Vol 22, No 4 (2022)
- Year: 2022
- Articles: 12
- URL: https://aspvestnik.ru/2410-3764/issue/view/6089
- DOI: https://doi.org/10.55531/AVP-2022v-4
Full Issue
INFECTIOUS DISEASES
A new SARS-Cov-2 coronavirus infection associated with respiratory syncytial virus in a child of the first month of life
Abstract
The article presents a clinical case of a combined course of a new coronavirus (SARS-CoV-2) and respiratory syncytial virus (RSV) infections in a young child with congenital heart disease. The disease began typically, with moderately severe catarrhal phenomena and intoxication. The deterioration of the child's condition was noted by the 3rd day from the onset of the disease, and was associated with the development of pneumonia and severe respiratory failure. The disease progressed with an increase in lung tissue damage and the appearance of multiple organ pathologies (cardiovascular, digestive, urinary, nervous system).
On the example of this clinical case, it was revealed that the new SARS-CoV-2 infection associated with RSV infection in a young child had a severe course accompanied by multiple organ failure, which was aggravated by the patient's comorbidity (congenital heart disease) and an unfavorable premorbid condition. Despite the extremely difficult course, the case ended happily.
Given the risk of developing mixed infections in newborns, the vigilance of a pediatrician, constant dynamic monitoring and preventive measures aimed at preventing the occurrence of complications in such children are important.
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Working conditions and psychological status of medical staff during the COVID-19 pandemic
Abstract
We consider the aspects of the adequate support for medical workers during the pandemic as an important topic for understanding the gaps and choice of the correct tactical measures is case the situation repeats. This article presents a review of the data on the condition of medical workers in various hospitals and clinics around the world.
The staff working in the "red zones" most frequently suffered from the following conditions: psychological stress, increased workload, social isolation / stigma, lack of motivation, lack of quality personal protective equipment, lack of coordination and proper management during the work.
Each day, the medical workers were exposed to the COVID-19 infection, and this situation had created clear risks to their physical health. The public healthcare system crisis impacted their mental health, contributing to anxiety, stress, depression, loneliness and other problems. Many authors had concluded that health professionals required a support for both physical and mental health.
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ORGANIZATION OF THE PHARMACEUTICAL BUSINESS
A structure of the antihypertensive drugs consumption in the population of several regions of the Russian Federation
Abstract
Aim – to study the characteristics of the consumption of antihypertensive (AG) drugs in the population of several regions of the Russian Federation – the Samara region, the Nizhny Novgorod region and the Republic of Tatarstan.
Material and methods. The range of AG drugs sold in the retail pharmaceutical market of the Samara and Nizhny Novgorod regions and the Republic of Tatarstan was selected for the study. To manage the obtained data, we used several methods like structural, comparative, logical, predictive, retrospective, graphic, marketing analysis. The results were processed using the normalization method and methods of mathematical statistics.
Results. The monopreparations kept the main share of sales in each region: 90.22% in the Samara region, 90.85% in the Nizhny Novgorod region, and 93.72% in the Republic of Tatarstan). In 2021, the leaders in consumption were ACE inhibitors (28.41%, 26.61% and 32.7%, respectively in each region) and β-blockers (25.87%, 29.02% and 21.15%). In total, these two subgroups accounted for more than a half of all monopreparations sold, counted in packages. In the subgroup of fixed combinations, the angiotensin II receptor blockers + diuretic were the most popular, which account for 35.38%, 29.73% and 22.13% of drug sales in this subgroup in the Samara, Nizhny Novgorod regions and the Republic of Tatarstan, respectively. In the subgroup of combined antihypertensive drugs, the multicomponent fixed combinations were among the leaders (10.22%, 8.20%, 12.10%, respectively in each region), however, in the total consumption of antihypertensive drugs, they accounted for less than 1%.
Conclusion. This study revealed the features of the consumption of drugs prescribed for arterial hypertension in the Samara and Nizhny Novgorod regions, as well as in the Republic of Tatarstan in 2021. We identified the groups of antihypertensive drugs of most demand and found the leaders within these groups. It was established that there was a relationship between the volume of sales of antihypertensive medicines in physical terms (in packages) in the Samara region for the period 2017–2021 and the population of this region.
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A comparative analysis of content requirements for clinical trials protocols in international regulatory documents
Abstract
Aim – to review the international regulatory documents on the requirements for the content of the protocol as the main document of a clinical trial.
Material and methods. The ICH GCP, the EU Directive 536/2014, the Order 200n, the Rules of Good Clinical Practice of the EAEU and the FDA documents were reviewed. The analysis followed the 46 points of section 6 of ICH GCP E6 (R2).
Results. As a result, 40 of the 46 points, considering the protocols’ content requirements, in all analyzed documents were similar. The essential differences were found in the Directive EU 236/2014. Firstly, the 6 points of the requirements were lacking; secondly, it contained points that were not reflected in any of the other 4 documents.
Conclusion. The Directive EU 236/2016 obliges the protocol developers to employ a more detailed and qualitative approach to the protocol creation and prescribes to provide a more detailed description of certain measures and information about drugs. The Directive EU 236/2016 is not interchangeable with the 4 regulatory documents mentioned above. Sponsors need to more carefully analyze the possibility of conducting clinical trials in the Russian Federation according to the protocols developed in the EU, paying attention to the additional points of the local requirements.
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DENTISTRY
Etiopathogenesis of gum recession: the current aspects
Abstract
The gum recession is difficult to diagnose due to the diversity of the clinical picture, the severity of the course and the form of the causative agent. The apical displacement of the marginal gingiva violates the aesthetics of the smile, causes the discomfort in chewing movements and requires a professional dental intervention. The knowledge of the current aspects of the etiopathogenesis of gum recession a dentist professionally identify the cause and type of development of this disease and provide the patient with the qualified medical care.
The article presents a review of modern literature that studies the factors influencing the occurrence of gum recession. The literature search has been done in the PubMed, Google Academy and Elibrary databases without language restrictions.
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PHARMACEUTICAL CHEMISTRY, PHARMACOGNOSY
Development and validation of a methodology for HPLC analysis of clopidogrel
Abstract
Aim – to develop a methodology for the chemical and toxicological analysis of clopidogrel using HPLC.
Material and methods. The study was performed on Clopidogrel bisulfate substance-powder, manufacturer: PJSC "Farmak", Ukraine, corresponding to the European Pharmacopoeia with an active substance content of 99.31% (LM2504208 series). For the chromatographic analysis we used a micro-column liquid chromatograph "Milichrome A-02" (CJSC "Econova", Russia). The analysis was done according to the unified HPLC technique developed by G.I. Baram.
Results. The highest spectral ratio by HPLC was observed at 280 nm / 210 nm (maximum clopidogrel peak area R = 1.0787). The calibration curve for the HPLC method was described by the equation: у = 0.0005912⋅х – 0.001385 (r = 0.9998; S02 = 25.29⋅10-7); linearity within 1−400 mcg/ml, which corresponded to the content of clopidogrel in the sample from 2 ng to 800 ng, respectively. Based on the values of the calibration curve, the LOD and LOQ were calculated: 2,334 mcg/ml and 7,074 mcg/ml, respectively.
Conclusion. A technique for the quantitative determination of clopidogrel by HPLC has been developed that allows for determining the substance in a mixture. The methodology was validated according to the following criteria: specificity, limit of detection, limit of quantitative determination, linearity, correctness and precision.
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Current aspects of qualitative and quantitative analysis of common yarrow (Achillea Millefolium L.)
Abstract
Aim – to develop a methodology for qualitative and quantitative analysis of flavonoids in the herb of Achillea millefolium L.
Material and methods. The material of the study was the yarrow herb harvested in 2020 and 2021, and an industrial sample from JSC "Krasnogorskleksredstva". Additionally, we used the reference samples of flavonoids: rutin, quercetin, kaempferol, cynaroside, and luteolin, received previously during our studies of the raw materials containing the flavonoids and described using the NMR, UV and mass spectroscopy. The authenticity was determined by the thin layer chromatography (qualitative analysis). For the quantitative analysis of the total flavonoids, we used the differential spectrophotometry, conducted in accordance with Pharmacopoeial monograph 1.2.1.1.0003.15 "Spectrophotometry in ultraviolet and visible spectra". The spectral characteristics of the water-ethanolic extractions were marked using the spectrophotometer "Specord 40" (Analytik Jena AG, Germany), in cuvettes with layer thickness of 10 mm.
Results. Based on the results of the authenticity determination, we revealed three adsorption zones with bright yellow glow in UV light at a wavelength of 365 nm (reagent – AlCl3), one of which was at the level of the adsorption zone in the chromatogram of the solution of standard sample of cinaroside with a value of Rf ≈ 0.7. The dominant adsorption zone with a value of Rs 1.3 in respect to the reference sample of cynaroside was presumably attributed to cosmosiin, while the adsorption zone with a value of Rf ≈ 0.8 was detected at the level of standard sample of kaempferol. The obtained data confirmed the presence of cynaroside in the herb of common yarrow, and also the possibility to conduct the qualitative and quantitative analysis of the given raw material with the use of cynaroside as a reference sample. We developed the method of quantitative determination of the total flavonoids in yarrow herb using a reference sample of cynaroside and differential spectrophotometry at an analytical wave length of 400 nm. The content of the total flavonoids for the common yarrow herb varied from 0.41±0.02% to 0.74±0.03% (equivalent to cynaroside). The error of single determination with 95% confidence interval was 6.70%.
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The composition of flavonoids in the inflorescences of spreading marigold (Tagetes Patula L.)
Abstract
Aim – to isolate and identify individual compounds of flavonoid nature from the inflorescences of spreading marigold (T. patula L.).
Material and methods. The research material was the inflorescences of T. patula L. of the variety "Mandarin", collected in August 2018 in the Botanical Garden of the Samara University during the mass flowering and fruiting period. We isolated individual substances by adsorption column chromatography on silica gel L 40/100 (Czech Republic) with subsequent recrystallization. For the identification of the isolated compounds, we used the UV, 1H-NMR, 13C-NMR spectroscopy and mass spectrometry data.
Results. The dominant and diagnostically significant flavonoids of the inflorescences of the spreading marigold, patulitrin and patuletin, were isolated and identified. For the first time, the 6-methoxykaempferol and 7-O-β-D-glucopyranoside of 6-methoxykaempferol were isolated from this type of plant raw material. Quercetin was obtained in minor quantities. The results of the study can be used for developing the methods of identification and standardization of the inflorescences of Tagetes patula L.
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Poly(l-lactide-со-glycolide) and shellac in the development of phase-sensitive in situ implants
Abstract
Aim – to consider the potential prospects of using Poly(l-lactide-co-glycolide) (PLGA) and shellac to obtain phase-dependent in situ implants.
Material and methods. The study required two stages: stage I was the evaluation of NMP-polymer compositions, and stage II was the evaluation of NMP-polymer-PEG compositions. We used PLGA with various ratios of lactide and glycolide units (75:25, 50:50), dewaxed bleached shellac, N-methylpyrrolidone (NMP) as a solvent, and PEG-1500 at a concentration of 5% (wt/vol) as a co-solvent. The experimental formulations contained matrix formers at a concentration of 33%. The formulations were screened for polymer solubility in NMP, homogeneity and permeability through the needle of the resulting polymer-NMP system, the implant formation rate during the liquid-liquid extraction in a phosphate buffer solution (pH=6.8), and the implant morphology. The rate of implant formation and the diffusion of the dye from the delivery systems were also studied using the in vitro agar gingiva model, previously developed in the laboratory of the A.P. Nelyubin Institute of Pharmacy.
Results. The first stage of the study showed that the NMP-PLGA system (75:25) formed a solid implant in 1 hour, and the NMP-shellac system – in 2 hours. The formulations were positively assessed according to the presented criteria, despite the very different diffusion volumes – 1414 µl for NMP-shellac and 1065 µl for NMP-PLGA (75:25) – which indicates the possibility of their use without the introduction of additional excipients. The NMP-PLGA system (50:50) had not completely precipitated after the critical time (3 hours) and was considered as requiring an adjustment due to the insufficient implant formation rate.
In the stage II, a less intense diffusion of the dye from the implants into agar was observed. For example, for NMP-PLGA(50:50) – 641 µl, and for NMP-PLGA(50:50)-PEG – 25 µl. At the same time, there was the positive dynamics in the time of their precipitation both in phosphate buffer medium (instantaneous precipitation without the need for shaking) and in the in vitro agar gingiva model – after 3 hours, the composition of NMP-PLGA (50:50)-PEG, in contrast to NMP-PLGA (50:50), had formed a semi-solid implant.
Conclusion. In the course of the experiments, the compositions of NMP-shellac and NMP-PLGA (75:25) were selected as the most promising for further development of a phase-sensitive in situ dental implant. The addition of PEG was found to be rational in terms of increasing the rate of implant precipitation and reducing the initial diffusion of the solvent.
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The study of flavonoids accumulation by the herb Polygonum aviculare of the synanthropic flora of the Rostov Region
Abstract
Aim – to study the flavonoid accumulation peculiarities in the birdweed herb (Polygonum aviculare) harvested in the Rostov Region.
Material and methods. Several raw material sampling areas in the Morozovsky District of the Rostov Region were selected for the study. The birdweed grass was harvested near a major highway M-21 (IA category), a low-speed road (IV category) with little traffic, and a railway line of the North Caucasus Railway. The sampling was conducted at distances from 1 to 300 meters at 100-meter intervals. The choice of harvesting areas was determined by the lack of accurate and reliable information on the accumulation of biologically active substances in the raw material depending on the distance from highways and railroads. In addition, we harvested the birdweed grass in ecologically clean areas far away from the objects of anthropogenic impact (control areas).
Results. The study of the plant raw material harvested along a low-speed road with little traffic revealed a direct correlation in the reduction of flavonoid content, in terms of avicularin, with increasing distance from the road. The results obtained in the study of samples harvested along the highway M-21 and the railway line also reflected the dependence of the induction of phenolic compounds in the raw material on its growth near the highway. However, in conditions of remoteness from a source of anthropogenic impact on 200 meters and more, there was a decrease in the content of flavonoids, which was approximately equal to their content in the raw material harvested in the control areas.
Conclusion. A moderate anthropogenic impact, which is characterized by the release of various ecotoxicants into the environment, can induce the biosynthesis of flavonol compounds.
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A comparative evaluation of the antimicrobial activity of aqueous extracts from aerial organs of meadowsweet (Filipendula Ulmaria (L.) Maxim.) and dropwort (Filipendula Hexapetala Gilib.)
Abstract
Aim – to evaluate the comparative antimicrobial activity of the aqueous extracts from the aerial organs of the meadowsweet and dropwort.
Material and methods. The objects of the research were the aqueous extracts of the aerial organs of the meadowsweet and dropwort. For the preparation of the extracts we used the raw material harvested in 2021 in the village of Alekseevka, Samara Region. The antimicrobial activity of the aqueous extracts was determined by the method of two-fold dilution in the Mueller–Hinton broth.
Results. According to the results of screening of the antibacterial activity of the aqueous extracts from the aerial organs of the meadowsweet and dropwort, the significant activity against gram-positive bacteria of S. aureus and B. cereus strains was detected. The studied extracts demonstrated not lower antimicrobial activity than the reference samples of 0.1% alcohol solution of levomycetin (chloramphenicol) and freshly prepared 0.1% benzylpenicillin solution. The results have confirmed the prospects for further study of the aerial organs of the meadowsweet (Filipendula ulmaria (L.) Maxim.) and dropwort (Filipendula hexapetala Gilib.) as a possible source of biologically active substances with antimicrobial activity.
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The antimicrobial activity of Thymus marshallianus extract against clinical cultures S. aureus and C. albicans
Abstract
Aim – to study the antimicrobial activity of the Thymus marshallianus extract against clinical cultures of microorganisms isolated from patients' material.
Material and methods. The extract from the herb Th. marshallianus was obtained according to the method previously described and used, since the extraction obtained by this method presented the antimicrobial activity against standard cultures of microorganisms. The antimicrobial activity of extracts was studied in accordance with the Guidelines 4.2.1890-04 for 6 clinical isolates of Staphylococcus aureus and 5 clinical isolates of Candida albicans taken from patients' material (nasopharyngeal smear, blood, wound fluid) in the laboratory of the S. R. Mirovtsev of the Saratov State Medical University. The sectoral seeding was performed on dense nutrient media from test tubes with the colonies count, compared with the control seeding.
Results. The antimicrobial activity of Th. marshallianus extract, obtained by the patented method, against clinical cultures of microorganisms was studied for the first time. A pronounced anti-staphylococcal effect of Th. marshallianus extract was established against clinical culture of S. aureus (the minimum inhibitory concentration ranged from 0.78 mg/ml to 0.39 mg/ml). The antimycotic activity was detected only for one culture of C. albicans (minimum inhibitory concentration 25.0 mg/ml).
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