The study of the stability of pessaries, designed to prepare the birth canal before childbirth

Abstract

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».