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The assessment of economic affordability of antiviral herbal medicines presented at the domestic pharmaceutical market 国内医药市场上抗病毒草药的经济负担能力评估
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.64
V. Khodakivska, N. Senkiv
One of the most urgent problems of our time is the high morbidity and mortality of people from viral infections, which can affect almost all organs and systems of the host body. Significant damage to the health of the population and the economy of countries is caused by the incidence of viral diseases. An important issue in the process of pharmacotherapy of patients with viral infections is to provide them with a sufficient number of effective, safe and affordable drugs, especially during the coronavirus pandemic, which humanity actively fought during 2019-2020 and is still fighting today.Aim. To conduct the marketing analysis of the range of antiviral herbal medicines presented at the pharmaceutical market of Ukraine during 2019-2020 and their marketing characteristics.Materials and methods. The study used a list of antiviral herbal medicines according to the State Register of Medicines of Ukraine, the Compendium, and scientific articles of professional publications. The main research methods were systematic, comparative, marketing analysis of the drug market structure, monitoring and graphical method.Results and discussion. According to the PBX international classification system, antiviral medicines based on the plant raw material belong to the group of drugs applied as antimicrobial agents for systemic use. According to the PBX classification, medicines that mainly belong to the J05AX ** group – “Antiviral drugs for systemic use. Antiviral drugs.Others.” were of interest. It was found that as of 01.01.2019, the Ukrainian market of the group studied was formed by domestic manufacturers, there were 4 names of medicines and 4 manufacturing companies. Drugs were presented at the pharmaceutical market in the form of drops, syrups, suppositories and tablets. It was determined that the most available drugs within 2019-2020 were Altabor, Erebra and Flavovir although during the study period there was a steady increase in prices for drugs of this group at the pharmaceutical market. Therefore, it should be noted that from year to year their affordability for consumers decreases.Conclusions. The marketing research has been performed, and the assortment structure of antiviral herbal medicines presented at the pharmaceutical market of Ukraine has been analyzed. The indicators characterizing the market situation, such as offers, product range, price dynamics and the coefficients of availability, adequacy of solvency, etc., have been studied.
我们这个时代最紧迫的问题之一是病毒感染的高发病率和死亡率,病毒感染可以影响宿主身体的几乎所有器官和系统。病毒性疾病的发生对各国人民的健康和经济造成了重大损害。在病毒感染患者的药物治疗过程中,一个重要的问题是为他们提供足够数量的有效、安全、负担得起的药物,特别是在2019-2020年和今天人类仍在积极抗击的冠状病毒大流行期间。对2019-2020年乌克兰医药市场上出现的抗病毒草药的范围及其营销特征进行营销分析。材料和方法。该研究使用了乌克兰国家药品登记册、药典和专业出版物的科学文章列出的抗病毒草药清单。主要研究方法有系统分析、比较法、市场营销分析、监测法和图解法。结果和讨论。根据PBX国际分类系统,以植物原料为基础的抗病毒药物属于作为全身使用的抗菌药物的一类。按照PBX分类,药品主要属于J05AX **类——“全身使用的抗病毒药物”。抗病毒drugs.Others。我很感兴趣。调查发现,截至2019年1月1日,所研究集团的乌克兰市场由国内生产商组成,共有4个药品名称和4家生产企业。药品以滴剂、糖浆、栓剂和片剂的形式出现在医药市场上。确定2019-2020年期间最可获得的药物是Altabor, Erebra和Flavovir,尽管在研究期间,制药市场上该类药物的价格稳步上涨。因此,应该注意的是,消费者的负担能力逐年下降。进行了市场研究,并分析了乌克兰制药市场上抗病毒草药的分类结构。研究了表征市场情况的指标,如报价、产品范围、价格动态和可得性系数、偿付能力是否充足等。
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引用次数: 0
The theoretical substantiation of the composition of a wound-healing ointment with active components of plant origin 含有植物活性成分的伤口愈合药膏的理论证实
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.81
O. I. Trembach, N. Khokhlenkova
Aim. To theoretically substantiate the composition of a wound healing ointment with active substances of plant origin for the therapy in the second and third phases of the wound process.Materials and methods. The study object was the generalization and analysis of scientific literature data on the use of medicinal plants in the treatment of the wound process.Results and discussion. Based on the analysis of scientific literature data on the chemical composition and pharmacological properties of medicinal plants used in the treatment of the wound process, the expediency of using the lipophilic extract of marigold flowers, amaranth oil, fennel essential oil as active ingredients in the wound healing ointment has been substantiated. Marigold flowers due to the presence of a large number of carotenoids and flavonoidswill provide a high level of the antimicrobial, reparative action of the ointment. Due to the content of complex biologically active compounds, such as tocopherols, polyunsaturated fatty acids, vitamins, phytosterols and squalene, the amaranth oil has a pronounced antioxidant activity. The components that are part of the essential oil of fennel contributeto the connective tissue growth and the skin restoration, as well as provide a high level of the antifungal action.Conclusions. The analysis of scientific literature data has shown the possibility of using herbal medicines in the treatment of the wound process. The greatest advantage of herbal medicines is the high degree of assimilation of molecules of biologically active substances, which are part of natural compounds as the most physiological form, by skin cells. The expediency of using the lipophilic extract of marigold, amaranth oil and fennel essential oil when developing a wound-healing ointment has been proven. The composition selected will provide the predicted antibacterial, antifungal, antioxidant and reparative effect of the ointment, reduce the likelihood of resistance in pathogenic microorganisms, and accelerate granulation and epithelialization of tissues.
的目标。从理论上证实含有植物活性物质的伤口愈合药膏的组成,用于伤口过程的第二和第三阶段的治疗。材料和方法。研究对象是对药用植物在伤口治疗过程中应用的科学文献资料进行归纳和分析。结果和讨论。通过对治疗创面过程中常用药用植物的化学成分和药理特性的科学文献资料分析,证实了万金菊亲脂提取物、苋菜油、茴香精油作为创面愈合软膏的有效成分是适宜的。万寿菊花由于存在大量的类胡萝卜素和类黄酮,会提供高水平的抗菌、修复作用的软膏。由于含有复杂的生物活性化合物,如生育酚、多不饱和脂肪酸、维生素、植物甾醇和角鲨烯,苋菜油具有明显的抗氧化活性。茴香精油的部分成分有助于结缔组织的生长和皮肤修复,并提供高水平的抗真菌作用。对科学文献数据的分析表明,在伤口治疗过程中使用草药是可能的。草药的最大优点是生物活性物质的分子被皮肤细胞高度同化,这些物质是天然化合物的一部分,是最生理的形式。在开发伤口愈合软膏时,使用万金菊、苋菜油和茴香精油的亲脂提取物的便利性已被证明。所选择的组合物将提供所述软膏的预期抗菌、抗真菌、抗氧化和修复作用,降低病原微生物耐药的可能性,并加速组织的肉芽化和上皮化。
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引用次数: 0
The study of the effectiveness of the antibacterial action of the combination of a bacteriophage with a probiotic 研究噬菌体与益生菌联合使用的抑菌效果
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.83
M. Rybalkin, N. Khokhlenkova, К. Y. Nikiforova
Intestinal infections occupy one of the leading places in diseases of the gastrointestinal tract in humans and animals. Strains of Staphylococcus spp are one of the causative agents of an intestinal infection. When treating an intestinal infection caused by staphylococcus, antibiotics are most often used, but in recent years there has been the formation of resistance in staphylococcus strains to antibiotics that have been used for many years. One of the promising ways to solve the problem of antimicrobial resistance is the use of drugs based on bacteriophages, which have a specific effect on the disease pathogens, however, they are free of toxic and allergenic side effects on the human body and do not cause resistance.Aim. To study the antibacterial effect of the combination of a staphylococcal bacteriophage and a probiotic based on L. acidophilus lactobacilli to different staphylococcal strains.Materials and methods. The following bacterial strains were used in the study: St. aureus ATCC 25923 and St. epidermidis ATCC 12228. The “Polyphag Staf” staphylococcal bacteriophage (manufactured by NVK MVK, Ukraine) and the “Lactofor” probiotic (manufactured by Ananta Medicare Limited, India) based on L. acidophilus lactobacilli were selected as objects. In the study, the antibiotic “Erythromycin” in tablets of 100 mg (the manufacturer – Borschagovsky HFZ, Ukraine) was used as a reference drug. To detect the antibacterial activity to the experimental strains of St. aureus and St. epidermidis, the methods of Appelman and agar diffusion were used.Results and discussion. It was found that when using the combination of a staphylococcal bacteriophage and a probiotic with L. acidophilus lactobacilli the level of the antibacterial activity to the experimental strains of St. aureus and St. epidermidis was higher than when using only the bacteriophage. This is probably due to the synergism of the interaction of the components of the combination of active substances proposed. It was also found that the antibacterial activity of the combination of drugs and the antibiotic erythromycin proposed was at the same level. Thus, the combination of a bacteriophage that destroys staphylococcal bacteria, has no side effects, and does not cause resistance and a probiotics that improves the microflora of the gastrointestinal tract has a number of advantages over antibioticsin the treatment of intestinal infections caused by staphylococcal strains.Conclusions. The studies conducted indicate the prospects of using the combination of a staphylococcal bacteriophage and a probiotic based on L. acidophilus lactobacilli for the treatment of intestinal infections caused by different staphylococcal strains.
肠道感染在人类和动物的胃肠道疾病中占主要地位之一。葡萄球菌是引起肠道感染的病原体之一。在治疗葡萄球菌引起的肠道感染时,抗生素是最常用的,但近年来,葡萄球菌菌株对使用多年的抗生素形成了耐药性。解决抗菌素耐药性问题的一个很有希望的方法是使用基于噬菌体的药物,这些药物对疾病病原体有特定的作用,但它们对人体没有毒性和过敏性副作用,不会引起耐药性。研究葡萄球菌噬菌体与以嗜酸乳杆菌为基础的益生菌联合使用对不同葡萄球菌菌株的抑菌效果。材料和方法。本研究使用的菌株为金黄色葡萄球菌ATCC 25923和表皮葡萄球菌ATCC 12228。选取以嗜酸乳杆菌L. acidophilus乳酸菌为基础的“Polyphag”staphylococcus噬菌体(乌克兰NVK MVK公司生产)和“Lactofor”益生菌(印度Ananta Medicare Limited公司生产)作为研究对象。在这项研究中,抗生素“红霉素”片剂为100毫克(制造商- Borschagovsky HFZ,乌克兰)作为参比药物。采用Appelman法和琼脂扩散法检测其对金黄色葡萄球菌和表皮葡萄球菌的抑菌活性。结果和讨论。结果表明,葡萄球菌噬菌体和益生菌与嗜酸乳杆菌联合使用时,对金黄色葡萄球菌和表皮葡萄球菌的抑菌活性高于单独使用噬菌体。这可能是由于所提出的活性物质组合的成分相互作用的协同作用。同时发现,联合用药与提出的抗生素红霉素的抑菌活性处于同一水平。因此,在治疗葡萄球菌菌株引起的肠道感染方面,无副作用、不产生耐药性的噬菌体和改善胃肠道微生物群的益生菌相结合具有许多优于抗生素的优势。这些研究表明,葡萄球菌噬菌体与基于嗜酸乳杆菌的益生菌联合治疗不同葡萄球菌菌株引起的肠道感染具有广阔的前景。
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引用次数: 0
The analysis of the legislative framework regarding pharmaceutical provision of orphan patients in Ukraine 乌克兰关于孤儿患者药品供应的立法框架分析
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.75
M. Podgaina, N. Sliptsova
A rare (orphan) disease is a disease that threatens a person’s life or chronically progresses; it leads to a reduction in life expectancy or disability, which prevalence among the population is not more than 1 : 2000 in Ukraine and not more than 1 : 5000-8000 in other countries.Aim. To analyze the current legal framework on pharmaceutical provision of orphan patients in Ukraine.Materials and methods. The current regulatory framework on pharmaceutical provision of orphan patients in Ukraine was analyzed by constructing and studying the hierarchy of legislative acts regulating the issues of management of orphan (rare) diseases in the world and in Ukraine.Results and discussion. The article describes the main stages of the legislation formation, starting from the USA in 1983 to the EU and Ukraine in 2021. The practical value of the article consists in the current list of normative acts regulating the provision of patients with orphan diseases. The scientific significance is in the use of the results of previous studies of others domestic researchers (2016). The analysis of the legislation and the main issues of providing orphan patients allowed us to formulate the basic problems of the national healthcare system listed in the article.Conclusions. The current state of the legal regulation of orphan patients in Ukraine has been studied. It has been found that the legislative regulation of the issue under study has been actively carried out over the past 7 years by implementing the adopted Law of Ukraine, resolutions of the Cabinet of Ministers and orders of the Ministry ofHealth. The results of the study of international experience in introducing the basic concepts of orphan diseases and orphan patients into the healthcare system in the United States (since 1983), EU countries (since 1999), Japan (since 1993), etc., have been summarized. It has been found that 275 nosologies of orphan diseases have been approved in Ukraine; they are grouped by 11 nosological categories, there are 104 nosologies (+40 %) more than in 2016. A positive trend towards intensification of the process of improving the provision of orphan patients in Ukraine has been revealed.
罕见病(孤儿病)是一种威胁到人的生命或慢性进展的疾病;它导致预期寿命缩短或残疾,在乌克兰人口中的患病率不超过1:20 00,在其他国家不超过1:5 000-8000。分析乌克兰目前为孤儿患者提供药品的法律框架。材料和方法。通过构建和研究规范世界和乌克兰孤儿(罕见)病管理问题的立法行为层级,分析了乌克兰目前孤儿患者药物供应的监管框架。结果和讨论。本文描述了立法形成的主要阶段,从1983年的美国到2021年的欧盟和乌克兰。该条的实际价值在于目前规范向孤儿疾病患者提供服务的规范性行为清单。其科学意义在于借鉴了国内其他研究者之前的研究成果(2016)。通过对孤儿提供立法和主要问题的分析,我们制定了国家医疗保健制度的基本问题,并在文章中列出了结论。对乌克兰孤儿患者的法律监管现状进行了研究。调查发现,在过去7年中,通过执行通过的《乌克兰法》、部长内阁的决议和卫生部的命令,积极开展了对所研究问题的立法管理。总结了美国(1983年以来)、欧盟国家(1999年以来)、日本(1993年以来)等将孤儿病和孤儿患者基本概念引入医疗体系的国际经验研究结果。据发现,乌克兰批准了275种孤儿病分类学;按11个病种分类,共有104个病种,比2016年增加40%。在乌克兰,已经出现了加强改善向孤儿病人提供服务的进程的积极趋势。
{"title":"The analysis of the legislative framework regarding pharmaceutical provision of orphan patients in Ukraine","authors":"M. Podgaina, N. Sliptsova","doi":"10.24959/nphj.22.75","DOIUrl":"https://doi.org/10.24959/nphj.22.75","url":null,"abstract":"A rare (orphan) disease is a disease that threatens a person’s life or chronically progresses; it leads to a reduction in life expectancy or disability, which prevalence among the population is not more than 1 : 2000 in Ukraine and not more than 1 : 5000-8000 in other countries.\u0000Aim. To analyze the current legal framework on pharmaceutical provision of orphan patients in Ukraine.\u0000Materials and methods. The current regulatory framework on pharmaceutical provision of orphan patients in Ukraine was analyzed by constructing and studying the hierarchy of legislative acts regulating the issues of management of orphan (rare) diseases in the world and in Ukraine.\u0000Results and discussion. The article describes the main stages of the legislation formation, starting from the USA in 1983 to the EU and Ukraine in 2021. The practical value of the article consists in the current list of normative acts regulating the provision of patients with orphan diseases. The scientific significance is in the use of the results of previous studies of others domestic researchers (2016). The analysis of the legislation and the main issues of providing orphan patients allowed us to formulate the basic problems of the national healthcare system listed in the article.\u0000Conclusions. The current state of the legal regulation of orphan patients in Ukraine has been studied. It has been found that the legislative regulation of the issue under study has been actively carried out over the past 7 years by implementing the adopted Law of Ukraine, resolutions of the Cabinet of Ministers and orders of the Ministry ofHealth. The results of the study of international experience in introducing the basic concepts of orphan diseases and orphan patients into the healthcare system in the United States (since 1983), EU countries (since 1999), Japan (since 1993), etc., have been summarized. It has been found that 275 nosologies of orphan diseases have been approved in Ukraine; they are grouped by 11 nosological categories, there are 104 nosologies (+40 %) more than in 2016. A positive trend towards intensification of the process of improving the provision of orphan patients in Ukraine has been revealed.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78570692","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}
引用次数: 0
Substantiation of the target quality profile and risk assessment in the development of a combined drug for injection 注射用复方药物开发中目标质量概况和风险评估的证实
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.89
K. M. Semenova, L. Almakaieva
Aim. To substantiate the target quality profile for planning the development of a combined drug for injection based on sodium hyaluronate (SH) and dihydroquercetin (DHQ) with an expanded spectrum of the specific activity, as well as to determine the risk factors affecting the quality of the combined drug for injections at the stage of pharmaceuticaldevelopment (PD).Materials and methods. The study objects were the active pharmaceutical ingredients (АРІ) of SH, DHQ and a drug in the form of a solution for injection based on them, as well as potential risk factors affecting the quality of the product. The target product quality profile (QTPP) was developed based on the review and analysis of scientific literature, materials of the State Register of Medicines of Ukraine, pharmacopoeias of the leading countries of the world, articles of scientific publications. The Ishikawa diagram was used to analyze potential risk factors for a drug for injection at the stage of PD.Results and discussion. The application of scientific approaches to the analysis of scientific materials from various information sources on combination therapy with drugs with multidirectional medicinal substances and the availability of information on parenteral medicines (PM) allowed us to plan a QTPP for the development of a combined drug for injection for intradermal administration. In order to identify the most dangerous factors affecting the quality of the drug, the causal analysis of these factors at the PD stage of the combined drug for injection was carried out, and an Ishikawa diagram was constructed.Conclusions. The QTPP has been developed. The expected set of quality indicators that would ideally be achieved to ensure the required quality of the drug has been determined taking into account its safety and efficacy. Based on the risk assessment methodology, the Ishikawa diagram for a combined drug for injection has been constructed; potential risks associated with the quality of active ingredients (AI) and excipients, quality of primary packaging, production conditions, quality control of the drug, the technological process affecting the quality of the combined drug for injection and the causes leading to deviations from these indicators have been identified. This diagram is used as a baseline for the overall assessment of quality risks at the stage of drug development.
的目标。以透明质酸钠(SH)和二氢槲皮素(DHQ)为基础的注射用联合药物的目标质量概况,扩大其比活性谱,并确定药物开发阶段(PD)影响注射用联合药物质量的风险因素。材料和方法。研究对象为SH、DHQ的有效药物成分(АРІ)和以其为基础的注射用溶液形式的药物,以及影响产品质量的潜在危险因素。目标产品质量概况(QTPP)是基于对科学文献、乌克兰国家药品注册材料、世界主要国家药典、科学出版物文章的审查和分析而制定的。石川图用于分析注射用药物在PD阶段的潜在危险因素。结果和讨论。应用科学方法分析来自各种信息源的关于药物与多向药物联合治疗的科学材料,以及关于静脉注射药物(PM)信息的可用性,使我们能够计划QTPP,以开发用于皮内注射的联合药物。为了找出影响药品质量的最危险因素,对这些因素在注射用联合用药PD阶段的因果关系进行了分析,并构建了石川图。QTPP已经形成。考虑到药物的安全性和有效性,确定了一组理想的质量指标,以确保药物的要求质量。基于风险评价方法,构建了注射用联合用药石川图;已确定了与活性成分和辅料质量、初级包装质量、生产条件、药品质量控制、影响注射用联合用药质量的工艺过程以及导致偏离这些指标的原因相关的潜在风险。该图用作药物开发阶段质量风险总体评估的基线。
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引用次数: 0
Analysis of the use of PR-technologies by domestic pharmaceutical enterprises in the implementation of socially oriented marketing in the conditions of the global COVID-19 pandemic 全球COVID-19大流行条件下国内制药企业在实施社会化营销中pr技术的运用分析
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.71
I. Pestun, G. S. Babicheva, S. Zhadko
Today, leading foreign and domestic pharmaceutical companies are aware of the importance of using socially oriented tools of marketing communication to achieve economic stability, strengthen competitive positions and form a positive image at the pharmaceutical market.Aim. To study PR-technologies used by domestic pharmaceutical companies as part of the implementation of the concept of socially oriented marketing in the global COVID-19 pandemic.Materials and methods. The methods of logical and meaningful problem formation, desk marketing research, the content analysis of publications in scientific and practice-oriented medical and pharmaceutical literature were used in the work.Results and discussion. The issues of social responsibility of pharmaceutical industry enterprises as a key factor in the successful development of companies under the conditions of coronavirus infection have been highlighted. The specificityhas been considered, and the features of modern PR-tools of pharmaceutical companies have been determined. The Internet resources play an important role among them. The content analysis of the web-sites of the TOP-5 major manufacturers of drugs at the pharmaceutical market of Ukraine has been conducted; the social responsibility areas and the main PR-technologies have been analyzed.Conclusions. It has been found that the leading domestic pharmaceutical companies take an active public position and constantly implement various social programs aimed at supporting the society welfare, especially in the conditions of the COVID-19 pandemic. The information content of the sites of the enterprises under study fully reflects the activities of companies in the field of public relations on the principles of openness, relevance, reliability and social responsibility. Considerable attention is paid to the quality, safety and availability of pharmaceutical products and the provision ofappropriate assistance to healthcare institutions in the fight against COVID-19.
今天,国内外领先的制药公司都意识到利用面向社会的营销传播工具来实现经济稳定、加强竞争地位和在制药市场上形成积极形象的重要性。研究国内制药企业在全球COVID-19大流行中实施社会营销理念的pr技术。材料和方法。在工作中采用了逻辑和有意义的问题形成方法、桌面营销研究方法、科学和实践性医学和药学文献出版物的内容分析方法。结果和讨论。医药行业企业的社会责任问题,作为企业在冠状病毒感染条件下成功发展的关键因素,得到了重视。分析了医药企业公关工具的特殊性,确定了现代公关工具的特点。网络资源在其中扮演着重要的角色。对乌克兰药品市场前5大药品制造商的网站进行了内容分析;分析了社会责任领域和主要公关技术。调查发现,国内主要制药企业积极开展公益活动,特别是在新冠疫情背景下,不断开展各种社会公益活动。被研究企业网站的信息内容充分反映了企业在公共关系领域本着公开、相关、可靠和社会责任的原则开展的活动。药品的质量、安全性和可获得性以及向医疗机构提供抗击COVID-19的适当援助得到了相当大的关注。
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引用次数: 0
The choice of excipients and optimization of the composition of orally disintegrating tablets based on paracetamol and N-acetyl-D-glucosamine 对乙酰氨基酚- n -乙酰- d -氨基葡萄糖口腔崩解片辅料的选择及组成的优化
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.76
I. Zupanets, O. Ruban
Aim. The choice of the qualitative and quantitative composition of excipients to provide the required mechanical strength and disintegration time when developing a pharmaceutical composition in the form of orally disintegrating tablets (ODT) based on paracetamol and N-acetyl-D-glucosamine.Materials and methods. The study object was pharmaceutically accepted excipients used in the pharmaceutical development of solid dosage forms. To conduct the statistical analysis of experimental data, a Minitab® 19.1.1 software was used.Results and discussion. The excipients (povidone of different brands, copovidone, crospovidone of different brands, croscarmellose) used when developing ODT were considered, and it was determined that copovidone and crospovidone type A showed the most optimal quality indicators of the composition. It was found that the particle sizeof crospovidone and the route of its introduction affected the rate of disintegration in the aqueous medium. Using the method of mathematical prediction the optimal content of excipients in the composition and the experimental confirmation ofthe quality indicators of the mixture selected to create ODT were determined.Conclusions. Excipients used in the development of ODT have been considered, and the excipients exhibiting the best quality indicators of the compositions have been found. Both the influence of the particle size of crospovidone, and the route of its administration have been determined. The optimal content of excipients in the composition and their experimental confirmation have been determined due to mathematical prediction.
的目标。在以对乙酰氨基酚和n -乙酰- d -氨基葡萄糖为基础开发口腔崩解片(ODT)形式的药物组合物时,辅料的定性和定量组成的选择以提供所需的机械强度和崩解时间。材料和方法。研究对象是用于固体剂型药物开发的药学上公认的赋形剂。采用Minitab®19.1.1软件对实验数据进行统计分析。结果和讨论。考察了开发ODT时使用的辅料(不同品牌聚维酮、不同品牌聚维酮、不同品牌交叉聚维酮、交联棉糖),确定了该制剂的质量指标以不同品牌的聚维酮和A型交叉聚维酮最优。研究发现,交叉聚维酮的粒径大小和引入途径影响其在水介质中的分解速率。采用数学预测的方法确定了制剂中辅料的最佳含量,并对优选的制剂质量指标进行了实验确认。考虑了ODT开发中使用的赋形剂,并找到了具有最佳质量指标的赋形剂。确定了交叉聚维酮的粒径和给药途径。通过数学预测,确定了该制剂中辅料的最佳含量并进行了实验验证。
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引用次数: 0
Marketing analysis of influenza vaccines in Ukraine 乌克兰流感疫苗的市场分析
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.51
V. Zlahoda, T. Ivko, Т. A. Germanyuk, L. Bobrytska
Acute respiratory viral infections (ARVI) are highly prevalent, and it is especially dangerous during the COVID-19 pandemic. The most effective way to prevent the ARVI is vaccination.Aim. To analyze the pharmaceutical market of vaccines registered in Ukraine.Material and methods. The material of the study was data of the State Register of Medicines of Ukraine 2020, information on the results of the epidemic season of influenza and ARVI of the Center for Public Health of the Ministry of Health of Ukraine, declared wholesale prices for vaccines in Ukraine in December 2020. The methods of frequencyand descriptive analysis were used.Results and discussion. As a result of the structural analysis of ATC classification it was found that viral vaccines against influenza of J07B В group were presented at the pharmaceutical market. The frequency analysis revealed that there were 665.000 doses of vaccines of 4 trade names at the pharmaceutical market of Ukraine in 2020, all of them were of foreign production from France, the Netherlands, Great Britain, Korea. Among the vaccines purchased, 75 % were French-made vaccines. The cost of one vaccine dose ranged from 185.00 to 249.69 UAH. It was found that the number of vaccine doses purchased for the population during the study period (2016-2020) increased in 190 times. The population vaccination increased from 106683 to 238079 people, i.e. by 123 %.Conclusions. As a result of the research conducted it was found that in 2020-2021 there were 4 trade names of foreign vaccines at the pharmaceutical market of Ukraine. The cost of one dose of vaccines ranged from 185.00 tо 249.69 UAH.
急性呼吸道病毒感染(ARVI)非常普遍,在COVID-19大流行期间尤其危险。预防ARVI最有效的方法是接种疫苗。分析乌克兰注册疫苗的医药市场。材料和方法。该研究的材料是乌克兰2020年国家药品登记处的数据、乌克兰卫生部公共卫生中心关于流感流行季节结果和ARVI的信息、乌克兰2020年12月公布的疫苗批发价格。采用频率分析和描述性分析方法。结果和讨论。通过对ATC分类的结构分析,发现针对J07B В组流感病毒疫苗已在医药市场上市。频率分析显示,2020年乌克兰药品市场上有4个商品名称的66.5万剂疫苗,全部为法国、荷兰、英国、韩国等外国生产。在购买的疫苗中,75%是法国制造的疫苗。一剂疫苗的费用为185.00至249.69亚元。研究发现,在研究期间(2016-2020年),人群购买的疫苗剂量增加了190倍。人群疫苗接种率从106683人增加到238079人,增加了123%。根据所进行的研究,在2020-2021年期间,乌克兰药品市场上有4个外国疫苗的商品名称。一剂疫苗的费用为185.00至249.69亚元。
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引用次数: 0
The methodological approach to determination of the optimal content of excipients in the composition of tablets 片剂中辅料最佳含量测定的方法学方法
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.62
O. Kutova, О. Ruban, W. A. Alkhalaf Malek
Aim. To determine the algorithm of the optimal amount of excipients in the composition of tablets based on common ginger.Materials and methods. The study object was the regression equations determining the quantitative effect of excipients in the composition of the dosage form on the target pharmacopeial characteristics. The mathematical processing of these equations was carried out using the Mathcad 15 computer program according to the algorithm proposed.Results and discussion. It has been proposed to use the approximation function to determine the level of optimization. The approximation function is the sum of the squares of deviations of the objective functions from their optimal values. It has been proven that identification of mathematical models in pharmaceutical studies with three dependent factors, which total value is determined by the quantitative composition of a dosage form and is fixed at a certain level, is difficult to perform due to the complicated interpretation of multiple regression parameters as characteristics of factors in an isolated form through their correlation. The region for the optimal solution has been proposed with respect to the values of factors and effective indicators of a multiple regression model. The methodological approach to determining the optimal content of excipients in the composition of the given dosage form has been proposed.Conclusions. The optimal content of excipients – neusilin and colidone – has been determined while developing the composition of tablets based on common ginger with the necessary pharmacological and technological indicators that meet the requirements of the State Pharmacopoeia of Ukraine. The approach to the formation of the region offeasibility in two-way studies has been considered. Using the theory of multi-vector optimization a criterion has been developed; it allows determining the optimal feasible solution in the region under conditions of restrictions both by factors and target indicators.
的目标。确定以普通姜为原料的片剂中辅料最佳用量的算法。材料和方法。研究对象为确定剂型组成中辅料对目标药典特征定量影响的回归方程。根据所提出的算法,利用Mathcad 15计算机程序对这些方程进行了数学处理。结果和讨论。有人提出用近似函数来确定优化的水平。逼近函数是目标函数与其最优值的偏差的平方和。事实证明,在具有三个因变量的药物研究数学模型中,其总价值由剂型的定量组成决定并固定在一定水平上,由于将多元回归参数通过相关性解释为孤立形式的因素特征很复杂,因此很难进行数学模型的识别。根据多元回归模型的因子值和有效指标值,提出了最优解的区域。提出了确定给定剂型组成中辅料最佳含量的方法学方法。在研制以普通姜为原料的片剂时,确定了最佳辅料- - -纽西林和colidone的含量,其药理学和技术指标符合乌克兰国家药典的要求。考虑了双向研究中区域可行性形成的方法。利用多向量优化理论,提出了一种优化准则;它允许在受因素和目标指标双重限制的条件下确定区域内的最优可行解。
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引用次数: 0
The study of the qualitative and quantitative content of the amount of flavonoids and hydroxycinnamic acids in a dense extract of common tansy flowers 对普通三色堇花密萃液中黄酮类化合物和羟基肉桂酸含量的定性和定量研究
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.55
N. Herbina, O. Ruban, T. Gontova, M. Yaremenko, C. Yurchenko
In recent years, herbal medicines have become increasingly popular in the pharmacotherapy of many diseases. One of the medicinal plants widely distributed in the wild on the territory of Ukraine is common tansy (Tanacetum vulgare L.) of the Asteraceae family; it is a promising raw material for the development of new medicines. In this regard,it is relevant to study and standardize a dense extract of common tansy flowers (DECTF) to predict the possible pharmacological action and the feasibility of further use in the production of solid dosage forms.Aim. To study the qualitative and quantitative content of the amount of flavonoids and the amount of hydroxycinnamic acids in a dense extract of common tansy flowers.Materials and methods. The study object was DECTF. The qualitative composition of phenolic compounds in the extract was determined by TLC. The quantitative determination of the amount of flavonoids calculated with reference to luteolin was performed by the spectrophotometric method.Results and discussion. The identification of DECTF was performed by TLC. It allowed us to identify 3 dominant compounds of phenolic nature – luteolin, luteolin-7-glycoside and chlorogenic acid. The quantitative content of phenolic substances in DECTF was studied by spectrophotometry; it was found that the amount of flavonoids (calculated with reference to luteolin) was 3.69 ± 0.01 %; the amount of hydroxycinnamic acids (calculated with reference to chlorogenic acid) was 16.88 ± 0.02 %.Conclusions. A significant content of flavonoids and hydroxycinnamic acids in DECTF indicates the prospects for further research and development of new drugs with the anti-inflammatory, antimicrobial and choleretic action based on it.
近年来,草药在许多疾病的药物治疗中越来越受欢迎。在乌克兰境内广泛分布的野生药用植物之一是菊科的普通三色堇(Tanacetum vulgare L.);它是一种很有前途的新药开发原料。因此,研究和规范一种普通三色花致密提取物(DECTF),以预测其可能的药理作用和进一步用于固体剂型生产的可行性具有重要意义。研究普通三色堇花密萃液中总黄酮和羟基肉桂酸的定性定量含量。材料和方法。研究对象为DECTF。采用薄层色谱法测定了提取物中酚类化合物的定性组成。以木犀草素为参考,用分光光度法定量测定黄酮类化合物的含量。结果和讨论。采用薄层色谱法鉴别。鉴定出3种主要的酚类化合物:木犀草素、木犀草素-7-糖苷和绿原酸。采用分光光度法研究了DECTF中酚类物质的定量含量;结果表明,黄酮类化合物(以木犀草素为基准计算)含量为3.69±0.01%;羟基肉桂酸(参照绿原酸计算)含量为16.88±0.02%。DECTF中黄酮类化合物和羟基肉桂酸的含量显著,预示着在其基础上进一步研究和开发具有抗炎、抗菌和降胆作用的新药的前景。
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