纤维蛋白原国家标准品的研制

Preparation of national standard for fibfinogen

目的研制纤维蛋白原(fibfinogen,Fib)国家标准品。方法采用冷沉淀法从血浆中获得Fib沉淀,与原料血浆混合,配制Fib含量为4、2、0.75 mg/mL的定值血浆(水平Ⅰ、Ⅱ、Ⅲ),冻干,即为Fib国家标准品。分别对Fib国家标准品的水分、均匀性、稳定性进行检测,并联合9家实验室进行协作标定。结果水平Ⅰ、Ⅱ、ⅢFib国家标准品的水分均值分别为4.2%、4.8%、4.3%,均匀性效价比值(Pt)变异系数分别为4.64%、4.38%、4.49%,于2~8及20~25℃条件下的稳定性良好。水平Ⅰ、Ⅱ、Ⅲ的Fib国家标准品经9家实验室协作标定蛋白含量定值分别为3.7、1.4、0.75 mg/mL。结论研制的Fib国家标准品具有良好的均匀性和稳定性,可用于血浆中Fib含量检测试剂的质量评价。

Objective To prepare the national standard for fibfinogen(Fib).Methods Fib precipitate was separated from clinical plasma by cold precipitation,and mixed with material plasma to prepare the plasma of levelsⅠ,ⅡandⅢat Fib contents of 4,2 and 0.75 mg/mL respectively and lyophilized.The obtained national standard for Fib of levelsⅠ,ⅡandⅢwere determined for moisture content,uniformity and stability,and was calibrated collaboratively by nine laboratories.Results The mean moisture contents in national standard for Fib of levelsⅠ,ⅡandⅢwere 4.2%,4.8%and 4.3%,while the coefficients of variation of uniformity titer ratios were 4.64%,4.38%and 4.49%,respectively.The standard showed good stability after storage at 2~8 and 20~25℃,of which the Fib contents calibrated collaboratively were 3.7,1.4 and 0.75 mg/mL respectively.Conclusion The national standard for Fib was prepared,which showed good uniformity and stability,and might be used for the quality control of detection kit for Fib in plasma.