bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development and Validation of the ELISA Method for Anti-trastuzumab Antibodies Determination in Human Serum
Authors: Eliseeva O. A. , Kolganova M. A. , Shokhin I. E. , Dementyev S. P. , Vlasov A. M. , Zamyatnin A. A. , Dubovik N. S. , Savchenko A. Yu. , Dozmorova N. V. , Luzhanin V. G. 
Published: December 2022

Introduction. One of the widely used specific anti-HER2 (human epidermal growth factor receptor 2) MAb drugs is trastuzumab. Trastuzumab is highly effective for malignant HER2 hyperexpression reduction, which results in HER2 oncogenicity decrease. As any other biotherapeutics trastuzumab can cause immunological adverse reactions, e.g. immunogenicity or anti-drug antibodies (ADAs) production.Aim. The aim of this study was to develop and validate the analytical method for anti-trastuzumab antibodies determination in human blood serum.Materials and methods. The semi-quantitative anti-trastuzumab antibody determination was carried out by the ELISA method combined with ACE technique, using spectrophotometric detection in the visible range of the spectrum.Results and discussion. The developed method was validated for cut point, selectivity, sensitivity, "hook" effect, drug tolerance, precision and stability (short-term and long-term). To decrease the background noise from non-specific binding of sera components, the minimum required dilution value was determined at 10 % serum. The calculated values for screening cut point (normalization factor) and confirmatory cut point were 0.004 and 34.59 %, respectively. The sensitivity of the developed method was estimated at 99.5 ng/mL of anti-trastuzumab antibodies.Conclusion. The obtained results allow us to use the developed ACE ELISA method for the determination of anti-trastuzumab antibodies in human serum during trastuzumab safety clinical trials.
Destruction of Narcotic Drugs and Psychotropic Substances as a Stage of Circulation of Medicines
Authors: Malkova T. L. , Berezina E. S. 
Published: December 2022

Introduction. Destruction is one of the stages of the circulation of medicines. Special importance is attached to this stage in relation to drugs related to narcotic drugs and psychotropic substances. The activities of pharmacy and medical organizations in relation to the turnover of these funds are strictly regulated.Aim. The purpose of the study was to study the procedure for the destruction of narcotic drugs and psychotropic substances included in Lists II and III of the List, as a stage of the circulation of medicines, to identify trends in the appointment of individual drugs for pain relief based on the generalization of archival data of the commission on destruction established on the basis of the Perm State Pharmaceutical Academy.Materials and methods. Archival materials of the destruction commission for 2012–2021 were used in the execution of the work. Each archive folder for a certain month of the year included the following documents: an order for the commission on destruction and appendices, a set of documents and acts of destruction for each institution that provided medicines. Statistical and empirical methods were used, such as observation, description, study, generalization and grouping, comparison, proof.Results and discussion. Data on prescribing drugs to cancer patients and data on drugs submitted for destruction correlate. Therefore, the range and quantity of medicines transferred for destruction by medical institutions allows us to see trends in their appointment and use in medical practice.Conclusion. Optimization of activities related to the turnover of controlled substances can be ensured by building a clear algorithm of actions in a medical organization for each type of work and services specified in the license, including the type of work – destruction. The procedure for the destruction of narcotic and psychotropic drugs, which is accompanied by verification of accompanying documents and objects at the meetings of the commission, allows monitoring the use and accounting of drugs in medical institutions.
On the Formation of Professionally Specialized Competencies and Training of Specialists and Managers in the Pharmacovigilance System of the Marketing Authorization Holder
Authors: Kurganova E. Yu. , Soloninina A. V. 
Published: December 2022

Introduction. The key role in the organization of the pharmacovigilance system is played by the Marketing Authorization Holder (MAH), who monitors the safety and effectiveness at all stages of the life cycle of drugs, the need for which is determined by regulatory documents in the field of pharmacovigilance. The possibility of ensuring the required quality of the processes and the results obtained in the pharmacovigilance system of the MAH is directly related to the availability of a sufficient number of competent, qualified and trained personnel in the units that closely interact in the pharmacovigilance system of the MAH, which necessitates the formation of appropriate competencies for the implementation of procedures provided for when identifying changes in the safety profile of drugs. An integral part of the formation of competencies of employees and departments involved in the pharmacovigilance system of the MAH is training according to a specially developed program and evaluation of its effectiveness.Aim. Substantiation of the formation of professionally specialized competencies and training of employees in the pharmacovigilance system of the MAH.Materials and methods. The research materials were the results of the works of domestic scientists, data from their own research and regulatory legal acts regulating pharmacovigilance in the Russian Federation, the EAEU. Methods of sociological, logical analysis, and interactive learning were used as research methods.Results and discussion. The necessity has been established and the professionally specialized competencies of managers and specialists of the MAH in the pharmacovigilance system have been formed, for the mastery of which an educational program has been developed and training has been conducted. Information and methodological support of personnel has been introduced.Conclusion. In the course of the conducted research, it was found that training is an integral part of the organization of an employee's independent workflow. In order to achieve high-quality performance of processes and tasks related to pharmacovigilance, it is necessary to have a sufficient number of competent and trained personnel in the MAH. In order to update the acquired knowledge on pharmacovigilance, it is advisable to carry out intra-corporate training with a certain frequency.
Phyto-stimulating Effect of Paracetamol Biodestruction Product on Calendula Officinalis
Authors: Vihareva E. V. , Mishenina I. I. , Gapechkina E. D. , Selyaninov A. A. , Rychkova M. I. 
Published: December 2022

Introduction. In recent years, there has been an increase in fundamental interest in the search for effective, including microbiological, methods for processing pharmaceutical waste to obtain new biologically active compounds on their basis. Our results showed that the product of bacterial degradation of paracetamol (BDP) exhibits pronounced stimulating properties in relation to medicinal plants of the families Plantaginaceae, Lamiaceae, Urticaceae, Linaceae and can be used as an inducer of the accumulation of biologically active substances in them.Aim. The purpose of this work is to study the effect of BDP on the dynamics of biomass accumulation and the content of flavonoids in the flowers of Calendula officinalis L., fam. Asteraceae in comparison with the control (water) and growth stimulator "Zircon".Materials and methods. BDP obtained on the basis of the Laboratory of Alkanotrophic Microorganisms Institute of Ecology and Genetics of Microorganism UB RAS (Perm). Calendula officinalis flowers collected from plants treated with BDP and Zircon growth stimulator were used to study the dynamics of dry biomass accumulation and changes in the content of flavonoids by the spectrophotometric method. For a comparative analysis of the intensity of the increase in the biomass of flowers during the treatment of plants with these agents, as well as to predict the accumulation of flavonoids, kinetic modeling was used.Results and discussion. The total biomass harvest of calendula officinalis flowers when treated with BDP increased by 55 %, and when treated with the Zircon growth stimulator, by 24 % compared to the control. The content of flavonoids in flowers when treated with these agents increased by 101 and 40 %, respectively. The dates for the beginning of the collection of calendula officinalis flowers in the conditions of the Western Urals were determined: with the use of the Zircon growth stimulator – from July 20, BDP – from August 1, without treatment with growth stimulants – from August 14. Both stimulants increase the end date of the collection of raw materials by 10 days.Conclusion. The product of bacterial degradation of paracetamol has a pronounced stimulating effect on calendula officinalis, significantly increasing the biomass of flowers and the content of flavonoids in them compared to the control (water) and growth stimulator "Zircon". With the use of kinetic modeling, the values of the parameters of the growth rate of the biomass of plant raw materials during the treatment of plants with these agents were established, a forecast was made for the accumulation of flavonoids, and the timing of the collection of calendula officinalis flowers in the conditions of the Western Urals was substantiated.
The Synthesis and Evaluation of Non-steroidal Antiinflammatory Activity of <i>N</i>,6-diaryl-4-methyl-2-thioxo-1,2,3,6-tetrahydropyrimidine-5-carboxamides
Authors: Buzmakova N. A. , Rudakova I. P. , Zamaraeva T. M. , Dozmorova N. V. , Slepova N. V. 
Published: December 2022

Introduction.New potential biologically active compounds with different pharmacological activities were found among pyrimidine derivatives. Simple and available synthesis of tetrahydropyrimidine-5-carboxamides was developed in Perm State Pharmaceutical Academy. Products of this reaction previously shown high analgesic and anti-inflammatory activities.Aim.To get previously unknown functionalized pyrimidines and to study their analgesic, anti-inflammatory and antipyretic activities.Materials and methods.11 compoundsN,6-diaryl-4-methyl-2-thioxo-1,2,3,6-tetrahydropyrimidine-5-carboxamides are objects of research. Their structure has been confirmed by spectroscopy methods. The biological activities were carried out by recommended methods for preclinical study of new pharmacological substances.Results and discussion.This paper presents the results of preclinical tests of the obtained compounds.Conclusion.Some compounds demonstrated high analgesic, anti-inflammatory and antipyretic activities and could be recommend for further study as perspective non-steroidal drugs.
Component Composition and Antimicrobial Activity of Fractions from the Aerial Part of Common Toadflax (<i>Linaria vulgaris</i> Mill.)
Authors: Bombela T. V. , Krotkova O. A. , Galishevskaya E. E. , Anisimova A. G. , Yagontseva T. A. , Agafontseva A. V. , Novikova V. V. , Whaley A. K. , Ponkratova A. O. , Luzhanin V. G. 
Published: December 2022

Introduction. Natural biologically active substances (BAS) are distinguished by different polarity, which determines their physicochemical properties, including solubility. When using solvents of different polarity, it is possible to influence the spectrum of BAS extracted from plants, achieving their division into groups, and further achieving isolation in an individual form. Тhe aerial part of Linaria vulgaris Mill. (common toadflax) contains both lipophilic and hydrophilic substances. The herb L. vulgaris is widely used in folk medicine for treatment of angina, conjunctivitis, dermatomycosis, periodontitis and other diseases. Bacterial factors play an important role in the pathogenesis of these diseases.Aim. To study the effect of solvents of different polarity on the component composition of extracted BAS and to study the antimicrobial activity of fractions from the herb L. vulgaris.Materials and methods. The aerial part of L. vulgaris was collected at the flowering stage – at the beginning of fruiting stage in July 2021 in the Perm region. The fractions were obtained by sequential exhaustive liquid-liquid extraction of an alcoholic extract from the herb L. vulgaris with hexane, dichloromethane, and n-butanol. Detection of BAS was carried out by HPLC and planar chromatography on paper. Antimicrobial activity was studied against Escherichia coli, Staphylococcus aureus and Candida albicans.Results and discussion. Using solvents of different polarity four fractions were obtained from the alcohol extract of L. vulgaris: hexane, dichloromethane, n-butanol and water. These fractions have differences in the composition of BAS. The number of polyphenolic substances in the fractions increases with increasing of solvent polarity: hexane (14), dichloromethane (55), butanol (61). The dichloromethane and n-butanol fractions have a similar composition, represented by polyphenolic compounds and iridoids. The main groups of compounds in these fractions are phenolic acids and flavonoids. Iridoids are found in trace amounts. In the hexane fraction, the smallest number of substances was found, iridoids are completely absent, and phenolic acids were found in trace amounts. The water fraction is characterized by the content of the entire BAS complex. The highest antibacterial activity against Escherichia coli and Staphylococcus aureus was found for the aqueous fraction, while the highest antifungal activity was found for the hexane and dichloromethane fractions.Conclusion. Using solvents of different polarity, fractions containing a diverse set of BAS were obtained from the alcoholic extract of L. vulgaris. Fractions exhibiting different polarities from L. vulgaris have antimicrobial activity against Staphylococcus aureus and Escherichia coli, as well as against pathogenic fungi from the genus Candida.
Determination of Phytotechnological Parameters of the Dense Extract from Peach (<i>Persica vulgaris</i>) Leaves
Authors: Molokhova E. I. , Ivantsova L. V. , Belonogova V. D. 
Published: December 2022

Introduction. Leaves of peach (Persica vulgaris), containing a large amount of biologically active substances, including flavonoids, are considered as promising plant source for producing extraction preparations.Aim. The purpose of the study: to establish the influence of phytotechnological parameters for efficiency of isolation of complex of biologically active substances from peach leaves.Materials and methods. The object of the study was samples of dried leaves of the cultivated peach tree – Persica vulgaris Mill. (Rosaceae family) collected during the growing season (at the end of August). The main technological parameters of vegetable raw materials were studied: average particle size and fractional composition, volume characteristics of specific, volume and bulk mass, porosity, porosity and free volume of the raw material layer, аs well as the absorption coefficient of the extractant.Results and discussion. The obtained values of the fractional composition and volume characteristics indicate the expediency of using the maceration method in plant raw materials extraction. Experimental studies were carried out to select optimal modes of extraction of flavonoids from peach leaves (extractant, extraction temperature, extraction duration, degree of raw material grinding, hydromodule), which ensure high output of BAS complex into extract.Conclusion. The study presents the analysis of phytotechnological parameters of peach leaves, a rational extraction method is justified – maceration at heating with periodic stirring, and extraction conditions are determined; providing maximum yield of active substances: temperature – 70 °С in 40 min, extractant – alcohol, ethyl solution 70 %, degree of raw material grinding – 2 mm, raw material : extractant ratio (1 : 10).
Study of the Influence of the Technological Regime of the Production of Water Extraction from Rosehip Fruits (<i>Rosae fructus</i>) on the Content of Ascorbic Acid
Authors: Sobin F. V. , Korosteleva L. K. , Lutkova T. A. , Dozmorova N. V. 
Published: December 2022

Introduction. COVID-19 is recognized as the most significant pandemic of the modern era. Studies have shown the potential benefits of taking ascorbic acid in the complex treatment of this disease, especially in people with vitamin C deficiency. One of the most popular and affordable sources of ascorbic acid in the diet are rosehip fruits. The quality of water extracts from plant raw materials depends on a number of technological factors. The study of the influence of the technological regime of the production of water extraction from rosehip fruits on the release of ascorbic acid in the obtained dosage forms is relevant.Aim. To obtain water extracts from rosehip fruits by various production modes and to study the effect of technological parameters on the content of ascorbic acid.Materials and methods. The object of the study was rosehip fruits in bundles and water extracts based on them, obtained in the 6 different ways. Pharmacopoeial techniques, manufacturers' recommendations, as well as thermos infusion with and without preheating of the thermos flask were used. For quantitative determination of the ascorbic acid in the obtained aqueous extracts, we used the pharmacopoeia method (titration with 2,6-dichlorophenolindophenolate sodium).Results and discussion. The lowest content of ascorbic acid was noted in the decoction according to the pharmacopoeia method. High levels of ascorbic acid content were noted in the variants of thermos infusion of rosehip fruits.Conclusion. We have obtained extemporal water extracts of rosehip fruits by the 6 different extraction modes. According to the content of ascorbic acid, the most effective method of obtaining extemporal water extraction of rosehip fruits is a six-hour thermos infusion with preheating of the thermos flask. The largest amount of ascorbic acid is released during a six-hour thermos infusion. In the twelve-hour thermos infusions, a decrease in the amount of ascorbic acid was found. It was found that preheating the thermos flask leads to an increase in the yield of ascorbic acid in aqueous extraction by 25 %.
Chemical Analysis of the Main Groups of Biologically Active Substances in Sedative Collection
Authors: Zamakhaeva E. A. , Oleshko O. A. , Yaborova O. V. , Smirnova M. M. 
Published: December 2022

Introduction. According to the World Health Organization, the number of patients with diseases of the nervous system in the world is increasing every year. The use of phytopreparations is a promising direction of pharmacotherapy; preparations from medicinal plant materials have a number of advantages in the treatment of chronic diseases.Aim. Qualitative analysis and quantitative determination of the main groups of biologically active substances collected from medicinal plant materials.Materials and methods. As an object of study, we used a collection of medicinal plant materials developed at the Department of Pharmaceutical Technology of the PSFA together with the Department of Pharmacognosy. Quantitative determination of biologically active substances of the collection was carried out by spectrophotometric method [Jenway PortLab 511 UV spectrophotometer PortLab Int., UK)] and by visual titration.Results and discussion. In this work, a qualitative analysis and quantitative determination of the content of flavonoids, phenolic compounds, sesquiterpenic acids and ascorbic acid was carried out, and the water absorption coefficient of the collection was determined.Conclusion. As a result of the work, the content of flavonoids, phenolic compounds, sesquiterpenic acids and ascorbic acid in the developed collection was confirmed, their amount was determined, which directly affects the pharmacological effect of the collection.
Seasonal Changes in the Sorption Activity of Water-soluble Polysaccharides in Scotch Pine Cones (<i>Pinus sylvestris</i> L.)
Authors: Gulyaev D. K. , Belonogova V. D. 
Published: December 2022

Introduction. Currently, there is much tension around the issue of increasing the efficiency of use of forest resources. One of these resources are scotch pine cones, which remain at the felling areas. Polysaccharides of scotch pine cones have a significant sorption activity; however, it remains unclear does the month, when raw materials were collected, affect the sorption activity.Aim. The research of the content, sorption activity and molecular weight of water-soluble polysaccharides of scotch pine cones in different seasons of the year.Materials and methods. Water-soluble polysaccharide complex (WSPC) of scotch pine cones was obtained with a method based on the well-known scheme for the carbohydrates separation according to Bailey et al. WSPC was obtained from the samples of scotch pine cones collected from July till March. Determination of the content of scots pine cones WSPC was spectrophotometrically carried out, with the modified Draywood anthrone-sulfurous method. The sorption activity of polysaccharides was determined by the methylene blue. The molecular weight of polysaccharides was identified by the viscosimetric method.Results and discussion. The content of WSPC in scotch pine cones from July till March was identified. The highest yield of WSPC was registered in winter (3.24 ± 0.31 %), and the lowest in summer (0.46 ± 0.01 %). The sorption activity of scotch pine cones WSPC in terms of methylene blue from July till March was researched in vitro. It was found that WSPC has the highest sorption activity in October (230.69 ± 4.18 %) and November (243.30 ± 9.43 %). The WSPC sorption activity is above the activity of standard medications: absorbent carbon (230.9 ± 2.34 mg/g) and colloidal silicon dioxide ("Рolisorb MP") (211.5 ± 1.87 mg/g). The average molecular weight of scotch pine cones WSPC from July till March was determined. The average molecular weight of WSPC is in the range from 6 872,27 to 21 598,06. The dependence of the scotch pine cones WSPC sorption activity on the molecular weight was registered.Conclusion. The water-soluble polysaccharide complex of scotch pine cones, obtained at different seasons, has different sorption activity, which depends on a polysaccharide molecular weight. The highest content and sorption activity of scotch pine cones WSPC matches with the period of wood production, which stipulates a practical use of cones and directions for future research.