| 李晶1 王永利2 杨化新1△ 梁成罡1 程速远1 丁晓丽1 吕萍1.三硝基苯磺酸法测定聚乙二醇化重组人生长激素的平均修饰度[J].现代生物医学进展英文版,2011,11(9):1609-1612. |
| 三硝基苯磺酸法测定聚乙二醇化重组人生长激素的平均修饰度 |
| Determination of Average Degree of Modification of Pegylated RecombinantHuman Growth Hormone by Trinitrobenzene Sulfonic Acid |
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| DOI： |
| 中文关键词: 聚乙二醇化重组人生长激素 三硝基苯磺酸法 平均修饰度 |
| 英文关键词: Pegylated recombinant human growth hormone Trinitrobenzene sulfonic acid Average extent of PEG modification |
| 基金项目:本文由" 重大新药创制" 科技部重大专项课题" 生物技术药物质量标准和质量控制技术平台（2009ZX09307）
及中国药品生物制品检定所中青年发展基金课题（2009A5）资助 |
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| 中文摘要: |
| 目的：建立测定三种不同结构聚乙二醇化重组人生长激素（PEG-rhGH）平均修饰度的三硝基苯磺酸法（TNBS）。方法：采用
基质辅助激光解吸附飞行时间质谱（MALDI-TOF）测定PEG-rhGH 的分子量，求得理论平均修饰度。既而通过正交试验、游离
PEG 干扰等方法学考察，建立TNBS 法。结果：从质谱法可知PEG-rhGH 的理论修饰度为10%，TNBS 法测得三种PEG-rhGH 的修
饰度分别为为10%、12%及10%，与理论值相符。结论：TNBS 操作简单，不需要专门的仪器，可作为测定PEG-rhGH 平均修饰度的
方法。 |
| 英文摘要: |
| Objective: To determine the average extent of modification of PEG-rhGH by the established TNBS method. Methods:
MALDI TOF mass spectrometry was used to detecte the molecular weight and the theoretical extent of modification of PEG-rhGH.
TNBS method was established by the orthogonal experiment and the interference test of free PEG. Results: The actual modification extent
of three kinds of PEG-rhGHs were 10%, 12% and 10% respectively, and corresponding to the theoretical value of the modification
extent it was 10%. Conclusions: TNBS method is an efficient, convenient and suitable method for the quality control of PEG-rhGH on
the average extent of modification. |
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