Development of analysis methods and study of antimicrobial activity of vaginal suppositories with chlorophyllipt

DOI: https://doi.org/10.29296/25419218-2023-03-02
Issue: 
3
Year: 
2023

V.M. Kishchenko(1), E.I. Zilfikarova(2), I.N. Zilfikarov(1, 3, 4), N.N. Boyko(1), I.I. Bochkareva(4), A.K. Arutyunov(4), T.A. Ibragimov(5)
1-Closed joint stock company «VIFITECH», GNTS PMB, 84, Obolensk settlement, Moscow Region, 142279, Russian Federation;
2-Ryazan State Medical University, Vysokovoltnaya str., 9, Ryazan, 390026, Russian Federation;
3-All-Russian Research Institute of Medicinal and Aromatic Plants, Grina str., 7/1, Moscow, 117216, Russian Federation;
4-Maykop State Technological University, Pervomaiskaya str., 191, Maykop, Republic of Adygea, 385000, Russian Federation;
5-Dagestan State University, Gadzhieva str., 43-a, Makhachkala, Republic of Dagestan, North Caucasian Federal District, 367000, Russian Federation

Introduction. Medicinal preparations, containing chlorophyllipt, have been successfully used in medicine as antibacterial agents in therapy of infectious and inflammatory diseases of the female reproductive system. We have developed vaginal suppositories with chlorophyllipt which combine ease of use with dosing accuracy and intended for the treatment of diseases of the cervix caused by gram-positive pathogenic microflora. Objective: to develop the methods of physico-chemical analysis and standardization of vaginal suppositories containing chlorophyllipt and evaluation of their antimicrobial activity. Material and methods. The objects of the study were experimental series of vaginal suppositories with chlorophyllipt. The determination of the amount of phenolic aldehydes in suppositories was carried out by direct UV spectrophotometry. The validation of the methodology was carried out using eucalimine-standard, a sample of the chlorophyllipt substance and model mixtures of the drug in accordance with the requirements of the State Pharmacopoeia of the Russian Federation (SP RF) 14th edition. The antimicrobial activity of the suppositories was determined on the test strains Bacillus cereus ATCC 10702 and Staphylococcus aureus ATCC 6538-P by the method of serial dilutions. Results and discussion. Vaginal suppositories have been developed containing propylene glycol and polyethylene glycol 1500 as auxiliary components. The average weight is 3.0239 g, the deviation from the average weight is from -3.72% to +1.08%, which corresponds to the allowable interval. A method for the quantitative determination of the amount of phenolic aldehydes in suppositories in terms of eucalimine has been developed and validated. The norms of their content in one suppository are determined – from 90 to 110 mg. Conclusion. The developed method for determining the amount of phenolic aldehydes in vaginal suppositories with chlorophyllipt is characterized by ease of execution, rapidity, reproducibility, meets validation criteria and can be used for standardization and quality control at all stages of industrial production. Vaginal suppositories with chlorophyllipt have bacteriostatic properties against gram-positive microorganisms.
Keywords: 
chlorophyllipt
eucalymine
phenoloaldehydes
vaginal suppositories
antimicrobial activity.
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