Abstract
The aim: the aim of our work was to experimentally substantiate the effectiveness of antimicrobial preservatives in the design of the composition of the combined gel for the treatment of acute and chronic inflammation of the joints. Methods: biological pharmacopoeial method of research was used (research of the effectiveness of antimicrobial preservatives). Results. All drugs must meet the requirements of regulatory documents on indicators Microbiological purity. To ensure the microbiological stability of the preparations, it is necessary to eliminate the factors associated with microbial contamination, therefore we carried out experimental studies on the choice of preservative and its concentration for the developed gel. According to the results of experimental studies on the effectiveness of antimicrobial preservatives in gel samples, the following data were obtained. Samples of the studied gel with sodium preservatives benzoate 0.5 % and nipagin 0.2 % meet the criterion A according to the requirements of SPHU for drugs for skin application. But, according to research results, the antimicrobial efficacy of the gel with the preservative nipagin 0.2 % was slightly higher (lg reduction in the number of viable Staphylococcus aureus ATCC 6538 cells was 3.32 and 4.81; Pseudomonas aeruginosa ATCC 9027 - 3.28 and 4.66 ; Candida albicans ATCC 885-653 - 3.50 and 4.09; Aspergillus brasiliensis ATCC 16404 - 3.10 and 4.00 (2 and 7 days, respectively) and the spectrum of antimicrobial action is wider, which will contribute to the quality of the rotated gel also during storage. Therefore, for further research, we will use nipagin 0.2 % as a preservative. Conclusions: The expediency of using nipagin 0.2 % as a part of a combined gel for the treatment of acute and chronic joint inflammation has been theoretically proved and experimentally proved
Highlights
Despite the fact that several dozen innovative and hundreds of generic drugs appear on the global pharmaceutical market each year, medicinal plant raw material (MPRM) continue to account for a significant proportion
The obtained results are shown in Tab. 1 and indicate that in the sample of gel with preservative nipagine 0.1 % after 2 days of storage of inoculated samples, the logarithm of reducing the number of viable microorganisms of bacteria was more than 2.0 and amounted for Staphylococcus aureus 2.01, for Pseudomonas aeruginosa – 2.81
At the 7th day of storage of inoculated samples of 0.1 % of preservative nipagin, the study showed that the logarithm of reducing the number of viable microorganisms of bacteria was less than 3.0 and amounted to Staphylococcus aureus 2.98, for Pseudomonas aeroginosa – 3.1
Summary
Despite the fact that several dozen innovative and hundreds of generic drugs appear on the global pharmaceutical market each year, medicinal plant raw material (MPRM) continue to account for a significant proportion. When designing the composition of the drug - a combined gel for the treatment of acute and chronic joint diseases, the choice of preservative and the determination of its concentration are relevant research. In order to ensure the microbiological stability of new dosage forms that meet the requirements of normative documents according to the indicator "Microbiological purity", maximum elimination of the factors related to microbial contamination is necessary, it is expedient to conduct experimental research on the choice of preservative and its concentration for the developed gel It is precisely the definition of the optimal concentration of preservatives in the composition of medicinal products, which is one of the approaches to solving the problem of microbiological purity and stability of the drugs [7, 8]. Antimicrobial effect of 0.1 % nipagin preservative in the gel samples under study
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