Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection
10.13303/j.cjbt.issn.1004-549x.2025.03.017
- VernacularTitle:注射用重组人凝血因子Ⅶa效价检测方法的建立
- Author:
Rong WU
1
;
Liping WANG
1
;
Jinye LANG
1
;
Yue ZHU
1
;
Jing ZHOU
1
;
Xun LIU
1
;
Jing NI
1
;
Shunbo ZHOU
1
;
Yaling DING
1
Author Information
1. Chengdu Rongsheng Pharmaceutical Co, Ltd, Chengdu 610000, China
- Publication Type:Journal Article
- Keywords:
recombinant human coagulation factor Ⅶa;
clotting method;
detecting of potency
- From:
Chinese Journal of Blood Transfusion
2025;38(3):415-420
- CountryChina
- Language:Chinese
-
Abstract:
[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.
