Pub Date : 2021-12-20DOI: 10.32352/0367-3057.6.21.06
О. О. Салій, О. В. Лось, О. П. Баула, В. Ю. Турчина
Diacerein is a new generation of symptomatic slow-acting agent for the treatment of osteoarthritis, when taken orally, it exhibits moderate anti-inflammatory and analgesic activity, slows down the decay of cartilage tissue and relieves pain and swelling, but its physicochemical properties it is practically insoluble in water, due to which only 35‒56% the drug reaches systemic circulation. Therefore, the search for approaches to increase the dissolution rate of a practically insoluble API using the formulation, type of excipients, degree of solubility and kinetics of the substance release from hard gelatin capsules should provide guaranteed drug efficacy. The aim of the work is to develop the composition of the drug in the form of hard gelatin capsules based on diacerein, to experimentally study the solubility of diacerein, and to evaluate the composition by studying the kinetics of dissolution of the drug. Determination of the pH-dependent solubility of diacerein was carried out in the conditions: the volume of the dissolution medium is 250 ml; dissolution temperature 37.0 ± 0.5 ºС. The highest recommended single dose of 50 mg was investigated. The development of the composition of the drug Diacerein, capsules, 50 mg was carried out with the use of various types of excipients and their modifications to achieve the proper technological properties in terms of fluidity (flowability) and a short disintegration time of the capsules for the release of the active substance. Comparative studies of the kinetics of dissolution were carried out by the in vitro method, the test «Dissolution» was studied a «Paddle apparatus» with a rotation speed of 75 rpm, a dissolution medium with a pH value of 1.2, 4.5 and 6.8, in a volume of 900 ml at a temperature of 37 ± 0.5 ºС. The reference drug was used «Artrodarin®», capsules of 50 mg, manufactured by TRB PHARMA S. A.,vArgentina. It was found that diacerein is practically insoluble in a buffer solution with a pH of 1.2, has a relatively low solubility in a buffer solution with a pH of 4.5, while the solubility of diacerein increases with an increase in the pH of the medium to 6.8. The optimal composition of capsules with diacerein using the wet granulation technology has been developed. The obtained data for bulk density and Carr's index indicate satisfactory flowability of the encapsulating mass. Comparative studies of the dissolution kinetics of the investigational medicinal product and the original drug «Artrodarin®», capsules of 50 mg were carried out. According to the calculations, all the obtained values of the similarity factor are in the range from 50 to 100 and indicate the similarity in buffer media with pH 1.2, 4.5 and 6.8. The developed composition of the preparation is equivalent in dissolution kinetics to the original medicine.
{"title":"Development of composition and evaluation of equivalence of diacerein hard gelatin capsules","authors":"О. О. Салій, О. В. Лось, О. П. Баула, В. Ю. Турчина","doi":"10.32352/0367-3057.6.21.06","DOIUrl":"https://doi.org/10.32352/0367-3057.6.21.06","url":null,"abstract":"Diacerein is a new generation of symptomatic slow-acting agent for the treatment of osteoarthritis, when taken orally, it exhibits moderate anti-inflammatory and analgesic activity, slows down the decay of cartilage tissue and relieves pain and swelling, but its physicochemical properties it is practically insoluble in water, due to which only 35‒56% the drug reaches systemic circulation. Therefore, the search for approaches to increase the dissolution rate of a practically insoluble API using the formulation, type of excipients, degree of solubility and kinetics of the substance release from hard gelatin capsules should provide guaranteed drug efficacy. \u0000The aim of the work is to develop the composition of the drug in the form of hard gelatin capsules based on diacerein, to experimentally study the solubility of diacerein, and to evaluate the composition by studying the kinetics of dissolution of the drug. \u0000Determination of the pH-dependent solubility of diacerein was carried out in the conditions: the volume of the dissolution medium is 250 ml; dissolution temperature 37.0 ± 0.5 ºС. The highest recommended single dose of 50 mg was investigated. The development of the composition of the drug Diacerein, capsules, 50 mg was carried out with the use of various types of excipients and their modifications to achieve the proper technological properties in terms of fluidity (flowability) and a short disintegration time of the capsules for the release of the active substance. Comparative studies of the kinetics of dissolution were carried out by the in vitro method, the test «Dissolution» was studied a «Paddle apparatus» with a rotation speed of 75 rpm, a dissolution medium with a pH value of 1.2, 4.5 and 6.8, in a volume of 900 ml at a temperature of 37 ± 0.5 ºС. The reference drug was used «Artrodarin®», capsules of 50 mg, manufactured by TRB PHARMA S. A.,vArgentina. \u0000It was found that diacerein is practically insoluble in a buffer solution with a pH of 1.2, has a relatively low solubility in a buffer solution with a pH of 4.5, while the solubility of diacerein increases with an increase in the pH of the medium to 6.8. The optimal composition of capsules with diacerein using the wet granulation technology has been developed. The obtained data for bulk density and Carr's index indicate satisfactory flowability of the encapsulating mass. Comparative studies of the dissolution kinetics of the investigational medicinal product and the original drug «Artrodarin®», capsules of 50 mg were carried out. According to the calculations, all the obtained values of the similarity factor are in the range from 50 to 100 and indicate the similarity in buffer media with pH 1.2, 4.5 and 6.8. The developed composition of the preparation is equivalent in dissolution kinetics to the original medicine.","PeriodicalId":32942,"journal":{"name":"Farmatsevtichnii zhurnal","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44952183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-20DOI: 10.32352/0367-3057.6.21.08
О. А. Євтіфєєва, В. А. Георгіянц
In most foreign countries, compounding medicines preparation are an important element of the pharmaceutical sector, the formulation of which is being distributed and developed taking into account the needs of today. Legal regulation of the circulation of these drugs is subject to the general requirements of the National Pharmacopoeia and the EuPh to SPhU but is carried out taking into account the characteristics of compounding medicines preparation: individual purpose, formulation, manufacture, quality control and implementation. In Ukraine, SPhU has monographs on various categories of compounding medicines preparation. But today there are some issues to ensure the quality control of compounding medicines preparation, which need to be consistent with the general requirements for medicines. The purpose of this work is to generalize the previously defined approaches and evaluate the results of their use in experimental studies on the development and validation of methods for quality control of compounding medicines preparation; substantiation and development of a fragment of the general monograph «Compounding medicines preparation» of SPhU. As a result of a critical analysis of the general requirements for validation of analysis methods and specifics of compounding medicines preparation, a standardized validation procedure was developed. When forming the tolerances of the content of individual ingredients in pharmaceutical dosage forms, the SPhU approach was chosen, that is the tolerances of the content at the level of ± 5%, ± 10%, ± 15% were chosen. Approbation of the standardized procedure for validation of methods for the quantitative determination of API in drugs manufactured in pharmacies was carried out on a significant number of names of about 50 compounding medicines preparation using spectrophotometric, photocolorimetric, refractometric and titrimetric methods of analysis. Studies have been conducted for different categories of drugs: concentrate solutions, semi-finished products, drugs made in stock, drugs made from finished drugs. The proposed standardized procedure for validation of analytical methods allows controlling of the quality of compounding medicines preparation in accordance with the requirements of the SPhU and avoids excessive costs. Based on the statistical analysis of experimental data, a draft part of the general monograph on compounding medicines preparation was formed: validation of analytical methods and tests.
{"title":"Medicines manufactured in pharmacies: features of validation of analytical methods and tests (Prior to the introduction of the monograph section of the SPU)","authors":"О. А. Євтіфєєва, В. А. Георгіянц","doi":"10.32352/0367-3057.6.21.08","DOIUrl":"https://doi.org/10.32352/0367-3057.6.21.08","url":null,"abstract":"In most foreign countries, compounding medicines preparation are an important element of the pharmaceutical sector, the formulation of which is being distributed and developed taking into account the needs of today. Legal regulation of the circulation of these drugs is subject to the general requirements of the National Pharmacopoeia and the EuPh to SPhU but is carried out taking into account the characteristics of compounding medicines preparation: individual purpose, formulation, manufacture, quality control and implementation. \u0000In Ukraine, SPhU has monographs on various categories of compounding medicines preparation. But today there are some issues to ensure the quality control of compounding medicines preparation, which need to be consistent with the general requirements for medicines. \u0000The purpose of this work is to generalize the previously defined approaches and evaluate the results of their use in experimental studies on the development and validation of methods for quality control of compounding medicines preparation; substantiation and development of a fragment of the general monograph «Compounding medicines preparation» of SPhU. \u0000As a result of a critical analysis of the general requirements for validation of analysis methods and specifics of compounding medicines preparation, a standardized validation procedure was developed. When forming the tolerances of the content of individual ingredients in pharmaceutical dosage forms, the SPhU approach was chosen, that is the tolerances of the content at the level of ± 5%, ± 10%, ± 15% were chosen. \u0000Approbation of the standardized procedure for validation of methods for the quantitative determination of API in drugs manufactured in pharmacies was carried out on a significant number of names of about 50 compounding medicines preparation using spectrophotometric, photocolorimetric, refractometric and titrimetric methods of analysis. Studies have been conducted for different categories of drugs: concentrate solutions, semi-finished products, drugs made in stock, drugs made from finished drugs. \u0000The proposed standardized procedure for validation of analytical methods allows controlling of the quality of compounding medicines preparation in accordance with the requirements of the SPhU and avoids excessive costs. \u0000Based on the statistical analysis of experimental data, a draft part of the general monograph on compounding medicines preparation was formed: validation of analytical methods and tests.","PeriodicalId":32942,"journal":{"name":"Farmatsevtichnii zhurnal","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48070798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-20DOI: 10.32352/0367-3057.6.21.03
М. В. Подгайна, Н. А. Сліпцова, В. В. Тутук
Rare (orphan) diseases (RD) are a global priority for health systems. In Europe, including Ukraine, the disease is considered rare with a prevalence of 1 patient per 2,000 population. To date, by the orphanet data, 6,172 unique rare diseases have been discovered. An important issue today is the understanding and analysis of data on the prevalence of RD in Ukraine, which will effectively plan the need for therapy and predict its cost. Aim of the investigation was to analyze the available data on the of the registered cases of orphan diseases among children and adults in all Ukraine’s regions and determining the share of each disease in the overall structure in terms of age group of patients. The object of the in vestigation are data of the Department of Statistics of the Ministry of Health on the cases of rare diseases, that were registered in Ukraine as of January 2020 and Medical Genetics Center’s data. The study was conducted using informative methods of analysis (collection and data processing), systematization and generalization, mathematical and statistical calculations. According to the Сenter’s of Medical Statistics of the Ministry of Health data the total number of registered patients was 10786 patients, of whom children accounted for 54%. Among given diseases the largest proportion of patients had been registered with a diagnosis of «juvenile rheumatoid arthritis» – 2,291 patients, most of whom, almost 80%, are children. Among 18 rare diseases, 11%, were registered only among pediatric patients: Pump's disease, Fabri's disease. It has been established that Kyiv, Poltava, Dnipro, Ivano-Frankivsk and Kharkiv regions had been characterized by the highest total number of orphan patients. Regions with the lowestregistered number of orphan patients – are Luhansk, Lviv, Kherson, Sumyand Volyn. There was no information on registered RDs in Chernivtsi, Odesa, Zakarpattia regions and Kyiv city from the Center for Medical Statistics of the Ministry of Health, but it was indicated the cases of four RDs in Odessa region and Kyiv city by newborn screening program in 2020, that has shown problems in the collection, centralization and coordination of the statistic information of RDs and needs to be resolved in the future at the state and regional levels.
{"title":"Analysis of the number of registered patients whis rare diseases in some regions of Ukraine","authors":"М. В. Подгайна, Н. А. Сліпцова, В. В. Тутук","doi":"10.32352/0367-3057.6.21.03","DOIUrl":"https://doi.org/10.32352/0367-3057.6.21.03","url":null,"abstract":"Rare (orphan) diseases (RD) are a global priority for health systems. In Europe, including Ukraine, the disease is considered rare with a prevalence of 1 patient per 2,000 population. To date, by the orphanet data, 6,172 unique rare diseases have been discovered. An important issue today is the understanding and analysis of data on the prevalence of RD in Ukraine, which will effectively plan the need for therapy and predict its cost. \u0000Aim of the investigation was to analyze the available data on the of the registered cases of orphan diseases among children and adults in all Ukraine’s regions and determining the share of each disease in the overall structure in terms of age group of patients. \u0000The object of the in vestigation are data of the Department of Statistics of the Ministry of Health on the cases of rare diseases, that were registered in Ukraine as of January 2020 and Medical Genetics Center’s data. The study was conducted using informative methods of analysis (collection and data processing), systematization and generalization, mathematical and statistical calculations. \u0000According to the Сenter’s of Medical Statistics of the Ministry of Health data the total number of registered patients was 10786 patients, of whom children accounted for 54%. Among given diseases the largest proportion of patients had been registered with a diagnosis of «juvenile rheumatoid arthritis» – 2,291 patients, most of whom, almost 80%, are children. Among 18 rare diseases, 11%, were registered only among pediatric patients: Pump's disease, Fabri's disease. It has been established that Kyiv, Poltava, Dnipro, Ivano-Frankivsk and Kharkiv regions had been characterized by the highest total number of orphan patients. Regions with the lowestregistered number of orphan patients – are Luhansk, Lviv, Kherson, Sumyand Volyn. There was no information on registered RDs in Chernivtsi, Odesa, Zakarpattia regions and Kyiv city from the Center for Medical Statistics of the Ministry of Health, but it was indicated the cases of four RDs in Odessa region and Kyiv city by newborn screening program in 2020, that has shown problems in the collection, centralization and coordination of the statistic information of RDs and needs to be resolved in the future at the state and regional levels.","PeriodicalId":32942,"journal":{"name":"Farmatsevtichnii zhurnal","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48356082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-20DOI: 10.32352/0367-3057.6.21.05
Ю. С. Маслій, К. В. Крива, І. В. Ковалевська, О. А. Рубан, О. О. Ляпунова
Despite the development of the dental industry, the prevalence of dental hypersensitivity does not decrease but increases at a progressive rate. Given the above, the subject of our research was the development of dental medicinal films with micronized calcium hydroxyapatite under the trade name «Kalident Powder 100» (Kalichem, Italy) for the treatment of dental hyperesthesia and caries prevention. To establish the optimal method of calcium hydroxyapatite introduction into the dental film, it was necessary to study the influence of different dispersion mediums on the physicochemical characteristics of the substance under study. Purified water, ethyl alcohol 96%, polysorbate 80, glycerol, polyethylene oxide-400, propylene glycol, sunflower oil, vaseline oil were used as dispersion medium in the studies. Research of physico-chemical characteristics was performed both for the substance «Kalident Powder 100» separately and for its mixtures with the studied liquids and their combinations (in a ratio of 1:1). The following physico-chemical characteristics have been determined: disperse and diffraction analysis of particle size distribution, morphological description, linear dimensions, shape factor, volume coefficient, Martin and Ferret diameters, wettability. The results of crystallographic and disperse analysis have revealed the polydispersity of the substance «Kalident Powder 100» and its high ability to agglomerate, which may adversely affect the homogeneity of its distribution in the dental medicinal product. A study of the effect of different dispersion medium on the physicochemical characteristics of calcium hydroxyapatite has shown a positive effect of hydrophilic liquids on the wettability of powder particles, changes in their shape, size, and distribution in the studied samples. It has been established that the combination of the substance «Kalident Powder 100» with combined solvent systems containing purified water, polysorbate 80, glycerol, and PEO-400, allows achieving optimal shape and particle size of calcium hydroxyapatite with their uniform distribution throughout the liquid, which is also confirmed by the results of laser diffraction. The obtained results will be used in further research on the development of dental medicinal film.
{"title":"Study of physicochemical characteristics of calcium hydroxyapatite «Kalident Powder 100» in the development of dental medicine","authors":"Ю. С. Маслій, К. В. Крива, І. В. Ковалевська, О. А. Рубан, О. О. Ляпунова","doi":"10.32352/0367-3057.6.21.05","DOIUrl":"https://doi.org/10.32352/0367-3057.6.21.05","url":null,"abstract":"Despite the development of the dental industry, the prevalence of dental hypersensitivity does not decrease but increases at a progressive rate. Given the above, the subject of our research was the development of dental medicinal films with micronized calcium hydroxyapatite under the trade name «Kalident Powder 100» (Kalichem, Italy) for the treatment of dental hyperesthesia and caries prevention. To establish the optimal method of calcium hydroxyapatite introduction into the dental film, it was necessary to study the influence of different dispersion mediums on the physicochemical characteristics of the substance under study. \u0000Purified water, ethyl alcohol 96%, polysorbate 80, glycerol, polyethylene oxide-400, propylene glycol, sunflower oil, vaseline oil were used as dispersion medium in the studies. Research of physico-chemical characteristics was performed both for the substance «Kalident Powder 100» separately and for its mixtures with the studied liquids and their combinations (in a ratio of 1:1). The following physico-chemical characteristics have been determined: disperse and diffraction analysis of particle size distribution, morphological description, linear dimensions, shape factor, volume coefficient, Martin and Ferret diameters, wettability. \u0000The results of crystallographic and disperse analysis have revealed the polydispersity of the substance «Kalident Powder 100» and its high ability to agglomerate, which may adversely affect the homogeneity of its distribution in the dental medicinal product. A study of the effect of different dispersion medium on the physicochemical characteristics of calcium hydroxyapatite has shown a positive effect of hydrophilic liquids on the wettability of powder particles, changes in their shape, size, and distribution in the studied samples. It has been established that the combination of the substance «Kalident Powder 100» with combined solvent systems containing purified water, polysorbate 80, glycerol, and PEO-400, allows achieving optimal shape and particle size of calcium hydroxyapatite with their uniform distribution throughout the liquid, which is also confirmed by the results of laser diffraction. The obtained results will be used in further research on the development of dental medicinal film.","PeriodicalId":32942,"journal":{"name":"Farmatsevtichnii zhurnal","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48847900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-20DOI: 10.32352/0367-3057.6.21.02
О. М. Заліська, Ю. В. Качерай, З. О. Заболотня, О. М. Семенов
Medicines for children are insufficiently represented in pediatric dosages and appropriate dosage forms in the pharmaceutical market of Ukraine. Pediatricians are forced to prescribe children's medicines in dosages that are not available in the State Register of Medicines of Ukraine. Extemporaneously compounded medicines (ECM) are useful when a required dose or dose form is unavailable commercially, or is needed for individualised dosing. The aim of the study was to analysis a real data of the list of medicines which are produced in hospital and public pharmacies of Lviv region during 2020–2021. Methods. Content analysis of extemporal prescriptions for children, depending on the composition of the active pharmaceutical ingredient, dose and dosage form, comparative cost analysis of ECM and industrial medicines. In the hospital doctors prescribe ECМ in liquid forms (75%) – solutions for injection and in solid forms (25%) – dosed simple powders – 19%, dosed complex powders – 6%. It was determined the structure of ECM, which are produced in 6 studied pharmacies in 2020–2021. There are soft ECM 61.6% in dosage forms: ointments, creams, paste; liquid ECM are 28.3% in mixtures, solutions, mumbles; solid ECM are 8.3% in mono, combine powders, suppositories and 1.8% – other ECM: powders and nail polishs. There were highlighted unique recipes of ECM which analogues were not present in industrial dosage forms. We conducted analysis of the cost of children’s ECM in these pharmacies. It was determined that ECM cost were 40.5–305.6 UAH depending on the dosage form. The comparative analysis showed that ECM are in 2.2–4.9 times more cheaper for children compare with similar active ingredients in industrial medicines. ECMs are much more compliant for treatment in children and babies, they provide higher effect, safety, reduce dosing errors, especially at the inpatient stage, and continuation of therapy on an outpatient basis and more cost-effective for individual needs. The use of ECMs allows parents to properly dose them for children, to avoid errors in dosing, improper administration, which is extremely important to ensure the rational use of medicines in pediatric practice.
{"title":"Analysis of extemporal production trends in pharmacies for children","authors":"О. М. Заліська, Ю. В. Качерай, З. О. Заболотня, О. М. Семенов","doi":"10.32352/0367-3057.6.21.02","DOIUrl":"https://doi.org/10.32352/0367-3057.6.21.02","url":null,"abstract":"Medicines for children are insufficiently represented in pediatric dosages and appropriate dosage forms in the pharmaceutical market of Ukraine. Pediatricians are forced to prescribe children's medicines in dosages that are not available in the State Register of Medicines of Ukraine. Extemporaneously compounded medicines (ECM) are useful when a required dose or dose form is unavailable commercially, or is needed for individualised dosing. \u0000The aim of the study was to analysis a real data of the list of medicines which are produced in hospital and public pharmacies of Lviv region during 2020–2021. \u0000Methods. Content analysis of extemporal prescriptions for children, depending on the composition of the active pharmaceutical ingredient, dose and dosage form, comparative cost analysis of ECM and industrial medicines. \u0000In the hospital doctors prescribe ECМ in liquid forms (75%) – solutions for injection and in solid forms (25%) – dosed simple powders – 19%, dosed complex powders – 6%. It was determined the structure of ECM, which are produced in 6 studied pharmacies in 2020–2021. There are soft ECM 61.6% in dosage forms: ointments, creams, paste; liquid ECM are 28.3% in mixtures, solutions, mumbles; solid ECM are 8.3% in mono, combine powders, suppositories and 1.8% – other ECM: powders and nail polishs. There were highlighted unique recipes of ECM which analogues were not present in industrial dosage forms. \u0000We conducted analysis of the cost of children’s ECM in these pharmacies. It was determined that ECM cost were 40.5–305.6 UAH depending on the dosage form. The comparative analysis showed that ECM are in 2.2–4.9 times more cheaper for children compare with similar active ingredients in industrial medicines. \u0000ECMs are much more compliant for treatment in children and babies, they provide higher effect, safety, reduce dosing errors, especially at the inpatient stage, and continuation of therapy on an outpatient basis and more cost-effective for individual needs. The use of ECMs allows parents to properly dose them for children, to avoid errors in dosing, improper administration, which is extremely important to ensure the rational use of medicines in pediatric practice.","PeriodicalId":32942,"journal":{"name":"Farmatsevtichnii zhurnal","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47506407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-20DOI: 10.32352/0367-3057.6.21.01
О. О. Комаріда, С. Г. Убогов, Н. В. Суртаєва, В. І. Тодорова, Л. О. Федорова
One of the most important issues of interest to scientists and practitioners of pharmacy is medicines quality assurance at all stages of their life cycle. From 2021 in Ukraine, the retail trade of medicines via the Internet was allowed. The system of electronic (distance) retail trade (ERT) has its obvious advantages for consumers of pharmaceutical services, but also its potential risks for the medicines quality being sold. The aim of the study is analysis of legislative innovations on ERT in medicines, determination of advantages and possible problems of ERT in medicines, identification of potential risks to the medicines quality during ERT and determination of organizational and practical measures to prevent and minimize them. The research materials were scientific publications, legislative and regulatory acts of Ukraine and the EU, public information of public authorities and pharmaceutical enterprises, data from own observations. The following methods were used in the work: system and content analysis, generalization, systematization, structural-logical, visual-graphic. The analysis of sources of scientific and professional literature showed that domestic and foreign scientists have studied the legal, socio-economic and marketing aspects of ERT in medicines. We studied this issue from the standpoint of quality assurance and risk management for the medicines quality. The paper provides a system and content analysis of legislative innovations on ERT in medicines, summarizes and systematizes the general and special requirements for the procedure for ERT in medicines, identifies the advantages and possible problems of ERT in medicines. The structural and logical scheme of the ERT in medicines process is developed. It is proposed to use this scheme as a basis for the regulation and documentation of the ERT in medicines process by developing appropriate regulatory and instructional documents (regulations or techniques for performing the process, standard operating procedures, work instructions, etc.). According to the research results, the potential risks for the medicines quality in the conditions of ERT are identified and the complex of organizational and practical measures for their prevention and minimization is determined. It is proposed to implement this complex in the overall risk management process for the medicines quality and pharmaceutical services, which should be an integral part of the quality management system of the pharmaceutical enterprise that performs ERT in medicines. These measures should be taken into account when developing standard operating procedures for different stages of ERT in medicines and documentation on risk management for the medicines quality (passports of risk profiles, risk register, risk management plan, etc.).
{"title":"Study of the advantages and risks of electronic retail trade in medicines","authors":"О. О. Комаріда, С. Г. Убогов, Н. В. Суртаєва, В. І. Тодорова, Л. О. Федорова","doi":"10.32352/0367-3057.6.21.01","DOIUrl":"https://doi.org/10.32352/0367-3057.6.21.01","url":null,"abstract":"One of the most important issues of interest to scientists and practitioners of pharmacy is medicines quality assurance at all stages of their life cycle. From 2021 in Ukraine, the retail trade of medicines via the Internet was allowed. The system of electronic (distance) retail trade (ERT) has its obvious advantages for consumers of pharmaceutical services, but also its potential risks for the medicines quality being sold. \u0000The aim of the study is analysis of legislative innovations on ERT in medicines, determination of advantages and possible problems of ERT in medicines, identification of potential risks to the medicines quality during ERT and determination of organizational and practical measures to prevent and minimize them. \u0000The research materials were scientific publications, legislative and regulatory acts of Ukraine and the EU, public information of public authorities and pharmaceutical enterprises, data from own observations. The following methods were used in the work: system and content analysis, generalization, systematization, structural-logical, visual-graphic. \u0000The analysis of sources of scientific and professional literature showed that domestic and foreign scientists have studied the legal, socio-economic and marketing aspects of ERT in medicines. We studied this issue from the standpoint of quality assurance and risk management for the medicines quality. \u0000The paper provides a system and content analysis of legislative innovations on ERT in medicines, summarizes and systematizes the general and special requirements for the procedure for ERT in medicines, identifies the advantages and possible problems of ERT in medicines. The structural and logical scheme of the ERT in medicines process is developed. It is proposed to use this scheme as a basis for the regulation and documentation of the ERT in medicines process by developing appropriate regulatory and instructional documents (regulations or techniques for performing the process, standard operating procedures, work instructions, etc.). \u0000According to the research results, the potential risks for the medicines quality in the conditions of ERT are identified and the complex of organizational and practical measures for their prevention and minimization is determined. It is proposed to implement this complex in the overall risk management process for the medicines quality and pharmaceutical services, which should be an integral part of the quality management system of the pharmaceutical enterprise that performs ERT in medicines. These measures should be taken into account when developing standard operating procedures for different stages of ERT in medicines and documentation on risk management for the medicines quality (passports of risk profiles, risk register, risk management plan, etc.).","PeriodicalId":32942,"journal":{"name":"Farmatsevtichnii zhurnal","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45957428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-20DOI: 10.32352/0367-3057.6.21.04
С. О. Соловйов, О. В. Назар, М. В. Лелека
Cerebral palsy (CP) represents a group of disorders of the mechanisms of movement and body position, causing limitations of activity, which are caused by non-progressive damage to the developing brain, fetus or child. About 80% of cases are spastic forms of cerebral palsy. Along with motor rehabilitation, the use of botulinum toxin type A (BoNT-A) is considered one of the main methods of treatment of choice for focal spastic and dystonic syndromes, regardless of their etiology. At present, there are no studies in Ukraine on the analysis of the costs of using drugs based on BoNT-A, taking into account the recommended dose and frequency of administration. The aim of the work. Carrying out an analysis of minimizing the cost of botulinum therapy for spastic forms of cerebral palsy in patients aged two years and older. The annual dosage and frequency of administration of abobotulotoxin and onabotolutoxin for the treatment of dynamic equinus deformity of the foot caused by focal spasticity due to cerebral palsy in children over two years of age were obtained from the instructions for use. The cost of abobotulotoxin and onabotolutoxin was obtained from the Register of Wholesale Prices of the Ministry of Health of Ukraine. Cost analysis for a model cohort of children in different weight categories showed that abobotulotoxin 500 U will be the least expensive treatment technology in the weight category of 21–33 kg at a dosage of 15 U/kg in the treatment of diplegia. Abobotulotoxin 300 U is most rationally used in weight categories 10–20 kg and 34–40 kg with a dosage of 15 U/kg in the treatment of hemiplegia and in the weight category 17–20 kg with a dosage of 30 U/kg in the treatment of diplegia. Weight categories were identified in which the costs of using abobotulotoxin 300 U and abobotulotoxin 500 U were equal to and less than the costs of onabotolutoxin treatment. The study was the first to analyze the cost of botulinum therapy, which identified the benefits of abobotulotoxin in the symptomatic treatment of hemiplegia and diplegia in cerebral palsy in the focus of different weight groups of children. Possible variability in the dosage and frequency of administration of onabotolutoxin per year indicates the relevance of collecting additional information on the application in real clinical practice and further pharmacoeconomic studies.
{"title":"Cost analysis of botulinum therapy of spastic forms of cerebral palsy in Ukraine","authors":"С. О. Соловйов, О. В. Назар, М. В. Лелека","doi":"10.32352/0367-3057.6.21.04","DOIUrl":"https://doi.org/10.32352/0367-3057.6.21.04","url":null,"abstract":"Cerebral palsy (CP) represents a group of disorders of the mechanisms of movement and body position, causing limitations of activity, which are caused by non-progressive damage to the developing brain, fetus or child. About 80% of cases are spastic forms of cerebral palsy. Along with motor rehabilitation, the use of botulinum toxin type A (BoNT-A) is considered one of the main methods of treatment of choice for focal spastic and dystonic syndromes, regardless of their etiology. At present, there are no studies in Ukraine on the analysis of the costs of using drugs based on BoNT-A, taking into account the recommended dose and frequency of administration. \u0000The aim of the work. Carrying out an analysis of minimizing the cost of botulinum therapy for spastic forms of cerebral palsy in patients aged two years and older. \u0000The annual dosage and frequency of administration of abobotulotoxin and onabotolutoxin for the treatment of dynamic equinus deformity of the foot caused by focal spasticity due to cerebral palsy in children over two years of age were obtained from the instructions for use. The cost of abobotulotoxin and onabotolutoxin was obtained from the Register of Wholesale Prices of the Ministry of Health of Ukraine. \u0000Cost analysis for a model cohort of children in different weight categories showed that abobotulotoxin 500 U will be the least expensive treatment technology in the weight category of 21–33 kg at a dosage of 15 U/kg in the treatment of diplegia. Abobotulotoxin 300 U is most rationally used in weight categories 10–20 kg and 34–40 kg with a dosage of 15 U/kg in the treatment of hemiplegia and in the weight category 17–20 kg with a dosage of 30 U/kg in the treatment of diplegia. Weight categories were identified in which the costs of using abobotulotoxin 300 U and abobotulotoxin 500 U were equal to and less than the costs of onabotolutoxin treatment. \u0000The study was the first to analyze the cost of botulinum therapy, which identified the benefits of abobotulotoxin in the symptomatic treatment of hemiplegia and diplegia in cerebral palsy in the focus of different weight groups of children. Possible variability in the dosage and frequency of administration of onabotolutoxin per year indicates the relevance of collecting additional information on the application in real clinical practice and further pharmacoeconomic studies.","PeriodicalId":32942,"journal":{"name":"Farmatsevtichnii zhurnal","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49215411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-20DOI: 10.32352/0367-3057.6.21.07
О. А. Колпакова, Н. В. Кучеренко
One of the important aspects in the development of new drugs is their standardization and comprehensive assessment of quality indicators, which guarantees safety and stability throughout the life cycle of the drug. Soft drugs for external use with components of natural origin usually require the introduction of preservatives to ensure microbiological stability. Therefore, research on the selection of preservative is a necessary phase in pharmaceutical composition preparation. Purpose – foundation of the type choice and concentration of an effective preservative (or their combination) for the introduction into the composition of the ointment of anti-scarring activity with a water-soluble protein-polysaccharide complex of the fungus Pleurotus ostreatus. The object of the study was an original ointment composition based on an emulsion, the active component of which is a water-soluble protein-polysaccharide complex of the fungus Pleurotus ostreatus. To increase microbiological stability, preservatives were added to the samples, which are most common in soft dosage forms (nipagin:nipazol, triclosan, bronopol and benzoic acid). Determination of the sensitivity of ointment samples to microorganisms was performed by the method of diffusion into agar («well method»), as a microbiological model used a common set of test strains of reference cultures of gram-positive and gram-negative bacteria and fungi. The study found that sample 7 had demonstrated high antimicrobial properties, where the diameters of the growth retardation zones were 34–35 mm to Staphylococcus aureus ATCC 25923, Basillus subtilis ATCC 6633, 29–31 mm for Escherichia coli ATCC 25922, Proteus vulgaris ATCC 4636 and Pseudomonas aeruginosa ATCC 27853. Growth retardation zones were 27–28 mm to fungi Candida albicans ATCC 653/885. Bronopol was introduced into the sample, this preservative should provide the necessary microbiological purity and stability of the prepared ointment. Studies show that soft dosage forms with substances of natural origin require the administration of antimicrobial agents. It has been experimentally proven that 0.2% bronopol provides effective microbiological stability of the soft dosage form with anti-scarring activity of water-soluble protein-polysaccharide complex of the fungus Pleurotus ostreatus.
{"title":"Research on the selection of a preservative for a soft dosage form with a water-soluble protein-polysaccharide complex of the fungus pleurotus ostreatus","authors":"О. А. Колпакова, Н. В. Кучеренко","doi":"10.32352/0367-3057.6.21.07","DOIUrl":"https://doi.org/10.32352/0367-3057.6.21.07","url":null,"abstract":"One of the important aspects in the development of new drugs is their standardization and comprehensive assessment of quality indicators, which guarantees safety and stability throughout the life cycle of the drug. \u0000Soft drugs for external use with components of natural origin usually require the introduction of preservatives to ensure microbiological stability. Therefore, research on the selection of preservative is a necessary phase in pharmaceutical composition preparation. \u0000Purpose – foundation of the type choice and concentration of an effective preservative (or their combination) for the introduction into the composition of the ointment of anti-scarring activity with a water-soluble protein-polysaccharide complex of the fungus Pleurotus ostreatus. \u0000The object of the study was an original ointment composition based on an emulsion, the active component of which is a water-soluble protein-polysaccharide complex of the fungus Pleurotus ostreatus. To increase microbiological stability, preservatives were added to the samples, which are most common in soft dosage forms (nipagin:nipazol, triclosan, bronopol and benzoic acid). Determination of the sensitivity of ointment samples to microorganisms was performed by the method of diffusion into agar («well method»), as a microbiological model used a common set of test strains of reference cultures of gram-positive and gram-negative bacteria and fungi. \u0000The study found that sample 7 had demonstrated high antimicrobial properties, where the diameters of the growth retardation zones were 34–35 mm to Staphylococcus aureus ATCC 25923, Basillus subtilis ATCC 6633, 29–31 mm for Escherichia coli ATCC 25922, Proteus vulgaris ATCC 4636 and Pseudomonas aeruginosa ATCC 27853. Growth retardation zones were 27–28 mm to fungi Candida albicans ATCC 653/885. Bronopol was introduced into the sample, this preservative should provide the necessary microbiological purity and stability of the prepared ointment. \u0000Studies show that soft dosage forms with substances of natural origin require the administration of antimicrobial agents. It has been experimentally proven that 0.2% bronopol provides effective microbiological stability of the soft dosage form with anti-scarring activity of water-soluble protein-polysaccharide complex of the fungus Pleurotus ostreatus.","PeriodicalId":32942,"journal":{"name":"Farmatsevtichnii zhurnal","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48502853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-20DOI: 10.32352/0367-3057.6.21.10
В. Ю. Анісімов, І. Ю. Борисюк, В. О. Гельмбольдт
At present, ammonium hexafluorosilicate and hexafluorosilicates of organic amonium cations are actively studied as potential anticaries agents, which demonstrate certain advantages over traditional compounds of fluorine. Previously, it was shown that hexafluorosilicates with bactericidal cations of chlorhexidine, polyhexamethyleneguanidine and cetylpyridinium effectively reduce the number and depth of carious lesions of teeth in rats and at the same time significantly improve the biochemical parameters of the pulp of the teeth. The aim of the work – to study the effect of different doses of octenidine hexafluorosilicate (OHFS) on the incidence of dental caries in rats fed a cariogenic diet (CD). OHFC preparations were applied to the teeth and gums of rats in the composition of phytogels based on Na-salt of carboxymethylcellulose. In the incisor pulp, the activity of alkaline (ALP) and acidic (ACP) phosphatases, elastase, lysozyme was determined, and the mineralizing index (MI) was calculated. The number and depth of dental caries lesions were calculated and caries prophylactic efficacy (CPE) was calculated. The activity of elastase, catalase, lysozyme and urease was determined in the gums, and the degree of atrophy of the alveolar process was determined. Determination of dental caries lesions shows that CD does not increase the number of carious lesions, and after the application of gels with OHFS, their number significantly decreases. The most effective was the concentration of the OHFS gel, equal to 2 mg/ml, although the concentration of the OHFS gel 1 mg/ml showed a decrease by 33.3%. The calculated CPE is 33.3% for a gel with 1 mg/ml OHFS, 36.4% for a gel with 2 mg/ml and 24.2% for a gel with 4 mg/ml. It has been shown that in rats receiving CD, the ALP activity significantly decreases and the ACP activity significantly increases, which gives a significant decrease in MI from 43.9 to 28.9. Application of gels with OHFS returns the activity of both phosphatases to the control level and almost completely normalizes MI, and the concentration of OHFS gel of 2 mg/ml turned out to be the most effective. Application of gels with 1 mg/ml and 2 mg/ml OHFS reduced elastase activity by 6% and 12%, respectively, whereas application of a gel with 4 mg/ml OHFS did not result in a decrease in elastase activity. From the results of determining the degree of dysbiosis in the blood serum of rats, it can be seen that CD causes the development of generalized dysbiosis. Application of gels with OHFS significantly reduce the degree of dysbiosis, especially gels with OHFS concentrations of 1 and 2 mg/ml. Oral application of gels containing OHFS reduces the incidence of caries on the teeth, increases the mineralizing activity of the pulp and reduces the degree of generalized dysbiosis. The most effective concentration of the OHFS gel is 2 mg/ml, which corresponds to a dose of 2.2 mg/kg.
{"title":"The effect of different doses of octenidine hexafluorosilicate on the development of dental caries in rats","authors":"В. Ю. Анісімов, І. Ю. Борисюк, В. О. Гельмбольдт","doi":"10.32352/0367-3057.6.21.10","DOIUrl":"https://doi.org/10.32352/0367-3057.6.21.10","url":null,"abstract":"At present, ammonium hexafluorosilicate and hexafluorosilicates of organic amonium cations are actively studied as potential anticaries agents, which demonstrate certain advantages over traditional compounds of fluorine. Previously, it was shown that hexafluorosilicates with bactericidal cations of chlorhexidine, polyhexamethyleneguanidine and cetylpyridinium effectively reduce the number and depth of carious lesions of teeth in rats and at the same time significantly improve the biochemical parameters of the pulp of the teeth. \u0000The aim of the work – to study the effect of different doses of octenidine hexafluorosilicate (OHFS) on the incidence of dental caries in rats fed a cariogenic diet (CD). \u0000OHFC preparations were applied to the teeth and gums of rats in the composition of phytogels based on Na-salt of carboxymethylcellulose. In the incisor pulp, the activity of alkaline (ALP) and acidic (ACP) phosphatases, elastase, lysozyme was determined, and the mineralizing index (MI) was calculated. The number and depth of dental caries lesions were calculated and caries prophylactic efficacy (CPE) was calculated. The activity of elastase, catalase, lysozyme and urease was determined in the gums, and the degree of atrophy of the alveolar process was determined. \u0000Determination of dental caries lesions shows that CD does not increase the number of carious lesions, and after the application of gels with OHFS, their number significantly decreases. The most effective was the concentration of the OHFS gel, equal to 2 mg/ml, although the concentration of the OHFS gel 1 mg/ml showed a decrease by 33.3%. The calculated CPE is 33.3% for a gel with 1 mg/ml OHFS, 36.4% for a gel with 2 mg/ml and 24.2% for a gel with 4 mg/ml. It has been shown that in rats receiving CD, the ALP activity significantly decreases and the ACP activity significantly increases, which gives a significant decrease in MI from 43.9 to 28.9. Application of gels with OHFS returns the activity of both phosphatases to the control level and almost completely normalizes MI, and the concentration of OHFS gel of 2 mg/ml turned out to be the most effective. Application of gels with 1 mg/ml and 2 mg/ml OHFS reduced elastase activity by 6% and 12%, respectively, whereas application of a gel with 4 mg/ml OHFS did not result in a decrease in elastase activity. From the results of determining the degree of dysbiosis in the blood serum of rats, it can be seen that CD causes the development of generalized dysbiosis. Application of gels with OHFS significantly reduce the degree of dysbiosis, especially gels with OHFS concentrations of 1 and 2 mg/ml. \u0000Oral application of gels containing OHFS reduces the incidence of caries on the teeth, increases the mineralizing activity of the pulp and reduces the degree of generalized dysbiosis. The most effective concentration of the OHFS gel is 2 mg/ml, which corresponds to a dose of 2.2 mg/kg.","PeriodicalId":32942,"journal":{"name":"Farmatsevtichnii zhurnal","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47965455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-20DOI: 10.32352/0367-3057.6.21.09
Т. М. Гонтова, В. П. Руденко, В. П. Гапоненко, С. А. Козира, С. В. Романова
The monograph «Goldenrod» SPhU 2.0 describes the general morphological and anatomical features of two species – Solidago gigantea Ait and Solidago canadensis L., which are similar. Not all diagnostic signs can be identified in powdered raw materials. It was important to investigate domestic series of сanadian goldenrod and to identify additional diagnostic signs. The aim of the work was to study the series of domestic raw materials of сanadian goldenrod by anatomical features and to determine the totality of individual features of the species to establish the identity of raw materials. The object of the study were samples of сanadian goldenrod grass, which were harvested in August 2020 in the regions of Ukraine. We used an iPhone XR camera, Item PB-2610 V microscope. Important features of the anatomical structure of the raw material of сanadian goldenrod include: the cells of the stem epidermis are parenchymal, ortho-walled, porous, the leaves – sinuous- and ortho-walled. The presence in the pubescence of stems and leaves 3 types of hairs: simple long, 5–8-celled (up to 20), with thickened walls and pointed cell; short, 2–3-celled, with a dormant apical cell; short and headed with a 2–3-celled stalk and a rounded unicellular head; on the surface and edge of the leaves of the involucre – simple short and 3–4-cell hairs, corollas of flowers – multicellular double-row hairs; stem vessels are spiral, ladder, porous and reticulate; schizogenous structures in the stems, leaves and leaves of the involucre; sphenocrystals of inulin in the parenchyma and vessels of the stem, the cells of the corollas of flowers. A series of domestic raw materials of сanadian goldenrod has been studied according to anatomical features, a set of individual features of the species has been determined. The obtained results can be used in plant taxonomy for comparative analysis of morphologically similar species of the genus Zolotushnik, as well as to supplement the section «Identification B» of the monograph SPhU 2.0 «Zolotushnik».
{"title":"Investigation of anatomical signs of canadian goldenrod herbs, introduced in Ukraine","authors":"Т. М. Гонтова, В. П. Руденко, В. П. Гапоненко, С. А. Козира, С. В. Романова","doi":"10.32352/0367-3057.6.21.09","DOIUrl":"https://doi.org/10.32352/0367-3057.6.21.09","url":null,"abstract":"The monograph «Goldenrod» SPhU 2.0 describes the general morphological and anatomical features of two species – Solidago gigantea Ait and Solidago canadensis L., which are similar. Not all diagnostic signs can be identified in powdered raw materials. It was important to investigate domestic series of сanadian goldenrod and to identify additional diagnostic signs. \u0000The aim of the work was to study the series of domestic raw materials of сanadian goldenrod by anatomical features and to determine the totality of individual features of the species to establish the identity of raw materials. \u0000The object of the study were samples of сanadian goldenrod grass, which were harvested in August 2020 in the regions of Ukraine. We used an iPhone XR camera, Item PB-2610 V microscope. \u0000Important features of the anatomical structure of the raw material of сanadian goldenrod include: the cells of the stem epidermis are parenchymal, ortho-walled, porous, the leaves – sinuous- and ortho-walled. The presence in the pubescence of stems and leaves 3 types of hairs: simple long, 5–8-celled (up to 20), with thickened walls and pointed cell; short, 2–3-celled, with a dormant apical cell; short and headed with a 2–3-celled stalk and a rounded unicellular head; on the surface and edge of the leaves of the involucre – simple short and 3–4-cell hairs, corollas of flowers – multicellular double-row hairs; stem vessels are spiral, ladder, porous and reticulate; schizogenous structures in the stems, leaves and leaves of the involucre; sphenocrystals of inulin in the parenchyma and vessels of the stem, the cells of the corollas of flowers. \u0000A series of domestic raw materials of сanadian goldenrod has been studied according to anatomical features, a set of individual features of the species has been determined. The obtained results can be used in plant taxonomy for comparative analysis of morphologically similar species of the genus Zolotushnik, as well as to supplement the section «Identification B» of the monograph SPhU 2.0 «Zolotushnik».","PeriodicalId":32942,"journal":{"name":"Farmatsevtichnii zhurnal","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48181642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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