| 用高效液相色谱测定重组人尿激酶原制剂的蛋白含量 |
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| 引用本文： | 陶铜静,袁婀娜,杨旭,将琴,李小强,李世崇,高丽华,胡显文,胥照平,张正光. 用高效液相色谱测定重组人尿激酶原制剂的蛋白含量[J]. 生物技术通讯, 2010, 21(1): 80-82. DOI: 10.3969/j.issn.1009-0002.2010.01.020 |
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| 作者姓名： | 陶铜静 袁婀娜 杨旭 将琴 李小强 李世崇 高丽华 胡显文 胥照平 张正光 |
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| 作者单位： | 1. 上海天士力药业有限公司,上海,201203
2. 军事科学医学院,生物工程研究所,北京,100071 |
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| 摘 要： | 目的:用RP-HPLC方法对注射用重组人尿激酶原制剂蛋白含量进行定量分析。方法:用反相C18柱、0.1%TFA水溶液与0.1%乙腈进行梯度洗脱,280nm波长紫外检测器监测;以重组人尿激酶原同质标准品作为对照品,根据进样量和相应的峰面积建立标准曲线方程,将待测定样品的峰面积代入标准曲线方程,可测得蛋白含量。结果:按照方法学验证要求对此方法进行了专属性、检测限、定量限、线形、精密度(重复性、中间精密度)、准确度(回收率)考察,线性范围为9～27μg,回收率在97%以上,RSD2.0%,完全满足对制剂蛋白的定量需求。结论:本方法准确,适用于注射用重组人尿激酶原成品制剂蛋白定量测定。
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| 关 键 词： | 注射用重组人尿激酶原 蛋白含量 高效液相色谱 方法学验证 |
Determination of the Content of Recombinant Human Pro-Urokinase in Injection Preparation by High Performance Liquid Chromatography |
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| TAO Tong-Jing,YUAN E-Nuo,YANG Xu,JIANG Qin,LI Xiao-Qiang,LI Shi-Chong,GAO Li-Hua,HU Xian-Wen,XU Zhao-Ping,ZHANG Zheng-Guang. Determination of the Content of Recombinant Human Pro-Urokinase in Injection Preparation by High Performance Liquid Chromatography[J]. Letters in Biotechnology, 2010, 21(1): 80-82. DOI: 10.3969/j.issn.1009-0002.2010.01.020 |
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| Authors: | TAO Tong-Jing YUAN E-Nuo YANG Xu JIANG Qin LI Xiao-Qiang LI Shi-Chong GAO Li-Hua HU Xian-Wen XU Zhao-Ping ZHANG Zheng-Guang |
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| Affiliation: | TAO Tong-Jing1,YUAN E-Nuo1,YANG Xu1,JIANG Qin1,LI Xiao-Qiang1,LI Shi-Chong2,GAO Li-Hua2,XU Zhao-Ping2,HU Xian-Wen2,ZHANG Zheng-Guang2 1.Shanghai Tasly Pharmaceutical Limited Company,Shanghai 201203,2.Beijing Institute of Biotechnology,Beijing 100071,China |
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| Abstract: | Objective:The method of separation and quantity of the recombinant human pro-urokinase(pro-UK) preparation for injection that contains vehicles is necessary.Methods:The high performance liquid chromatography (HPLC)was used for separation and determination of the pro-UK preparation and the reversed-phase C18 column was made to use.The pro-UK of the sample was eluted by gratiet elution method with 0.1%of TFA of water 0.1%of acetonitrile used for mobile phase.The 280 nm UV detector was used for detection of th... |
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| Keywords: | recombinant human pro-urokinase high performance liquid chromatography validation of method |
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