| 引用本文: | 张姮婕,唐瑶,王觉晓,蒋佳兴,龙丽娟,马晶,王叔桥,李炎,杨蕾.UHPLC-LTQ-Orbitrap-MS分析人血白蛋白及人免疫球蛋白中非目标蛋白成分[J].中国现代应用药学,2023,40(19):2713-2720. |
| ZHANG Hengjie,TANG Yao,WANG Juexiao,JIANG Jiaxing,LONG Lijuan,MA Jing,WANG Shuqiao,LI Yan,YANG Lei.Analysis of Non-target Proteins in Human Albumin and Human Immunoglobulin by UHPLC-LTQ- Orbitrap-MS[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(19):2713-2720. |
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| UHPLC-LTQ-Orbitrap-MS分析人血白蛋白及人免疫球蛋白中非目标蛋白成分 |
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张姮婕, 唐瑶, 王觉晓, 蒋佳兴, 龙丽娟, 马晶, 王叔桥, 李炎, 杨蕾
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四川省药品检验研究院(四川省医疗器械检测中心), 国家药品监督管理局疫苗及生物制品质量控制与评价重点实验室, 四川省药品监督管理局生物制品质量监测与风险评估重点实验室, 成都 611731
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| 摘要: |
| 目的 采用超高效液相色谱-串联线性离子阱-轨道阱组合高分辨质谱技术对人血白蛋白及人免疫球蛋白中非目标蛋白成分进行定性分析。方法 采用ACQUITY UPLC peptide BEH C18(300Å，1.7 μm，2.1 mm×100 mm)色谱柱，以0.1%甲酸水溶液-0.1%甲酸乙腈为流动相进行梯度洗脱，质谱采用Full MS/dd-MS2(TopN)扫描模式。结果 从人血白蛋白及人免疫球蛋白中共鉴定出非目标蛋白52个，其中人血白蛋白样本中鉴定非目标蛋白25个，人免疫球蛋白样本中鉴定非目标蛋白27个。结论 建立的定性方法可快速、准确、系统地识别出人血白蛋白及人免疫球蛋白中多种蛋白，为该类制剂质量控制及进一步的临床应用提供参考。 |
| 关键词: 超高效液相色谱-串联线性离子阱-轨道阱组合高分辨质谱技术 血液制品 非目标蛋白 定性研究 人血白蛋白 人免疫球蛋白 |
| DOI：10.13748/j.cnki.issn1007-7693.20223178 |
| 分类号:R917.101 |
| 基金项目:国家药典委员会国家药品标准制修订研究课题(2022S06) |
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| Analysis of Non-target Proteins in Human Albumin and Human Immunoglobulin by UHPLC-LTQ- Orbitrap-MS |
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ZHANG Hengjie, TANG Yao, WANG Juexiao, JIANG Jiaxing, LONG Lijuan, MA Jing, WANG Shuqiao, LI Yan, YANG Lei
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Sichuan Institute for Drug Control(Sichuan Testing Center of Medical Devices), NMPA Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, SCMPA Key Laboratory for Quality Monitoring and Risk Assessment of Biological Products, Chengdu 611731, China
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| Abstract: |
| OBJECTIVE To analyze and identify non-target proteins in human albumin and human immunoglobulin by ultra high performance liquid chromatography tandem linear ion trap orbitrap mass spectrometry. METHODS The extract was separated on a ACQUITY UPLC peptide BEH C18(300Å, 1.7 μm, 2.1 mm×100 mm) column and the gradient elution was performed with mobile phase consisting of 0.1% formic acid aqueous solution-0.1% formic acid acetonitrile. The analytes were detected in Full MS/dd-MS2(TopN). RESULTS A total of 52 non-target proteins were identified from human albumin and human immunoglobulin. Among them, 25 non-target proteins were identified in human albumin samples, and 27 non-target proteins were identified in human immunoglobulin samples. CONCLUSION The established qualitative method can rapidly, accurately and systematically identify various proteins in human albumin and human immunoglobulin. The results provide reference for the quality control of the preparation as well as its further clinical application. |
| Key words: UHPLC-LTQ-Orbitrap-MS blood products non-target proteins qualitative analysis human albumin human immunoglobulin |
