MEDICINAL PREPARATION IN THE FORM OF ANTISTAPHYLOCOCCAL PHAGE LYSATE, PROCESS OF ITS PREPARATION AND USE

摘要

A process of production of a medicinal product in the form of antistaphylococcal phage lysate, including the following successive steps: revival of a bacterial strain, passaging of the bacterial strain, preparation of cell sub-cultures, preparation of the phage starter via a double-layer agar method, preparation of the phage starter in a liquid medium, preparation of bacterial suspension, preparation of phage lysate, filtration of phage lysate or a lysate mixture, filling of filtered lysate or a lysate mixture in vials, lyophilisation of lysate or a lysate mixture in vials; whereas the final medicinal product is lyophilized powder for preparation of solution (lyophilisate) produced via sterile filtration and lyophilisation of a mixture of antistaphylococcal phage lysate containing active phage particles of a polyvalent staphylococcal bacteriophage. The medicinal product for local use contains high-potent virulent phage particles with a polyvalent effect.