Procedure for biphasic preparation of liposomes and application thereof in manufacturing diagnostic reagents

Abstract

The invention relates to a procedure for biphasic preparation of liposomes, in the course of which technically simple and cheap mechanical mixing methods are used to commingle non-polar organic phase containing an individual mixture of natural and synthetic phospholipids and polar aqueous (buffer) phase not miscible with it, resulting in a liposome emulsion of a unique structure. Furthermore, the invention comprises embodiments of the procedure related to the in vitro diagnostic use of liposomes prepared in this way, when protein type active components are anchored to the surface of liposome membranes without application of any detergents and non-protein type active components are simply mixed with the liposome emulsion of a unique structure. In one of the possible embodiments of the procedure a Prothrombin Time (PT) reagent is prepared. Another possible embodiment of the procedure is the preparation of an activated partial thromboplastin time (APTT) reagent.

Description

technical field [0001] The present invention relates to a two-phase method for the preparation of liposomes, during which a non-polar organic phase comprising separate mixtures of natural and synthetic phospholipids is mixed with polar water immiscible therewith using technically simple mechanical means buffer) phase. When the active ingredient is anchored to the surface of the liposome membrane, liposome emulsions with unique structures prepared by this method are preferred for in vitro application. [0002] Furthermore, possible embodiments of the invention relate to the preparation of diagnostic reagents for blood coagulation in vitro. In one set of embodiments of the present invention, the agent consists of our uniquely structured liposomal emulsions, i.e. native or recombinant tissue factor, that provide a membrane surface for active ingredients and protein-type active ingredients . In a possible embodiment of this group, the anchoring of proteins to the membrane surfa...

AI Technical Summary

Problems solved by technology

Although the size distribution of the manufactured product can be controlled to some extent, the use of an extruder (homogenizer) to produce the final product makes the process more expensive

[0031] Of the known methods, groups "A", "B" and "D" do not require expensive additives, but methods "A", and "B" produce multilamellar liposomes with a broad size distribution, enabling subsequent homogeneous are unavoidable, so they make the final manufactured product expensive