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Determination of technological parameters of powder masses of the propolis phenolic hydrophobic drug, grape seeds, bitter chestnut seeds and their mixtures in solid dosage forms 蜂胶酚醛疏水性药物、葡萄籽、苦栗子籽及其固体剂型混合物粉末质量的工艺参数测定
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.66
A. S. Gurtovsky, O. Shpychak, S. Spyrydonov
An important task in the course of pharmaceutical development of solid dosage forms is to determine a set of technological methods and study the technological parameters of the powders under research for the purpose of further encapsulation or tabletting of substances with different physicochemical characteristics.Aim. To study the main technological parameters of the standardized substance of the propolis phenolic hydrophobic drug (PPHD), grape seeds, bitter chestnut seeds and their mixtures for the purpose of their further introduction into the capsules with the anti-inflammatory and venotonic action developed.Materials and methods. The pharmaco-technological studies of AFI powder masses (fluidity, angle of repose, bulk density, etc.) were performed in accordance with the requirements of the State Pharmacopoeia of Ukraine and scientific and practical sources of literature.Results and discussion. The tests performed indicate that the substances studied and their mixtures do not have satisfactory pharmaco-technological properties, are characterized by a low value of fluidity and the ability to absorb moisture during storage.Conclusions. The results of the research conducted confirm the need to add certain groups of excipients in the powder mass for their further encapsulation and the use of appropriate technological methods when developing oral dosage forms.
固体剂型药物开发过程中的一项重要任务是确定一套工艺方法,研究所研究粉体的工艺参数,以便对具有不同理化特性的物质进行进一步的包封或片化。研究蜂胶酚类疏水药、葡萄籽、苦板栗籽及其混合物的标准化物质的主要工艺参数,以便进一步将其引入具有抗炎和舒张作用的胶囊中。材料和方法。根据乌克兰国家药典的要求和科学实用的文献资料,对AFI粉团(流动性、休歇角、容重等)进行药理学研究。结果和讨论。试验结果表明,所研究的物质及其混合物具有令人满意的药效学性能,其特点是流动性低,在储存过程中吸湿能力差。所进行的研究结果证实,需要在粉末中添加某些组的赋形剂,以便进一步封装,并在开发口服剂型时使用适当的技术方法。
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引用次数: 0
The study of fatty acids in Anchusa officinalis L. herb of the Ukrainian flora 乌克兰植物区系石菖蒲中脂肪酸的研究
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.61
S. Svirska
The presence of different groups of biologically active substances in the medicinal plant raw material determines its wide use in medical practice. The study of the chemical composition and possible pharmacological effects of medicinal plants are priorities in the process of their research.Aim. To study the content and the composition of fatty acids in Anchusa officinalis L. herb of the Ukrainian flora using the gas chromatography/mass spectrometry method (GC/MS).Materials and methods. The samples of Anchusa officinalis L. herb were harvested in June 2017 in the Ivano-Frankivsk region. The study was performed using the GC/MS method. To identify the components, the spectra obtained were considered on the basis of general laws of fragmentation for molecules of organic compounds under the action of the electron impact, as well as by comparing the results with data from NIST05 and WILEY 2007 mass spectrum libraries. The data analysis was performed using Statistic 7.0, Excel 7.0 statistical program package for Microsoft Office for Windows.Results and discussion. This study presents the results the fatty acids investigation in Anchusa officinalis L. herb of the Ukrainian flora. For the first time, 8 fatty acids were identified. They were myristic acid (163.36 mg/kg), palmitic acid (2324.39 mg/kg), linoleic acid (1498.33 mg/kg), linolenic acid (2696.36 mg/kg), stearic acid (410.16 mg/kg), arachidic acid (240.43 mg/kg), behenic acid (409.23 mg/kg), lignoceric acid (498,38 mg/kg). The total mass of unsaturated fatty acids (linoleic and linolenic acid) was 4045.95 mg/kg, while the total mass of saturated fatty acids (myristic, palmitic, stearic, arachidic, behenic and lignoceric acid) was 4194.69 mg/kg. It indicates an insignificant predominance of unsaturated acids in the plant raw material. The total content of fatty acids in Anchusa officinalis L. herb was 8240.64 mg/kg (0.8 % by weight of the plant raw material).Conclusions. The study of fatty acids in Anchusa officinalis L. herb of the Ukrainian flora has been conducted for the first time. In the raw material, the following 8 fatty acids have been identified: unsaturated fatty acids (linoleic and linolenic acid) and saturated fatty acids (myristic, palmitic, stearic, arachidic, behenic and lignoceric acid). The total content of fatty acids in Anchusa officinalis L. herb is 0.8 % by weight of a dry raw material. The dominant compound among fatty acids is linolenic acid (2696.36 mg/kg of a dry raw material). Taking into account the above the further search for the method of obtaining the fatty acid complex from Anchusa officinalis L. herb is promising in order to develop the effective and safe herbal medicines.
药用植物原料中不同种类生物活性物质的存在决定了其在医疗实践中的广泛应用。药用植物的化学成分及其可能的药理作用的研究是其研究的重点。采用气相色谱/质谱联用技术(GC/MS)对乌克兰产山茱萸中脂肪酸的含量和组成进行了研究。材料和方法。2017年6月,在伊万诺-弗兰科夫斯克地区采集了安丘草。采用GC/MS法进行研究。为了鉴定组分,根据有机化合物分子在电子冲击作用下的一般破碎规律,并与NIST05和WILEY 2007质谱库的数据进行了比较。数据分析采用Microsoft Office for Windows统计软件包Statistic 7.0、Excel 7.0进行。结果和讨论。本文报道了乌克兰植物凤尾草中脂肪酸的研究结果。首次鉴定出8种脂肪酸。分别是肉豆蔻酸(163.36 mg/kg)、棕榈酸(2324.39 mg/kg)、亚油酸(1498.33 mg/kg)、亚麻酸(2696.36 mg/kg)、硬脂酸(410.16 mg/kg)、花生酸(240.43 mg/kg)、脱酸(409.23 mg/kg)、木质素酸(498,38 mg/kg)。不饱和脂肪酸(亚油酸和亚麻酸)的总质量为4045.95 mg/kg,饱和脂肪酸(肉豆蔻酸、棕榈酸、硬脂酸、花生酸、白酸和木质素酸)的总质量为4194.69 mg/kg。这表明植物原料中不饱和酸的优势不显著。山茱萸总脂肪酸含量为8240.64 mg/kg(占植物原料重量的0.8%)。本文首次对乌克兰凤尾莲属植物的脂肪酸进行了研究。在原料中,已鉴定出以下8种脂肪酸:不饱和脂肪酸(亚油酸和亚麻酸)和饱和脂肪酸(肉豆蔻酸、棕榈酸、硬脂酸、花生酸、白原酸和木质酸)。秋茱萸中脂肪酸的总含量为干燥原料重量的0.8%。脂肪酸中的主要化合物是亚麻酸(2696.36 mg/kg干原料)。综上所述,进一步探索从水草中提取脂肪酸复合物的方法,为开发安全有效的中草药提供了良好的前景。
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引用次数: 0
Psychotropic properties of a potential anticonvulsant of 5-[(Z)-(4-nitrobenzylidene)]-2- (thiazol-2-ylimino)-4-thiazolidinone 潜在抗惊厥药5-[(Z)-(4-硝基苄基)]-2-(噻唑-2-ylimino)-4-噻唑烷酮的精神药物特性
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.53
M. Mishchenko, S. Shtrygol’, A. Lozynskyi, R. Lesyk
Aim. To study the range of psychotropic properties of a new original compound of 5-[(Z)-(4-nitrobenzylidene)]-2-(thiazol-2-ylimino)-4 thiazolidinone with the anticonvulsant activity.Materials and methods. Adult nonlinear white mice of both sexes weighing 20-27 g were used in the experiments. The locomotor, exploratory, emotional activities were studied in the open field test. The elevated plus maze was used to study anxiety. The effect of the compound on depressive behavior was studied by the tail suspension test. The passive avoidance test was used to study memory. The influence of the compound on the skeletal muscle tone and coordination was studied in the rotarod test. Actoprotective properties were studied in a swimming test with a load of 10 % by weight of the animal.Results and discussion. In the previous studies, 5-[(Z)-(4-nitrobenzylidene)]-2-(thiazol-2-ylimino)-4-thiazolidinone showed a pronounced anticonvulsant effect in seizure models with different pathogenesis. In this study the related psychotropic effects of the test compound were studied. It was found that in intact mice 5-[(Z)-(4-nitrobenzylidene)]-2-(thiazol-2-ylimino)-4-thiazolidinone in the dose of 100 mg/kg by intragastrical administration did not affect the locomotor, exploratory, emotional activity and its vegetative support, anxiety, depressive activity (in contrast to the reference drug – a classic anticonvulsant sodium valproate, which showed depressive properties), and memory. The test compound did not have a negative effect on the skeletal muscle tone and coordination, but statistically significantly increased the physical endurance of animals, being only slightly inferior to the classic CNS stimulant caffeine.Conclusions. Thus, 5-[(Z)-(4-nitrobenzylidene)]-2-(thiazol-2-ylimino)-4-thiazolidinone in the dose of 100 mg/kg can be considered as a potential anticonvulsant without related psychotropic effects and with actoprotective properties.
的目标。目的研究具有抗惊厥活性的5-[(Z)-(4-硝基苄基)]-2-(噻唑-2-ylimino)-4噻唑烷酮的新化合物的精神药物性质范围。材料和方法。实验采用体重20 ~ 27g的雌雄非线性成年小白鼠。在开场试验中研究了运动、探索和情绪活动。采用高架+迷宫法研究焦虑。通过尾悬试验研究了该化合物对抑郁行为的影响。采用被动回避测验研究记忆。通过旋转杆试验研究了该化合物对骨骼肌张力和协调性的影响。在动物体重10%的负荷下进行游泳试验,研究其运动保护性能。结果和讨论。在以往的研究中,5-[(Z)-(4-硝基苄基)]-2-(噻唑-2-ylimino)-4-噻唑烷酮在不同发病机制的癫痫发作模型中均表现出明显的抗惊厥作用。本研究对该化合物的相关精神作用进行了研究。结果发现,正常小鼠5-[(Z)-(4-硝基苄基)]-2-(噻唑-2-ylimino)-4-噻唑烷酮100 mg/kg的剂量对运动、探索、情绪活动及其植物支持、焦虑、抑郁活动(与经典抗惊厥药丙戊酸钠相反,丙戊酸钠具有抑郁特性)和记忆没有影响。测试化合物对骨骼肌张力和协调性没有负面影响,但统计上显着增加了动物的身体耐力,仅略低于经典的中枢神经兴奋剂咖啡因。因此,剂量为100 mg/kg的5-[(Z)-(4-硝基苄基)]-2-(噻唑-2-ylimino)-4-噻唑烷酮可被认为是一种潜在的抗惊厥药,没有相关的精神作用,具有活性保护作用。
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引用次数: 1
Soft dosage forms as interfaces 软剂型作为界面
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.57
L. Ivanov, O. Р. Bezugla, O. Shcherbak, L. Derymedvid, V. Kravchenko
Aim. To analyze data on combined drugs in soft dosage forms as potential drug interfaces.Materials and methods. The bibliosemantic research method was used in the work.Results and discussion. By analogy with foreign interfaces of carbon nanotubes with neurons it has been proposed to consider a number of soft dosage forms as interfaces between inanimate organic structures of dosage forms and living cells of the skin tissue or the mucous membrane. A number of soft dosage forms, which can be considered as interfaces between the inanimate organics of dosage forms and living cells of the skin tissue and mucosa, has been studied and analyzed. Interfaces are polymer matrices made of polyethylene glycols, high molecular weight polysaccharides, carbomers, etc. A carbomer can be considered as the basis of plastic, conformationally mobile interfaces between the general dosage form and living cells of the skin and mucosa. It has been shown that the mechanism of increasing biocompatibility with the help of polyethylene glycols is the ability of PEG molecules due to compaction (spiralization) or expansion of the molecules to accept the optimal conformation, giving their hydrophobic or polar groups for the optimal binding, on the one hand, with medicinal substances (drugs), and, on the other hand, with bioobjects. It has been shown that the affinity for PEG-400 phosphatidylcholine liposomes is 6 times greater than that of propylene glycol, and the affinity for PEG-1500 liposomes is 24 times higher than that of propylene glycol. Upon contact with the skin or the mucosa the interface structure may be destroyed as the components of the dosage form have different affinities for membranes of cells of biological surfaces – surface active substances that quickly bind to the lipid bilayer of the membranes of the skin or mucous membranes are the first ones that leave the dosage forms. Then, other auxiliary substances of the interface bind to the cell membranes at different speeds and in different ways.Conclusions. Therefore, a dosage form as an interface is a dynamic matrix that can rebuild and, as it contacts the membranes of skin cells or mucous membranes, promote absorption of the drug substance according to a specific program.
的目标。分析软剂型联合药物作为潜在药物界面的数据。材料和方法。本文采用文献语义学研究方法。结果和讨论。与国外碳纳米管与神经元的界面类似,有人提出考虑一些软剂型作为剂型的无生命有机结构与皮肤组织或粘膜的活细胞之间的界面。研究和分析了许多软剂型,它们可以被认为是剂型的无生命有机体与皮肤组织和粘膜的活细胞之间的界面。界面是由聚乙二醇、高分子量多糖、碳水化合物等组成的聚合物基质。卡波姆可被认为是一般剂型与皮肤和粘膜的活细胞之间的塑性构象移动界面的基础。研究表明,在聚乙二醇的帮助下增加生物相容性的机制是PEG分子由于压实(螺旋化)或分子膨胀而接受最佳构象的能力,使其疏水或极性基团一方面与药用物质(药物)结合,另一方面与生物物体结合。对PEG-400磷脂酰胆碱脂质体的亲和力是丙二醇的6倍,对PEG-1500脂质体的亲和力是丙二醇的24倍。当与皮肤或粘膜接触时,界面结构可能被破坏,因为剂型的组分对生物表面的细胞膜具有不同的亲和力-迅速结合到皮肤或粘膜的脂质双分子层的表面活性物质是首先离开剂型的物质。然后,界面的其他辅助物质以不同的速度和方式与细胞膜结合。因此,剂型作为界面是一个动态的基质,它可以重建,当它接触皮肤细胞或粘膜时,根据特定的程序促进药物的吸收。
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引用次数: 0
The study of the current attitude of specialists to the system of the staff motivation in a pharmacy 专科医生对某药房员工激励制度现状的研究
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.70
M. Kobets, Yuri Kobets, N. Malinina, O. Filiptsova, O. Ibrahimova
Every pharmacy manager is faced with the question of motivating his/her employees. Unfortunately, there are no single motivational schemes that would effectively affect all pharmacists in the same manner.Aim. To study the current attitude of specialists to the system of the staff motivation in a pharmacy.Materials and methods. The field studies were used in the work. A survey of pharmacists and pharmaceutists of one of the pharmacy chain in Kharkiv was carried out. 107 specialists were interviewed. The database obtained as a result of the questionnaire was formed in Microsoft Excel. All calculations were performed in Microsoft Excel.Results and discussion. A survey of pharmacists and pharmaceutists of pharmacies of one of the pharmacy network in Kharkiv was carried out. The information obtained as a result of the questionnaire was collected in accordance with ethical requirements. The relationship between qualitative characteristics was carried out using the χ2 test. The current attitude of specialists to the system of motivation in a pharmacy was studied. It was revealed that the employee’s motivation depended by 70 % on how the manager worked on this problem. As a result of the study, it was found that 46 % of the surveyed specialists went to work with a sense of habit and only 16 % with a sense of a creative impulse. The question of changing the place of work was investigated. It was determined that 34 % of respondents wanted to change their place of work, 28 % of respondents were completely satisfied with their position. Although a significant percentage of the surveyed specialists are now thinking about changing jobs, the COVID-19 pandemic has made its own adjustments. Most workers remain at their jobs for now, fearing that they will lose their jobs altogether. Motivating and demotivating factors for pharmacy workers were determined. Among the motivating factors, one can single out the loyal attitude of the management, a friendly team, the presence of social guarantees (the right to work, the right to rest, retirement benefits). Demotivating factors are the lack of career prospects, inadequate working conditions, the lack of innovation, insufficient technological support.Conclusions. As a result of the study of the motivational environment of one of the network of pharmacies in Kharkiv, it has been found that the mechanisms used do not sufficiently ensure the achievement of the goals of this network of pharmacies. For optimal motivation, it is necessary to apply the elements of the motivation system in a comprehensive manner.
每个药房经理都面临着激励员工的问题。不幸的是,没有一个单一的激励方案能以同样的方式有效地影响所有的药剂师。探讨专科医生对某药房员工激励制度的态度现状。材料和方法。工作中采用了实地考察的方法。对哈尔科夫一家连锁药店的药剂师和药剂师进行了调查。访谈了107位专家。通过问卷调查得到的数据库在Microsoft Excel中形成。所有计算均在Microsoft Excel中完成。结果和讨论。对哈尔科夫一个药房网络药房的药剂师和药剂师进行了调查。从问卷中获得的信息是按照道德要求收集的。质性特征间的关系采用χ2检验。研究了目前专科医生对药店激励制度的态度。据透露,员工的动机70%取决于经理如何处理这个问题。研究结果发现,46%的受访专家带着一种习惯去工作,只有16%的人带着一种创造性的冲动去工作。对改变工作地点的问题进行了调查。调查确定,34%的受访者想要改变他们的工作地点,28%的受访者对他们的职位完全满意。尽管有相当大比例的受访专家正在考虑换工作,但COVID-19大流行也做出了自己的调整。大多数工人目前仍留在他们的工作岗位上,担心他们会完全失去工作。确定药学工作者的激励因素和抑制因素。在激励因素中,人们可以挑选出忠诚的管理态度,友好的团队,社会保障(工作权,休息权,退休福利)的存在。消极因素是缺乏职业前景、工作条件不足、缺乏创新、技术支持不足。由于对哈尔科夫一家药店网络的动机环境进行了研究,发现所使用的机制不足以确保实现该药店网络的目标。为了实现最优激励,需要综合运用激励系统的各个要素。
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引用次数: 0
The study of the elemental composition of common domestic types of the medicinal plant raw material 国内常见药用植物原料种类的元素组成研究
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.68
Y. Zudova, O. Khvorost
Aim. To determine the elemental composition of common domestic types of the medicinal plant raw material, such as Sophora japonica flower buds, Crataegus sanguinea leaves and flowers, Astragalus dasyanthus herb, Mentha piperita leaves, Arctium lappa roots.Materials and methods. The elemental composition was studied by atomic absorption spectrography with photographic registration. The research was conducted at the premises of STC “Institute of Single Crystals” of the National Academy of Sciences of Ukraine (Kharkiv).Results and discussion. The results of the research obtained show that the samples of common domestic types of the medicinal plant raw material studied contain at least 19 chemical elements; potassium, calcium, magnesium, and phosphorus predominate among them.Conclusions. The study shows the prospects of creating new original complex drugs from the raw material of the plants studied for the prevention and treatment of diseases of the cardiovascular system, in particular hypertension.
的目标。测定国内常见类型药用植物原料的元素组成,如苦参花蕾、山楂叶和花、黄芪、薄荷叶、牛蒡根等。材料和方法。用照相配准原子吸收光谱法研究了其元素组成。这项研究是在乌克兰国家科学院(哈尔科夫)STC“单晶研究所”进行的。结果和讨论。所获得的研究结果表明,所研究的国内常见药用植物原料样品含有至少19种化学元素;其中以钾、钙、镁、磷为主。该研究显示了从所研究的植物原料中创造新的原始复合药物的前景,用于预防和治疗心血管系统疾病,特别是高血压。
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引用次数: 0
The cluster analysis in the development of priority directions of informatization of logistics processes in the medical supply system of the Armed Forces of Ukraine 乌克兰武装部队医疗供应系统后勤过程信息化优先方向发展中的聚类分析
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.69
M. Bilous
Aim. To conduct the cluster analysis of the results of an expert survey for the development of priority directions of informatization of logistics processes in the medical supply system of the Armed Forces of Ukraine.Materials and methods. To achieve the goal of the study, the analysis of foreign and domestic scientific sources and the current legal documents was conducted. The methods of information retrieval, systematization, content analysis and the technology of hierarchical agglomeration cluster analysis were used.Results and discussion. By clustering the results of an expert survey on informatization of logistic processes in the medical supply system of the Armed Forces of Ukraine the distribution into seven clusters formed due to similar answers to the questionnaire was obtained. The number of clusters was determined by the dendrogram construction program without any researcher’s assumptions. The cluster analysis showed stable cluster groupings with a certain level of tightness of relations between features both within a cluster and among several clusters. This corresponds to the vision of the experts who outlined the problem on the research topic and determine the ways to solve it.Conclusions. Based on the results of the analysis of the personal composition of each cluster, a sufficiently high level of consistency of the conclusions of experts of the medical supply system of the Armed Forces of Ukraine to the need for the introduction of informatization of logistics processes has been determined. Priority directions of informatization of logistic processes in the medical supply system of the Armed Forces of Ukraine have been developed; a decisive place in these directions belongs to the implementation of a program for automatic accounting of medical supplies in the Armed Forces of Ukraine. The need for the introduction of modern software for decision-making support in the management of flow processes of providing medical supplies and equipment of the Armed Forces of Ukraine, as well as information analytical tools for the needs of the Medical Supply Directorate of the Medical Forces Command of the Armed Forces of Ukraine has been substantiated.
的目标。对专家调查结果进行聚类分析,以制定乌克兰武装部队医疗供应系统后勤过程信息化的优先方向。材料和方法。为了达到研究的目的,对国内外的科学资料和现行的法律文件进行了分析。采用了信息检索、系统化、内容分析和层次集聚聚类分析技术。结果和讨论。通过对乌克兰武装部队医疗供应系统后勤过程信息化专家调查的结果进行聚类,得到了由于问卷答案相似而形成的七个聚类。簇的数量由树形图构建程序决定,没有任何研究者的假设。聚类分析显示稳定的聚类分组,在一个簇内和几个簇之间的特征之间具有一定程度的紧密关系。这符合专家的观点,他们概述了研究课题的问题,并确定了解决问题的方法。根据对每组人员构成的分析结果,确定乌克兰武装部队医疗供应系统专家的结论与需要采用后勤过程信息化的情况高度一致。制定了乌克兰武装部队医疗供应系统后勤过程信息化的优先方向;在这些方向上具有决定性地位的是执行乌克兰武装部队医疗用品自动核算方案。有必要采用现代软件,在管理向乌克兰武装部队提供医疗用品和设备的流程过程中提供决策支持,并采用信息分析工具,满足乌克兰武装部队医疗部队司令部医疗供应司的需求。
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引用次数: 0
Development of conceptual approaches for regulating the turnover of cosmetic products in Ukraine 制定概念性方法,以规范乌克兰化妆品的营业额
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.63
I. Kazakova, S. Kovalenko, V. Lebedynets, V. Kazakova
Aim. To develop conceptual approaches for regulating the turnover of cosmetic products in Ukraine.Materials and methods. As research materials the processes of technical regulation of cosmetic products were studied; logical, research methods, as well as the method of content analysis were used.Results and discussion. The state of technical regulation of the turnover of cosmetic products in a number of foreign countries has been studied. The analysis of the implementation of the specifications on cosmetic products has been performed, and the potential risks during its implementation in Ukraine have been determined. The model of the implementation plan of the normative legal act and the procedure of application of its basic provisions has been developed.Conclusions. Based on the analysis of the issues of technical regulation of cosmetic products the methodology for implementing the normative legal act, which regulates the rules of the product turnover at the Ukrainian market, has been proposed.
的目标。制定概念性方法,以规范乌克兰化妆品的营业额。材料和方法。作为研究材料,对化妆品的技术法规过程进行了研究;采用了逻辑方法、研究方法以及内容分析法。结果和讨论。对国外一些国家化妆品周转技术法规的现状进行了研究。已对化妆品规范的实施情况进行了分析,并确定了其在乌克兰实施期间的潜在风险。制定了规范性法律行为实施方案的模式及其基本条款的适用程序。在分析化妆品技术法规问题的基础上,提出了实施规范法律行为的方法,该法律行为规范了乌克兰市场上产品周转的规则。
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引用次数: 0
The risk assessment of the combined medicine in the capsule dosage form at the pharmaceutical development stage 药物开发阶段胶囊剂型联合用药的风险评估
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.54
M. Almakaiev, O. Bashura, L. Sidenko
Aim. To determine the potential risk factors associated with the critical quality indicators of the combined medicine “Neuronucleos” in the capsule dosage form for the treatment of polyneuropathies using the general risk assessment methodology while planning the drug quality at the stage of pharmaceutical development (PD).Materials and methods. The series of the combined medicine “Neuronucleos” in the capsule dosage form, critical indicators of the drug quality, the flowchart of the drug production, critical control points of the drug manufacturing process were developed. The method of causality was used. The quantitative assessment of risk factors was carriedout using the FMECA methodology.Results and discussion. The main objective of this study was to apply the Quality-by-Design (QbD) approach to PD of the combined medicine in the capsule dosage form based on uridine-5 monophosphate disodium salt (UMP), cytidine-5-monophosphate disodium salt (CMF), vitamin B6, thioctic acid and magnesium lactate dihydrate. For better patient compliance and the product quality, a target quality profile as a base for PD planning, as well as critical quality attributes (CQA) related to the product safety and efficacy were determined. The criticality of each CQA was assessed using a special scale. It was shown that “Quantitative content”, “Uniformity of dosage units”, “Dissolution”, “Impurities” were defined as the most CQA due to the minimum amount of UMF and CMF in the capsule and the possibility of their decomposition and increase in the quantity of impurities. The critical attributes of materials (CMA) were identified, and the characteristics required to control them were determined in order to ensure the expected product quality. The primary assessment of the quality indicator risks of the active ingredients was performed. It was found that the particle size affected the homogeneity, the quantitative content of API and dissolution in FPP, and it was shown that the solubility of active substances had a high risk when performing the “Dissolution” test. To determine the potential factors with a significant impact on the drug quality the maximum number of factors was found, and the Ishikawa diagram was constructed. The risk factors associated with the quality and compatibility of active substances and excipients, the quality of primary packaging, production conditions, the drug quality control and the technological process were identified. These factors are the causes of risk and can lead to a situation with negative consequences for the quality of a medicinal product. The FMECA process assessment allowed us to determine the impact of the manufacturing process on the CQA.Conclusions. At the stage of PD for the combined medicine in the capsule dosage form the potential critical indicators of the drug quality have been determined. The critical parameters of the quality of the initial components and the properties of the product have been assessed; the most probab
的目标。在药物开发(PD)阶段进行药物质量规划时,采用一般风险评估方法确定治疗多发性神经病的联合药物“神经核”胶囊剂型中关键质量指标相关的潜在风险因素。材料和方法。研制了联合用药“神经核素”系列胶囊剂型、药品质量关键指标、药品生产流程图、药品生产过程关键控制点。采用因果关系法。采用FMECA方法对风险因素进行定量评估。结果和讨论。本研究的主要目的是将质量设计(QbD)方法应用于由尿苷-5-单磷酸二钠盐(UMP)、胞苷-5-单磷酸二钠盐(CMF)、维生素B6、硫辛酸和乳酸二水镁组成的胶囊制剂的PD分析。为了提高患者依从性和产品质量,确定了目标质量概况作为PD计划的基础,以及与产品安全性和有效性相关的关键质量属性(CQA)。每个CQA的关键程度使用一个特殊的量表进行评估。结果表明,“定量含量”、“剂量单位均匀性”、“溶出度”、“杂质”被定义为最大的CQA,因为胶囊中UMF和CMF的含量最少,并且它们有可能分解并增加杂质的数量。识别材料的关键属性(CMA),确定控制这些属性所需的特性,以确保预期的产品质量。对活性成分的质量指标风险进行了初步评价。发现FPP中颗粒大小影响均匀性、原料药定量含量和溶出度,在进行“溶出度”测试时,活性物质的溶解度存在较高的风险。为确定对药品质量有显著影响的潜在因素,找出最大影响因素数,构建石川图。确定了与原料药和辅料的质量和配伍性、原包装质量、生产条件、药品质量控制和工艺过程相关的危险因素。这些因素是造成风险的原因,并可能导致对药品质量产生负面影响的情况。FMECA工艺评估使我们能够确定生产工艺对cqa结论的影响。在PD阶段,对胶囊剂型中联合用药的药物质量的潜在关键指标进行了确定。对初始组分质量和产品性能的关键参数进行了评估;对药品质量最可能的风险进行了识别、分析和评估。进一步的研究应侧重于研究工艺参数对产品质量关键参数的影响,评估质量风险,制定验证计划并实施。
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引用次数: 0
The study of epidemiology of dementia and Alzgeimer’s disease in Ukraine 乌克兰痴呆症和阿尔茨海默病的流行病学研究
Pub Date : 2021-10-19 DOI: 10.24959/nphj.21.58
M. Fedotova, H. Panfilova, O. Tsurikova, O. M. Blazhiievska
Against the background of systematic aging of the population and increase in life expectancy the problems of the spread of all forms of dementia, including Alzheimer’s disease, are becoming increasingly important.Аim. To study epidemiology of dementia and Alzheimer’s disease in Ukraine.Materials and methods. Data from the Center for Mental Health and Monitoring of Drugs and Alcohol of the Ministry of Health of Ukraine for 2015-2019 were studied. In the research, in addition to general theoretical methods, methods of epidemiological studies were also used.Results and discussion. It has been found that since 2018 in Ukraine, the incidence rates of all mental disorders (4.0 %) increased, including organic lesions with symptomatic manifestations of cognitive impairment (2.0 %), all forms of dementia (6.0 %), vascular dementia and Alzheimer’s disease (9.0 % each). The structure of dementia is dominated by vascular forms of dementia (62.59 %), while Alzheimer’s disease has been characterized since 2015 by a systematic increase in the proportion (%) from 7.0 % to 12.0 %. The average prevalence of dementia in Ukraine is 99.72, and Alzheimer’s disease is 5.34 per 100 thousand population. A significant fluctuation in the prevalence of dementia and Alzheimer’s disease in different regions of the country has been proven. Thus, in the regions of the country, these indicators differed by 6 or more times. The highest prevalence rates of dementia were observed in 7 regions (Vinnytsia, Donetsk, Zaporizhia, Zhytomyr, Kharkiv, Cherkasy and Chernihiv regions) and Kyiv, and for Alzheimer’s disease – in 3 regions (Zaporizhia, Kherson, Chernihiv) and Kyiv.Conclusions. It is necessary to introduce an effective system for recording and monitoring cases of all forms of dementia, including Alzheimer’s disease. This will form the basis for the development of models for the rational distribution of healthcare resources for the effective treatment and social rehabilitation of these groups of patients in Ukraine.
在人口系统老龄化和预期寿命延长的背景下,各种形式的痴呆症,包括阿尔茨海默病的蔓延问题日益严重important.Аim。研究乌克兰痴呆症和阿尔茨海默病的流行病学。材料和方法。研究人员研究了乌克兰卫生部心理健康与药物和酒精监测中心2015-2019年的数据。本研究除采用一般理论方法外,还采用了流行病学研究方法。结果和讨论。研究发现,自2018年以来,乌克兰所有精神障碍的发病率(4.0%)都有所增加,包括有认知障碍症状表现的器质性病变(2.0%)、所有形式的痴呆(6.0%)、血管性痴呆和阿尔茨海默病(各9.0%)。痴呆症的结构以血管性痴呆形式为主(62.59%),而阿尔茨海默病的特征是自2015年以来,其比例(%)从7.0%系统性增加到12.0%。乌克兰痴呆症的平均患病率为99.72,阿尔茨海默病为每10万人5.34人。已证实,该国不同地区的痴呆症和阿尔茨海默病患病率有很大波动。因此,在该国各区域,这些指标相差6倍或更多。痴呆患病率最高的地区为文尼察、顿涅茨克、扎波罗热、日托米尔、哈尔科夫、切尔卡西和切尔尼耶夫7个地区和基辅,阿尔茨海默病患病率最高的地区为扎波罗热、赫尔松、切尔尼耶夫3个地区和基辅。有必要引入一个有效的系统来记录和监测包括阿尔茨海默病在内的所有形式的痴呆症病例。这将成为制定合理分配保健资源的模式的基础,以便在乌克兰对这些患者群体进行有效治疗和社会康复。
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News of Pharmacy
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