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期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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利用欧洲药典方法评价国产重组人干扰素α-2原液的制品相关蛋白含量

Analysis of product related protein in the bulk of recombinant human interferon α-2 produced in China using the method in European Pharmacopoeia

作者(英文):
分类号:R917
出版年·卷·期(页码):2018,38 (11):1865-1869
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:对不同企业生产的重组人干扰素α-2原液的制品相关蛋白含量情况进行调查分析,为新版《中华人民共和国药典》(简称《中国药典》)提高该品种质量标准提供数据支持。方法:采用欧洲药典收载的标准和方法,对全国7家企业生产的20批重组人干扰素α-2原液产品进行相关蛋白含量的检测,分析不同企业产品的质量情况。结果:经过检测分析,其中5家企业的16批产品符合欧洲药典规定,2家企业的4批产品不符合规定。20批产品的相关蛋白总含量最低为0.9%,最高为58.2%,其中含量大于3%的相关蛋白峰的数量最高为5个,单个相关蛋白峰的含量最高为19.9%。结论:建议在下一版《中国药典》的重组人干扰素α-2原液质量标准中,增加制品相关蛋白含量检测项目,全面提高产品质量。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To provide data support for improving the quality standard in the new edition of Chinese Pharmacopoeia by investigating and analyzing the product related protein content in recombinant human interferon alpha-2 drug substances produced by different manufacturers. Methods: Twenty batches of recombinant human interferon alpha-2 drug substances produced by seven domestic manufacturers were tested for related protein content using the methods in European Pharmacopoeia (EP) to analyze the quality of products from different manufacturers. Results: After testing and analysis,16 batches of products from 5 companies met the requirements of EP,and 4 batches of products from 2 companies did not meet the requirements. The lowest total product related protein content of the 20 batches of products was 0.9% and the highest was 58.2%. The highest number of product related protein peaks with content greater than 3% was 5,and the highest content of single product related protein peak was 19.9%. Conclusion: It is recommended to add the detection items of product related protein content to the quality standard of recombinant human interferon alpha-2 in the next edition of Chinese Pharmacopoeia to improve the quality of the products.

-----参考文献:---------------------------------------------------------------------------------------
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