53 research outputs found
Evaluation of the applicability of immunochromatography to the identification of live plague vaccines and the tularaemia allergen (Tularin)
The regulatory standards require that the identification of live plague vaccines and the liquid tularaemia allergen (Tularin) should be performed by immunofluorescence. A major drawback of the recommended method is its labour intensive nature. However, immunochromatography represents an alternative method that offers a number of advantages, including rapid testing and easy result interpretation.Β The aim of the study was to assess the applicability of immunochromatography to the identification of live plague vaccines and the liquid tularaemia allergen (Tularin).Materials and methods. The authors performed identification tests using samples of the pharmacopoeia standard for live plague vaccines, three commercial batches of a live plague vaccine, and two batches of the liquid tularaemia allergen (Tularin). These samples were tested using immunochromatographic assay (ICA) reagent kits for rapid detection and identification of Yersinia pestis (ICA System for Y. pestis) and Francisella tularensis (ICA System for F. tularensis) manufactured by the State Scientific Center for Applied Microbiology and Biotechnology.Results. The findings show that immunochromatography is an effective, rapid, and species-specific method to confirm the presence of Y. pestis in a sample of a live plague vaccine or F. tularensis in a sample of the liquid tularaemia allergen (Tularin). To perform identification tests by immunochromatography, the authors recommend diluting live plague vaccine samples to a concentration of 109 bacterial cells/mL and using undiluted samples of the liquid tularaemia allergen (Tularin).Conclusions. The study results may support the inclusion of ICA into the regulatory standards for live plague vaccines and the liquid tularaemia allergen (Tularin) as an alternative identification method
Using Shewhart charts to monitor quality characteristics of preventive vaccines for tuberculosis
Scientific relevance. The quality of medicinal products, particularly vaccines, is contingent on the stability of the manufacturing process at all stages, which can be evaluated using Shewhart charts for data obtained by monitoring the quality attributes of interest.Aim. This study evaluatedΒ the stability of the quality and manufacturing processes of the BCG and BCG-M tuberculosis vaccines using Shewhart charts.Materials and methods. This study focused on samples of the BCG tuberculosis vaccine and the BCG-M tuberculosis vaccine, a less reactogenic alternative for primary immunisation. Both vaccines were released to the market in 2019β2022. The quality of samples was assessed for stability based on their potency and total bacterial count, which are the key parameters for immunogenicity evaluation. These quality parameters were compared using test results submitted by the manufacturer and obtained at the testing centre. The authors plotted individuals charts (X-charts) and moving range charts (R-charts) in accordance with national standards GOST R 50779.42-99 and GOST R ISO 7870-2-2015.Results. The quality of the BCG and BCG-M vaccines remained stable during the entire follow-up period (2019β2022). For some periods, the retrospective analysis of R- and X-charts revealed characteristic trends meeting special cause criteria. The Pearson correlation coefficient (r) between the data submitted by the manufacturer and the data obtained at the testing centre ranged from 0.2 to 0.8.Conclusions. The Shewhart charts demonstrated that the quality parameters of the BCG and BCG-M tuberculosis vaccines tested in 2019β2022 were stable. These vaccines had stable manufacturing processes, as shown by the R- and X-charts. However, the warning signs indicated that additional measures should be taken to standardise the manufacturing processes. The findings suggest that Shewhart charts may be recommended for monitoring the production and quality of tuberculosis vaccines
Certification of a New Batch of the Industry Reference Standard for the Control of Specific Activity and Thermal Stability of Live Plague Vaccine
In accordance with the State Pharmacopoeia (SPh) requirements for live plague vaccine, a reference standard has to be used when testing the specific activity and thermal stability of plague vaccine commercial batches in order to assess the consistency and acceptability of the test results. Since there is no international reference standard for plague vaccine, the certification of a new batch of the industry reference standard (IRS) of live plague vaccine in terms of the above-mentioned quality parameters is an urgent challenge. Therefore, a certification programme for the industry reference standard was developed that establishes the design and scope of testing required to obtain statistically significant results. A candidate IRS was represented by a commercial batch of the product meeting the specification requirements for live plague vaccine. The certification parameters were: Β«Specific activity: microbial cell concentrationΒ», Β«Specific activity: live microbial cell percentageΒ» and Β«Thermal stabilityΒ». The article presents the results of the certification of a new batch of the live plague vaccine IRS, detailed evaluation of the candidate IRS in terms of: Β«Average weight and uniformity of weightΒ», Β«Loss on dryingΒ», and statistical interpretation of the test results. It also summarises the results of the product testing in terms of Β«Specific activity: immunogenicityΒ». The results of application of the previous batch of the live plague vaccine IRS (OSO 42-28-392-2013) and the results of monitoring the stability of its certification parameters demonstrated that the IRS shelf life could be extended by 6 months relative to the established period (from 2 to 2.5 years). All the certified and additional characteristics are reflected in the official documents for the scientific/technological product β live plague vaccine IRS, OSO 42-28-392-2017: passport, labelling and patient information leaflet
ΠΠ΅ΡΡΠΏΠ΅ΠΊΡΠΈΠ²Ρ ΡΠΎΠ²Π΅ΡΡΠ΅Π½ΡΡΠ²ΠΎΠ²Π°Π½ΠΈΡ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ Π±ΡΡΡΠ΅Π»Π»Π΅Π·Π½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ»
Prophylactic immunisation against brucellosis is part of the National Immunisation Schedule for Epidemic Settings. The immunisation is performed with a live vaccineβa lyophilized suspension of the Brucella abortus strain 19 BΠ in a stabilizing medium. The paper presents the results of quality evaluation of 9 batches of live brucellosis vaccine that were submitted to the Testing Centre for Evaluation of Medicinal Immunobiological Productsβ Quality of the Federal State Budgetary Institution βScientific Centre for Expert Evaluation of Medicinal Productsβ of the Ministry of Health of the Russian Federation for assessment of the productβs compliance with the established specifications. The paper also presents the results of evaluation of the passport information provided by the manufacturer for these batches. There is no doubt about the need for objective quality evaluation of brucellosis vaccines as well as about the significance of its improvement.The aim of study was to assess the prospects for improvingΒ quality evaluation of live brucellosis vaccines in terms of Specific activity (concentration of microbial cells, number of living microbial cells, number of cutaneous doses).Materials and methods: specific activity (concentration of microbial cells and number of living microbial cells) was determined by visual and microbiological methods using the industrial reference standard of brucellosis vaccine OSO 42-28-396-2018, batch 6 and the bacterial suspension of the Brucella abortus strain 19 BΠ acquired from the joint stock company Scientific and Production Association βMicrogenβ in 2016. The number of cutaneous doses in the brusellosis vaccine was determined by the calculation method. Statistical processing of the results was performed using Microsoft Excel.Results: there was a mismatch between the brucella concentration coefficient of 1.7Γ109 microbial cells/mL determined by comparison with the industrial reference standard of bacterial suspension turbidity, 10 IU and the actual concentration of microbial cells obtained in the study. According to preliminary results, the brucella concentration coefficient corresponding to the industrial reference standard of bacterial suspension turbidity, 10 IU can reach 3.0Γ109 microbial cells/mL.Conclusions: the obtained results can serve as a basis for amending the data on the brucella concentration coefficient in the Passport and the Instructions for use of the industrial reference standard of bacterial suspension turbidity, 10 IU, as well as the Specific activity section (concentration of microbial cells, number of living microbial cells, number of cutaneous doses) of the established specifications for the brucellosis vaccine. Before amending the information on the brucella concentration corresponding to 10 IU in the Passport and the Instructions for use of the reference standard of bacterial suspension turbidity (OSO 42-28-85P), additional studies should be performed with other types of brucella.ΠΡΠΎΡΠΈΠ»Π°ΠΊΡΠΈΡΠ΅ΡΠΊΠ°Ρ ΠΈΠΌΠΌΡΠ½ΠΈΠ·Π°ΡΠΈΡ ΠΏΡΠΎΡΠΈΠ² Π±ΡΡΡΠ΅Π»Π»Π΅Π·Π° Π²Ρ
ΠΎΠ΄ΠΈΡ Π² ΠΠ°ΡΠΈΠΎΠ½Π°Π»ΡΠ½ΡΠΉ ΠΊΠ°Π»Π΅Π½Π΄Π°ΡΡ ΠΏΡΠΈΠ²ΠΈΠ²ΠΎΠΊ ΠΏΠΎ ΡΠΏΠΈΠ΄Π΅ΠΌΠΈΡΠ΅ΡΠΊΠΈΠΌ ΠΏΠΎΠΊΠ°Π·Π°Π½ΠΈΡΠΌ. ΠΠ»Ρ ΠΈΠΌΠΌΡΠ½ΠΈΠ·Π°ΡΠΈΠΈ Π»ΡΠ΄Π΅ΠΉ ΠΏΡΠΈΠΌΠ΅Π½ΡΠ΅ΡΡΡ ΠΆΠΈΠ²Π°Ρ Π²Π°ΠΊΡΠΈΠ½Π°, ΠΏΡΠ΅Π΄ΡΡΠ°Π²Π»ΡΡΡΠ°Ρ ΡΠΎΠ±ΠΎΠΉ Π»ΠΈΠΎΡΠΈΠ»ΠΈΠ·ΠΈΡΠΎΠ²Π°Π½Π½ΡΡ Π²Π·Π²Π΅ΡΡ Π²Π°ΠΊΡΠΈΠ½Π½ΠΎΠ³ΠΎ ΡΡΠ°ΠΌΠΌΠ° Brucella abortus 19 BΠ Π² ΡΡΠ°Π±ΠΈΠ»ΠΈΠ·ΠΈΡΡΡΡΠ΅ΠΉ ΡΡΠ΅Π΄Π΅. Π ΡΡΠ°ΡΡΠ΅ ΠΏΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½Ρ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ Π°Π½Π°Π»ΠΈΠ·Π° ΠΊΠ°ΡΠ΅ΡΡΠ²Π° 9 ΡΠ΅ΡΠΈΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ Π±ΡΡΡΠ΅Π»Π»Π΅Π·Π½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ, ΠΏΠΎΡΡΡΠΏΠΈΠ²ΡΠΈΡ
Π² ΠΡΠΏΡΡΠ°ΡΠ΅Π»ΡΠ½ΡΠΉ ΡΠ΅Π½ΡΡ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΠΠΠΠ Π€ΠΠΠ£ Β«ΠΠ¦ΠΠ‘ΠΠΒ» ΠΠΈΠ½Π·Π΄ΡΠ°Π²Π° Π ΠΎΡΡΠΈΠΈ Π΄Π»Ρ ΠΎΡΠ΅Π½ΠΊΠΈ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΠΈΡ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ° Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΡΠΌ ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡΠΌ, Π° ΡΠ°ΠΊΠΆΠ΅ Π°Π½Π°Π»ΠΈΠ· ΠΏΠ°ΡΠΏΠΎΡΡΠ½ΡΡ
Π΄Π°Π½Π½ΡΡ
ΠΏΡΠ΅Π΄ΠΏΡΠΈΡΡΠΈΡ-ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΡΠ΅Π»Ρ Π½Π° ΡΡΠΈ ΡΠ΅ΡΠΈΠΈ. ΠΠ΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΡΡΡ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ ΠΎΠ±ΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΠΉ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ Π±ΡΡΡΠ΅Π»Π»Π΅Π·Π½ΠΎΠΉ, Π° ΡΠ°ΠΊΠΆΠ΅ Π°ΠΊΡΡΠ°Π»ΡΠ½ΠΎΡΡΡ Π΅Π΅ ΡΠΎΠ²Π΅ΡΡΠ΅Π½ΡΡΠ²ΠΎΠ²Π°Π½ΠΈΡ Π½Π΅ Π²ΡΠ·ΡΠ²Π°ΡΡ ΡΠΎΠΌΠ½Π΅Π½ΠΈΠΉ.Π¦Π΅Π»Ρ ΡΠ°Π±ΠΎΡΡ: ΠΎΡΠ΅Π½ΠΊΠ° ΠΏΠ΅ΡΡΠΏΠ΅ΠΊΡΠΈΠ²Ρ ΡΠΎΠ²Π΅ΡΡΠ΅Π½ΡΡΠ²ΠΎΠ²Π°Π½ΠΈΡ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ Π±ΡΡΡΠ΅Π»Π»Π΅Π·Π½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ» (ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΡ ΠΌΠΈΠΊΡΠΎΠ±Π½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ, ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²ΠΎ ΠΆΠΈΠ²ΡΡ
ΠΌΠΈΠΊΡΠΎΠ±Π½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ, ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²ΠΎ Π½Π°ΠΊΠΎΠΆΠ½ΡΡ
Π΄ΠΎΠ·).ΠΠ°ΡΠ΅ΡΠΈΠ°Π»Ρ ΠΈ ΠΌΠ΅ΡΠΎΠ΄Ρ: ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΡΡ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ (ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΡ ΠΌΠΈΠΊΡΠΎΠ±Π½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ, ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²ΠΎ ΠΆΠΈΠ²ΡΡ
ΠΌΠΈΠΊΡΠΎΠ±Π½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ) ΠΎΠΏΡΠ΅Π΄Π΅Π»ΡΠ»ΠΈ Π²ΠΈΠ·ΡΠ°Π»ΡΠ½ΡΠΌ ΠΈ ΠΌΠΈΠΊΡΠΎΠ±ΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΠΌ ΠΌΠ΅ΡΠΎΠ΄Π°ΠΌΠΈ Π½Π° ΠΎΠ±ΡΠ°Π·ΡΠ°Ρ
ΠΠ‘Π 42-28-396-2018 Π²Π°ΠΊΡΠΈΠ½Ρ Π±ΡΡΡΠ΅Π»Π»Π΅Π·Π½ΠΎΠΉ ΡΠ΅ΡΠΈΠΈ 6 ΠΈ Π½Π° Π±Π°ΠΊΡΠ΅ΡΠΈΠ°Π»ΡΠ½ΠΎΠΉ Π²Π·Π²Π΅ΡΠΈ Π²Π°ΠΊΡΠΈΠ½Π½ΠΎΠ³ΠΎ ΡΡΠ°ΠΌΠΌΠ° Brucella abortus 19 BΠ, ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΠΎΠ³ΠΎ ΠΈΠ· ΠΠ Β«ΠΠΠ Β«ΠΠΈΠΊΡΠΎΠ³Π΅Π½Β» Π² 2016 Π³. ΠΠΎΠ»ΠΈΡΠ΅ΡΡΠ²ΠΎ Π½Π°ΠΊΠΎΠΆΠ½ΡΡ
Π΄ΠΎΠ· Π² Π²Π°ΠΊΡΠΈΠ½Π΅ Π±ΡΡΡΠ΅Π»Π»Π΅Π·Π½ΠΎΠΉ ΠΎΠΏΡΠ΅Π΄Π΅Π»ΡΠ»ΠΈ ΡΠ°ΡΡΠ΅ΡΠ½ΡΠΌ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ. Π‘ΡΠ°ΡΠΈΡΡΠΈΡΠ΅ΡΠΊΠ°Ρ ΠΎΠ±ΡΠ°Π±ΠΎΡΠΊΠ° ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ² Π±ΡΠ»Π° Π²ΡΠΏΠΎΠ»Π½Π΅Π½Π° Ρ ΠΏΠΎΠΌΠΎΡΡΡ ΠΏΡΠΎΠ³ΡΠ°ΠΌΠΌΡ Microsoft Excel.Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ: ΡΡΡΠ°Π½ΠΎΠ²Π»Π΅Π½ΠΎ Π½Π΅ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΠΈΠ΅ ΠΊΠΎΡΡΡΠΈΡΠΈΠ΅Π½ΡΠ° ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΠΈ Π±ΡΡΡΠ΅Π»Π» 1,7Γ109 ΠΌ.ΠΊ./ΠΌΠ» ΠΏΠΎ ΠΠ‘Π ΠΌΡΡΠ½ΠΎΡΡΠΈ Π±Π°ΠΊΡΠ΅ΡΠΈΠ°Π»ΡΠ½ΡΡ
Π²Π·Π²Π΅ΡΠ΅ΠΉ 10Β ΠΠ ΡΠ°ΠΊΡΠΈΡΠ΅ΡΠΊΠΈΠΌ Π΄Π°Π½Π½ΡΠΌ, ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΡΠΌ Π² ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠ΅ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½Π½ΡΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ. ΠΡΠ΅Π΄Π²Π°ΡΠΈΡΠ΅Π»ΡΠ½ΡΠΉ ΠΊΠΎΡΡΡΠΈΡΠΈΠ΅Π½Ρ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΠΈ Π±ΡΡΡΠ΅Π»Π»Π΅Π·Π½ΠΎΠ³ΠΎ ΠΌΠΈΠΊΡΠΎΠ±Π° ΠΏΠΎ ΠΠ‘Π ΠΌΡΡΠ½ΠΎΡΡΠΈ Π±Π°ΠΊΡΠ΅ΡΠΈΠ°Π»ΡΠ½ΡΡ
Π²Π·Π²Π΅ΡΠ΅ΠΉ 10 ΠΠ ΠΌΠΎΠΆΠ΅Ρ Π΄ΠΎΡΡΠΈΠ³Π°ΡΡ 3,0Γ109 ΠΌ.ΠΊ./ΠΌΠ».ΠΡΠ²ΠΎΠ΄Ρ: ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΡΠ΅ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ ΠΌΠΎΠ³ΡΡ ΠΏΠΎΡΠ»ΡΠΆΠΈΡΡ ΠΎΡΠ½ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ Π΄Π»Ρ Π²Π½Π΅ΡΠ΅Π½ΠΈΡ ΠΈΠ·ΠΌΠ΅Π½Π΅Π½ΠΈΡ Π² ΠΏΠ°ΡΠΏΠΎΡΡ ΠΈ ΠΈΠ½ΡΡΡΡΠΊΡΠΈΡ ΠΏΠΎ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΠ‘Π ΠΌΡΡΠ½ΠΎΡΡΠΈ Π±Π°ΠΊΡΠ΅ΡΠΈΠ°Π»ΡΠ½ΡΡ
Π²Π·Π²Π΅ΡΠ΅ΠΉ 10 ΠΠ ΠΏΠΎ ΠΊΠΎΡΡΡΠΈΡΠΈΠ΅Π½ΡΡ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΠΈ Π±ΡΡΡΠ΅Π»Π»Π΅Π·Π½ΠΎΠ³ΠΎ ΠΌΠΈΠΊΡΠΎΠ±Π° ΠΈ Π² ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡ Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΠΎΠΉ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠ°ΡΠΈΠΈ Π½Π° Π²Π°ΠΊΡΠΈΠ½Ρ Π±ΡΡΡΠ΅Π»Π»Π΅Π·Π½ΡΡ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ» (ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΡ ΠΌΠΈΠΊΡΠΎΠ±Π½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ, ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²ΠΎ ΠΆΠΈΠ²ΡΡ
ΠΌΠΈΠΊΡΠΎΠ±Π½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ, ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²ΠΎ Π½Π°ΠΊΠΎΠΆΠ½ΡΡ
Π΄ΠΎΠ·). ΠΠ»Ρ Π²Π½Π΅ΡΠ΅Π½ΠΈΡ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΡΡΡΠΈΡ
ΠΈΠ·ΠΌΠ΅Π½Π΅Π½ΠΈΠΉ ΠΏΠΎ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΠΈ Π±ΡΡΡΠ΅Π»Π», ΡΠΊΠ²ΠΈΠ²Π°Π»Π΅Π½ΡΠ½ΠΎΠΉ 10 ΠΠ, Π² ΠΏΠ°ΡΠΏΠΎΡΡ ΠΈ ΠΈΠ½ΡΡΡΡΠΊΡΠΈΡ ΠΏΠΎ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ Π½Π° ΠΠ‘Π ΠΌΡΡΠ½ΠΎΡΡΠΈ Π±Π°ΠΊΡΠ΅ΡΠΈΠ°Π»ΡΠ½ΡΡ
Π²Π·Π²Π΅ΡΠ΅ΠΉ (ΠΠ‘Π 42-28-85Π) Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎ ΠΏΡΠΎΠ²Π΅ΡΡΠΈ Π΄ΠΎΠΏΠΎΠ»Π½ΠΈΡΠ΅Π»ΡΠ½ΡΠ΅ ΠΈΡΠΏΡΡΠ°Π½ΠΈΡ Π½Π° Π΄ΡΡΠ³ΠΈΡ
Π²ΠΈΠ΄Π°Ρ
Π±ΡΡΡΠ΅Π»Π»
Π’Π΅ΠΎΡΠ΅ΡΠΈΡΠ΅ΡΠΊΠΎΠ΅ ΠΈ ΡΠΊΡΠΏΠ΅ΡΠΈΠΌΠ΅Π½ΡΠ°Π»ΡΠ½ΠΎΠ΅ ΠΎΠ±ΠΎΡΠ½ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΠ΅ΡΡΠΏΠ΅ΠΊΡΠΈΠ²Π½ΡΡ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ² ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ ΡΠΈΠ±ΠΈΡΠ΅ΡΠ·Π²Π΅Π½Π½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ
Preventive immunisation against anthrax is carried out in accordance with the national Immunisation Schedule for Epidemic Settings. The vaccination is performed using a live vaccineβa freeze-dried suspension of Bacillus anthracis STI-1 vaccine strain spores in a stabilizing media. Improvement of the quality control of immunobiological medicines is a pressing issue and an integral part of the quality management system. The aim of study was to streamline quality control of live anthrax vaccine in terms of the following test parameters: identification and specific activity (total spore concentration). Materials and methods: identification and specific activity (total spore concentration) tests were performed for samples of live anthrax vaccine, batch 266, produced by the 48 Central Scientific Research Institute. The identification test was performed using the B. anthracis immunochromatography test kit for express detection and identification of anthrax pathogen spores produced by the State Research Center for Applied Microbiology and Biotechnology (Obolensk). The specific activity (total spore concentration)Β was assessed by the visual method and calculated in the Goryaev chamber using the industry reference standard of bacterial suspension turbidity equivalent to 10 IUβOSO 42-28-85 (by the Scientific Centre for Expert Evaluation of Medicinal Products). The number of live spores in live anthrax vaccine was determined by the microbiological method (by inoculating media). The statistical processing of the results was performed using Excel and Statistica 10.0. Results: the authors provided theoretical and experimental substantiation to support the feasibility of using immunochromatography as an alternative identification test method for live anthrax vaccine. Test samples dilutions of 108 microbial cells per millilitre and 109 microbial cells per millilitre are used in the test. The authors developed a test procedure for determination of the total spore concentration (specific activity) in live anthrax vaccine using an industry reference standard of turbidity equivalent to 10 IU, and proposed a formula for calculation of the total spore concentration. Conclusions: the developed test procedures could be recommended for inclusion in the live anthrax vaccine specification files as alternative methods of quality control.Β ΠΠ°ΠΊΡΠΈΠ½Π°ΡΠΈΡ ΠΏΡΠΎΡΠΈΠ² ΡΠΈΠ±ΠΈΡΡΠΊΠΎΠΉ ΡΠ·Π²Ρ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΡΡΡ Π² ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΠΈΠΈ Ρ Π½Π°ΡΠΈΠΎΠ½Π°Π»ΡΠ½ΡΠΌ ΠΠ°Π»Π΅Π½Π΄Π°ΡΠ΅ΠΌ ΠΏΡΠΎΡΠΈΠ»Π°ΠΊΡΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΏΡΠΈΠ²ΠΈΠ²ΠΎΠΊ ΠΏΠΎ ΡΠΏΠΈΠ΄Π΅ΠΌΠΈΡΠ΅ΡΠΊΠΈΠΌ ΠΏΠΎΠΊΠ°Π·Π°Π½ΠΈΡΠΌ. ΠΠ»Ρ ΠΈΠΌΠΌΡΠ½ΠΈΠ·Π°ΡΠΈΠΈ Π»ΡΠ΄Π΅ΠΉ ΠΏΡΠΈΠΌΠ΅Π½ΡΠ΅ΡΡΡ ΠΆΠΈΠ²Π°Ρ Π²Π°ΠΊΡΠΈΠ½Π°, ΠΏΡΠ΅Π΄ΡΡΠ°Π²Π»ΡΡΡΠ°Ρ ΡΠΎΠ±ΠΎΠΉ Π»ΠΈΠΎΡΠΈΠ»ΠΈΠ·ΠΈΡΠΎΠ²Π°Π½Π½ΡΡ Π²Π·Π²Π΅ΡΡ ΡΠΏΠΎΡ Π²Π°ΠΊΡΠΈΠ½Π½ΠΎΠ³ΠΎ ΡΡΠ°ΠΌΠΌΠ° Πacillus anthracis Π‘Π’Π-1 Π² ΡΡΠ°Π±ΠΈΠ»ΠΈΠ·ΠΈΡΡΡΡΠ΅ΠΉ ΡΡΠ΅Π΄Π΅. Π£ΡΠΎΠ²Π΅ΡΡΠ΅Π½ΡΡΠ²ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΠΈΠΌΠΌΡΠ½ΠΎΠ±ΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΡ
Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² ΠΏΠΎΡΡΠ΅Π΄ΡΡΠ²ΠΎΠΌ Π²Π½Π΅Π΄ΡΠ΅Π½ΠΈΡ ΡΠΎΠ²ΡΠ΅ΠΌΠ΅Π½Π½ΡΡ
ΡΡΠ°Π½Π΄Π°ΡΡΠ½ΡΡ
ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ² ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ ΡΠ²Π»ΡΠ΅ΡΡΡ Π°ΠΊΡΡΠ°Π»ΡΠ½ΠΎΠΉ ΠΈ Π½Π΅ΠΎΡΡΠ΅ΠΌΠ»Π΅ΠΌΠΎΠΉ ΡΠ°ΡΡΡΡ ΡΠΈΡΡΠ΅ΠΌΡ ΠΌΠ΅Π½Π΅Π΄ΠΆΠΌΠ΅Π½ΡΠ° ΠΊΠ°ΡΠ΅ΡΡΠ²Π°. Π¦Π΅Π»Ρ ΡΠ°Π±ΠΎΡΡ: ΡΠΎΠ²Π΅ΡΡΠ΅Π½ΡΡΠ²ΠΎΠ²Π°Π½ΠΈΠ΅ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ ΡΠΈΠ±ΠΈΡΠ΅ΡΠ·Π²Π΅Π½Π½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ» ΠΈ Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ» (ΠΎΠ±ΡΠ°Ρ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΡ ΡΠΏΠΎΡ). ΠΠ°ΡΠ΅ΡΠΈΠ°Π»Ρ ΠΈ ΠΌΠ΅ΡΠΎΠ΄Ρ: ΠΈΡΠΏΡΡΠ°Π½ΠΈΠ΅ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»ΡΠΌ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ» ΠΈ Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ» (ΠΎΠ±ΡΠ°Ρ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΡ ΡΠΏΠΎΡ) ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΠΈ Π½Π° ΠΎΠ±ΡΠ°Π·ΡΠ°Ρ
Π²Π°ΠΊΡΠΈΠ½Ρ ΡΠΈΠ±ΠΈΡΠ΅ΡΠ·Π²Π΅Π½Π½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ ΡΠ΅ΡΠΈΠΈ 266 ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° Π€ΠΠΠ£ Β«48 Π¦ΠΠΠΒ» ΠΠΈΠ½ΠΎΠ±ΠΎΡΠΎΠ½Ρ Π ΠΎΡΡΠΈΠΈ. ΠΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΈΠΌΠΌΡΠ½ΠΎΡ
ΡΠΎΠΌΠ°ΡΠΎΠ³ΡΠ°ΡΠΈΡΠ΅ΡΠΊΠΈΠΌ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ» ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΠΈ Ρ ΠΏΠΎΠΌΠΎΡΡΡ Π½Π°Π±ΠΎΡΠ° ΡΠ΅Π°Π³Π΅Π½ΡΠΎΠ² ΠΈΠΌΠΌΡΠ½ΠΎΡ
ΡΠΎΠΌΠ°ΡΠΎΠ³ΡΠ°ΡΠΈΡΠ΅ΡΠΊΠ°Ρ ΡΠ΅ΡΡ-ΡΠΈΡΡΠ΅ΠΌΠ° Π΄Π»Ρ ΡΠΊΡΠΏΡΠ΅ΡΡ-Π²ΡΡΠ²Π»Π΅Π½ΠΈΡ ΠΈ ΠΈΠ΄Π΅Π½ΡΠΈΡΠΈΠΊΠ°ΡΠΈΠΈ ΡΠΏΠΎΡ Π²ΠΎΠ·Π±ΡΠ΄ΠΈΡΠ΅Π»Ρ ΡΠΈΠ±ΠΈΡΡΠΊΠΎΠΉ ΡΠ·Π²Ρ Β«ΠΠ₯ ΡΠ΅ΡΡ-ΡΠΈΡΡΠ΅ΠΌΠ° B. anthracisΒ» ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° Π€ΠΠΠ£ Β«ΠΠΠ¦ ΠΠΠΒ» Π ΠΎΡΠΏΠΎΡΡΠ΅Π±Π½Π°Π΄Π·ΠΎΡΠ° (Π³. ΠΠ±ΠΎΠ»Π΅Π½ΡΠΊ); ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ» (ΠΎΠ±ΡΠ°Ρ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΡ ΡΠΏΠΎΡ) ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΠΈ Π²ΠΈΠ·ΡΠ°Π»ΡΠ½ΡΠΌ ΠΈ ΡΠ°ΡΡΠ΅ΡΠ½ΡΠΌ ΠΌΠ΅ΡΠΎΠ΄Π°ΠΌΠΈ Ρ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ΠΌ ΠΊΠ°ΠΌΠ΅ΡΡ ΠΠΎΡΡΠ΅Π²Π° ΠΈ ΠΎΡΡΠ°ΡΠ»Π΅Π²ΠΎΠ³ΠΎ ΡΡΠ°Π½Π΄Π°ΡΡΠ½ΠΎΠ³ΠΎ ΠΎΠ±ΡΠ°Π·ΡΠ° (ΠΠ‘Π) ΠΌΡΡΠ½ΠΎΡΡΠΈ Π±Π°ΠΊΡΠ΅ΡΠΈΠ°Π»ΡΠ½ΡΡ
Π²Π·Π²Π΅ΡΠ΅ΠΉ 10 ΠΠ β ΠΠ‘Π 42-28-85 (Π€ΠΠΠ£ Β«ΠΠ¦ΠΠ‘ΠΠΒ» ΠΠΈΠ½Π·Π΄ΡΠ°Π²Π° Π ΠΎΡΡΠΈΠΈ); ΠΈΡΠΏΡΡΠ°Π½ΠΈΠ΅ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ» (ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²ΠΎ ΠΆΠΈΠ²ΡΡ
ΡΠΏΠΎΡ) ΡΠΈΠ±ΠΈΡΠ΅ΡΠ·Π²Π΅Π½Π½ΠΎΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΠΈ ΠΌΠΈΠΊΡΠΎΠ±ΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΠΌ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ (ΠΏΠΎΡΠ΅Π²ΠΎΠΌ Π½Π° ΠΏΠΈΡΠ°ΡΠ΅Π»ΡΠ½ΡΠ΅ ΡΡΠ΅Π΄Ρ). Π‘ΡΠ°ΡΠΈΡΡΠΈΡΠ΅ΡΠΊΠ°Ρ ΠΎΠ±ΡΠ°Π±ΠΎΡΠΊΠ° ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ² Π±ΡΠ»Π° Π²ΡΠΏΠΎΠ»Π½Π΅Π½Π° Ρ ΠΏΠΎΠΌΠΎΡΡΡ ΠΏΡΠΎΠ³ΡΠ°ΠΌΠΌΡ Microsoft Excel ΠΈ Statistica 10.0. Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ: ΡΠ΅ΠΎΡΠ΅ΡΠΈΡΠ΅ΡΠΊΠΈ ΠΎΠ±ΠΎΡΠ½ΠΎΠ²Π°Π½Π° ΠΈ ΡΠΊΡΠΏΠ΅ΡΠΈΠΌΠ΅Π½ΡΠ°Π»ΡΠ½ΠΎ Π΄ΠΎΠΊΠ°Π·Π°Π½Π° Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΡ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΈΠΌΠΌΡΠ½ΠΎΡ
ΡΠΎΠΌΠ°ΡΠΎΠ³ΡΠ°ΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΌΠ΅ΡΠΎΠ΄Π° ΠΊΠ°ΠΊ Π°Π»ΡΡΠ΅ΡΠ½Π°ΡΠΈΠ²Π½ΠΎΠ³ΠΎ Π΄Π»Ρ ΠΎΡΠ΅Π½ΠΊΠΈ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ» Π²Π°ΠΊΡΠΈΠ½Ρ ΡΠΈΠ±ΠΈΡΠ΅ΡΠ·Π²Π΅Π½Π½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ. ΠΡΠΈ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΠΈ Π΄Π°Π½Π½ΠΎΠ³ΠΎ ΠΈΡΠΏΡΡΠ°Π½ΠΈΡ ΠΏΡΠ΅ΠΏΠ°ΡΠ°Ρ ΡΠ»Π΅Π΄ΡΠ΅Ρ ΡΠ°Π·Π²ΠΎΠ΄ΠΈΡΡ Π΄ΠΎ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΠΉ 108 ΠΈ 109 ΠΌ.ΠΊ./ΠΌΠ». Π Π°Π·ΡΠ°Π±ΠΎΡΠ°Π½Π° ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊΠ° ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΠΎΠ±ΡΠ΅ΠΉ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΠΈ ΡΠΏΠΎΡ (ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ») Π²Π°ΠΊΡΠΈΠ½Ρ ΡΠΈΠ±ΠΈΡΠ΅ΡΠ·Π²Π΅Π½Π½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ Ρ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ΠΌ ΠΠ‘Π ΠΌΡΡΠ½ΠΎΡΡΠΈ Π±Π°ΠΊΡΠ΅ΡΠΈΠ°Π»ΡΠ½ΡΡ
Π²Π·Π²Π΅ΡΠ΅ΠΉ 10 ΠΠ. ΠΡΠ΅Π΄Π»ΠΎΠΆΠ΅Π½Π° ΡΠΎΡΠΌΡΠ»Π° ΡΠ°ΡΡΠ΅ΡΠ° ΠΎΠ±ΡΠ΅ΠΉ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΠΈ ΡΠΏΠΎΡ Π² Π²Π°ΠΊΡΠΈΠ½Π΅. ΠΡΠ²ΠΎΠ΄: ΠΏΡΠ΅Π΄Π»ΠΎΠΆΠ΅Π½Π½ΡΠ΅ ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊΠΈ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ ΡΠΈΠ±ΠΈΡΠ΅ΡΠ·Π²Π΅Π½Π½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ ΠΌΠΎΠ³ΡΡ Π±ΡΡΡ ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄ΠΎΠ²Π°Π½Ρ Π΄Π»Ρ Π²ΠΊΠ»ΡΡΠ΅Π½ΠΈΡ Π² Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΡΡ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠ°ΡΠΈΡ Π² ΠΊΠ°ΡΠ΅ΡΡΠ²Π΅ Π°Π»ΡΡΠ΅ΡΠ½Π°ΡΠΈΠ²Π½ΡΡ
ΠΡΠ΅Π½ΠΊΠ° Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΠΈ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΈΠΌΠΌΡΠ½ΠΎΡ ΡΠΎΠΌΠ°ΡΠΎΠ³ΡΠ°ΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΌΠ΅ΡΠΎΠ΄Π° Π΄Π»Ρ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ ΠΈ Π°Π»Π»Π΅ΡΠ³Π΅Π½Π° ΡΡΠ»ΡΡΠ΅ΠΌΠΈΠΉΠ½ΠΎΠ³ΠΎ (Π’ΡΠ»ΡΡΠΈΠ½Π°) ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ»
The regulatory standards require that the identification of live plague vaccines and the liquid tularaemia allergen (Tularin) should be performed by immunofluorescence. A major drawback of the recommended method is its labour intensive nature. However, immunochromatography represents an alternative method that offers a number of advantages, including rapid testing and easy result interpretation.Β The aim of the study was to assess the applicability of immunochromatography to the identification of live plague vaccines and the liquid tularaemia allergen (Tularin).Materials and methods. The authors performed identification tests using samples of the pharmacopoeia standard for live plague vaccines, three commercial batches of a live plague vaccine, and two batches of the liquid tularaemia allergen (Tularin). These samples were tested using immunochromatographic assay (ICA) reagent kits for rapid detection and identification of Yersinia pestis (ICA System for Y. pestis) and Francisella tularensis (ICA System for F. tularensis) manufactured by the State Scientific Center for Applied Microbiology and Biotechnology.Results. The findings show that immunochromatography is an effective, rapid, and species-specific method to confirm the presence of Y. pestis in a sample of a live plague vaccine or F. tularensis in a sample of the liquid tularaemia allergen (Tularin). To perform identification tests by immunochromatography, the authors recommend diluting live plague vaccine samples to a concentration of 109 bacterial cells/mL and using undiluted samples of the liquid tularaemia allergen (Tularin).Conclusions. The study results may support the inclusion of ICA into the regulatory standards for live plague vaccines and the liquid tularaemia allergen (Tularin) as an alternative identification method.ΠΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΠ΅ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ», ΡΠΎΠ³Π»Π°ΡΠ½ΠΎ ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡΠΌ Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΠΎΠΉ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠ°ΡΠΈΠΈ Π½Π° Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΡΡ ΠΆΠΈΠ²ΡΡ ΠΈ Π°Π»Π»Π΅ΡΠ³Π΅Π½ ΡΡΠ»ΡΡΠ΅ΠΌΠΈΠΉΠ½ΡΠΉ ΠΆΠΈΠ΄ΠΊΠΈΠΉ (Π’ΡΠ»ΡΡΠΈΠ½), ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΡΡΡ ΠΈΠΌΠΌΡΠ½ΠΎΡΠ»ΡΠΎΡΠ΅ΡΡΠ΅Π½ΡΠ½ΡΠΌ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ, ΠΎΠ΄Π½Π°ΠΊΠΎ ΡΠ΅ΡΡΠ΅Π·Π½ΡΠΌ Π½Π΅Π΄ΠΎΡΡΠ°ΡΠΊΠΎΠΌ ΠΌΠ΅ΡΠΎΠ΄Π° ΡΠ²Π»ΡΠ΅ΡΡΡ Π΅Π³ΠΎ ΡΡΡΠ΄ΠΎΠ΅ΠΌΠΊΠΎΡΡΡ. ΠΠ»ΡΡΠ΅ΡΠ½Π°ΡΠΈΠ²Π½ΡΠΌ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ ΠΈΡΠΏΡΡΠ°Π½ΠΈΡ Π΄Π°Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² ΡΠ²Π»ΡΠ΅ΡΡΡ ΠΈΠΌΠΌΡΠ½ΠΎΡ
ΡΠΎΠΌΠ°ΡΠΎΠ³ΡΠ°ΡΠΈΡΠ΅ΡΠΊΠΈΠΉ (ΠΠ₯) ΠΌΠ΅ΡΠΎΠ΄, ΠΎΠ±Π»Π°Π΄Π°ΡΡΠΈΠΉ ΡΡΠ΄ΠΎΠΌ ΠΏΡΠ΅ΠΈΠΌΡΡΠ΅ΡΡΠ², Π² ΡΠΎΠΌ ΡΠΈΡΠ»Π΅ Π²ΡΡΠΎΠΊΠΎΠΉ ΡΠΊΠΎΡΠΎΡΡΡΡ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ ΠΈΡΠΏΡΡΠ°Π½ΠΈΡ ΠΈ ΠΏΡΠΎΡΡΠΎΡΠΎΠΉ ΡΡΠ΅ΡΠ° ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ².Π¦Π΅Π»Ρ ΡΠ°Π±ΠΎΡΡ: ΠΎΡΠ΅Π½ΠΊΠ° Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΠΈ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΈΠΌΠΌΡΠ½ΠΎΡ
ΡΠΎΠΌΠ°ΡΠΎΠ³ΡΠ°ΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΌΠ΅ΡΠΎΠ΄Π° Π΄Π»Ρ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ ΠΈ Π°Π»Π»Π΅ΡΠ³Π΅Π½Π° ΡΡΠ»ΡΡΠ΅ΠΌΠΈΠΉΠ½ΠΎΠ³ΠΎ (Π’ΡΠ»ΡΡΠΈΠ½Π°) ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ».ΠΠ°ΡΠ΅ΡΠΈΠ°Π»Ρ ΠΈ ΠΌΠ΅ΡΠΎΠ΄Ρ: ΠΈΡΠΏΡΡΠ°Π½ΠΈΠ΅ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ» ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΠΈ Π½Π° ΠΎΠ±ΡΠ°Π·ΡΠ°Ρ
ΡΠ°ΡΠΌΠ°ΠΊΠΎΠΏΠ΅ΠΉΠ½ΠΎΠ³ΠΎ ΡΡΠ°Π½Π΄Π°ΡΡΠ½ΠΎΠ³ΠΎ ΠΎΠ±ΡΠ°Π·ΡΠ° Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ ΠΈ ΡΡΠ΅Ρ
ΠΊΠΎΠΌΠΌΠ΅ΡΡΠ΅ΡΠΊΠΈΡ
ΡΠ΅ΡΠΈΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ; Π°Π»Π»Π΅ΡΠ³Π΅Π½Π° ΡΡΠ»ΡΡΠ΅ΠΌΠΈΠΉΠ½ΠΎΠ³ΠΎ ΠΆΠΈΠ΄ΠΊΠΎΠ³ΠΎ (Π’ΡΠ»ΡΡΠΈΠ½) Π΄Π²ΡΡ
ΡΠ΅ΡΠΈΠΉ. ΠΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ» ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² ΠΠ₯ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΠΈ Ρ ΠΏΠΎΠΌΠΎΡΡΡ ΡΠ»Π΅Π΄ΡΡΡΠΈΡ
Π½Π°Π±ΠΎΡΠΎΠ² ΡΠ΅Π°Π³Π΅Π½ΡΠΎΠ²: ΠΠ₯ ΡΠ΅ΡΡ-ΡΠΈΡΡΠ΅ΠΌΠ° Π΄Π»Ρ ΡΠΊΡΠΏΡΠ΅ΡΡ-Π²ΡΡΠ²Π»Π΅Π½ΠΈΡ ΠΈ ΠΈΠ΄Π΅Π½ΡΠΈΡΠΈΠΊΠ°ΡΠΈΠΈ ΠΌΠΈΠΊΡΠΎΠ±Π½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ Yersinia pestis Β«ΠΠ₯ ΡΠ΅ΡΡ-ΡΠΈΡΡΠ΅ΠΌΠ° Y. pestisΒ» ΠΈ ΠΠ₯ ΡΠ΅ΡΡ-ΡΠΈΡΡΠ΅ΠΌΠ° Π΄Π»Ρ ΡΠΊΡΠΏΡΠ΅ΡΡ-Π²ΡΡΠ²Π»Π΅Π½ΠΈΡ ΠΈ ΠΈΠ΄Π΅Π½ΡΠΈΡΠΈΠΊΠ°ΡΠΈΠΈ Francisella tularensis Β«ΠΠ₯ ΡΠ΅ΡΡ-ΡΠΈΡΡΠ΅ΠΌΠ° F. tularensisΒ» ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° Π€ΠΠ£Π Β«ΠΠΎΡΡΠ΄Π°ΡΡΡΠ²Π΅Π½Π½ΡΠΉ Π½Π°ΡΡΠ½ΡΠΉ ΡΠ΅Π½ΡΡ ΠΏΡΠΈΠΊΠ»Π°Π΄Π½ΠΎΠΉ ΠΌΠΈΠΊΡΠΎΠ±ΠΈΠΎΠ»ΠΎΠ³ΠΈΠΈ ΠΈ Π±ΠΈΠΎΡΠ΅Ρ
Π½ΠΎΠ»ΠΎΠ³ΠΈΠΈΒ».Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ: ΠΏΠΎΠΊΠ°Π·Π°Π½ΠΎ, ΡΡΠΎ ΠΠ₯ ΠΌΠ΅ΡΠΎΠ΄ ΡΠ²Π»ΡΠ΅ΡΡΡ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΡΠΌ ΡΠΊΡΠΏΡΠ΅ΡΡ-ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ Π΄Π»Ρ Π²ΠΈΠ΄ΠΎΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΏΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π΅Π½ΠΈΡ Π½Π°Π»ΠΈΡΠΈΡ Y. pestis Π² Π²Π°ΠΊΡΠΈΠ½Π΅ ΡΡΠΌΠ½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ ΠΈ F. tularensis Π² Π°Π»Π»Π΅ΡΠ³Π΅Π½Π΅ ΡΡΠ»ΡΡΠ΅ΠΌΠΈΠΉΠ½ΠΎΠΌ ΠΆΠΈΠ΄ΠΊΠΎΠΌ (Π’ΡΠ»ΡΡΠΈΠ½). Π£ΡΡΠ°Π½ΠΎΠ²Π»Π΅Π½Π° ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄ΡΠ΅ΠΌΠ°Ρ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΡ Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ Π΄Π»Ρ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ ΠΈΡΠΏΡΡΠ°Π½ΠΈΡ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ» ΠΠ₯ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ β 109 ΠΌ.ΠΊ./ΠΌΠ». ΠΡΠΏΡΡΠ°Π½ΠΈΠ΅ Π°Π»Π»Π΅ΡΠ³Π΅Π½Π° ΡΡΠ»ΡΡΠ΅ΠΌΠΈΠΉΠ½ΠΎΠ³ΠΎ ΠΆΠΈΠ΄ΠΊΠΎΠ³ΠΎ (Π’ΡΠ»ΡΡΠΈΠ½Π°) ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ» ΠΠ₯ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄ΠΎΠ²Π°Π½ΠΎ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΡΡ Ρ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ ΡΠ΅Π»ΡΠ½ΠΎΠ³ΠΎ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°.ΠΡΠ²ΠΎΠ΄Ρ: ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΡΠ΅ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ ΠΌΠΎΠ³ΡΡ ΡΠ»ΡΠΆΠΈΡΡ ΠΎΡΠ½ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ Π΄Π»Ρ Π²Π½Π΅ΡΠ΅Π½ΠΈΡ ΠΠ₯ ΠΌΠ΅ΡΠΎΠ΄Π° Ρ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ ΡΠΊΠ°Π·Π°Π½Π½ΡΡ
Π½Π°Π±ΠΎΡΠΎΠ² ΡΠ΅Π°Π³Π΅Π½ΡΠΎΠ² Π² Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΡΡ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠ°ΡΠΈΡ Π½Π° Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΡΡ ΠΆΠΈΠ²ΡΡ ΠΈ Π½Π° Π°Π»Π»Π΅ΡΠ³Π΅Π½ ΡΡΠ»ΡΡΠ΅ΠΌΠΈΠΉΠ½ΡΠΉ ΠΆΠΈΠ΄ΠΊΠΈΠΉ (Π’ΡΠ»ΡΡΠΈΠ½) Π² ΠΊΠ°ΡΠ΅ΡΡΠ²Π΅ Π°Π»ΡΡΠ΅ΡΠ½Π°ΡΠΈΠ²Π½ΠΎΠ³ΠΎ ΠΌΠ΅ΡΠΎΠ΄Π° ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«ΠΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡΒ»
ΠΠ΅Π½ΠΈΠ½Π³ΠΎΠΊΠΎΠΊΠΊΠΎΠ²Π°Ρ ΠΈΠ½ΡΠ΅ΠΊΡΠΈΡ. ΠΠΎΠ»ΠΈΡΠ°Ρ Π°ΡΠΈΠ΄Π½ΡΠ΅ ΠΌΠ΅Π½ΠΈΠ½Π³ΠΎΠΊΠΎΠΊΠΊΠΎΠ²ΡΠ΅ Π²Π°ΠΊΡΠΈΠ½Ρ. ΠΡΡΠΎΡΠΈΡΠ΅ΡΠΊΠΈΠ΅ Π°ΡΠΏΠ΅ΠΊΡΡ ΠΈ ΡΠΎΠ²ΡΠ΅ΠΌΠ΅Π½Π½ΠΎΠ΅ ΡΠΎΡΡΠΎΡΠ½ΠΈΠ΅ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΎΠΊ. Π‘ΠΎΠΎΠ±ΡΠ΅Π½ΠΈΠ΅ 2
The present article describes clinical signs of meningococcal disease. It justifies the necessity of its vaccine prevention. The article provides with the historical data on the evolution of inoculants from corpuscular inactivated vaccines to modern chemical polyvalent vaccines. It provides a glimpse of the efficacy of the use of corpuscular vaccines and considers the corresponding implications. The historical overview includes the use of mono-, di-, tetravalent polysaccharide vaccines, and the discussion on the role of bactericidal antibodies in the formation of immunity against meningococcal disease. The article also describes the experience of using polysaccharide vaccines in various countries and in different age groups in randomized clinical trials. It provides with the data analysis about the effect of vaccination on the level of meningococcal carriage and the incidence of meningococcal disease. The WHOβs position on the use of polysaccharide meningococcal vaccines in routine practice are also provided. In the conclusion the article presents the prospects for further use of polysaccharide vaccines to control the spread of meningococcal disease.ΠΠ°Π½ΠΎ ΠΏΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½ΠΈΠ΅ ΠΎ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΏΡΠΎΡΠ²Π»Π΅Π½ΠΈΡΡ
ΠΌΠ΅Π½ΠΈΠ½Π³ΠΎΠΊΠΎΠΊΠΊΠΎΠ²ΠΎΠΉ ΠΈΠ½ΡΠ΅ΠΊΡΠΈΠΈ. ΠΠ±ΠΎΡΠ½ΠΎΠ²Π°Π½Π° Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΡΡΡ Π΅Π΅ Π²Π°ΠΊΡΠΈΠ½ΠΎΠΏΡΠΎΡΠΈΠ»Π°ΠΊΡΠΈΠΊΠΈ. ΠΡΠΈΠ²Π΅Π΄Π΅Π½Ρ ΠΈΡΡΠΎΡΠΈΡΠ΅ΡΠΊΠΈΠ΅ Π΄Π°Π½Π½ΡΠ΅ ΠΎΠ± ΡΠ²ΠΎΠ»ΡΡΠΈΠΈ ΠΏΡΠΈΠ²ΠΈΠ²ΠΎΡΠ½ΠΎΠ³ΠΎ ΠΌΠ°ΡΠ΅ΡΠΈΠ°Π»Π° ΠΎΡ ΠΊΠΎΡΠΏΡΡΠΊΡΠ»ΡΡΠ½ΡΡ
ΠΈΠ½Π°ΠΊΡΠΈΠ²ΠΈΡΠΎΠ²Π°Π½Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½ Π΄ΠΎ ΡΠΎΠ²ΡΠ΅ΠΌΠ΅Π½Π½ΡΡ
Ρ
ΠΈΠΌΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΏΠΎΠ»ΠΈΠ²Π°Π»Π΅Π½ΡΠ½ΡΡ
Π²Π°ΠΊΡΠΈΠ½. ΠΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½Ρ ΡΠ²Π΅Π΄Π΅Π½ΠΈΡ ΠΎΠ± ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΊΠΎΡΠΏΡΡΠΊΡΠ»ΡΡΠ½ΡΡ
Π²Π°ΠΊΡΠΈΠ½ ΠΈ ΡΠ°ΡΡΠΌΠΎΡΡΠ΅Π½Ρ ΠΎΡΠ»ΠΎΠΆΠ½Π΅Π½ΠΈΡ, Π²ΠΎΠ·Π½ΠΈΠΊΠ°ΡΡΠΈΠ΅ ΠΏΡΠΈ ΠΈΡ
ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠΈ. ΠΠ·Π»ΠΎΠΆΠ΅Π½Π° ΠΈΡΡΠΎΡΠΈΡ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΌΠΎΠ½ΠΎ-, Π΄ΠΈ-, ΡΠ΅ΡΡΠ°Π²Π°Π»Π΅Π½ΡΠ½ΡΡ
ΠΏΠΎΠ»ΠΈΡΠ°Ρ
Π°ΡΠΈΠ΄Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½, ΠΎΠ±ΡΡΠΆΠ΄Π°Π΅ΡΡΡ ΡΠΎΠ»Ρ Π±Π°ΠΊΡΠ΅ΡΠΈΡΠΈΠ΄Π½ΡΡ
Π°Π½ΡΠΈΡΠ΅Π» Π² ΡΠΎΡΠΌΠΈΡΠΎΠ²Π°Π½ΠΈΠΈ ΠΈΠΌΠΌΡΠ½ΠΈΡΠ΅ΡΠ° ΠΏΡΠΎΡΠΈΠ² ΠΌΠ΅Π½ΠΈΠ½Π³ΠΎΠΊΠΎΠΊΠΊΠΎΠ²ΠΎΠΉ ΠΈΠ½ΡΠ΅ΠΊΡΠΈΠΈ. ΠΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½Π° ΠΈΠ½ΡΠΎΡΠΌΠ°ΡΠΈΡ ΠΎΠ± ΠΎΠΏΡΡΠ΅ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΡ ΠΏΠΎΠ»ΠΈΡΠ°Ρ
Π°ΡΠΈΠ΄Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½ Π² ΡΠ°Π·Π»ΠΈΡΠ½ΡΡ
ΡΡΡΠ°Π½Π°Ρ
ΠΈ ΡΠ°Π·Π½ΡΡ
Π²ΠΎΠ·ΡΠ°ΡΡΠ½ΡΡ
Π³ΡΡΠΏΠΏΠ°Ρ
ΠΏΡΠΈ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΠΈ ΡΠ°Π½Π΄ΠΎΠΌΠΈΠ·ΠΈΡΠΎΠ²Π°Π½Π½ΡΡ
ΠΈΡΠΏΡΡΠ°Π½ΠΈΠΉ. ΠΡΠΎΠ°Π½Π°Π»ΠΈΠ·ΠΈΡΠΎΠ²Π°Π½Ρ ΡΠ²Π΅Π΄Π΅Π½ΠΈΡ ΠΎ Π²Π»ΠΈΡΠ½ΠΈΠΈ Π²Π°ΠΊΡΠΈΠ½Π°ΡΠΈΠΈ Π½Π° ΡΡΠΎΠ²Π΅Π½Ρ Π½ΠΎΡΠΈΡΠ΅Π»ΡΡΡΠ²Π° ΠΌΠ΅Π½ΠΈΠ½Π³ΠΎΠΊΠΎΠΊΠΊΠ° ΠΈ Π·Π°Π±ΠΎΠ»Π΅Π²Π°Π΅ΠΌΠΎΡΡΡ ΠΌΠ΅Π½ΠΈΠ½Π³ΠΎΠΊΠΎΠΊΠΊΠΎΠ²ΠΎΠΉ ΠΈΠ½ΡΠ΅ΠΊΡΠΈΠ΅ΠΉ. Π Π°ΡΡΠΌΠΎΡΡΠ΅Π½Π° ΠΏΠΎΠ·ΠΈΡΠΈΡ ΠΠΠ Π² ΠΎΡΠ½ΠΎΡΠ΅Π½ΠΈΠΈ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΏΠΎΠ»ΠΈΡΠ°Ρ
Π°ΡΠΈΠ΄Π½ΡΡ
ΠΌΠ΅Π½ΠΈΠ½Π³ΠΎΠΊΠΎΠΊΠΊΠΎΠ²ΡΡ
Π²Π°ΠΊΡΠΈΠ½ Π² ΡΡΡΠΈΠ½Π½ΠΎΠΉ ΠΏΡΠ°ΠΊΡΠΈΠΊΠ΅. ΠΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½Ρ ΠΏΠ΅ΡΡΠΏΠ΅ΠΊΡΠΈΠ²Ρ Π΄Π°Π»ΡΠ½Π΅ΠΉΡΠ΅Π³ΠΎ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΡ ΠΏΠΎΠ»ΠΈΡΠ°Ρ
Π°ΡΠΈΠ΄Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½ Π΄Π»Ρ ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ Π½Π°Π΄ ΡΠ°ΡΠΏΡΠΎΡΡΡΠ°Π½Π΅Π½ΠΈΠ΅ΠΌ ΠΌΠ΅Π½ΠΈΠ½Π³ΠΎΠΊΠΎΠΊΠΊΠΎΠ²ΠΎΠΉ ΠΈΠ½ΡΠ΅ΠΊΡΠΈΠΈ
ΠΠΎΠ½ΠΈΡΠΎΡΠΈΠ½Π³ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Π΅ΠΉ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½ Π΄Π»Ρ ΠΏΡΠΎΡΠΈΠ»Π°ΠΊΡΠΈΠΊΠΈ ΡΡΠ±Π΅ΡΠΊΡΠ»Π΅Π·Π° ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ ΠΊΠΎΠ½ΡΡΠΎΠ»ΡΠ½ΡΡ ΠΊΠ°ΡΡ Π¨ΡΡ Π°ΡΡΠ°
Scientific relevance. The quality of medicinal products, particularly vaccines, is contingent on the stability of the manufacturing process at all stages, which can be evaluated using Shewhart charts for data obtained by monitoring the quality attributes of interest.Aim. This study evaluatedΒ the stability of the quality and manufacturing processes of the BCG and BCG-M tuberculosis vaccines using Shewhart charts.Materials and methods. This study focused on samples of the BCG tuberculosis vaccine and the BCG-M tuberculosis vaccine, a less reactogenic alternative for primary immunisation. Both vaccines were released to the market in 2019β2022. The quality of samples was assessed for stability based on their potency and total bacterial count, which are the key parameters for immunogenicity evaluation. These quality parameters were compared using test results submitted by the manufacturer and obtained at the testing centre. The authors plotted individuals charts (X-charts) and moving range charts (R-charts) in accordance with national standards GOST R 50779.42-99 and GOST R ISO 7870-2-2015.Results. The quality of the BCG and BCG-M vaccines remained stable during the entire follow-up period (2019β2022). For some periods, the retrospective analysis of R- and X-charts revealed characteristic trends meeting special cause criteria. The Pearson correlation coefficient (r) between the data submitted by the manufacturer and the data obtained at the testing centre ranged from 0.2 to 0.8.Conclusions. The Shewhart charts demonstrated that the quality parameters of the BCG and BCG-M tuberculosis vaccines tested in 2019β2022 were stable. These vaccines had stable manufacturing processes, as shown by the R- and X-charts. However, the warning signs indicated that additional measures should be taken to standardise the manufacturing processes. The findings suggest that Shewhart charts may be recommended for monitoring the production and quality of tuberculosis vaccines.ΠΠΊΡΡΠ°Π»ΡΠ½ΠΎΡΡΡ. ΠΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²ΠΎ ΠΊΠ°ΡΠ΅ΡΡΠ²Π΅Π½Π½ΡΡ
Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ², Π² ΡΠΎΠΌ ΡΠΈΡΠ»Π΅ Π²Π°ΠΊΡΠΈΠ½, Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎ ΡΠΎΠ»ΡΠΊΠΎ Π² ΡΡΠ»ΠΎΠ²ΠΈΡΡ
ΡΠΎΡ
ΡΠ°Π½Π΅Π½ΠΈΡ ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ Π²ΡΠ΅Ρ
ΡΡΠ°Π΄ΠΈΠΉ ΡΠ΅Ρ
Π½ΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΏΡΠΎΡΠ΅ΡΡΠ° ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π°. ΠΠΎΠ΄Ρ
ΠΎΠ΄ΠΎΠΌ Π΄Π»Ρ ΠΎΡΠ΅Π½ΠΊΠΈ ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ ΠΏΡΠΎΡΠ΅ΡΡΠ° ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° ΡΠ²Π»ΡΠ΅ΡΡΡ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΊΠΎΠ½ΡΡΠΎΠ»ΡΠ½ΡΡ
ΠΊΠ°ΡΡ Π¨ΡΡ
Π°ΡΡΠ°, ΠΏΠΎΡΡΡΠΎΠ΅Π½Π½ΡΡ
ΠΏΠΎ Π΄Π°Π½Π½ΡΠΌ Π°Π½Π°Π»ΠΈΠ·ΠΈΡΡΠ΅ΠΌΡΡ
ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Π΅ΠΉ ΠΊΠ°ΡΠ΅ΡΡΠ²Π°.Π¦Π΅Π»Ρ. ΠΡΠ΅Π½ΠΊΠ° ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΡΡΠ±Π΅ΡΠΊΡΠ»Π΅Π·Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½ ΠΠ¦Π ΠΈ ΠΠ¦Π-Π ΠΈ ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ ΠΏΡΠΎΡΠ΅ΡΡΠ° ΠΈΡ
ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° Ρ ΠΏΠΎΠΌΠΎΡΡΡ ΠΊΠΎΠ½ΡΡΠΎΠ»ΡΠ½ΡΡ
ΠΊΠ°ΡΡ Π¨ΡΡ
Π°ΡΡΠ°.ΠΠ°ΡΠ΅ΡΠΈΠ°Π»Ρ ΠΈ ΠΌΠ΅ΡΠΎΠ΄Ρ. ΠΠ±ΡΠ°Π·ΡΡ Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠ±Π΅ΡΠΊΡΠ»Π΅Π·Π½ΠΎΠΉ (ΠΠ¦Π) ΠΈ Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠ±Π΅ΡΠΊΡΠ»Π΅Π·Π½ΠΎΠΉ Π΄Π»Ρ ΡΠ°Π΄ΡΡΠ΅ΠΉ ΠΏΠ΅ΡΠ²ΠΈΡΠ½ΠΎΠΉ ΠΈΠΌΠΌΡΠ½ΠΈΠ·Π°ΡΠΈΠΈ (ΠΠ¦Π-Π) ΡΠ΅ΡΠΈΠΉ, Π²ΡΠΏΡΡΠ΅Π½Π½ΡΡ
Π² Π³ΡΠ°ΠΆΠ΄Π°Π½ΡΠΊΠΈΠΉ ΠΎΠ±ΠΎΡΠΎΡ Π² 2019β2022 Π³Π³. Π‘ΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΡ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½ ΠΎΡΠ΅Π½ΠΈΠ²Π°Π»ΠΈ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»ΡΠΌ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ» ΠΈ Β«ΠΠ±ΡΠ΅Π΅ ΡΠΎΠ΄Π΅ΡΠΆΠ°Π½ΠΈΠ΅ Π±Π°ΠΊΡΠ΅ΡΠΈΠΉΒ», ΠΊΠΎΡΠΎΡΡΠ΅ ΡΠ²Π»ΡΡΡΡΡ ΠΊΠ»ΡΡΠ΅Π²ΡΠΌΠΈ ΠΏΡΠΈ ΠΎΡΠ΅Π½ΠΊΠ΅ ΠΈΠΌΠΌΡΠ½ΠΎΠ³Π΅Π½Π½ΠΎΡΡΠΈ. Π‘ΡΠ°Π²Π½ΠΈΡΠ΅Π»ΡΠ½ΡΡ ΠΎΡΠ΅Π½ΠΊΡ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Π΅ΠΉ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΠΈ ΡΠΎΠ³Π»Π°ΡΠ½ΠΎ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠ°ΠΌ Π°Π½Π°Π»ΠΈΠ·Π°, ΠΏΡΠ΅Π΄ΠΎΡΡΠ°Π²Π»Π΅Π½Π½ΡΠΌ ΠΏΡΠ΅Π΄ΠΏΡΠΈΡΡΠΈΠ΅ΠΌ-ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΡΠ΅Π»Π΅ΠΌ, Π° ΡΠ°ΠΊΠΆΠ΅ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠ°ΠΌ, ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΡΠΌ ΠΏΡΠΈ ΠΊΠΎΠ½ΡΡΠΎΠ»Π΅ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π² ΠΈΡΠΏΡΡΠ°ΡΠ΅Π»ΡΠ½ΠΎΠΌ ΡΠ΅Π½ΡΡΠ΅. ΠΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΠΈ ΠΏΠΎΡΡΡΠΎΠ΅Π½ΠΈΠ΅ ΠΊΠΎΠ½ΡΡΠΎΠ»ΡΠ½ΡΡ
ΠΊΠ°ΡΡ Π¨ΡΡ
Π°ΡΡΠ° ΠΈΠ½Π΄ΠΈΠ²ΠΈΠ΄ΡΠ°Π»ΡΠ½ΡΡ
Π·Π½Π°ΡΠ΅Π½ΠΈΠΉ (Π₯-ΠΊΠ°ΡΡΠ°) ΠΈ ΠΊΠ°ΡΡ ΡΠΊΠΎΠ»ΡΠ·ΡΡΠΈΡ
ΡΠ°Π·ΠΌΠ°Ρ
ΠΎΠ² (R-ΠΊΠ°ΡΡΠ°) Π² ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΠΈΠΈ Ρ ΠΠΠ‘Π’ Π 50779.42-99 ΠΈ ΠΠΠ‘Π’ Π ΠΠ‘Π 7870-2-2015.Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ.Β ΠΠΎΠΊΠ°Π·Π°Π½ΠΎ, ΡΡΠΎ ΠΊΠ°ΡΠ΅ΡΡΠ²ΠΎ Π²Π°ΠΊΡΠΈΠ½ ΠΠ¦Π ΠΈ ΠΠ¦Π-Π ΠΎΡΡΠ°Π²Π°Π»ΠΎΡΡ ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΡΠΌ Π² ΡΠ΅ΡΠ΅Π½ΠΈΠ΅ Π²ΡΠ΅Π³ΠΎ ΠΏΠ΅ΡΠΈΠΎΠ΄Π° Π½Π°Π±Π»ΡΠ΄Π΅Π½ΠΈΡ (2019β2022 Π³Π³.). Π Π΅ΡΡΠΎΡΠΏΠ΅ΠΊΡΠΈΠ²Π½ΡΠΉ Π°Π½Π°Π»ΠΈΠ· R- ΠΈ X-ΠΊΠ°ΡΡ Π²ΡΡΠ²ΠΈΠ» Π½Π°Π»ΠΈΡΠΈΠ΅ Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠ½ΡΡ
ΡΡΠ΅Π½Π΄ΠΎΠ², ΠΏΡΠΈΡΡΡΠΈΡ
ΠΊΡΠΈΡΠ΅ΡΠΈΡΠΌ Π΄Π»Ρ ΠΎΡΠΎΠ±ΡΡ
ΠΏΡΠΈΡΠΈΠ½ Π² ΠΎΡΠ΄Π΅Π»ΡΠ½ΡΠ΅ Π²ΡΠ΅ΠΌΠ΅Π½Π½ΡΠ΅ ΠΏΡΠΎΠΌΠ΅ΠΆΡΡΠΊΠΈ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡ. ΠΠ½Π°ΡΠ΅Π½ΠΈΠ΅ ΠΊΠΎΡΡΡΠΈΡΠΈΠ΅Π½ΡΠ° ΠΊΠΎΡΡΠ΅Π»ΡΡΠΈΠΈ ΠΠΈΡΡΠΎΠ½Π° (r) ΠΌΠ΅ΠΆΠ΄Ρ Π΄Π°Π½Π½ΡΠΌΠΈ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΡΠ΅Π»Ρ ΠΈ Π΄Π°Π½Π½ΡΠΌΠΈ, ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΡΠΌΠΈ ΠΏΡΠΈ ΠΊΠΎΠ½ΡΡΠΎΠ»Π΅ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π² ΠΈΡΠΏΡΡΠ°ΡΠ΅Π»ΡΠ½ΠΎΠΌ ΡΠ΅Π½ΡΡΠ΅, ΡΠΎΡΡΠ°Π²ΠΈΠ»ΠΎ ΠΎΡ 0,2 Π΄ΠΎ 0,8.ΠΡΠ²ΠΎΠ΄Ρ. Π‘ ΠΏΠΎΠΌΠΎΡΡΡ ΠΊΠΎΠ½ΡΡΠΎΠ»ΡΠ½ΡΡ
ΠΊΠ°ΡΡ Π¨ΡΡ
Π°ΡΡΠ° ΠΏΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π΅Π½Π° ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΡ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΡΡΠ±Π΅ΡΠΊΡΠ»Π΅Π·Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½ ΠΠ¦Π ΠΈ ΠΠ¦Π-Π, Π²ΡΠΏΡΡΠ΅Π½Π½ΡΡ
Π² 2019β2022 Π³Π³. ΠΡΠΎΠ²Π΅Π΄Π΅Π½Π½ΡΠΉ Π°Π½Π°Π»ΠΈΠ· R- ΠΈ X-ΠΊΠ°ΡΡ ΡΠ²ΠΈΠ΄Π΅ΡΠ΅Π»ΡΡΡΠ²ΡΠ΅Ρ ΠΎ ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ ΠΏΡΠΎΡΠ΅ΡΡΠ° ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½, ΠΎΠ΄Π½Π°ΠΊΠΎ Π½Π°Π»ΠΈΡΠΈΠ΅ ΠΏΡΠ΅Π΄ΡΠΏΡΠ΅ΠΆΠ΄Π°ΡΡΠΈΡ
ΡΠΈΠ³Π½Π°Π»ΠΎΠ² ΡΠΊΠ°Π·ΡΠ²Π°Π΅Ρ Π½Π° Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΡΡΡ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ Π΄ΠΎΠΏΠΎΠ»Π½ΠΈΡΠ΅Π»ΡΠ½ΡΡ
ΠΌΠ΅ΡΠΎΠΏΡΠΈΡΡΠΈΠΉ, Π½Π°ΠΏΡΠ°Π²Π»Π΅Π½Π½ΡΡ
Π½Π° ΡΡΠ°Π½Π΄Π°ΡΡΠΈΠ·Π°ΡΠΈΡ ΡΠ΅Ρ
Π½ΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΏΡΠΎΡΠ΅ΡΡΠ°. ΠΠΎΠ»ΡΡΠ΅Π½Π½ΡΠ΅ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ ΠΌΠΎΠ³ΡΡ ΡΠ»ΡΠΆΠΈΡΡ ΠΎΡΠ½ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ Π΄Π»Ρ ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°ΡΠΈΠΈ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΊΠ°ΡΡ Π¨ΡΡ
Π°ΡΡΠ° ΠΏΡΠΈ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅ ΠΈ ΠΊΠΎΠ½ΡΡΠΎΠ»Π΅ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΡΡΠ±Π΅ΡΠΊΡΠ»Π΅Π·Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½
ΠΡΡΡΠ½ΠΎΡΠΈΡΠΎΠ·Π½ΡΠ΅ Π²Π°ΠΊΡΠΈΠ½Ρ. ΠΡΡΠΎΡΠΈΡ ΡΠΎΠ·Π΄Π°Π½ΠΈΡ ΠΈ ΡΠΎΠ²ΡΠ΅ΠΌΠ΅Π½Π½ΡΠ΅ Π²Π°ΠΊΡΠΈΠ½Π½ΡΠ΅ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΡ
Typhoid fever is an acute infectious disease caused by Salmonella enterica subsp. enterica serovar Typhi (S. Typhi), which is still extremely common in endemic low- and middle-income countries of Asia and Africa. Industrialised countries may also be affected by typhoid fever outbreaks due to booming international tourism, and natural disasters. Given S. Typhi progressive resistance to antibiotics, high epidemiological burden, and lack of adequate sanitation and hygiene in a number of regions, the introduction of new treatment protocols and the improvement of preventive vaccination are critical tasks in global healthcare. The aim of the study was to highlight the main historical aspects of the typhoid vaccine development, to summarise data on the licensed vaccines and promising approaches to the development of new typhoid vaccines. The paper describes the current epidemiological situation of typhoid fever globally and in the Russian Federation. It dwells upon the global experience in typhoid vaccine development from the production of an inactivated vaccine to the development of conjugated vaccines. The paper summarises data on Russian and foreign-made typhoid fever vaccines currently available in the global pharmaceutical market. It outlines the main trends in the development of vaccines against the disease caused by S. Typhi. The paper demonstrates the need for improving the efficacy of existing vaccines and development of new typhoid combination vaccines.ΠΡΡΡΠ½ΠΎΠΉ ΡΠΈΡ β ΠΎΡΡΡΠΎΠ΅ ΠΈΠ½ΡΠ΅ΠΊΡΠΈΠΎΠ½Π½ΠΎΠ΅ Π·Π°Π±ΠΎΠ»Π΅Π²Π°Π½ΠΈΠ΅, Π²ΡΠ·ΡΠ²Π°Π΅ΠΌΠΎΠ΅ Π²ΠΎΠ·Π±ΡΠ΄ΠΈΡΠ΅Π»Π΅ΠΌ Salmonella enterica subsp. enterica ΡΠ΅ΡΠΎΡΠΈΠΏ Typhi (S. Typhi), ΠΏΠΎ-ΠΏΡΠ΅ΠΆΠ½Π΅ΠΌΡ ΡΠ²Π»ΡΠ΅ΡΡΡ ΠΎΠ΄Π½ΠΎΠΉ ΠΈΠ· ΠΎΡΠ½ΠΎΠ²Π½ΡΡ
ΠΏΡΠΈΡΠΈΠ½ Π·Π°Π±ΠΎΠ»Π΅Π²Π°Π΅ΠΌΠΎΡΡΠΈ Π½Π°ΡΠ΅Π»Π΅Π½ΠΈΡ Π² ΡΠ½Π΄Π΅ΠΌΠΈΡΠ½ΡΡ
ΡΠΊΠΎΠ½ΠΎΠΌΠΈΡΠ΅ΡΠΊΠΈ ΡΡΠ΅Π΄Π½Π΅- ΠΈ ΡΠ»Π°Π±ΠΎΡΠ°Π·Π²ΠΈΡΡΡ
ΡΡΡΠ°Π½Π°Ρ
ΠΠ·ΠΈΠΈ ΠΈ ΠΡΡΠΈΠΊΠΈ. ΠΠ½Π΄ΡΡΡΡΠΈΠ°Π»ΡΠ½ΡΠ΅ ΡΡΡΠ°Π½Ρ ΠΌΠΎΠ³ΡΡ Π±ΡΡΡ ΠΏΠΎΠ΄Π²Π΅ΡΠΆΠ΅Π½Ρ Π²ΡΠΏΡΡΠΊΠ°ΠΌ Π±ΡΡΡΠ½ΠΎΠ³ΠΎ ΡΠΈΡΠ° Π²Π²ΠΈΠ΄Ρ ΡΡΡΠ΅ΠΌΠΈΡΠ΅Π»ΡΠ½ΠΎ ΡΠ°Π·Π²ΠΈΠ²Π°ΡΡΠ΅Π³ΠΎΡΡ ΠΌΠ΅ΠΆΠ΄ΡΠ½Π°ΡΠΎΠ΄Π½ΠΎΠ³ΠΎ ΡΡΡΠΈΠ·ΠΌΠ°, Π° ΡΠ°ΠΊΠΆΠ΅ ΡΡΠΈΡ
ΠΈΠΉΠ½ΡΡ
Π±Π΅Π΄ΡΡΠ²ΠΈΠΉ. Π ΡΡΠ»ΠΎΠ²ΠΈΡΡ
ΠΏΡΠΎΠ³ΡΠ΅ΡΡΠΈΡΡΡΡΠ΅ΠΉ ΡΠ΅Π·ΠΈΡΡΠ΅Π½ΡΠ½ΠΎΡΡΠΈ S. Typhi ΠΊ Π°Π½ΡΠΈΠΌΠΈΠΊΡΠΎΠ±Π½ΡΠΌ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°ΠΌ, Π²ΡΡΠΎΠΊΠΎΠΉ ΡΠΏΠΈΠ΄Π΅ΠΌΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΎΠΉ Π½Π°Π³ΡΡΠ·ΠΊΠΈ ΠΈ Π½Π΅Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΠΈ ΠΎΠ±Π΅ΡΠΏΠ΅ΡΠ΅Π½ΠΈΡ ΡΠ΄ΠΎΠ²Π»Π΅ΡΠ²ΠΎΡΠΈΡΠ΅Π»ΡΠ½ΡΡ
ΡΠ°Π½ΠΈΡΠ°ΡΠ½ΠΎ-Π³ΠΈΠ³ΠΈΠ΅Π½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΡΡΠ»ΠΎΠ²ΠΈΠΉ Π² ΡΡΠ΄Π΅ ΡΠ΅Π³ΠΈΠΎΠ½ΠΎΠ², Π½Π°ΡΡΠ΄Ρ Ρ Π²Π½Π΅Π΄ΡΠ΅Π½ΠΈΠ΅ΠΌ Π½ΠΎΠ²ΡΡ
ΠΏΡΠΎΡΠΎΠΊΠΎΠ»ΠΎΠ² Π»Π΅ΡΠ΅Π½ΠΈΡ Π·Π°Π±ΠΎΠ»Π΅Π²Π°Π½ΠΈΡ, Π°ΠΊΡΡΠ°Π»ΡΠ½ΠΎΠΉ Π·Π°Π΄Π°ΡΠ΅ΠΉ ΠΌΠΈΡΠΎΠ²ΠΎΠ³ΠΎ Π·Π΄ΡΠ°Π²ΠΎΠΎΡ
ΡΠ°Π½Π΅Π½ΠΈΡ ΡΠ²Π»ΡΠ΅ΡΡΡ ΡΠ°Π·Π²ΠΈΡΠΈΠ΅ Π²Π°ΠΊΡΠΈΠ½ΠΎΠΏΡΠΎΡΠΈΠ»Π°ΠΊΡΠΈΠΊΠΈ Π±ΡΡΡΠ½ΠΎΠ³ΠΎ ΡΠΈΡΠ°. Π¦Π΅Π»Ρ ΡΠ°Π±ΠΎΡΡ β ΠΎΡΠ²Π΅ΡΠ΅Π½ΠΈΠ΅ ΠΎΡΠ½ΠΎΠ²Π½ΡΡ
Π°ΡΠΏΠ΅ΠΊΡΠΎΠ² ΠΈΡΡΠΎΡΠΈΠΈ ΡΠΎΠ·Π΄Π°Π½ΠΈΡ Π±ΡΡΡΠ½ΠΎΡΠΈΡΠΎΠ·Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½, ΡΠΈΡΡΠ΅ΠΌΠ°ΡΠΈΠ·Π°ΡΠΈΡ Π΄Π°Π½Π½ΡΡ
ΠΎ Π»ΠΈΡΠ΅Π½Π·ΠΈΡΠΎΠ²Π°Π½Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°Ρ
ΠΈ ΠΏΠ΅ΡΡΠΏΠ΅ΠΊΡΠΈΠ²Π½ΡΡ
Π½Π°ΠΏΡΠ°Π²Π»Π΅Π½ΠΈΡΡ
ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠΈ Π½ΠΎΠ²ΡΡ
Π²Π°ΠΊΡΠΈΠ½. Π ΡΡΠ°ΡΡΠ΅ ΠΎΠΏΠΈΡΠ°Π½Π° ΡΠΏΠΈΠ΄Π΅ΠΌΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠ°Ρ ΠΊΠ°ΡΡΠΈΠ½Π° Π±ΡΡΡΠ½ΠΎΠ³ΠΎ ΡΠΈΡΠ° Π² ΠΌΠΈΡΠ΅ ΠΈ Π² Π ΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ Π€Π΅Π΄Π΅ΡΠ°ΡΠΈΠΈ. ΠΠ·Π»ΠΎΠΆΠ΅Π½ ΠΌΠΈΡΠΎΠ²ΠΎΠΉ ΠΎΠΏΡΡ ΡΠΎΠ·Π΄Π°Π½ΠΈΡ Π²Π°ΠΊΡΠΈΠ½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² ΠΎΡ ΠΌΠΎΠΌΠ΅Π½ΡΠ° ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΡ ΡΠ±ΠΈΡΠΎΠΉ Π±ΡΡΡΠ½ΠΎΡΠΈΡΠΎΠ·Π½ΠΎΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ Π΄ΠΎ ΡΡΠ°ΠΏΠ° ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° ΠΊΠΎΠ½ΡΡΠ³ΠΈΡΠΎΠ²Π°Π½Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½. ΠΡΠΈΠ²Π΅Π΄Π΅Π½Π° ΠΈΠ½ΡΠΎΡΠΌΠ°ΡΠΈΡ ΠΎΠ± ΠΎΡΠ΅ΡΠ΅ΡΡΠ²Π΅Π½Π½ΡΡ
ΠΈ Π·Π°ΡΡΠ±Π΅ΠΆΠ½ΡΡ
Π²Π°ΠΊΡΠΈΠ½Π°Ρ
, ΠΏΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½Π½ΡΡ
Π½Π° ΠΌΠΈΡΠΎΠ²ΠΎΠΌ ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΠΎΠΌ ΡΡΠ½ΠΊΠ΅. ΠΠ±ΠΎΠ·Π½Π°ΡΠ΅Π½Ρ ΠΎΡΠ½ΠΎΠ²Π½ΡΠ΅ ΡΠ΅Π½Π΄Π΅Π½ΡΠΈΠΈ Π² ΡΡΠ΅ΡΠ΅ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠΈ Π²Π°ΠΊΡΠΈΠ½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² ΠΏΡΠΎΡΠΈΠ² Π·Π°Π±ΠΎΠ»Π΅Π²Π°Π½ΠΈΡ, Π²ΡΠ·ΡΠ²Π°Π΅ΠΌΠΎΠ³ΠΎ S. Typhi. Π‘Π΄Π΅Π»Π°Π½ Π²ΡΠ²ΠΎΠ΄ ΠΎ Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΡΡΠΈ ΠΏΠΎΠ²ΡΡΠ΅Π½ΠΈΡ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΡΠ°Π½Π΅Π΅ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠ°Π½Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½, Π° ΡΠ°ΠΊΠΆΠ΅ ΡΠΎΠ·Π΄Π°Π½ΠΈΡ Π½ΠΎΠ²ΡΡ
, ΠΊΠΎΠΌΠ±ΠΈΠ½ΠΈΡΠΎΠ²Π°Π½Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² ΠΏΡΠΎΡΠΈΠ² Π±ΡΡΡΠ½ΠΎΠ³ΠΎ ΡΠΈΡΠ°
ΠΡΡΠ΅ΡΡΠ°ΡΠΈΡ Π½ΠΎΠ²ΠΎΠΉ ΡΠ΅ΡΠΈΠΈ ΠΎΡΡΠ°ΡΠ»Π΅Π²ΠΎΠ³ΠΎ ΡΡΠ°Π½Π΄Π°ΡΡΠ½ΠΎΠ³ΠΎ ΠΎΠ±ΡΠ°Π·ΡΠ° Π΄Π»Ρ ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠΉ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΈ ΡΠ΅ΡΠΌΠΎΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ
In accordance with the State Pharmacopoeia (SPh) requirements for live plague vaccine, a reference standard has to be used when testing the specific activity and thermal stability of plague vaccine commercial batches in order to assess the consistency and acceptability of the test results. Since there is no international reference standard for plague vaccine, the certification of a new batch of the industry reference standard (IRS) of live plague vaccine in terms of the above-mentioned quality parameters is an urgent challenge. Therefore, a certification programme for the industry reference standard was developed that establishes the design and scope of testing required to obtain statistically significant results. A candidate IRS was represented by a commercial batch of the product meeting the specification requirements for live plague vaccine. The certification parameters were: Β«Specific activity: microbial cell concentrationΒ», Β«Specific activity: live microbial cell percentageΒ» and Β«Thermal stabilityΒ». The article presents the results of the certification of a new batch of the live plague vaccine IRS, detailed evaluation of the candidate IRS in terms of: Β«Average weight and uniformity of weightΒ», Β«Loss on dryingΒ», and statistical interpretation of the test results. It also summarises the results of the product testing in terms of Β«Specific activity: immunogenicityΒ». The results of application of the previous batch of the live plague vaccine IRS (OSO 42-28-392-2013) and the results of monitoring the stability of its certification parameters demonstrated that the IRS shelf life could be extended by 6 months relative to the established period (from 2 to 2.5 years). All the certified and additional characteristics are reflected in the official documents for the scientific/technological product β live plague vaccine IRS, OSO 42-28-392-2017: passport, labelling and patient information leaflet.Π ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΠΈΠΈ Ρ ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡΠΌΠΈ ΠΠΎΡΡΠ΄Π°ΡΡΡΠ²Π΅Π½Π½ΠΎΠΉ ΡΠ°ΡΠΌΠ°ΠΊΠΎΠΏΠ΅ΠΈ Π ΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ Π€Π΅Π΄Π΅ΡΠ°ΡΠΈΠΈ (XIII ΠΈΠ·Π΄Π°Π½ΠΈΠ΅, ΡΠΎΠΌ III) Π½Π° Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΡΡ ΠΆΠΈΠ²ΡΡ ΠΏΡΠΈ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΠΈ ΠΈΡΠΏΡΡΠ°Π½ΠΈΡ ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠΉ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΈ ΡΠ΅ΡΠΌΠΎΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½Π½ΡΡ
ΡΠ΅ΡΠΈΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ ΡΡΠ°Π½Π΄Π°ΡΡΠ½ΠΎΠ³ΠΎ ΠΎΠ±ΡΠ°Π·ΡΠ° Π΄Π»Ρ ΠΎΡΠ΅Π½ΠΊΠΈ ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ ΠΈ ΠΏΡΠΈΠ΅ΠΌΠ»Π΅ΠΌΠΎΡΡΠΈ ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΡΡ
ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ². Π’Π°ΠΊ ΠΊΠ°ΠΊ ΠΠ΅ΠΆΠ΄ΡΠ½Π°ΡΠΎΠ΄Π½ΡΠΉ ΡΡΠ°Π½Π΄Π°ΡΡΠ½ΡΠΉ ΠΎΠ±ΡΠ°Π·Π΅Ρ Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΠΎΠΉ ΠΎΡΡΡΡΡΡΠ²ΡΠ΅Ρ, ΡΠΎ Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΡ Π½ΠΎΠ²ΠΎΠΉ ΡΠ΅ΡΠΈΠΈ ΠΎΡΡΠ°ΡΠ»Π΅Π²ΠΎΠ³ΠΎ ΡΡΠ°Π½Π΄Π°ΡΡΠ½ΠΎΠ³ΠΎ ΠΎΠ±ΡΠ°Π·ΡΠ° (ΠΠ‘Π) Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ Π΄Π»Ρ ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠΉ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΈ ΡΠ΅ΡΠΌΠΎΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½Π½ΡΡ
ΡΠ΅ΡΠΈΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠ° ΠΈ Π°ΠΊΡΡΠ°Π»ΡΠ½Π°. ΠΠ»Ρ ΡΡΠΎΠ³ΠΎ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠ°Π»ΠΈ ΠΏΡΠΎΠ³ΡΠ°ΠΌΠΌΡ Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ, ΡΡΡΠ°Π½ΠΎΠ²ΠΈΠ² Π² Π½Π΅ΠΉ ΡΡ
Π΅ΠΌΡ ΠΈ ΠΎΠ±ΡΠ΅ΠΌ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠΌΡΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ Π΄Π»Ρ ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΡ ΡΡΠ°ΡΠΈΡΡΠΈΡΠ΅ΡΠΊΠΈ Π·Π½Π°ΡΠΈΠΌΡΡ
ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ². Π ΠΊΠ°ΡΠ΅ΡΡΠ²Π΅ ΠΊΠ°Π½Π΄ΠΈΠ΄Π°ΡΠ° Π² ΠΠ‘Π ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π»ΠΈ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½Π½ΡΡ ΡΠ΅ΡΠΈΡ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°, ΡΠ΄ΠΎΠ²Π»Π΅ΡΠ²ΠΎΡΡΡΡΡΡ ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡΠΌ Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΠΎΠΉ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠ°ΡΠΈΠΈ Π½Π° Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΡΡ ΠΆΠΈΠ²ΡΡ. ΠΡΡΠ΅ΡΡΡΠ΅ΠΌΡΠΌΠΈ Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊΠ°ΠΌΠΈ ΡΠ²Π»ΡΡΡΡΡ: Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ: ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠ°ΡΠΈΡ ΠΌΠΈΠΊΡΠΎΠ±Π½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊΒ», Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ: ΠΏΡΠΎΡΠ΅Π½Ρ ΠΆΠΈΠ²ΡΡ
ΠΌΠΈΠΊΡΠΎΠ±Π½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊΒ» ΠΈ Β«Π’Π΅ΡΠΌΠΎΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΡΒ». Π ΡΡΠ°ΡΡΠ΅ ΠΏΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½Ρ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ ΠΈ ΡΡΠ°ΡΠΈΡΡΠΈΡΠ΅ΡΠΊΠΈ ΠΎΠ±ΡΠ°Π±ΠΎΡΠ°Π½Π½ΡΠ΅ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ ΠΈΡΠΏΡΡΠ°Π½ΠΈΠΉ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»ΡΠΌ: Β«Π‘ΡΠ΅Π΄Π½ΡΡ ΠΌΠ°ΡΡΠ° ΠΈ ΠΎΠ΄Π½ΠΎΡΠΎΠ΄Π½ΠΎΡΡΡ ΠΏΠΎ ΠΌΠ°ΡΡΠ΅Β», Β«ΠΠΎΡΠ΅ΡΡ Π² ΠΌΠ°ΡΡΠ΅ ΠΏΡΠΈ Π²ΡΡΡΡΠΈΠ²Π°Π½ΠΈΠΈΒ» Π½ΠΎΠ²ΠΎΠΉ ΡΠ΅ΡΠΈΠΈ ΠΠ‘Π Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ. ΠΡΠΈΠ²Π΅Π΄Π΅Π½Ρ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ: ΠΈΠΌΠΌΡΠ½ΠΎΠ³Π΅Π½Π½ΠΎΡΡΡΒ». ΠΡΠΎΠ³ΠΈ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΏΡΠ΅Π΄ΡΠ΄ΡΡΠ΅ΠΉ ΡΠ΅ΡΠΈΠΈ ΠΠ‘Π Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ (ΠΠ‘Π 42-28-392-2013) ΠΈ ΠΌΠΎΠ½ΠΈΡΠΎΡΠΈΠ½Π³Π° ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ Π΅Π΅ Π°ΡΡΠ΅ΡΡΠΎΠ²Π°Π½Π½ΡΡ
Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊ ΠΏΠΎΠΊΠ°Π·Π°Π»ΠΈ Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΡ ΡΠ²Π΅Π»ΠΈΡΠ΅Π½ΠΈΡ ΡΡΠΎΠΊΠ° Π³ΠΎΠ΄Π½ΠΎΡΡΠΈ ΠΠ‘Π Π½Π° 6 ΠΌΠ΅ΡΡΡΠ΅Π² ΠΏΠΎ ΠΎΡΠ½ΠΎΡΠ΅Π½ΠΈΡ ΠΊ ΡΡΡΠ°Π½ΠΎΠ²Π»Π΅Π½Π½ΠΎΠΌΡ (Ρ 2 Π΄ΠΎ 2,5 Π»Π΅Ρ). ΠΡΠ΅ Π°ΡΡΠ΅ΡΡΠΎΠ²Π°Π½Π½ΡΠ΅ ΠΈ Π΄ΠΎΠΏΠΎΠ»Π½ΠΈΡΠ΅Π»ΡΠ½ΡΠ΅ Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊΠΈ ΡΡΠ²Π΅ΡΠΆΠ΄Π΅Π½Ρ Π² Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠ°Ρ
Π½Π° Π½Π°ΡΡΠ½ΠΎ-ΡΠ΅Ρ
Π½ΠΈΡΠ΅ΡΠΊΡΡ ΠΏΡΠΎΠ΄ΡΠΊΡΠΈΡ ΠΠ‘Π 42-28-392-2017 Π²Π°ΠΊΡΠΈΠ½Ρ ΡΡΠΌΠ½ΠΎΠΉ ΠΆΠΈΠ²ΠΎΠΉ: ΠΏΠ°ΡΠΏΠΎΡΡ, ΠΌΠ°ΠΊΠ΅ΡΡ ΡΡΠΈΠΊΠ΅ΡΠΎΠΊ ΡΠΏΠ°ΠΊΠΎΠ²ΠΎΠΊ ΠΈ ΠΈΠ½ΡΡΡΡΠΊΡΠΈΡ ΠΏΠΎ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ
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