EVALUATION OF THE MICROBIOLOGICAL PURITY OF THE MEDICINAL PRODUCT «AS-PROBIONORM»

2026

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DOI 10.53729/mv-as.2026.02.08
Data confidence 70 medium
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Abstract

The article presents a study of the microbiological purity and quality characteristics of the new probiotic medicinal product «AS-Probionorm» (batch No. 5 2023) based on the association of lactic acid bacteria Lactobacillus fermentum 30 and Lactobacillus cellobiosus36, developed in the Republic of Kazakhstan. The work evaluated the physicochemical parameters (pH, dissolution time, fluidity, mass homogeneity) and carried out a quantitative determination of viable cells using the serial dilution method with the calculation of CFU/g, as well as tests for microbiological purity in accordance with the requirements of the State Pharmacopoeia of the Republic of Kazakhstan and OFS.1.7.2.0012.15. The obtained results indicate the suitability of "AS Probionorm" for further clinical use in the correction of intestinal microbiocenosis and the prevention of acute intestinal infections. В статье представлено исследование микробиологической чистоты и качественных характеристик нового пробиотического лекарственного препарата «АС-Пробионорм» (серия №5‑2023) на основе ассоциации молочнокислых бактерий Lactobacillus fermentum 30 и Lactobacillus cellobiosus 36, разработанного в Республике Казахстан. В работе оценены физико‑химические параметры (pH, время растворения, текучесть, однородность массы) и проведено количественное определение жизнеспособных клеток методом серийных разведений с расчетом КОЕ/г, а также испытания на микробиологическую чистоту в соответствии с требованиями Государственной фармакопеи Республики Казахстан и ОФС.1.7.2.0012.15. Полученные результаты свидетельствуют о пригодности «АС-Пробионорм» для дальнейшего клинического применения при коррекции кишечного микробиоценоза и профилактике острых кишечных инфекций.