[Streptokinase: correlation between different methods of biological evaluation].
A study was carried out to establish an appropriate method for streptokinase (SK) potency determination (biological assay) in order to fulfil the main function of the Instituto Nacional de Medicamentos respecting products marketed in Argentina. The potency of different commercial samples of SK was determined against the International Standard, and three internationally accepted methods were used for this purpose: fibrin plate, clot lysis and chromogenic method. The analysis of results suggests that the fibrin plate method is the least precise and reproducible. The clot lysis and chromogenic methods demonstrated great precision and reproducibility, giving a correlation coefficient of 0.99. It is concluded that both of these methods are best suited to determine potency of SK commercial products.
Oliva
L M
LM
Departamento de Productos Biológicos, Instituto Nacional de Medicamentos, Buenos Aires, Argentina.
Guagliardo
M V
MV
Albertengo
M E
ME
D000818:Animals; D002417:Cattle; D002863:Chromogenic Compounds / Q000378:metabolism; D005069:Evaluation Studies as Topic; D005337:Fibrin / Q000378:metabolism; D005342:Fibrinolysis / Q000187:drug effects; D005343:Fibrinolytic Agents / Q000032:analysis / Q000494:pharmacology* / Q000592:standards; D009842:Oligopeptides / Q000378:metabolism; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013300:Streptokinase / Q000032:analysis / Q000494:pharmacology* / Q000592:standards
D002863:Chromogenic Compounds; D005343:Fibrinolytic Agents; D009842:Oligopeptides; C018788:valyl-leucyl-lysine 4-nitroanilide; D005337:Fibrin; D013300:Streptokinase