TECHNOLOGY DEVELOPMENT OF PROBIOTIC “SPORO-LEKS” MANUFACTURING

Abstract

An important element of the probiotics quality is the technology of their production. There is great variability between the results of preclinical and clinical trials of probiotic microorganisms. To a large extent, this is influenced by the technology and conditions of production of probiotics. The purpose of the work was to compare the manufacturing technologies of “Sporo-leks” probiotic. Probiotic “Sporo-leks” is a mixture of probiotic cultures of Bacillus licheniformis VK-25 and Bacillus subtilis MK-3, sorbed on a complex activated with the addition of a natural standardized sorbent. Two versions of the “Sporo-leks” probiotic manufacturing technologies were developed: in a liquid nutrient medium and on a dense nutrient medium. During the tests, intermediate quality controls were developed. As a result of the conducted research, lists of intermediate quality controls were formed during the production of the probiotic “Sporo-leks” in a liquid nutrient medium and on a dense nutrient medium. Dense nutrient media manufacturing has been found to be faster and more cost-effective as it requires only 4 intermediate control stages compared to 5 stages in liquid nutrient media manufacturing. Depending on the stage and production technology, various intermediate studies were carried out, which included microscopy, determination of typicality of growth, determination of contamination by foreign bacterial and fungal microflora, determination of sporulation, determination of the concentration of colony-forming units. Also, during the research, a list of quality control indicators of the finished probiotic “Sporo-leks” was formed and tested. It has been proven that the process of sporulation during the production of the probiotic “Sporo-leks” on a dense nutrient medium occurred faster by 24 hours compared to the technology of production in a liquid nutrient medium. Probiotic production technology on a dense nutrient medium ensured the formation of a more mature spore, which led to the stability of the drug during storage according to the indicator "the number of living cells in 1 g of product." According to the rest of the quality indicators, both technologies equally ensured the stability of the product during storage for 36 months.