Biochemical characterization of prothrombin complex concentrates in China

Chinese PCCs contained FⅡ, Ⅶ, Ⅸ and Ⅹ, protein C, S and Z, heparin and extremely low level antithrombin, as well as Octaplex®. The measured FⅨ activities were similar to those declared, however the measured potency of FⅡ, Ⅶ and Ⅹ greatly exceeded the labeled. Though all preparations were negative for activated coagulation factors in non-activated partial thromboplastin time test, the activated coagulation factor Ⅶ (FⅦa) remained in all PCCs and its content differed greatly. Overall, FⅦa content of Chinese PCCs was higher than that of Octaplex®. Further, Chinese PCCs were inferior to Octaplex® in the thrombin inhibitory capacities, specific activity and purity. In summary, compared with Octaplex®, Chinese PCCs' errors about the labeled activity of coagulation factors and probably high risks of thrombosis should be considered.