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刊物信息

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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重组人干扰素β1b中ox-IFN β1b含量测定

Determination of ox-IFN β1b in recombinant human interferon β1b

作者(英文):
分类号:R917
出版年·卷·期(页码):2018,38 (11):1881-1886
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立重组人干扰素β1b(IFN β1b)中氧化型干扰素(ox-IFN β1b)的测定方法。方法:RP-HPLC色谱条件:RP-C8色谱柱(Grace Vydac,4.6 mm×250 mm,5μm),柱温40℃,0.1% TFA-10%乙腈-水溶液为流动相A,0.1% TFA-乙腈溶液为流动相B,梯度洗脱,流速为1.0 mL·min-1,检测波长214 nm。结果:ox-IFNβ1b峰与峰3的分离度约为4.0,理论塔板数大于20 000;6次进样的RSD小于5.0%;2个厂家共6批IFN β1b原液中均检出ox-IFN β1b,用面积归一化法计算百分含量为0.47%~0.96%。结论:新建方法可有效分离和测定不同厂家IFN β1b原液中的ox-IFN β1b,对IFNβ1b质量标准的提高具有重要意义。

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

Objective: To develop a method for determination of ox-IFN β1b in recombinant human interferon β1b(IFN β1b). Methods: The RP-HPLC was carried out on an RP-C8 column (Grace Vydac,4.6 mm×250 mm,5μm),at the temperature of 40. The mobile phase consisting of solution A (0.1% TFA-10% ACN-ddH2O) and solution B (0.1% TFA-ACN as solution B) was applied with a gradient elution at a flow rate of 1.0 mL·min-1. The detection wavelength was 214 nm. Results: The resolution of the ox-IFNβ1b peak relative to peak 3 was about 4.0 and theoretical plate number was more than 20 000. RSD of 6 injections was below 5.0%. ox-IFNβ1b was detected in 6 batches of IFN β1b bulks from two different manufacturers,and percentage contents were between 0.47% and 0.96%,which were determined by area normalization. Conclusion: The developed method could effectively separate and determine ox-IFNβ1b in IFN β1b bulks from different manufacturers,which was of great significance to the improvement of quality control of IFNβ1b.

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

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