关键词:  , 注射用重组人凝血因子Ⅷ；不确定度；人凝血因子Ⅷ；含量测定

Abstract:

Objective： To establish an evaluation method for the uncertainty of human coagulation factor Ⅷ content in recombinant human coagulation factor Ⅷ for injection.Method： The determination of human coagulation factor Ⅷ content was carried out using the import registration standard JS20210052. At the same time， according to the relevant provisions of JJF1059.1-2012 "Evaluation and Expression of Uncertainty in Measurement"， a mathematical model of uncertainty for the determination of human coagulation factor Ⅷ was established， and the sources of uncertainty were analyzed and evaluated.Results： The sources of uncertainty in the content of human coagulation factor Ⅷ mainly include preparation of reference solution （C_V）， preparation of test solution （V_S）， measurement repeatability of test sample （S_S） and standard curve of reference sample （Ci）. The combined uncertainty of the determination of human coagulation factor Ⅷ content in recombinant human coagulation factor Ⅷ for injection by activated partial thromboplastin time （APTT） method is 0.880 17 IU·mL^-1， and the expanded uncertainty is 1.760 34 （k=2， confidence probability is 95%）.Conclusion： The contribution to the uncertainty in determination of human coagulation factor Ⅷ contene in recombinant human coagulation factor Ⅷ for injection mainly comes from the preparation of the test solution and the standard curve of the standard substance， while the uncertainty contribution of the weighing and preparation of the reference sample is not significant in this experiment and can be ignored. This study quantified the uncertainty of this analytical method， and the established method is suitable for evaluating the uncertainty of the APTT method for determining the content of human coagulation factor Ⅷ in recombinant human coagulation factor Ⅷ for injection.

Key words: Recombinant human coagulation factor Ⅷ for injection； , Uncertainty； , Human coagulation factor Ⅷ； , Content determination