重组C因子试剂盒检测人血白蛋白稀配液细菌内毒素含量可行性研究.pdfVIP

中文科技期刊数据库（引文版）医药卫生 重组C 因子试剂盒检测人血白蛋白稀配液细菌内毒素含 量可行性研究 胡进维 李育琼 王 杰 华润博雅生物制药集团股份有限公司，江西 抚州 344000 摘要：目的考察使用重组C 因子试剂盒检测人血白蛋白稀配液中内毒素含量方法的稳定性与可行性。方法 选取 上海瑞诺生物生产的试剂盒对人血白蛋白稀配液进行方法学考察，从专属性、准确度、耐用性、线性方位、检测 限和精密度等项目进行实验。结果 该方法使用内毒素标准品进行配制标准曲线，结果表明0.005-5EU/ml 浓度的 范围线性值可以达到较好的线性反应关系，R 值均＞0.980；用内毒素不同浓度的标准品进行加标回收率进行试验。 均可在50%-200%的范围之间；本方法显示 β-葡聚糖不对样品的回收率产生影响,未激活重组C 因子成活化的C 因子，具有可靠的专属性;检测值在0.005EU/ml 回收率合格;仪器设置的增益对结果的影响程度低。结论 人血白 蛋白稀配液血液制品可使用重组C 因子法进行方法学考察，线性、精密性、专属性、准确度以及耐用性均有良好 的稳定性，可以选择用于人血白蛋白稀配液的内毒素含量进行检测。 关键词：细菌内毒素；人血白蛋白稀配液；方法学；鲎试剂；荧光酶标仪 中图分类号：R473 文献标识码：A Feasibility study of recombinant factor C kit for detecting bacterial endotoxin content in diluted solution of human serum albumin HU Jinwei LI Yuqiong WANG Jie China Resources Boya Biopharmaceutical Group Co., Ltd., Jiangxi Fuzhou 344000 Abstract: Objective To establish a bacterial endotoxin recombinant C factor kit for detection of human serum albumin dilute solution. Methods Rhinogen recombinant factor C kit was used to test the specificity, accuracy, durability, linear range, detection limit and precision of human albumin solution. Results The linear values of standard endotoxin in the concentration range of 0.005-5EU/ mL could achieve a good linear reaction relationship, with R values 0.980. The recovery rate of different concentrations of endotoxin standard can reach 50%-100%. This method does not react with β -glucan and has good specificity. Detection limit as low as 0.005EU/ mL; The linear slope and the sample value did not change with the gain value of the fluorescence detector. Conclusion The recombinant C factor method has good linearity, precision, specificity, accuracy and durability, and can be used for endotoxin quality control of human