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

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Abstract

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.

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About the authors

Victoria Mikhailovna Kishchenko

Closed joint stock company «VIFITECH»

Author for correspondence.
Email: viktoriya.kishchenko@yandex.ru
ORCID iD: 0000-0002-6947-7662

Сandidate of Pharmaceutical Sciences, chemical engineer of the laboratory of the quality control department of the closed joint stock company «VIFITECH»

Russian Federation, GNTS PMB, 84, Obolensk settlement, Moscow Region, 142279

Elvira Ifratovna Zilfikarova

Ryazan State Medical University

Email: alfavika@mail.ru
ORCID iD: 0000-0002-9620-5961

sixth-year student of the Faculty of Medicine Ryazan State Medical University

Russian Federation, Vysokovoltnaya str., 9, Ryazan, 390026

Ifrat Nazimovich Zilfikarov

Closed joint stock company «VIFITECH»; All-Russian Research Institute of Medicinal and Aromatic Plants; Maykop State Technological University

Email: dagfarm@mail.ru
ORCID iD: 0000-0002-8638-9963

professor of the Russian Academy of Sciences, Doctor of Pharmaceutical Sciences, head of the laboratory of the quality control department of the closed joint stock company «VIFITECH», chief researcher of the department of chemistry of natural compounds of All-Russian Research Institute of medicinal and aromatic plants, leading researcher of the department of pharmacy of Maikop State Technological University

Russian Federation, GNTS PMB, 84, Obolensk settlement, Moscow Region, 142279; Grina str., 7/1, Moscow, 117216; Pervomaiskaya str., 191, Maykop, Republic of Adygea, 385000

Nikolay Nikolaevich Boyko

Closed joint stock company «VIFITECH»

Email: boykoniknik@gmail.com
ORCID iD: 0000-0001-9222-2935

Doctor of Pharmaceutical Sciences, engineer of closed joint stock company «VIFITECH»

Russian Federation, GNTS PMB, 84, Obolensk settlement, Moscow Region, 142279

Inna Ivanovna Bochkareva

Maykop State Technological University

Email: bochkarevainna@gmail.com
ORCID iD: 0000-0002-7898-4404

Сandidate of Pharmaceutical Sciences, Associate Professor of the Department of Pharmacy, Dean of the Faculty of Postgraduate Education of Maikop State Technological University

Russian Federation, Pervomaiskaya str., 191, Maykop, Republic of Adygea, 385000

Artur Karpushovich Arutyunov

Maykop State Technological University

Email: ak.arut17@mail.ru
ORCID iD: 0000-0003-3883-6631

Candidate of Medical Sciences, Associate Professor, Dean of the Faculty of Pharmacy, Head of the Department of Pharmacy of Maikop State Technological University

Russian Federation, Pervomaiskaya str., 191, Maykop, Republic of Adygea, 385000

Timur Algasanovich Ibragimov

Dagestan State University

Email: aloefarm@mail.ru
ORCID iD: 0000-0001-9809-1120

Сandidate of Pharmaceutical Sciences, Associate Professor of the Department of Analytical and Pharmaceutical Chemistry of Dagestan State University

Russian Federation, Gadzhieva str., 43-a, Makhachkala, Republic of Dagestan, North Caucasian Federal District, 367000

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Supplementary files

Supplementary Files
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1. JATS XML
2. UV absorption spectra of the standard eucalymine solution (1), solution of the substance «Chlorophyllipt, thick extract» (2) and test solution prepared from vaginal suppositories with chlorophyllipt

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