The study of the stability of pessaries, designed to prepare the birth canal before childbirth
An urgent problem in obstetrics and gynecology is the prevention of soft tissue ruptures during childbirth. In addition to various physical exercises aimed at increasing elasticity and muscle tone, it is necessary to use aids designed to minimize perineal injuries. For this purpose, pessaries with hyaluronic acid and phytocomplex of CO2-extracts of aloe, calendula and green tea were created.
The aim of the work – study of the stability of the proposed extemporaneous pessaries in accordance with the requirements of the article «Suppositories and pessaries manufactured in pharmacies» of the State Pharmacopoeia of Ukraine (SPU) 2.0 and Guidelines ST-N MPH 42-4.5:2015 «Requirements for the manufacture of non-sterile drugs in pharmacies».
Quality control of pessaries was carried out on the following indicators: description, homogeneity, pH, average weight, time of deformation, decay time, melting point, acid number, microbiological purity. To detect falsified samples, a test was performed to check the base. Biopharmaceutical studies were also performed to evaluate the release of API of phytoextracts of calendula and aloe by the method of «diffusion into agar».
When assessing the appearance and homogeneity of pessaries, it was found that they have a yellowish color and a specific odor of cocoa butter and green tea extract. There were no patches on the longitudinal section. The pH values ranged from 3.80 to 4.50, which corresponds to the normal pH value of a woman's vagina. According to other quality indicators, such as average weight, melting point, time of complete deformation, decay time, acid number and microbiological purity, the investigated drug also fully satisfies the requirements of SPU 2.0 and Guidelines ST-N 42-4.5:2015. To detect falsified samples, a test was performed to check the base. Biopharmaceutical studies were performed to evaluate the release of API of phytoextracts of calendula and aloe by the method of «diffusion into agar». The research was conducted immediately after the manufacture of pessaries and in the process of their storage.
The stability of extemporaneous pessaries containing hyaluronic acid and phytocomplex of CO2-extracts of aloe, calendula and green tea, intended for the preparation of the birth canal before childbirth, was studied. The main quality indicators of pessaries immediately after their manufacture and during storage have been studied. It is shown that the samples of studied pessaries fully meet the requirements of the article «Suppositories and pessaries manufactured in pharmacies» of the State Pharmacopoeia of Ukraine 2.0 and Guidelines ST-N MPH 42-4.5:2015 «Requirements for the manufacture of non-sterile drugs in pharmacies».
Borscheva A. A., Pertseva G. M., Alekseeva N. A. Epiziotomiya kak odna iz problem sovremennoy perineologii // Med. vestn. Yuga Rossii – 2019. – № 10 (4). – S. 43–50. https://doi.org/10.21886/2219-8075-2019-10-4-43-50
Abells D., Kirkham Y. A., Ornstein M. P. Review of gynecologic and reproductive care for women with developmental disabilities // Curr. Opin. Obstet. Gynecol. – 2016. – V. 28, N 5. – P. 350–358. https://doi.org/10.1097/GCO.0000000000000299
Rubenstein E., Ehrenthal D., Mallinson D. et al. Pregnancy complications and maternal birth outcomes in women with intellectual and developmental disabilities in Wisconsin Medicaid // PLoS One. – 2020. – V. 27. – P. 15–21. https://doi.org/10.1371/journal.pone.0241298
Acosta C. D., Bhattacharya S., Tuffnell D. et al. Maternal sepsis: a Scottish population-based case–control study // BJOG. – 2012. – V. 119, N 4. – P. 474–483. https://doi.org/10.1111/j.1471-0528.2011.03239
WHO recommendations for prevention and treatment of maternal peripartum infections. – Geneva: World Health Organization, 2015. Available from: www.who.int/reproductivehealth/publications/maternal_perinatal_health/peripartum-infections-guidelines
Harvey M. A. Pelvic floor exercises during and after pregnancy: a systematic review of their role in preventing pelvic floor dysfunction // J. Obstet. Gyanec. Can. – 2013. – V. 25, N 6. – P. 487–498. https://doi.org/10.1016/s1701-2163(16)30310-3
Oboskalova T. A., Gluhov E. Yu., Konovalov V. I., Aslanova S. S. Lechenie poslerodovyih yazv promezhnosti rastvorami antiseptikov, kavitirovannyimi ultrazvukom // Uralskiy med. zhurn. – 2018. – № 5 (160). – S. 7–13. https://doi.org/10.25694/URMJ.2018.04.062
Bonet M., Ota E., Chibueze C. E., Oladapo O. T. Routine antibiotic prophylaxis after normal vaginal birth for reducing maternal infectious morbidity // Cochrane Database of Systematic Rev. – 2017. – Issue 11. – Art. No.: CD012137. https://doi.org/10.1002/14651858. CD012137.pub2
Zaliska O. M., Stasiv Kh.-O. Ya., Maksymovych N. M. Otsinka dostupnosti dopomizhnykh reproduktyvnykh tekhnolohii v Ukraini ta sviti // Farmats. zhurn. – 2020. – T. 75, № 4. – S. 49–59. https://doi.org/10.32352/0367-3057.4.20.05
Derzhavna farmakopeia Ukrainy: Supozytorii ta pesarii, vyhotovleni v aptekakh / DP «Naukovo-ekspertnyi farmakopeinyi tsentr». 2 vyd. – Kharkiv: RIREH, 2014. – S. 716–723.
Tykhonov O. I., Yarnykh T. H., Pasichnyk M. F. ta in. Vymohy do vyhotovlennia nesterylnykh likarskykh zasobiv v umovakh aptek. ST-N MOZU 42-4.6:2015. – Kyiv: MOZ Ukrainy, 2016. – 127 s. (nakaz MOZ Ukrainy № 398 vid 1 lypnia 2015 r.).
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