Comparative in vitro investigation of prothrombin complex concentrates.
Three commercial prothrombin complex concentrates (PCC) were compared in vitro. Differences in the activities or contents, respectively, of the PCC factors FII, FVII, FIX, FX and the proteins C, S, and Z (antigen) in particular were found. Global tests of activated factors did not reveal marked differences between the products. Neither free thrombin nor elevated levels of activated FX were detected. In contrast, analyses of FVIIa, of residual amidolytic activities, and of concentrations of unwanted ingredients demonstrated considerable differences between the products. While antithrombin III was detected only in two of three concentrates, heparin was found in all PCCs but in markedly different concentrations. Although the homogeneity of the products has been clearly improved in comparison with former comparative investigations, the products can be distinguished by their compound profile and by a couple of in vitro assays.
Römisch
J
J
Centeon Pharma GmbH, Marburg/Lahn, Germany.
Bonik
K
K
Müller
H G
HG
D001688:Biological Products / Q000737:chemistry*; D001779:Blood Coagulation Factors / Q000032:analysis* / Q000302:isolation & purification; D001780:Blood Coagulation Tests; D002863:Chromogenic Compounds / Q000378:metabolism; D004789:Enzyme Activation; D004797:Enzyme-Linked Immunosorbent Assay; D005164:Factor IX / Q000032:analysis; D005167:Factor VII / Q000032:analysis; D005170:Factor X / Q000032:analysis; D015951:Factor Xa / Q000378:metabolism; D006801:Humans; D009842:Oligopeptides / Q000378:metabolism; D011516:Prothrombin / Q000032:analysis; D011786:Quality Control; D012449:Safety
D001688:Biological Products; D001779:Blood Coagulation Factors; D002863:Chromogenic Compounds; D009842:Oligopeptides; C015608:benzoyl-Ile-Glu-Gly-Arg-p-nitroanilide; D005167:Factor VII; D011516:Prothrombin; D005164:Factor IX; D005170:Factor X; D015951:Factor Xa