Abstract
Bacteriophages are novel safe and efficacious medicinal products that are used for treatment of intestinal infections and purulent inflammations. The fact that virulent phages can be adapted to fight antibiotic-resistant bacterial strains makes this group of medicines a promising means of treatment of infections associated with medical interventions. The elaboration of quality standards for bacteriophage products will enable alignment of the quality requirements and test methods. There are no monographs on bacteriophage products in pharmacopoeias of other countries, therefore, the development of general chapters on groups of test methods used in bacteriophage quality control and monographs on bacteriophages for the State Pharmacopoeia of the Russian Federation (Ph. Rus.) was a very relevant and timely initiative. The aim of the study was to elaborate pharmacopoeial quality standards for bacteriophages approved in the Russian Federation for therapeutic and prophylactic indications. The authors of the study analysed product specification files and master production records for bacteriophages produced in the Russian Federation. They determined common GMP-compliant production steps, the selection criteria for bacteriophage strains and bacteria production strains, and cultivation and storage conditions. The authors standardised bacteriophage quality parameters and brought the test methods in line with the test procedures described in the Ph. Rus., 14th ed. The study summarised test methods used for identification of bacteriophages and determination of their specific activity. The main results of the study were included into the general monograph «Bacteriophages» and individual monographs on bacteriophage products that were included into the current edition of the Ph. Rus. Further studies and elaboration of new quality standards for mono- and multicomponent bacteriophage products, and the use of such products in clinical practice will improve prophylaxis and treatment of various infectious diseases.
Highlights
Лечебно-профилактические бактериофаги — современные безопасные эффективные лекарственные средства, предназначенные для терапии кишечных инфекций и гнойно-воспалительных заболеваний
Bacteriophages are novel safe and efficacious medicinal products that are used for treatment of intestinal infections and purulent inflammations
There are no monographs on bacteriophage products in pharmacopoeias of other countries, the development of general chapters on groups of test methods used in bacteriophage quality control and monographs on bacteriophages for the State Pharmacopoeia of the Russian Federation
Summary
Bacteriophages are novel safe and efficacious medicinal products that are used for treatment of intestinal infections and purulent inflammations. Разработка фармакопейных стандартов качества на лекарственные препараты — бактериофаги Elaboration of Pharmacopoeial Quality Standards for Bacteriophage Products штаммы бактерий; сформулированы основные критерии, по которым осуществляется подбор фагов и бактериальных штаммов; указаны основные производственные этапы при изготовлении препаратов; обозначены условия культивирования и фильтрации; рекомендованы питательные среды; установлены сроки годности и режим хранения препаратов; определены основные качественные характеристики препаратов: стерильность, безвредность, литическая активность и описаны методы их определения. В данной ОФС обобщены и систематизированы основные требования к производственному процессу, унифицированы показатели качества в соответствии с областью применения препаратов и утверждены методы их контроля, приведена современная классификация лечебно-профилактических бактериофагов по их специфической направленности, подразделяющихся на монокомпонентные, содержащие вирулентные фаги против одного рода или вида бактерий и комбинированные, содержащие несколько видов монокомпонентных бактериофагов. 12 ФС на лечебно-профилактические бактериофаги, из них 3 — ФС на поликомпонентные препараты, представляющие собой комплексы очищенных бактериофагов 6 или 7 различных родов бактерий The list of monographs on therapeutic and prophylactic bacteriophages included in the State Pharmacopoeia of the Russian Federation, 14th ed
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