Determination of microbiological purity of rectal suppositories with diosmine and hesperidine

Abstract

Introduction. The use of conservative methods of treatment, in terms of increasing the number of patients with anorectal diseases, is becoming increasingly important in modern realities. Proctological pathologies are becoming more characteristic for people of working age, and can affect not only the physical and mental health of an individual, but also the future reproductive state of the nation as a whole. , It is advisable to use dosage forms that will effect on several factors in the pathogenesis, while showing resorptive and local effects. As an example, of such a dosage form (DF) are rectal suppositories, which according to a complex of structural-mechanical and biopharmaceutical factors is the optimal DF for the release of active substances on the place of the pathological process. An important stage in the formulation of rectal suppositories it isn`t only the choice of active substances, but also quality control of ready-made DF. The SPhU of Ukraine regulates the quality indicator "microbiological purity" for suppositories as a critical stage of control, which means the necessity for a full range of studies to identify possible of microbial contamination in the DF.Material & Methods. We have selected 3 samples of rectal suppositories with diosmin and hesperidin for microbiological studies. In order to substantiate the stability during storage, we have proposed to use samples with different durations from the date of manufacture (1- just made; 2- 2 weeks storage; 3- 6 months storage). The testing of suppository samples for microbiological purity was carried out using with the Chistovich medium, blood agar-based soybean casein digest agar and Endo medium. As a preliminary preparation for the study of microbiological purity, tests were performing for compliance with the growth qualities of nutrient mediums. The definitions of microscopic study were carried out a microscopic method using a Konus Academi Microscope of Italian production with a DLT-Cam Basic 2MP camera. The test of microbiological purity was conducted with methods direct seeded on liquid nutrient mediums. The definitions of quantity of viable cells of microorganisms and fungus for methods of deep seeding have been conducting with adding sample in quantity 0.1 in agar medium.  Results & discussion. The results of the study of growth properties of nutrient mediums was shown, that all cultures of microorganisms met to the taxonomic designation of the strain. The obtained results have shown that after 14 days of incubation of suppositories samples on the Saburo medium - the fungus haven't growth. The results of researches samples with soybean casein digest broth and thyoglycollate medium in the quantity 1.0 and 0.1 haven`t shown the growth of microorganisms. Registration of growth of the microorganisms has been shown in research of samples in the quantity of 0.01. The microorganisms that have been detected during the studies by morphology of colonies and biological properties belong to the genus Bacillus sp. According to the research results by the method of direct seeding on cups the growth of fungus has been absented in all suppositories samples. Conclusion. Taking into account the obtained data we was indicated that viable fungal cells weren`t detected in the suppositories samples. The quantity of microorganisms was lower by 10<sup>3</sup> CFU/ml that meets the requirements of SPhU. Microorganisms that have been detected during the studies belong to the genus Bacillus sp. The strains of S. aureus, P. аeruginosa and representatives of the genus Enterobacteriacea sp. haven`t been detected. Suppositories samples that have been determinations on indicator of microbiological purity, meets the requirements of SPhU.