboratory in practical application of analyzing recombinant human interferon α- 2b（ rhIFNα- 2b） related proteins.Methods： Totally 24 batches of rhIFNα- 2b from 8 manufacturers acquired in national sampling test for quality evaluation this year were selected and analyzed using the two methods; the separation efficacy and the determined protein content were compared. Results： Our method can separate N- terminal methionylated protein from intact rhIFNα- 2b,which was not obtained in the EP method. The N- terminal methionylated protein was detected in 15 of the total 24 batches of products,and the content was（ 23. 15 ± 8. 50） %. When the EP method was applied,the total content of related protein in 24 batches of products was（ 11. 53 ± 8. 31） % and the number of related peaks was 6. 1 ± 1. 9. When our method was applied,the total content of related protein was（ 30. 99 ± 17. 84） % and the number of related peaks was 12. 8 ± 2. 6. Conclusion： Our method can separate rhIFNα- 2b related proteins more efficiently,which can better control the quality of rhIFNα- 2b.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2014年第7期1204-1207,共4页
Chinese Journal of Pharmaceutical Analysis
基金
国家科技重大专项项目(2012ZX09304010)
