Investigation and evaluation of procoagulant substances in commercial intravenous immunoglobulin G(pH4)
10.13200/j.cnki.cjb.004736
- VernacularTitle:市售静注人免疫球蛋白（pH4）中促凝血物质考察及评价
- Author:
Wenxi WANG
- Publication Type:Journal Article
- Keywords:
Intravenous immunoglobulin G(IVIG)(pH4);
Human coagulation factor Ⅺ(FⅪ);
Activated human coagulation factor Ⅺ(FⅪa);
Activation rate
- From:
Chinese Journal of Biologicals
2026;39(07):821-827
- CountryChina
- Language:Chinese
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Abstract:
Objective To investigate the human coagulation factor Ⅺ(FⅪ) and activated human coagulation factor Ⅺ(FⅪa) in intravenous immunoglobulin G(IVIG)(pH4) products of different enterprises and perform correlation analysis on the results, in order to evaluate the coagulation risks of products from different enterprises.Methods One-stage method(coagulation method) and thrombin generation assay(TGA) were used to determine the FⅪ and FⅪa in IVIG products,and the results of different enterprises were compared and analyzed.Results The FⅪ activity of 115 batches of samples was 3. 3-524. 0 mIU/mL, and the FⅪa activity was 0. 5-120. 7 mIU/mL. There was a significant positive correlation between the activities of FⅪ and FⅪa, and the FⅪ activation rate of different enterprises was 3. 6%-75. 9%.Conclusion The activity of FⅪa in commercial IVIG is generally low, and the FⅪa in two batches of products from one enterprise exceeded80 mIU/mL. It is recommended that the enterprise continuously monitor the activity of FⅪa in the varieties and reduce the activation rate and residue of FⅪ by optimizing the chromatographic purification process and screening suitable filter materials,thereby reducing the risk of product coagulation.
