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卷 73, 编号 5 (2024)
Pharmaceutical chemistry and pharmacognosy
Phytochemical and genoprotective features of Elaeagnus angustifolia L. fruit mesocarpy extract
摘要
Introduction. Current pharmacological studies describe the immunomodulatory and antioxidant effects of extracts of biological substances of narrow-leaved loch (Elaeagnus angustifolia L.). The study of the phytochemical and genoprotective properties of the mesocarpy of this plant, which grows in the soil-climatic conditions of the Astrakhan region, will determine the possibilities of using narrow-leaved loch fruits in conditions of increasing anthropogenic load in the region, which inevitably leads to disruption of the stability of the human genome.
Objective: study of the phytochemical composition of the mesocarpy of the fruits of Elaeagnus angustifolia L.; determining the antimutagenic potential of the extract using an Ames microbial test system.
Material and methods. The fruits of E. Angustifolia were collected in the Kamyzyaksky district of the Astrakhan region. Quantitative determination of flavonoids was carried out by spectrophotometry, based on the ability of flavonoids from the mesocarp extract of E. Angustifolia to form a colored complex with an alcohol solution of aluminum chloride (a calibration graph based on rutin was used in the calculation). The content of phenolcarboxylic acids was determined by the spectrophotometric method, tannins – by complexometric titration (precipitation reagent – zinc sulfate). The amount of ascorbic acid was determined by titrating the acidified extract with a solution of sodium 2,6-dichlorophenolindophenolate. Using chromatography-mass spectrometry on a Hewlett PackardG device, the qualitative composition of the E. Angustifolia mesocarp extract was revealed. Antimutagenic activity of mesocarp extract against the test strain of Salmonella t. assessed in the Ames bacterial test system by determining the degree of inhibition of mutagen activity by the plant extract. We counted the number of grown his+ revertant colonies in the sample with sodium azide and extract, in comparison with control data.
Results. In the mesocarp of E. Angustifolia, the following were identified: flavonoids (4.2%), phenolcarboxylic acids (5.2%), hydrolyzable tannins (6.7%), ascorbic acid (2.3%), aliphatic acids (free and bound: vaccene, linoleic, eicosan and others), alcohols (phytol, hexadecanol, eicosenol and others), hydrocarbons (pentadecane, docosane and others).
Conclusion. The fruit mesocarp extract of E. angustifolia L. showed moderate antimutagenic activity in the Ames bacterial test system.
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Technology of medicines
Development of a venotonizing cream
摘要
Introduction. Diseases of the veins of the lower extremities, being one of the most common among the working age population, are currently acquiring the status of socially significant diseases. The main method used to treat this pathology at the initial stage is pharmacotherapy, which includes the use of both synthetic and phytopreparations containing a complex of biologically active substances that affect various links of the pathological process and have an anti-inflammatory, venotonizing, angioprotective, decongestant effect. The complex action of substances of plant origin determines the creation of drugs based on them for the prevention and treatment of veins and diseases of the lower extremities.
Objective. A promising area of pharmaceutical research is the development of a cream that combines anti-inflammatory and venotonizing effects based on the grapes of the cultivated leaves of the red extract of dry.
Material and methods. The article presents the justification for the choice of excipients in the development of the composition and technology of the venotonizing cream. Subject: dry purified extract based on polyphenol complex, from the leaves of red grapes (Vitis vinifera L.). The study methods comply with the requirements of the Rus. Pharm. The excipients used in the work are selected taking into account the physicochemical properties of the substance and the purpose of the dosage form.
Results. The optimal composition and technology of the cream of the cultural leaves of dry red extract has been developed. The cream quality criteria and critical characteristics are established in accordance with the requirements of regulatory documents for the following indicators: appearance, uniformity, pH value, identity, determination of the sum of phenolic compounds in terms of routine, identity. A rational scheme of cream production is proposed.
Conclusion. The cream quality parameters were established in accordance with the requirements of the regulatory documentation for the main indicators: appearance, uniformity, pH value, identity, quantitative determination of the sum of phenolic compounds in terms of rutin. Stability of the developed dosage form was established for 15 months of storage.
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Development of the composition and justification of the technology of biodegradable films with etoricoxib
摘要
Introduction. One of the current directions of pharmaceutical development is the creation of new drugs with anti-inflammatory and analgesic activity. Among the promising dosage forms are biodegradable films, which have a number of advantages over traditionally used forms. The use of biodegradable films containing nonsteroidal anti-inflammatory drugs as active ingredients prevents a number of side effects characteristic of oral dosage forms containing these drugs that enter directly into the gastrointestinal tract.
Objective: development of the optimal composition and substantiation of the technology of biodegradable films containing etoricoxib as an active ingredient, which has anti-inflammatory and analgesic activity.
Material and methods. The following pharmaceutical substances and excipients approved in the territory of the Russian Federation were used in the development of the composition of biodegradable films: etoricoxib (manufacturer Alembic Pharmaceuticals Ltd, India, serial number 2102010991), gelatin (PA.2.1.0099.18), sodium carmellose (PA.2.1.0377), dextrose (PA.2.1.0092.18), cocoa powder (SIS 108-214), citric acid (PA.2.1.0024.15), peppermint oil (PA.2.4.0001.18), glycerol (PA.2.2.0006.15), miramistin (PA 42-3498-98), sodium chloride (PA.2.2.0014), purified water (PA.2.2.0020).
The rationale for the choice of a carrier matrix was carried out by studying film-forming polymers with the addition of pharmacologically active and auxiliary substances permitted in the territory of the Russian Federation. The quality indicators of polymer bases were evaluated by organoleptic and pharmaceutical-technological characteristics.
To determine the dosing uniformity index, a VM-153M laboratory electronic scale (manufacturer LLC OKB Vesta, Saint-Petersburg, Russia) was used. The quality of the polymer bases was evaluated by organoleptic parameters and pharmaceutical and technological characteristics. Statistical analysis methods were used to substantiate the reliability of the results.
Results. As a result of the theoretical and experimental studies carried out, the choice of the active substance – a nonsteroidal anti–inflammatory agent of selective action etoricoxib was made and its optimal dosage of 60 mg was justified, providing significant relief of pain and improvement of the condition of patients suffering from osteoarthritis. The optimal composition of a biodegradable film containing 2.14% etoricoxib, 7.14% gelatin, 10.00% glycerol, 2.14% miramistin, 4.29% dextrose, 2.86% cocoa powder and 71.42% purified water has been developed. An optimal technology for the production of biodegradable films has been developed and justified, which is based on the method of casting films in the form of a suspension due to the availability of the technological process.
Conclusion. As a result of the conducted research, the optimal composition and technology of biodegradable films with etoricoxib based on gelatin have been theoretically and experimentally substantiated and developed. It has been established that the developed composition has satisfactory organoleptic properties and pharmaceutical and technological characteristics.
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Organization and economy
Economic analysis of the dynamics of procurement of drugs based on monoclonal antibodies and biosimilars: trends and prospects
摘要
Introduction. In recent years, in Russia there has been a tendency to increase the share of domestic biosimilars in the market of monoclonal antibodies (MA), which is associated with government support for domestic manufacturers.
Purpose of the study. The purpose of this analysis is to study the market for government procurement of drugs based on MA and its dynamics in 2018–2022. in connection with the emergence of domestic biosimilars.
Material and methods. Data from the State Register of Medicines was used to compile a list of all drugs based on MA registered from 2018 to 2022. The analysis of the Russian market was carried out on the basis of the Unified Information System (UIS) of procurement. Purchases of 68 mAb drugs were analyzed, and based on the calculation results, 10 drugs with the largest volume of purchases in monetary terms were identified.
Results. Over the five-year period, there was a significant increase in the share of purchases of domestic biosimilars, especially for the drugs Eculizumab, Bevacizumab, Trastuzumab and Rituximab. The share of purchases of domestic biosimilars reached 73% of the total purchase amount. The emergence of domestic biosimilars contributed to a decrease in purchases of imported original drugs.
Conclusion. The analysis showed that during the period under study there was a change in market shares in favor of Russian biosimilars. This trend is particularly noticeable for Eculizumab and Bevacizumab. Russian biosimilars occupied a significant market share, which contributed to a decrease in purchases of imported originals.
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Analysis of experience in the use of individually manufactured drugs in psychiatric practice
摘要
Introduction. The article provides an analysis of the problematic issues that medical organizations and pharmacies face when using drugs manufactured according to extemporaneous prescriptions in clinical practice in psychiatric medical organizations.
Objective. The purpose of this study is to analyze the experience of using extemporaneous formulations in psychiatric practice in order to determine the frequency of its prescription in the treatment of mental disorders.
Material and methods. The study used: content analysis, observation method, documentary, systemic, statistical and other methods for studying drug prescriptions for psychiatric patients. The basis of the research was the specialized departments and hospitals of the Sverdlovsk Regional Psychiatric Hospital, namely, prescription sheets and requirements-invoices for medications prepared according to extemporaneous prescriptions for adult patients from 18 to 60 years old with a psychiatric history
Results and discussion. During the study, a decrease in interest in extemporaneously manufactured dosage forms included in the pharmaceutical manual in the section for psychiatrists was noted. 11 prescriptions with analgesic and sedative effects were selected from the Pallas's cat. A study of the frequency of prescription of individually prepared dosage forms showed that the prescription of the studied prescriptions to patients is uneven. More often, extemporaneously manufactured drugs are prescribed in hospitals, with priority given to infusions of sedative preparations, Pavlov’s mixture, sodium bromide powder with valerian root powder and Dobronravy drops are less commonly prescribed. In the narcological department, painkillers are more often prescribed: painkiller lotion and chloroform oil. In the women's outpatient department No.43 and the men's outpatient department No.44, extemporaneous medications are prescribed extremely rarely and mainly valerian-based drugs.
Rarely in doctors' prescriptions were drugs with outdated formulations observed, such as Bekhterev's mixture, suppositories with chloral hydrate, and Professor Sirotin's pills. The decrease in interest in extemporaneously manufactured drugs can be explained by the lack of necessary substances in pharmacies; in addition, clinical recommendations contain only registered drugs; the prescription of extemporaneous dosage forms requires consideration by a medical commission, which complicates the work of doctors.
Conclusion. Drugs of extemporaneous manufacture can be used more widely as an addition to the main therapy in the prevention and treatment of psychiatric nosologies, subject to the adoption of regulatory documents and introduction into circulation as part of clinical recommendations, as well as updating the manual formulation.
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Pharmacists in the pharmacovigilance system
摘要
Introduction. In accordance with the rules of the GVP EAEU, good pharmacy practice and the national legislation of Russia, pharmacy organizations, as subjects of circulation of medicines, must collect and send reports of adverse reactions to the authorized body about the information they receive from patients.
Objective. Studying the level of knowledge and practical skills, as well as the opinions of pharmacy workers about the pharmacovigilance system in order to develop practical management solutions to increase the participation of the pharmacy link in the pharmacovigilance system.
Material and methods. Questionnaire method, descriptive statistics, non-prametric statistics according to the Kendal and Spearman test.
Results. A Google link to the questionnaire was sent to 150 pharmacy ratings to complete. Employees of the retail pharmaceutical sector of the Republic of North Ossetia (Alania) took part in the questionnaire. 105 valid completed questionnaires were received. The return rate of the questionnaire is 70%. 62% of the respondents answered that an AR notification should be reported only if there is a proven causal relationship between taking the drug and the resulting AR; 30% believe that it should be sent if a causal relationship is suspected; 1% in free time from other duties; 7% – believe that it is necessary to report if the buyer asks for it. 39 (37,1%) of respondents answered that the decisive factor preventing them from filling out notices is the too long filing procedure, 56 (53,4%) of respondents referred to the lack of time for this procedure, 10 (9,5%) respondents – on the lack of meaning in this activity. The main stimulating factor that, according to the respondents, can motivate the receipt of notices is material.
Conclusion. The study revealed an increase in the competencies of pharmacy workers and the search for solutions to motivate them to increase their involvement in the pharmacovigilance system.
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