2 research outputs found
ΠΠ°Π»ΠΈΠ΄Π°ΡΠΈΠΎΠ½Π½ΡΠ΅ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡ ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊΠΈ ΡΠΏΠΈΡΠ°Π»ΡΠ½ΠΎΠ³ΠΎ ΠΏΠΎΡΠ΅Π²Π° Π΄Π»Ρ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠΉ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈΒ» Π»Π°ΠΊΡΠΎΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠΈΡ ΠΏΡΠΎΠ±ΠΈΠΎΡΠΈΡΠ΅ΡΠΊΠΈΡ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ²
Scientific relevance. Viable cell counting is an important microbiological test for the quality assessment of medicinal products containing live microorganisms. To optimise labour and material costs and enhance testing precision and reproducibility, it is practical to use partially automated instrumental methods, such as the spiral plating method.Aim. The aim was to conduct a validation study of the spiral plating method for assessing the potency of biologicals containing live bacterial cells, using a lactobacillus-containing probiotic medicinal product as a case study.Materials and methods. This study used a culture of Lactiplantibacillus plantarum isolated from a probiotic medicinal product. Spiral plating on agar-based biological culture media was performed using an automatic Eddy Jet 2 plating system. The study used an IUL Flash & Go colony counter for automatic reporting of the results. The validation study was conducted according to the general chapter on the validation of microbiological testing methods (OFS.1.1.0021.18) of the State Pharmacopoeia of the Russian Federation.Results. According to the validation results for the main parameters, the spiral plating method had the range of 104β105 CFU/mL; the limit of quantification of 102 CFU/mL; and the coefficient of linear determination, R2, of 0.99. The accuracy of the spiral plating method in determining the potency of the test sample was 93%; the repeatability was 4.9%.Conclusions. The study results confirm the similarity of the spiral plating method with an automatic colony counter to Kochβs plating method, which is currently used in accordance with the State Pharmacopoeia of the Russian Federation, in terms of the validated parameters. Therefore, spiral plating can be used to evaluate the potency of lactobacillus-containing probiotics. Spiral plating can help improve the cost-effectiveness and accuracy of testing.ΠΠΊΡΡΠ°Π»ΡΠ½ΠΎΡΡΡ. ΠΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΠ΅ ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²Π° ΠΆΠΈΠ·Π½Π΅ΡΠΏΠΎΡΠΎΠ±Π½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ ΡΠ²Π»ΡΠ΅ΡΡΡ Π²Π°ΠΆΠ½ΡΠΌ ΠΌΠΈΠΊΡΠΎΠ±ΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΠΌ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ ΠΏΡΠΈ ΠΎΡΠ΅Π½ΠΊΠ΅ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ², ΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠΈΡ
ΠΆΠΈΠ²ΡΠ΅ ΠΌΠΈΠΊΡΠΎΠΎΡΠ³Π°Π½ΠΈΠ·ΠΌΡ. ΠΠ»Ρ ΠΎΠΏΡΠΈΠΌΠΈΠ·Π°ΡΠΈΠΈ ΡΡΡΠ΄ΠΎΠ²ΡΡ
ΠΈ ΠΌΠ°ΡΠ΅ΡΠΈΠ°Π»ΡΠ½ΡΡ
Π·Π°ΡΡΠ°Ρ, ΠΏΠΎΠ²ΡΡΠ΅Π½ΠΈΡ ΡΠΎΡΠ½ΠΎΡΡΠΈ ΠΈ Π²ΠΎΡΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΠΌΠΎΡΡΠΈ ΠΈΡΠΏΡΡΠ°Π½ΠΈΠΉ ΡΠ΅Π»Π΅ΡΠΎΠΎΠ±ΡΠ°Π·Π½ΠΎ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ ΡΠ°ΡΡΠΈΡΠ½ΠΎ Π°Π²ΡΠΎΠΌΠ°ΡΠΈΠ·ΠΈΡΠΎΠ²Π°Π½Π½ΡΡ
ΠΈΠ½ΡΡΡΡΠΌΠ΅Π½ΡΠ°Π»ΡΠ½ΡΡ
ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ², ΠΊ ΠΊΠΎΡΠΎΡΡΠΌ ΠΎΡΠ½ΠΎΡΠΈΡΡΡ ΠΌΠ΅ΡΠΎΠ΄ ΡΠΏΠΈΡΠ°Π»ΡΠ½ΠΎΠ³ΠΎ ΠΏΠΎΡΠ΅Π²Π°.Π¦Π΅Π»Ρ. ΠΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΠ΅ Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΎΠ½Π½ΡΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊΠΈ ΡΠΏΠΈΡΠ°Π»ΡΠ½ΠΎΠ³ΠΎ ΠΏΠΎΡΠ΅Π²Π° ΠΏΡΠΈ ΠΈΡΠΏΡΡΠ°Π½ΠΈΠΈ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ» Π±ΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΡ
Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ², ΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠΈΡ
ΠΆΠΈΠ²ΡΠ΅ Π±Π°ΠΊΡΠ΅ΡΠΈΠ°Π»ΡΠ½ΡΠ΅ ΠΊΠ»Π΅ΡΠΊΠΈ, Π½Π° ΠΏΡΠΈΠΌΠ΅ΡΠ΅ Π»Π°ΠΊΡΠΎΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠ΅Π³ΠΎ ΠΏΡΠΎΠ±ΠΈΠΎΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°.ΠΠ°ΡΠ΅ΡΠΈΠ°Π»Ρ ΠΈ ΠΌΠ΅ΡΠΎΠ΄Ρ. Π ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΈ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π»ΠΈ ΠΊΡΠ»ΡΡΡΡΡ Lactiplantibacillus plantarum, Π²ΡΠ΄Π΅Π»Π΅Π½Π½ΡΡ ΠΈΠ· ΠΎΠ±ΡΠ°Π·ΡΠ° ΠΏΡΠΎΠ±ΠΈΠΎΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°. Π‘ΠΏΠΈΡΠ°Π»ΡΠ½ΡΠΉ ΠΏΠΎΡΠ΅Π² Π½Π° Π°Π³Π°ΡΠΈΠ·ΠΎΠ²Π°Π½Π½ΡΠ΅ ΠΏΠΈΡΠ°ΡΠ΅Π»ΡΠ½ΡΠ΅ Π±Π°ΠΊΡΠ΅ΡΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΠ΅ ΡΡΠ΅Π΄Ρ ΠΎΡΡΡΠ΅ΡΡΠ²Π»ΡΠ»ΠΈ Ρ ΠΏΠΎΠΌΠΎΡΡΡ Π°Π²ΡΠΎΠΌΠ°ΡΠΈΡΠ΅ΡΠΊΠΎΠΉ ΡΠΈΡΡΠ΅ΠΌΡ Π½Π°Π½Π΅ΡΠ΅Π½ΠΈΡ ΠΏΡΠΎΠ±Ρ Eddy Jet 2 Ρ ΠΏΠΎΡΠ»Π΅Π΄ΡΡΡΠΈΠΌ Π°Π²ΡΠΎΠΌΠ°ΡΠΈΡΠ΅ΡΠΊΠΈΠΌ ΡΡΠ΅ΡΠΎΠΌ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ² Ρ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ΠΌ ΡΡΠ΅ΡΡΠΈΠΊΠ° ΠΊΠΎΠ»ΠΎΠ½ΠΈΠΉ IUL Flash & Go. ΠΠ°Π»ΠΈΠ΄Π°ΡΠΈΠΎΠ½Π½ΡΠ΅ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΠΈ ΡΠΎΠ³Π»Π°ΡΠ½ΠΎ ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡΠΌ ΠΠΎΡΡΠ΄Π°ΡΡΡΠ²Π΅Π½Π½ΠΎΠΉ ΡΠ°ΡΠΌΠ°ΠΊΠΎΠΏΠ΅ΠΈ Π ΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ Π€Π΅Π΄Π΅ΡΠ°ΡΠΈΠΈ (ΠΠ€Π‘.1.1.0021.18).Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ. ΠΠΏΡΠ΅Π΄Π΅Π»Π΅Π½Ρ ΠΎΡΠ½ΠΎΠ²Π½ΡΠ΅ Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΎΠ½Π½ΡΠ΅ Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊΠΈ ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊΠΈ ΡΠΏΠΈΡΠ°Π»ΡΠ½ΠΎΠ³ΠΎ ΠΏΠΎΡΠ΅Π²Π°: ΡΠ°Π±ΠΎΡΠΈΠΉ Π΄ΠΈΠ°ΠΏΠ°Π·ΠΎΠ½ ΠΎΡ 104 Π΄ΠΎ 105 ΠΠΠ/ΠΌΠ», ΠΏΡΠ΅Π΄Π΅Π» ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ β 102 ΠΠΠ/ΠΌΠ», ΠΊΠΎΡΡΡΠΈΡΠΈΠ΅Π½Ρ Π»ΠΈΠ½Π΅ΠΉΠ½ΠΎΠΉ Π΄Π΅ΡΠ΅ΡΠΌΠΈΠ½Π°ΡΠΈΠΈ R2 β 0,99. ΠΡΠ°Π²ΠΈΠ»ΡΠ½ΠΎΡΡΡ ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊΠΈ ΡΠΏΠΈΡΠ°Π»ΡΠ½ΠΎΠ³ΠΎ ΠΏΠΎΡΠ΅Π²Π° ΠΏΡΠΈ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΠΈ ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠΉ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΡΠΎΡΡΠ°Π²ΠΈΠ»Π° 93% Ρ ΠΏΠΎΠ²ΡΠΎΡΡΠ΅ΠΌΠΎΡΡΡΡ 4,9%.ΠΡΠ²ΠΎΠ΄Ρ. ΠΠ΅ΡΠΎΠ΄ΠΈΠΊΠ° ΡΠΏΠΈΡΠ°Π»ΡΠ½ΠΎΠ³ΠΎ ΠΏΠΎΡΠ΅Π²Π° Ρ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ΠΌ Π°Π²ΡΠΎΠΌΠ°ΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΡΡΠ΅ΡΡΠΈΠΊΠ° ΠΊΠΎΠ»ΠΎΠ½ΠΈΠΉ ΠΌΠΎΠΆΠ΅Ρ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°ΡΡΡΡ ΠΏΡΠΈ ΠΎΡΠ΅Π½ΠΊΠ΅ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π»Π°ΠΊΡΠΎΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠΈΡ
ΠΏΡΠΎΠ±ΠΈΠΎΡΠΈΡΠ΅ΡΠΊΠΈΡ
Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ», ΠΏΠΎΡΠΊΠΎΠ»ΡΠΊΡ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΎΠ½Π½ΡΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ ΠΏΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π°ΡΡ Π°Π½Π°Π»ΠΎΠ³ΠΈΡΠ½ΠΎΡΡΡ Π°Π½Π°Π»ΠΈΠ·ΠΈΡΡΠ΅ΠΌΡΡ
Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊ ΠΌΠ΅ΡΠΎΠ΄Ρ ΠΠΎΡ
Π°, ΠΊΠΎΡΠΎΡΡΠΉ ΠΏΡΠΈΠΌΠ΅Π½ΡΠ΅ΡΡΡ Π² Π½Π°ΡΡΠΎΡΡΠ΅Π΅ Π²ΡΠ΅ΠΌΡ Π² ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΠΈΠΈ Ρ ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡΠΌΠΈ ΠΠΎΡΡΠ΄Π°ΡΡΡΠ²Π΅Π½Π½ΠΎΠΉ ΡΠ°ΡΠΌΠ°ΠΊΠΎΠΏΠ΅ΠΈ Π ΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ Π€Π΅Π΄Π΅ΡΠ°ΡΠΈΠΈ. ΠΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊΠΈ ΡΠΏΠΈΡΠ°Π»ΡΠ½ΠΎΠ³ΠΎ ΠΏΠΎΡΠ΅Π²Π° ΡΠΏΠΎΡΠΎΠ±ΡΡΠ²ΡΠ΅Ρ ΠΎΠΏΡΠΈΠΌΠΈΠ·Π°ΡΠΈΠΈ Π·Π°ΡΡΠ°Ρ ΠΈ ΠΏΠΎΠ²ΡΡΠ΅Π½ΠΈΡ ΡΠΎΡΠ½ΠΎΡΡΠΈ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ² ΠΈΡΠΏΡΡΠ°Π½ΠΈΠΉ
The experimental correction of the dysbacteriosis by probiotics
In vivo, the obtained evidences were received to necessitate the performance of the standard preclinical research of different dosages of the probiotics in experimental model of the probiotics treatment efficiency study in the case of dysbacteriosis correction. The use of different commercial probiotics in the experimental disbiosis lead to various results of the corrections of intestinal microflora balance: to the increasing of normoflora without the correction of potentially harmful organisms in case of using the normoflora medication; to the increasing of lactose-positive E.coli, lactobacteria, without the bifidobacteria level shifting and to the elimination of fungi and staphylococcus in case of the biosporin. Bactisubtil didn't restore the normoflora and didn't correct the level of the fungi and staphylococcus