Objective To establish a method for determination of the content of free amino acids in coagulation factor products. Methods Sample were deproteinised with 12% trichloroacetic acid precipi-tation. The deproteinised samples were reacted with ninhydrin to produce a colored substance. Finally,ly-sine in samples were determined quantitively by spectrophotometry. Results The calibration curve for the amino acid was linear (r=0.9994±0. 0004) in the range of 5.2-26.0 mg/L. The coefficients of varia-tion for intra-assay and inter-assay precision were 1.07 % and 3.06 % ,respectively. The recovery rate was 94.60%-97.60%. Conclusions This method is highly sensitive,accurate, with good reproducibility. It is simple and rapid and can be used for the quality control of human coagulation factor products.%目的 建立一种检测人凝血因子制品中游离氨基酸含量的方法.方法采用茚三酮显色法结合三氯醋酸去蛋白质方法,利用分光光度计建立标准曲线,定量测定制品中的赖氨酸含量.结果用该方法绘制的标准曲线具有很好的相关性,相关系数(r)为0.9994±0.0004,线性范围为5.2～26.0 mg/L,试验内和试验间的变异系数分别为1.07%和3.06%,回收率为94.60%～97.60%.与氨基酸分析仪测定法比较,结果相近.结论本方法简便快速,灵敏度和准确度高,重复性好,适用于人凝血因子制品的生产质控.
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