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Study of dynamics of accumulation of tanning substances in raw materials of plants of the genus Geum L. flora of Ukraine 乌克兰金属植物原料鞣制物质积累动态研究
Pub Date : 2022-04-25 DOI: 10.32352/0367-3057.2.22.08
С. А. Козира, О. В. Радько, О. С. Мала, С. І. Степанова, Л. П. Міронець, О. М. Бабенко
Recently, in the pharmaceutical market, much attention is paid to medicinal products obtained from medicinal plant raw materials. Of great current interest is a search for new plants with sufficient domestic raw material base in order to introduce them into medical practice as well as to develop herbal preparations. Promising sources of medicinal plant raw materials for the development of herbal preparations with antimicrobial, astringent, anti-inflammatory and hemostatic properties are species of Gravilate genus (Geum L.), which accumulate a wide range of biologically active substances, including polyphenols. Plants of Geum L. genus (Gravilate) belong to Rosoideae (Rosaceae family). Two species, Geum urbanum L. (Wood Avens) and G. montanum L. (Mountain Gravilate), grow in Ukraine, and are used in folk medicine as anti-inflammatory, astringent, hemostatic and wound healing agents. A significant amount of research articles devoted to the chemical composition and use of Geum L. species indicate the prospects for the study of domestic raw materials of Ukrainian flora. An aimof the present study was to quantify tannins and oxidizable phenolic compounds in the vegetative organs of G. urbanum L. and G. montanum L. The objects of the study were herb and rhizomes with roots of G. urbanum L. and G. montanum L. harvested in Sumskaya and Ivano-Frankivsk regions in April–September 2020–2021. The content of oxidizable phenolic compounds and tannins was determined by permanganometric titration and complexometric titration. The results obtained were in the range from 8.30% to 28.10%, and 2.66% to 14.35%, respectively. As a result, in herb and rhizomes with roots of G. urbanum L. and G. montanum L., oxidizable phenolic compounds and tannins were quantified using permanganometric titration and complexometric titration. Taking into account the high content of tannins in vegetative organs of the studied Geum species, these species can be classified as tannin-bearing plant materials. In G. urbanum L. herb, the maximum content of tannins was determined at flowering stage, while in rhizomes with roots – at the end of the vegetative stage (in autumn). Given the data obtained, the abovementioned vegetative stages are set as optimal for the procurement of G. urbanum L. plant materials.
近年来,在医药市场上,以药用植物为原料制成的医药产品备受关注。目前最大的兴趣是寻找具有足够国内原料基础的新植物,以便将其引入医疗实践并开发草药制剂。具有抗菌、收敛、抗炎和止血作用的草药制剂的有希望的药用植物原料是Gravilate属(Geum L.)的物种,它们积累了广泛的生物活性物质,包括多酚。蔷薇科蔷薇总科蔷薇属植物。有两种植物,Geum urbanum L. (Wood Avens)和G. montanum L. (Mountain Gravilate),生长在乌克兰,在民间医学中用作消炎、收敛、止血和伤口愈合剂。大量关于金属植物的化学成分和利用的研究文章显示了乌克兰植物国产原料研究的前景。本研究的目的是定量测定城市羊草和山羊草营养器官中的单宁和可氧化酚类化合物。研究对象是2020-2021年4 - 9月在苏姆斯卡亚和伊万诺-弗兰克夫斯克地区收获的城市羊草和山羊草的草本植物和根茎。采用高锰钾滴定法和络合滴定法测定了氧化性酚类化合物和单宁的含量。所得结果分别为8.30% ~ 28.10%和2.66% ~ 14.35%。采用高锰钾滴定法和络合滴定法,测定了枸杞和枸杞中草药和根茎中可氧化酚类化合物和单宁的含量。考虑到所研究的金属植物营养器官中单宁含量较高,这些物种可归类为含单宁的植物材料。在城市草中,单宁含量在开花阶段最高,而在有根的根状茎中,单宁含量在营养末期(秋季)最高。根据所获得的数据,上述营养阶段被设定为城市羊草植物材料采购的最佳阶段。
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引用次数: 0
Comparative analysis of the range list of medicines for the treatment of arterial hypertension in accordance with domestic and international clinical guidelines 根据国内外临床指南对治疗动脉性高血压的药物范围清单进行比较分析
Pub Date : 2022-02-23 DOI: 10.32352/0367-3057.1.22.03
Н. В. Шолойко, А. О. Гончар
Cardiovascular disease is the most common cause of death and disability worldwide. There are more than 12 million patients with hypertension in Ukraine. Timely prescription of medicines patients with AH in accordance with current clinical guidelines significantly improves the quality of life and survival of patients. The purpose of the study was to conduct a comparative analysis of the international and domestic range of modern medicines for the treatment of hypertension according to INN and ATC-classification and to investigate the status of their registration and inclusion in the reimbursement lists in Ukraine in order to determine the potential physical availability of drugs for the treatment of hypertension. An analysis of the domestic regulatory framework showed that international CG for the treatment of hypertension and national CPs can be used in Ukraine. The content analysis of the CG showed that international CG include classes of medicines for initial and maintenance therapy of hypertension: ACE inhibitors, ARBs, diuretics (thiazide and thiazide-like), calcium antagonists and beta-blockers, while preference is given to combinations of these drugs due to better adherence patients for treatment. It was found that according to the ATC classification, 41 ACE inhibitors and their combinations are represented on the international pharmaceutical market for the treatment of hypertension; of which 16 are single-component drugs, 25 are combined; ARB II and their combinations ‒ 32, single-component 10, combinations ‒ 22; calcium channel blockers and their combinations ‒ 21, single-component ‒ 18, combinations ‒ 2, thiazide diuretics ‒ 10, thiazide-like diuretics ‒ 11. An analysis of the status of registration in Ukraine according to certain INN and ATC classification showed that 56 drugs were registered, which is 48.69% of the possible 115 (drugs and ACE inhibitors and their combinations 22 (53.65%), ARBs II and their combinations 21 (65.63%); CCBs and their combinations ‒ 8 (38.10%); thiazide diuretics ‒ 1 (10%), thiazide-like diuretics ‒ 3 (27.27%)).
心血管疾病是全世界最常见的死亡和残疾原因。乌克兰有1200多万高血压患者。根据现行临床指南及时给AH患者开药,可显著提高患者的生活质量和生存率。本研究的目的是根据INN和ATC分类,对国际和国内治疗高血压的现代药物范围进行比较分析,并调查其在乌克兰注册和列入报销名单的情况,以确定治疗高血压的药物的潜在实物供应情况高血压对国内监管框架的分析表明,用于治疗高血压的国际CG和国家CP可以在乌克兰使用。CG的含量分析表明,国际CG包括用于高血压初始和维持治疗的药物类别:ACE抑制剂、ARBs、利尿剂(噻嗪类和噻嗪类)、钙拮抗剂和β受体阻滞剂,而由于患者对治疗的依从性更好,因此优先选择这些药物的组合。研究发现,根据ATC分类,国际药物市场上有41种ACE抑制剂及其组合用于治疗高血压;其中16种为单组分药物,25种为联合用药;ARB II及其组合-32,单组分10,组合-22;钙通道阻滞剂及其组合-21,单组分-18,组合-2,噻嗪类利尿剂-10,噻嗪样利尿剂-11。根据某些INN和ATC分类对乌克兰注册情况进行的分析显示,有56种药物注册,占可能的115种药物的48.69%(药物和ACE抑制剂及其组合22(53.65%),ARBs II及其组合21(65.63%);CCBs及其组合-8个(38.10%);噻嗪类利尿剂-1(10%)、噻嗪样利尿剂-3(27.27%))。
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引用次数: 4
Study of the content of carbonic acids in the herbs of Сapsella bursa-pastoris (L.) Medik Сapsella法氏囊-pastoris (L.)药材中碳酸含量的研究Medik
Pub Date : 2022-02-23 DOI: 10.32352/0367-3057.1.22.08
Г. П. Смойловська, О. О. Малюгіна, О. К. Єренко, Т. В. Хортецька
Carboxylic acids are key compounds that play an important role in metabolism. They activate the endocrine glands, affect human immune status, have antioxidant, antimicrobial and anti-inflammatory effects. Plants rich in carboxylic acids are recommended for the prevention of various diseases. A promising source of biologically active substances are Capsella bursa-pastoris, which has a significant content of vitamins, flavonoids, organic, hydroxycinnamic, fatty acids, macro-and micronutrients, tannins. Capsella bursa-pastoris is known for such healing properties as wound healing, antimicrobial, antibacterial, antitumor, anti-inflammatory, antioxidant, antihypertensive, hepatoprotective. The plant material of Capsella bursa-pastoris has a hemostatic effect and stimulates the contractile activity of the uterus. The aim of the study was to study the qualitative composition and quantitative content of carboxylic acids in the herb of Capsella bursa-pastoris (L.) Medik. by chromato-mass spectrometry. For the study, we used the herb of Capsella bursa-pastoris (L.) Medik., which was collected during flowering period. Qualitative analysis of the content of organic acids was carried out by thin layer chromatography. Identification and quantitative content of carboxylic acids were performed by chromato-mass spectrometry on an Agilent Technology 6890N chromatograph with a mass spectrometric detector 5973N. 33 carboxylic acids were identified in the herb of Capsella bursa-pastoris – 14 organic and 19 fatty acids. The total content of organic acids is 8 041.60 ± 84.00 mg/kg with a predominance of aliphatic acids (citric, malic, fumaric and succinic). The fatty acid complex of the Capsella bursa-pastoris herb is represented by 11 saturated and 9 unsaturated fatty acids. The content of total fatty acids was 21 161.90 ± 256.45 mg/kg, of which the proportion of unsaturated acids is significantly higher than saturated. Linolenic, linoleic, palmitic acidsare dominant. The obtained resultsmake it possible to predict the antioxidant and anti-inflammatory activity of herbal medicines based on the raw materials of Capsella bursa-pastoris.
羧酸是在人体代谢中起重要作用的关键化合物。它们激活内分泌腺体,影响人体免疫状态,具有抗氧化、抗菌和抗炎作用。富含羧酸的植物被推荐用于预防各种疾病。荠菜具有丰富的维生素、类黄酮、有机、羟基肉桂酸、脂肪酸、宏微量营养素、单宁等多种营养成分,是一种很有前景的生物活性物质来源。巴斯德荠菜具有伤口愈合、抗菌、抑菌、抗肿瘤、抗炎、抗氧化、抗高血压、保肝等愈合特性。荠菜的植物成分有止血作用,能刺激子宫的收缩活动。本研究的目的是研究荠菜中羧酸的定性组成和定量含量。Medik。用色谱质谱法。本研究以荠菜(Capsella bursa-pastoris, L.)为原料。Medik。,采于花期。采用薄层色谱法对有机酸含量进行定性分析。采用Agilent Technology 6890N质谱联用仪和5973N质谱联用仪对羧酸进行鉴定和定量。从荠菜中鉴定出33种羧酸、14种有机酸和19种脂肪酸。有机酸总含量为8 041.60±84.00 mg/kg,以脂肪酸(柠檬酸、苹果酸、富马酸和琥珀酸)为主。荠菜的脂肪酸复合物由11种饱和脂肪酸和9种不饱和脂肪酸组成。总脂肪酸含量为21 161.90±256.45 mg/kg,其中不饱和脂肪酸所占比例显著高于饱和脂肪酸。亚麻酸、亚油酸、棕榈酸占主导地位。所得结果为预测以荠菜为原料的中草药的抗氧化和抗炎活性提供了可能。
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引用次数: 0
Decision-making regulatory framework of the introduction of health technologies at the hospitals in Ukraine 在乌克兰医院引进保健技术的决策管理框架
Pub Date : 2022-02-23 DOI: 10.32352/0367-3057.1.22.01
О. М. Філінюк, Д. В. Алешко, М. М. Бабенко, К. Л. Косяченко, Р. Кахвечі
The limited resources of the health care system and the COVID-19 pandemic encourage more rational and cost-effective administrative and clinical decisions. To achieve the best health care within available resources, the introduction of the most efficient technologies should be supported, considering organizational, social and ethical issues. Assessment of health technologies at different levels, namely national/regional and hospital, is becoming increasingly important. Adherence to cost-effective approaches to administrative and clinical decision-making will ensure the rational use of the state budget and improve clinical outcomes, improve the quality and life expectancy of patients. The purpose of the study was to analyze the current regulatory framework for the introduction of health technologies (medicines and medical devices) at the hospital level. During the research the methods of content analysis, historical, system-analytical, generalization was used. According to the analysis of the decision-making regulatory framework for the health technology’s introduction, it was drawn the next conclusions. The active HTA development in Ukraine is noted. In a short time, a legal framework for state HTA for medicines was created and approved, amendments were made to the Law of Ukraine ‘On Public Procurement’ and other Ukraine’s laws on medicine procurement under managed entry agreements, the further steps for development of the HTA ecosystem in Ukraine were identified. The legal framework for the circulation of medical devices needs to be updated in Ukraine, starting with technical regulations in accordance with EU regulations №745 and №746 and further approval of the Law on Medical Devices. Procedures for evaluation and selection of medicines and medical devices at the level of medical institutions are absent in Ukraine and require separate elaboration. The introduction of HB-HTA will help hospital managers to make independent, transparent, reasonable, and impartial management decisions on the selection of drugs and medical devices. The obtained results prove the need for further research of everyday decision-making practices on the introduction of health technologies at the hospitals, development of methodology for hospital-based HTA and update regulation of HB-HTA in the current legal framework of Ukraine.
医疗保健系统的有限资源和新冠肺炎大流行鼓励做出更合理、更具成本效益的行政和临床决策。为了在现有资源范围内实现最佳医疗保健,应考虑到组织、社会和道德问题,支持采用最有效的技术。在国家/区域和医院等不同层面对卫生技术进行评估正变得越来越重要。坚持成本效益高的行政和临床决策方法将确保合理使用国家预算,改善临床结果,提高患者的质量和预期寿命。该研究的目的是分析目前在医院层面引入卫生技术(药品和医疗器械)的监管框架。研究采用内容分析法、历史分析法、系统分析法、归纳法。通过对健康技术引进决策监管框架的分析,得出了下一步的结论。注意到乌克兰正在积极发展HTA。在很短的时间内,建立并批准了国家药品HTA的法律框架,对《乌克兰公共采购法》和乌克兰其他关于管理进入协议下药品采购的法律进行了修订,确定了乌克兰发展HTA生态系统的进一步步骤。乌克兰需要更新医疗器械流通的法律框架,从符合欧盟法规的技术法规开始№745和№746和进一步批准《医疗器械法》。乌克兰没有医疗机构一级的药品和医疗器械评估和选择程序,需要单独制定。HB-HTA的引入将有助于医院管理人员在药物和医疗器械的选择上做出独立、透明、合理和公正的管理决策。所获得的结果证明,有必要进一步研究在医院引入卫生技术的日常决策实践,开发基于医院的HTA方法,并在乌克兰现行法律框架中更新HB-HTA的监管。
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引用次数: 1
Analysis of the assortment of antibiotics in the State Medicines Formulary according to the WHO AWaRe classification with the purpose of their rational use and reducing the risk of antimicrobial resistance 为合理使用和降低抗菌素耐药风险,根据世卫组织知情意识分类对《国家药品处方集》中的抗生素进行分类分析
Pub Date : 2022-02-23 DOI: 10.32352/0367-3057.1.22.02
Л. В. Яковлєва, І. М. Романенко
Rational use of antimicrobials have been recognized as one of the strategies to fight AMR. In 2017 WHO proposed the classification of antibioticsAWaRe, dividing them into groups Access, Watch, Reserve, which takes into account the potential of AMR and emphasizes the importance of rational antibiotic therapy. In Ukraine, the State Formulary of Medicines (State Formulary of Ukraine) is the manual on the rational use of medicines. The aim of the work was to analyse the assortment of systemic antibiotics (J01) of the State Formulary of Ukraine, their compliance with the classification of antibiotics AWaRe according to the WHO database, which will contribute to rational antibiotic therapy. The objects of the study were antibiotics (J01), of the 13th version of the State Formulary of Ukraine, data on the belonging of antibiotics to the group Access, Observations, Reserve on WHO AWaRe antibiotic classification database.The following research methods were used in the work: system-review, analytical, method of comparison and generalization. According to the analysis, the group Access includes 23 INN antibiotics (J01) of the State Formulary of Ukraine. For 16 INNs of these antibioticsWHO provides recommendations for rational antibiotic therapy as the first choice for 31 infectious diseases and the second choice for 13 infectious diseases. The Observations group includes 31 INN antibiotics (J01) of the State Formulary of Ukraine. For 18 INNs of these antibiotics WHO provides recommendations for rational antibiotic therapy as the first choice for 21 infectious diseases and the second choice for 17 infectious diseases. The Reserve group includes 3 INN antibiotics (J01) of the State Formulary of Ukraine. The State Formulary of Ukraine includes 64 INN antibiotics of systemic action (J01), 23 INNs according to the WHO AWaRe antibiotic classification are assigned to the group Access, 31 ‒ Observations and 3 ‒ Reserve group. The analysis provides WHO recommendations for rational antibiotic therapy for the treatment of common infectious diseases, taking into account the degree of counteraction to the development of AMR. The results of the work can be used in the development of guidelines for the rational choice of antibiotics for the treatment of infectious diseases.
合理使用抗微生物药物已被公认为对抗抗生素耐药性的战略之一。2017年,世卫组织提出了抗生素aware分类,将其分为可及、观察和储备组,考虑到抗生素耐药性的可能性,并强调合理抗生素治疗的重要性。在乌克兰,国家药物处方集(乌克兰国家处方集)是关于合理使用药物的手册。这项工作的目的是分析乌克兰国家处方集系统抗生素(J01)的分类,以及它们是否符合世卫组织数据库中抗生素AWaRe分类,这将有助于合理的抗生素治疗。研究对象为乌克兰国家处方集第13版抗生素(J01),抗生素属于世卫组织AWaRe抗生素分类数据库获取、观察和储备组的数据。本文采用了系统综述法、分析法、比较法和泛化法等研究方法。根据分析,Access组包括乌克兰国家处方集的23种INN抗生素(J01)。对于这些抗生素中的16种,世卫组织建议将合理抗生素治疗作为31种传染病的第一选择和13种传染病的第二选择。观察组包括乌克兰国家处方集的31种非处方药抗生素(J01)。对于这些抗生素中的18种,世卫组织建议将合理抗生素治疗作为21种传染病的第一选择和17种传染病的第二选择。储备组包括乌克兰国家处方集的3种非处方药抗生素(J01)。乌克兰国家处方集包括64种全体性国际禁用抗生素(J01),根据世卫组织AWaRe抗生素分类,23种国际禁用抗生素分配给获取组,31种为观察组,3种为储备组。该分析为世卫组织提供了治疗常见传染病的合理抗生素治疗建议,同时考虑到对耐药性发展的反作用程度。这项工作的结果可用于制定合理选择抗生素治疗传染病的指导方针。
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引用次数: 1
Training of specialists of Health Technology Assessment: experience of foreign countries 卫生技术评估专家培训:国外经验
Pub Date : 2022-02-23 DOI: 10.32352/0367-3057.1.22.06
Н. А. Білоусова, О. В. Гетало, О. С. Яковлева
According to the main values of international HTA organizations regarding the development of scientific potential and training of specialists in this field and taking into account the conditions of implementation of medical technology assessment in Ukraine, the scientific interest includes the professional training of HTA users and developers. In this regard, the need of studying the foreign experience and best practices in the use of various curricula, the introduction of forms, methods and technologies is actualized. The author pays special attention to the issue of training these specialists in the system of postgraduate education. The aim of the article was to analyze the use of modern forms, methods and technologies in vocational education and training of specialists in the assessment of medical technologies. Materials and methods of the research were strategic programs of EU and Ukraine development, normative and legal documents regulating the implementation of HTA, legislative acts on education development in Ukraine, publications in scientometric databases of Scopus, Web of Science and others. Research methods used: systematic search of information using search engines, databases and websites by keywords; content analysis of documents; situational and comparative analysis; generalization; prognostication. According to the results of the analysis of scientific works, the study of international experience revealed that in foreign countries all types of education are used to train specialists in HTA: formal, non-formal, informal. It was found out that the most common forms of obtaining this specialty in the system of formal education are bachelor’s degree, master’s degree, training of doctors of philosophy. At the same time, for the training of such specialists in the middle-income countries, the programs of various duration in the system of non-formal education are used the most often. Among them: courses, trainings, seminars, internships, apprenticeships, mentoring, etc. Certification upon completion of the training is required. Based on the foreign experience and the analysis of scientific literature, the feasibility of creating and implementing various programs (long-term and short-term, in-service and non-in-service, distance, extramural, full-time, etc.) of the HTA specialists’ training in non-formal education completion of training was proved.
根据国际HTA组织在开发科学潜力和培训该领域专家方面的主要价值观,并考虑到乌克兰实施医疗技术评估的条件,科学利益包括对HTA用户和开发人员的专业培训。在这方面,需要学习外国在使用各种课程、采用形式、方法和技术方面的经验和最佳做法。作者特别关注在研究生教育体系中培养这些专家的问题。本文的目的是分析现代形式、方法和技术在职业教育和医学技术评估专家培训中的应用。研究材料和方法包括欧盟和乌克兰发展的战略计划、规范HTA实施的规范性和法律文件、乌克兰教育发展的立法法案、Scopus科学计量数据库、Web of Science等的出版物。使用的研究方法:利用搜索引擎、数据库和网站按关键词系统地搜索信息;文件内容分析;情景分析和比较分析;一般化预测。根据对科学著作的分析结果,对国际经验的研究表明,在外国,所有类型的教育都被用来培训HTA专家:正式的、非正式的、非正式的。研究发现,在正规教育体系中,获得该专业最常见的形式是学士学位、硕士学位和哲学博士培训。与此同时,为了在中等收入国家培训这类专家,最经常使用的是非正规教育系统中不同时期的方案。其中包括:课程、培训、研讨会、实习、学徒制、辅导等。完成培训后需要获得证书。根据国外经验和科学文献分析,证明了创建和实施HTA专家非正规教育培训完成培训的各种方案(长期和短期、在职和非在职、远程、校外、全日制等)的可行性。
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引用次数: 0
Development and optimization of quantitative composition of rectal suppositories with diosmin and hesperidin by the method of mathematical planning of the experiment 采用实验数学规划的方法,研制并优化薯蓣皂苷、橙皮苷直肠栓剂的定量组成
Pub Date : 2022-02-23 DOI: 10.32352/0367-3057.1.22.07
Є. А. Борко, І. В. Ковалевська, О. А. Рубан, О. В. Кутова
In the development of suppositories biphasic media are rarely used. It is due to the occurrence of possible instabilities within the system «dispersed phase and a dispersing medium». To solve such problems, it is rational to use the methods of mathematical planning of the experiment. The method of mathematical planning of the experiment feature is the diversity of approaches to model construction. This means that these methods are theoretically predict the results of a future experiment, analyze the data obtained, prevent the repetition of experiments and optimize the technology of medicine. The aim of the present research was to develop and optimize of quantitative composition of rectal suppositories with diosmin and hesperidin by the method of mathematical planning of experiment. Objects of the study were samples of suppositories of the biphasic type with diosmin and hesperidin. The dispersing medium of these samples consisted of hydrophobic (Witepsol W35 and emulsifiers) and hydrophilic parts (sodium alginate gel with the addition of Ca2+ as a complexing cation). Preliminary results of determining the percentage limits of the hydrophobic part of the dispersed medium were carried out by studying the indicators of the release of active substances from the dosage form and the laser diffraction method. As responses of experiments was used such indicator as: disintegration time, hardness and mucoadhesion. As a result of the studies, the functional dependence of the indicators on the amount of components of the suppository dispersed medium was established. It was found that acceptable values of the responses should conform to the following conditions: hardness and mucoadhesion should be close to the maximum, and the disintegration time – to the minimum. According to the results of the study it was found that the optimal content of the mixture of emulsifiers – 6.29%, solid fat – 39.51%, the hydrophilic part of the biphasic medium – 29.58%. Responses that will provide the system with the necessary structural-mechanical and pharmaco-technological properties are within: y1 (2.713); y2 (22.639); y3 (439.283). The obtained data will be used in further studies to optimize the composition and technology of rectal suppositories with diosmin and hesperidin.
在栓剂的研制中,双相介质很少使用。这是由于系统“分散相和分散介质”中可能出现的不稳定性。为了解决这类问题,采用实验的数学规划方法是合理的。实验特征的数学规划方法是模型构建方法的多样性。这意味着这些方法从理论上预测未来实验的结果,分析获得的数据,防止重复实验和优化医学技术。本研究的目的是通过实验的数学规划方法来开发和优化薯蓣皂苷和橙皮苷直肠栓剂的定量组成。以薯蓣皂苷和橙皮苷双相型栓剂为研究对象。这些样品的分散介质由疏水部分(Witepsol W35和乳化剂)和亲水部分(添加Ca2+作为络合阳离子的海藻酸钠凝胶)组成。通过对剂型中活性物质释放指标和激光衍射法的研究,初步确定了分散介质中疏水部分的百分限值。采用崩解时间、硬度、黏附力等指标作为实验反应。通过研究,建立了各指标对栓剂分散介质组分含量的功能依赖关系。研究发现,可接受的响应值应符合以下条件:硬度和粘着力应接近最大值,崩解时间-应接近最小值。根据研究结果发现,乳化剂混合物的最佳含量为6.29%,固体脂肪为39.51%,两相介质中亲水部分为29.58%。将为系统提供必要的结构力学和药物技术特性的反应在:y1 (2.713);日元(22.639);日元(439.283)。所得数据将用于进一步优化薯蓣皂苷和橙皮苷直肠栓剂的组成和工艺。
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引用次数: 1
Phytochemical characteristics and the study of acute toxicity of extracts from fruit Рrunus domestica 仙人掌果实提取物的植物化学特性及急性毒性研究
Pub Date : 2022-02-23 DOI: 10.32352/0367-3057.1.22.09
І. В. Сенюк, В. М. Кравченко, Бенарафа Ібрахім Амін
The increased demand for modern phytopreparations is dictated by their wide application in the complex treatment of various diseases, the presence of low toxicity and the pharmacoeconomic component. Phytochemical analysis of medicinal plants reveals not only potential therapeutic effects, but also assumes their toxicological properties. In this context, the Prunus domestica, widely spread on the territory of our country and well known for its medicinal properties and applications in folk medicine, has attracted our attention. The aim of the work was to investigate the phytochemical composition of extracts obtained from fruit Prunus domestica and to study their toxic properties. Phytochemical analysis of the extracts obtained from fruits Prunus domestica was carried out according to the original method of extracting biologically active compounds, using instrumental research methods using modern laboratory analytical equipment. Studies of the safety of four extracts from Prunus domestica (liquid EC-1, EC-2 and dry CEPC, CEV) with the calculation of median lethal doses were carried out on mice and rats with the single intragastric and intraperitoneal routes of administration according to the method of T. V. Pastushenko. The degree of toxicity was determined according to the classification of K. K. Sidorov. Phytochemical study of extracts from fruit Prunus domestica provided information on the presence in their chemical composition of flavonoids, the sum of phenolic compounds, anthocyanins, neutral sugars, amino acids, organic and hydroxycinnamic acids. A higher content of the sum of phenolic compounds in the aqueous (ЕС-1) and alcoholic extracts (ЕС-2) as well as the presence of neutral sugars as products of hydrolysis of homopolysaccharides (СEV extract) and heteropolysaccharides (CEPC extract). Experimental studies proved that EC-1, EC-2, CEPC and SEV extracts had low toxicity beyond 15 000 mg/kg when administered orally and 3 000 mg/kg when administered intraperitoneally. The LD50 of the studied extracts of mice and rats after intraperitoneal injection was determined, which was more than 3 000 mg/kg. The chemical composition of biologically active compounds of extracts from the fruit Prunus domestica, which provides promising directions for further study of their pharmacological properties, has been investigated. Analysis of experimental data on acute toxicity of the studied extracts showed that they belong to the IV class of toxicity “relatively harmless substances", according to K. K. Sidorov classification. The LD50 of extracts from the fruit Prunus domestica for oral administration could not be determined, and the LD50 of the studied extracts for mice and rats after intraperitoneal administration was more than 3 000 mg/kg.
对现代植物制剂的需求增加是由于它们在各种疾病的复杂治疗中的广泛应用、低毒性和药物经济成分的存在。药用植物的植物化学分析不仅揭示了其潜在的治疗作用,而且具有其毒理学特性。在这种背景下,在我国境内广泛分布、以其药用特性和在民间医学中的应用而闻名的家李引起了我们的注意。本工作的目的是研究家李提取物的植物化学成分,并研究其毒性特性。利用现代实验室分析设备,采用仪器研究方法,按照提取生物活性化合物的原始方法,对家李提取物进行了植物化学分析。根据T.V.Pastushenko的方法,对家李四种提取物(液体EC-1、EC-2和干CEPC、CEV)的安全性进行了研究,并计算了中位致死剂量。毒性程度根据K.K.Sidorov的分类确定。对家李提取物的植物化学研究提供了有关其化学成分中存在黄酮类化合物、酚类化合物、花青素、中性糖、氨基酸、有机酸和羟基肉桂酸的信息。水性提取物(СС-1)和醇性提取物(АС-2)中酚类化合物的总和含量较高,以及作为多糖(СEV提取物)和杂多糖(CEPC提取物)水解产物的中性糖的存在。实验研究证明,EC-1、EC-2、CEPC和SEV提取物在口服给药时具有超过15000 mg/kg和腹膜内给药时超过3000 mg/kg的低毒性。所研究的小鼠和大鼠腹腔注射后的提取物的LD50超过3000 mg/kg。对家李提取物中生物活性化合物的化学组成进行了研究,为进一步研究其药理性质提供了很好的方向。K.K.认为,对所研究提取物急性毒性的实验数据分析表明,它们属于IV类毒性“相对无害的物质”。Sidorov分类。家李果实提取物口服给药后的LD50无法测定,所研究的提取物腹腔给药后对小鼠和大鼠的LD50超过3000 mg/kg。
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引用次数: 0
Biosimilar insulins in international and domestic practice of pharmacist 生物仿胰岛素在国际和国内药剂师实践中的应用
Pub Date : 2022-02-23 DOI: 10.32352/0367-3057.1.22.05
І. О. Власенко, І. В. Ніженковська
In Ukraine, people with diabetes receive insulin, including insulin biosimilars in pharmacies, so pharmacists should increase their knowledge about biosimilar because they become more available in the coming years. The aim of the work was to summarize current information on insulin biosimilars. Research materials ‒ regulatory database information and scientific publications on biosimilars. Content analysis, bibliosemantic, analytical, generalizing analyzes were used. The terminology related to reproducible biological drugs (biosimilars) is difference and it depend on the regulatory agency or the country that controls the approve of drugs. Insulin was the first biopharmaceutical drug which was developed. For approving biosimilars, it is necessary to establish similarity with the reference drug in terms of safety, purity and efficacy. Regulatory of biosimilars and requirements for demonstration the biosimilarity are specified in regulatory of the EMA and WHO. The regulatory of the approving of biosimilar  in Ukraine is harmonized with European regulatory. The rules on interchangeability are not determined by all regulatory agency. The International Diabetes Federation emphasizes the role of the pharmacist, stating that they should be well informed about the forms of insulin, includes biosimilars. In Ukraine, pharmacists must dispense insulin, including biosimilars, exactly in accordance to the prescription in which the trade name of insulin (or biosimilars) is indicated. Insulin biosimilars can be an alternative to original insulins that have lost patent protection by increasing the availability of drugs, which can lead to increased market competition and access insulin for patients. Based on the analysis of current information on biosimilars, generalizations about their terminology, aspects of manufecture, regulatory, interchangeability, prospects in the treatment of diabetes and their replacement of referens insulins are presented. The potential impact of biosimilar insulins to patients and the health care system was determinated. The importance of awareness of these drugs by pharmacists as part of the diabetic team are highlighted.
在乌克兰,糖尿病患者可以在药店获得胰岛素,包括胰岛素生物仿制药,因此药剂师应该增加他们对生物仿制药的了解,因为在未来几年里,生物仿制药会越来越多。这项工作的目的是总结胰岛素生物仿制药的最新信息。研究材料——生物仿制药的监管数据库信息和科学出版物。采用内容分析法、文献语义分析法、分析法、概括分析法。与可再生生物药物(生物仿制药)相关的术语是不同的,它取决于监管机构或控制药物批准的国家。胰岛素是第一种被开发出来的生物药物。为了批准生物仿制药,有必要在安全性、纯度和疗效方面与参考药物建立相似性。EMA和世界卫生组织的监管规定了生物类似物的监管和生物类似性证明要求。乌克兰批准生物仿制药的监管与欧洲监管一致。互换性规则并非由所有监管机构决定。国际糖尿病联合会强调药剂师的作用,指出他们应该充分了解胰岛素的形式,包括生物仿制药。在乌克兰,药剂师必须严格按照标明胰岛素(或生物仿制药)商品名的处方配制胰岛素,包括生物仿制药。胰岛素生物仿制药可以替代因增加药物供应而失去专利保护的原始胰岛素,这可能导致市场竞争加剧,并为患者提供胰岛素。在分析当前生物仿制药信息的基础上,对其术语、制造、监管、互换性、糖尿病治疗前景及其替代参考胰岛素等方面进行了综述。确定了生物仿胰岛素对患者和医疗保健系统的潜在影响。作为糖尿病团队的一部分,药剂师对这些药物的认识非常重要。
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引用次数: 0
Analysis of the epidemiological state of mental disorders and pharmaceutical provision of patients with medicines by the government of Ukraine. 乌克兰政府对精神障碍的流行病学状况和向患者提供药物的分析。
Pub Date : 2022-02-23 DOI: 10.32352/0367-3057.1.22.04
А. С. Немченко, А. В. Ляденко
The number of patients with mental disorders is growing every year, which has a significant impact on the increase in cases of disability and loss of one of the five years of healthy life. In Ukraine, the incidence of depressive disorders and disorders caused by alcohol consumption exceeds that of Eastern Europe. The COVID-2019 global pandemic has affected the rapid spread of new cases of depressive disorders (53.2 million or 27.6%) and anxiety disorders (76.2 million or 25.6%) in 2020. These trends in Ukraine and the world have led to changes in the formation and implementation of the National Mental Health Policy, as most disorders are successfully treated with access to medicine and availability of medicines for patients. The aim of the work was to assess the current state of morbidity and prevalence of mental disorders in Ukraine and the world, as well as to analyse the access of medicines for patients according to current government programs. The objectі of the study were the data of the Center for Mental Health and Monitoring of Drugs and Alcohol of the Ministry of Health of Ukraine, regulations documents, analytical reports, international websites. The study used methods of analysis, systematization, generalization, analytical and graphical. The study found an annual increase in outpatient mental health care and a sharp decline in inpatient and day care. Depressive disorders show a growth trend of 6.25% in Ukraine for the period 2018–2020, for comparison – only in 2020 in the world such growth was 27.6%. Analysis of medical practice shows that most mental disorders are not diagnosed as special cases, and are treated as concomitant diseases, which significantly affects the incidence and prevalence and as a consequence of the formation of government programs to provide patients with vital medicines in outpatient treatment. The provision of drugs to patients on an outpatient basis today occurs according to the list of diseases defined by the Resolution of the Cabinet of Ministers of Ukraine No. 1303. Since October 1, the program of reimbursement of medicine for 9 INN has been expanded, which allowed patients with mental disorders to receive medicines free of charge or with a surcharge, without reference to their location. The study revealed negative trends in the incidence and prevalence of mental disorders in Ukraine as a whole and in regions compared to similar indicators in the world, as well as identify key issues affecting the formation of government programs to provide patients with basic medicines.
精神障碍患者的数量每年都在增长,这对残疾病例的增加和失去五年健康生活中的一年产生了重大影响。在乌克兰,抑郁障碍和饮酒引起的障碍的发病率超过了东欧。2019冠状病毒病全球大流行影响了2020年新发抑郁症(5320万,占27.6%)和焦虑症(7620万,约占25.6%)病例的快速传播。乌克兰和世界的这些趋势导致了国家精神卫生政策的制定和实施发生了变化,因为大多数疾病都能通过获得药物和患者获得药物而得到成功治疗。这项工作的目的是评估乌克兰和世界各地精神障碍的发病率和流行率,并根据目前的政府计划分析患者获得药物的情况。该研究的对象是乌克兰卫生部精神健康和药物酒精监测中心的数据、法规文件、分析报告、国际网站。研究采用了分析法、系统法、归纳法、分析法和图解法。研究发现,门诊精神卫生服务每年都在增加,住院和日托服务则急剧下降。2018年至2020年期间,乌克兰的抑郁症呈6.25%的增长趋势,相比之下,世界上只有2020年的增长率为27.6%。对医疗实践的分析表明,大多数精神障碍并没有被诊断为特殊病例,而是被视为伴发疾病,这对发病率和流行率产生了重大影响,也是政府在门诊治疗中为患者提供重要药物的计划形成的结果。今天,根据乌克兰内阁第1303号决议确定的疾病清单,在门诊基础上向患者提供药物。自10月1日以来,9家INN的药品报销计划已经扩大,允许精神障碍患者免费或附加费用获得药品,而无需考虑其所在地。该研究揭示了与世界上类似指标相比,乌克兰整体和各地区精神障碍的发病率和流行率呈负面趋势,并确定了影响政府为患者提供基本药物项目形成的关键问题。
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