Reasoning of concentrations preservative in the composition of medicinal syrup

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Department of Pharmaceutical Technology and Biopharmacy department Shupyk National Medical Academy of Postgraduate Education

Kharkiv Medical Academy of Postgraduate Education

Reasoning of concentrations preservative in the composition of medicinal syrup

Davtian L.L. Dr. Pharm. Sciences, Professor, Head of the Department of Pharmaceutical Technology and biopharmatics

Khomych O.O. Biryukova S. V. Dr. of medicine, professor Department of Clinical Immunology and Microbiology

Voida G.V. Assistant professor, Department of Clinical Immunology and Microbiology

Kyiv, Ukraine

Key words: medicinal syrup, preservatives, antimicrobial activity, specific antimicrobial activity.

Introduction

European pharmacopoeia is defined as liquids with sweet taste and high viscosity [4]. According to the State Pharmacopoeia of Ukraine, syrups are thick, transparent liquids containing one or more active substances dissolved in concentrated aqueous solutions of sucrose or other sugars. If necessary, antimicrobial preservatives, antioxidants, stabilizers, flavors, flavor additives and other excipients are added to the syrups [5] sorbic, nipagin, nipazole, benzoic acid and sodium benzoate. These preservatives are authorized for use in pharmaceutical technology. Therefore, we conducted microbiological studies to select the optimal concentration of a certain preservative.

Research methods. Tests of the antimicrobial activity of the preservative were carried out immediately after the production of syrup samples and during the shelf life of 12, 24 and 27 months.

Study of antimicrobial activity of investigated samples with preservatives was carried out by diffusion method in agar in modification of "wells". This method is based on the ability of the substances to diffuse into agar medium, which is pre-sown with the test culture. The level of antimicrobial activity of experimental samples was judged by the diameter of the zone of growth retardation of microorganisms around the well. Absence of test-crop suppression zones around the wells up to 10 mm indicates the insensitivity of microorganisms to the drug; The growth retardation zone of test cultures with a diameter of 10 - 15 mm indicates a low sensitivity of the culture; zones with a diameter of 15 - 25 mm is evaluated as an indicator of microorganism sensitivity to the drug; and zones above 25 mm - high sensitivity of microorganisms to samples of the drug.

Measurement of the diameters of the zones of growth inhibition of test strains of microorganisms to an accuracy of 0.01 mm was carried out using an electronic dial caliper.

Specific antimicrobial activity of the drug was studied on a nutrient medium - soy-casein agar (SCA) on various test strains of microorganisms. Suspensions of microorganisms were prepared and their optical density at 550 nm was determined using a densitometer "Densimat" in units of McFarland, listing the obtained parameters (Table 1) for determining the concentration of bacterial suspension in CFU / ml.

Table of correspondence of optical density in units

Table 1.Table of correspondence of optical density in units of McFarland concentration of microorganisms

The strains of the cultures were grown at 35 - 37 0C for 18-20 h in SKA, suspended in a saline solution, arranged a concentration of cells up to 109 CFU / ml, and prepared a series of 10-fold dilutions of up to 103 CFU / ml that were applied freshly prepared. In tabl. 2 shows the characteristic of SCA and physiological solution.

Table 2. List of nutrients used

The number of microorganisms in the suspension is confirmed simultaneously by the direct sowing method on Petri dishes with sterile nutrient medium of SKA, listing CU / ml. Each batch of prepared nutrient media was checked for sterility and growth properties. The appropriate molten agarized nutrient medium was cooled to 40 - 45 ° C, inoculated with the test strain of the microorganism at an optimal concentration of CuO / ml and placed in 20 ml of Petri dishes and left on a horizontal, even surface, until the agar was sealed. The number of vegetative cell suspensions was determined experimentally based on the following criteria: optimal growth of the test strain of the microorganism; presence of test-strain growth suppression zones. antimicrobial medicinal syrup

In the frozen nutrient medium, using a sterile metallic punch with an internal diameter of 6 mm and an external diameter of 8 mm, they made holes in which an equal number of nasal lesions were injected through the dispenser.

After being introduced into the wells, the Petri dishes were kept at room temperature for 1 hour, then incubated at 36 ± 1 ° C for 18 to 24 hours.

Discussion of research results

The results of the conducted research are presented in the table. 3

The results of studies on the effect of various concentrations of preservatives on the antimicrobial activity of medicinal syrup (n = 5, P 95%)

Table 3 The results of studies on the effect of various concentrations of preservatives on the antimicrobial activity of medicinal syrup (n = 5, P 95%)

The results of antimicrobial activity of preservatives (Table 3) showed that the optimum for sorbic acid is a concentration of 0.1%; for nipagin / nipazol - 0.12 / 0.04%; benzoic acid - 0, 15%; Sodium benzoate - 0.15%.

A comparative analysis of data indicates that sorbic acid, in contrast to nipagin / nipazole, benzoicacid, sodium benzoate, exhibits more pronounced antimicrobial activity. Since there is no significant difference in the diameters of the growth retardation band for sorbic acid at concentrations of 0.1 and 0.15%, it is advisable to use 0.1% sorbic acid content in order to ensure the antimicrobial stability of the syrup when stored for 27 months [6]. Thus, based on the performed comprehensive researches, we substantiated the composition of auxiliary substances of medicinal syrup: xylitol 30; fructose 40; agar 1; citric acid 1; glycerin 5; sorbitol acid 0,1; water purified to 100.

Reference

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