目的 建立并验证定量检测注射用培尿酸酶内毒素含量的重组C因子法。方法 使用重组C因子法，进行仪器增益参数调节、标准曲线可靠性验证，对该方法的专属性、线性、精密度、准确度、检测限和耐用性进行验证，并进行干扰试验及3批成品检测，同时与凝胶法检测结果对比。结果 仪器增益参数设为medium时，lg(Δ相对荧光单位)最接近3.5；重组C因子不与β-葡聚糖发生反应；在0.005~5.000 内毒素单位/mL范围内均呈现良好线性关系，决定系数均≥0.980；精密度的相对标准偏差（relative standard deviation，RSD）＜15.0%；不同浓度样品的回收率符合50%~200%的要求，回收率的RSD＜15.0%；检测限为0.005内毒素单位/mL；不同增益下决定系数均≥0.980，实测值的RSD＜15.0%。干扰试验结果表明，当样品40倍稀释时加入0.5 内毒素单位/mL标准内毒素测定回收率为97.2%。3批成品检测结果均符合标准限要求，且同凝胶法结果一致。结论 重组C因子法具有良好的专属性、线性、精密度、准确度和耐用性，可用于注射用培尿酸酶成品内毒素含量的定量检测。

Objective To establish and verify the quantitative detection of endotoxin content in PEGylated uricase for injection by recombinant C factor assay.Methods The adjustment of gain value and reliability verification of standard curve were carried out by recombinant C factor assay. This method was verified for specificity, linearity, precision, accuracy, detection limit and durability. The interference test and detection of 3 batches of final products were carried out. The results were compared with those of gel method.Results When the instrument gain value was set to medium, the lg(Δ relative fluorescence units) was the closest to 3.5. The recombinant C factor did not react with β-glucan. The standard curve showed good linear relationship within the range of 0.005-5.000 endotoxin units (EU) /mL, and coefficients of determination were all ≥ 0.980.The relative standard deviation (RSD) of precision was ＜ 15.0%.The recovery rates of samples with different concentrations met the requirement of 50%-200%, and the RSD of the recovery rates was ＜ 15.0%.The detection limit was 0.005 EU/mL.The coefficients of determination with different gain values were all ≥ 0.980, and the RSD of the measured values was ＜ 15.0%. The interference test result showed that the recovery rate was 97.2% when the test sample was diluted 40 times and 0.5 EU/mL standard endotoxin was added. The test results of 3 batches of final products met the requirements of the standard limit and were consistent with the results of gel method.Conclusion The recombinant C factor assay has good specificity, linearity, precision, accuracy and durability, which can be used for quantitative detection of endotoxin in the final products of pegylated uricase for injection.