目的：分析重组人C1酯酶抑制剂（rhC1INH）中相关蛋白rcc-rhC1INH和ox-rhC1INH的含量。方法：采用反相高效液相色谱法进行测定，对该方法进行专属性、准确性和精密度检验，并用该方法对4批样品中的相关蛋白进行检测。结果：低浓度下，rhC1INH对照品、rcc-rhC1INH对照品和ox-rhC1INH对照品能够较好分离。rcc-rhC1INH和ox-rhC1INH 2种对照品质量浓度为0.2、1和1.4 mg·mL-1时的回收率均在85%~115%的范围内。对同1批3个待测样品进行测定，rcc-rhC1INH含量为（0.082±0.008）%，RSD为9.8%；ox-rhC1INH含量为（0.35±0.05）%，RSD为14.3%，显示该方法具有较好的专属性、准确性和精密度。4批测试样品中，rcc-rhC1INH的含量分别为0.083%、0.021%、0.033%、0.042%，ox-rhC1INH的含量分别为0.34%、0、0、0。结论：经方法学验证，RP-HPLC方法可用于rhC1INH中rcc-rhC1INH和ox-rhC1INH的含量检测。
Objective: To analyze the contents of related proteins rcc-C1INH and ox-C1INH in the recombinant human C1 esterase inhibitor(rhC1INH). Methods: The reversed phase high-performance liquid chromatography (RP-HPLC) was used to determine the relative proteins,the test was verified in specificity,accuracy and precision,and was used to detect the rcc-C1INH and ox-C1INH in 4 batches of samples. Results: RhC1INH reference,rcc-rhC1INH reference and ox-rhC1INH reference could be well separated under the low concentrations. The recovery rates for the reference substances of rcc-C1INH and ox-C1INH at three concentrations (0.2,1 and 1.4 mg·mL-1) were all in the range of 85%~115%. Three groups from one batch were determined separately,the contents of rcc-C1INH were (0.082±0.008)%,and the contents of ox-C1INH were (0.35±0.05)%,with RSDs of 9.8% and 14.3%,respectively. This method showed good results in specificity,accuracy and precision. Four batches of rhC1INH were determined,the contents of rcc-C1INH were 0.083%,0.021%,0.033% and 0.042% for each,and ox-C1INH were 0.34%,0,0,and 0,respectively. Conclusion: RP-HPLC can be used for the content determination of rcc-rhC1INH and ox-rhC1INH in rhC1INH.
