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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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国产重组人粒细胞-巨噬细胞集落刺激因子原液中制品相关蛋白的定性定量分析

Identification and quantification of product-related proteins in the bulk of recombinant granulocyte-macrophage colony stimulating factor produced in China

作者(英文):
分类号:R917
出版年·卷·期(页码):2018,38 (11):1875-1880
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:分析鉴定国产重组人粒细胞-巨噬细胞集落刺激因子原液中的制品相关蛋白,为《中华人民共和国药典》(以下简称《中国药典》)标准提高提供依据。方法:采用欧洲药典方法测定所征集的样品中制品相关蛋白的含量;采用液相质谱联用法对制品相关蛋白进行鉴定,色谱柱为Waters BEH300 C4(2.1 mm×150 mm,1.7 μm),以0.1%的三氟乙酸水溶液(A)-0.1%的三氟乙酸90%乙腈溶液(B)为流动相,梯度洗脱,流速0.2 mL·min-1。质谱仪采用Waters公司Xevo G2-S质谱仪,正离子电喷雾离子源,毛细管电压3.0 kV,Cone电压40 V,去溶剂气体温度350℃,去溶剂气体流速800 L·h-1,扫描范围(m/z):500~3 000。结果:对4家生产企业的7批原液进行了检测,其中3家企业的5批原液符合欧洲药典标准,2家企业的2批原液不符合欧洲药典标准;相对分子质量测定结果显示,样品中普遍存在的制品相关蛋白为氧化形式及乙酰化形式,个别批次中存在相对分子质量不一的肽段。结论:本次征集的样品有71%符合欧洲药典标准,可以考虑将制品相关蛋白检测纳入新版《中国药典》,以提高国产重组人粒细胞-巨噬细胞集落刺激因子的产品质量。

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

Objective: To quantify and identify the product-related proteins in the bulk of recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) produced in China,and to provide the basis for improving the standard of Chinese Pharmacopoeia. Methods: The European Pharmacopoeia (EP) method was applied to determine the content of product-related proteins in the collected samples. Mass spectrometry combined with ultra performance liquid chromatography was used for the identification. The chromatographic separation was carried out on a Waters BEH300 C4 column (2.1 mm×150 mm,1.7 μm) with the mobile phase consisting of water containing 0.1% trifluoroacetic acid (A)-water containing 0.1% trifluoroacetic acid and 90% acetonitrile (B) in a gradient mode at the flow rate of 0.2 mL·min-1. The mass spectra were obtained by Waters Xevo G2-S mass spectrometer with electrospray ionization source in positive mode. The capillary voltage was 3 kV;Cone voltage was 40 V;the gas temperature was 350℃;the gas flow was 800 L·h-1 and mass scan range (m/z) was 500~3 000. Results: 7 lots of bulk produced by 4 manufacturers were analyzed. 5 lots produced by 3 manufacturers met the EP standard,and the other 2 lots produced by 2 manufacturers were substandard. Results of relative molecular weights showed that the most common product-related proteins were formed by oxidation and acetylation,and peptides with different relative molecular weights were only found in 2 batches. Conclusion: As shown in this study,71% of the collected samples met EP standard. It is reasonable to incorporate the EP method into the new version of Chinese Pharmacopoeia in order to improve the quality of domestic rhGM-CSF.

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

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