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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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重组人C1酯酶抑制剂中异天门冬氨酸含量检测

Determination of isoaspartic acid in the recombinant human C1 esterase inhibitor

作者(英文):
分类号:R917
出版年·卷·期(页码):2018,38 (11):1905-1910
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:检测重组人C1酯酶抑制剂(rhC1INH)中异天门冬氨酸(IsoAsp)的含量。方法:采用异天冬氨酸甲基转移酶催化结合反相高效液相色谱的方法进行测定,对该方法进行专属性、准确性和精密度检验,并用该方法对3批样品的IsoAsp含量进行检测。结果:浓度分别为10、30、60 pmol/60 μL的SAH标准品的检测结果均在90%~110%范围内。对同一批3个待测样品进行测定,IsoAsp含量为(0.413±0.020)μmol IsoAsp/g rhC1INH,RSD为4.8%,显示该方法具有较好的专属性、准确性和精密度。3批测试样品中,IsoAsp含量分别为0.633、0.827、0.487 μmol IsoAsp/g rhC1INH。结论:经方法学验证,异天门冬氨酸检测试剂盒结合RP-HPLC方法适用于rhC1INH中IsoAspr的含量检测,可为类似蛋白制品中该项目的检测提供借鉴。

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

Objective: To detect the content of isoaspartic acid(IsoAsp) in the recombinant human C1 esterase inhibitor(C1INH). Methods: Reversed phase high-performance liquid chromatography (RP-HPLC) was used to determine the IsoAsp after rhC1INH samples were catalyzed by PIMT,the test was verified in specificity,accuracy and precision,and used to detect the contents of IsoAsp in 3 batches of rhC1INH. Results: The detected results for the reference substance of SAH at three concentrations (10 pmol/60 μL,30 pmol/60 μL,60 pmol/60 μL) were all in the range of 90%-110%. Three groups from one batch were determined separately. The contents of IsoAsp were (0.414±0.020)μmol IsoAsp/g rhC1INH,and the RSD was 4.8%. This method showed good results in specificity,accuracy and precision. Three batches of rhC1INH were determined,and the contents of IsoAsp were 0.633μmol IsoAsp/g rhC1INH,0.827μmol IsoAsp/g rhC1INH and 0.487μmol IsoAsp/g rhC1INH,respectively. Conclusion: Methodological verification showed that the Isoaspartic Acid Detection Kit combined with RP-HPLC method was suitable for the determination of IsoAspr in rhC1INH,which could provide a reference for the detection of similar protein products.

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