Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection
[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 t...
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| Format: | Article |
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Institute of Blood Transfusion of Chinese Academy of Medical Sciences
2025-03-01
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| Series: | Zhongguo shuxue zazhi |
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| Online Access: | https://www.cjbt.cn/thesisDetails#10.13303/j.cjbt.issn.1004-549x.2025.03.017&lang=en |
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| author | WU Rong WANG Liping LANG Jinye ZHU Yue ZHOU Jing LIU Xun NI Jing ZHOU Shunbo DING Yaling |
| author_facet | WU Rong WANG Liping LANG Jinye ZHU Yue ZHOU Jing LIU Xun NI Jing ZHOU Shunbo DING Yaling |
| author_sort | WU Rong |
| collection | DOAJ |
| description | [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. |
| format | Article |
| id | doaj-art-66c7c2e661354239b468ea93f6ecee3c |
| institution | DOAJ |
| issn | 1004-549X |
| language | zho |
| publishDate | 2025-03-01 |
| publisher | Institute of Blood Transfusion of Chinese Academy of Medical Sciences |
| record_format | Article |
| series | Zhongguo shuxue zazhi |
| spelling | doaj-art-66c7c2e661354239b468ea93f6ecee3c2025-08-20T03:06:13ZzhoInstitute of Blood Transfusion of Chinese Academy of Medical SciencesZhongguo shuxue zazhi1004-549X2025-03-0138341542010.13303/j.cjbt.issn.1004-549x.2025.03.0171004-549X(2025)3-0415-06Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injectionWU Rong0WANG Liping1LANG Jinye2ZHU Yue3ZHOU Jing4LIU Xun5NI Jing6ZHOU Shunbo7DING Yaling8Chengdu Rongsheng Pharmaceutical Co, Ltd, Chengdu 610000, ChinaChengdu Rongsheng Pharmaceutical Co, Ltd, Chengdu 610000, ChinaChengdu Rongsheng Pharmaceutical Co, Ltd, Chengdu 610000, ChinaChengdu Rongsheng Pharmaceutical Co, Ltd, Chengdu 610000, ChinaChengdu Rongsheng Pharmaceutical Co, Ltd, Chengdu 610000, ChinaChengdu Rongsheng Pharmaceutical Co, Ltd, Chengdu 610000, ChinaChengdu Rongsheng Pharmaceutical Co, Ltd, Chengdu 610000, ChinaChengdu Rongsheng Pharmaceutical Co, Ltd, Chengdu 610000, ChinaChengdu Rongsheng Pharmaceutical Co, Ltd, Chengdu 610000, China[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.https://www.cjbt.cn/thesisDetails#10.13303/j.cjbt.issn.1004-549x.2025.03.017&lang=enrecombinant human coagulation factor ⅶaclotting methoddetecting of potency |
| spellingShingle | WU Rong WANG Liping LANG Jinye ZHU Yue ZHOU Jing LIU Xun NI Jing ZHOU Shunbo DING Yaling Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection Zhongguo shuxue zazhi recombinant human coagulation factor ⅶa clotting method detecting of potency |
| title | Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection |
| title_full | Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection |
| title_fullStr | Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection |
| title_full_unstemmed | Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection |
| title_short | Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection |
| title_sort | establishment of a method for detecting the potency of recombinant human coagulation factor viia for injection |
| topic | recombinant human coagulation factor ⅶa clotting method detecting of potency |
| url | https://www.cjbt.cn/thesisDetails#10.13303/j.cjbt.issn.1004-549x.2025.03.017&lang=en |
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