Validation of the method for evaluating the efficiency of solid lipid formulations containing streptokinase by biochemical method

Background and Aim : In order to confirm the effectiveness of biologically or recombinantly produced drugs by the competent legislative authorities, it is an indicator of the biological activity of those drugs. Recombinant streptokinase is no exception and determining its biological activity is an important factor in controlling the quality of this recombinant product. Previous studies have shown that solid lipid nanoparticles (SLN) as carriers of streptokinase increase the efficiency of this protein. In this dissertation, the efficiency of solid lipid nanoparticles containing streptokinase was studied by biochemical methodsMethods : For this purpose, rabbit blood and three different human blood groups were used and the efficiency of solid lipid nanoparticles containing streptokinase on clot lysis was investigated. In this study, di-dimer biochemical method was used and the results were evaluated by determining the biological activity using a chromogenic kit Results : The results of the biological activity of streptokinase containing lipid nanoparticles were measured on the produced samples according to the USP Pharmacopoeia method and then the results were compared with the dimer method.The dimer method was validated against the results of the kit and the results of the two methods were compared. The results showed that the dimer method is a low cost and high speed method that can be effective in screening the effectiveness of anticoagulants.Conclusion : In this study, a combination of D-dimer and WB clot weight was used to validate the WB lyselocyte method in vitro using nanoparticles, streptokinase, streptokinase-nanoparticles on human and rabbit blood. Similarly, no further investigation was possible.

کلیدواژه ها:

SLN-Nanoparticle-Recombinant-Streptokinase-in vitro