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Analysis of the stakeholders’ requirements to applicants for higher education of the “Quality, standardization and certification” educational program 利益相关者对高等教育“质量、标准化、认证”项目申请者的需求分析
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.86
S. Kovalenko, O. Romelashvili, О.V. Тkachenko
Aim. To substantiate the need to revise the educational program, the main requirements of the Ukrainian pharmaceutical market to modern professionals involved in the formation, maintenance and improvement of pharmaceuticalquality systems, and determine the components of the educational program.Materials and methods. The literature data on the pharmaceutical labor market and the need to improve the educational process, as well as statistical, analytical, comparative and logical research methods were used in the work.Results and discussion. The study was conducted during April, 2021, using an expert survey. It involved 56 respondents from 35 organizations in the pharmaceutical healthcare sector. Almost 100 % of employers have a division that performs functions related to the management / quality assurance of products and / or services in their organizational structure. The study of the relevance of the components of the “Quality, Standardization and Certification” educational program has shown the need to include disciplines that are able to solve practical problems and complex specialized taskscharacterized by complexity and uncertainty of conditions when performing management functions of pharmaceutical organizations and their departments on activities affecting the product quality, customer satisfaction and the ability ofthe organization to comply with regulatory requirements.Conclusions. A survey of employers in the pharmaceutical healthcare sector has been conducted in order to improve the educational program taking into account the basic requirements of the Ukrainian pharmaceutical market to modern specialists. Based on the results of the survey, the requirements for the professional competence of applicants for higher education have been formed, and a list of disciplines that can form them has been compiled.
的目标。为了证实修改教育计划的必要性,乌克兰制药市场对参与形成,维护和改进药品质量体系的现代专业人员的主要要求,并确定教育计划的组成部分。材料和方法。本研究采用了统计、分析、比较、逻辑等研究方法,收集了医药劳动力市场及教育过程改进需求的文献数据。结果和讨论。该研究于2021年4月进行,采用了专家调查。该调查涉及来自医药保健行业35个组织的56名受访者。几乎所有的雇主都有一个部门,在他们的组织结构中执行与产品和/或服务的管理/质量保证有关的职能。对“质量、标准化和认证”教育计划组成部分相关性的研究表明,在制药组织及其部门对影响产品质量的活动执行管理职能时,需要包括能够解决实际问题和复杂专业任务的学科,这些任务的特点是条件的复杂性和不确定性。顾客满意和组织遵守法规要求的能力。结论。对医药保健部门的雇主进行了调查,以改进教育方案,同时考虑到乌克兰医药市场对现代专家的基本要求。根据调查结果,形成了高等教育申请人的专业能力要求,并编制了可以形成这些要求的学科清单。
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引用次数: 0
The study of factors affecting the socio-psychological climate in the labor collective of a pharmacy institution 某医药机构劳动集体社会心理气候影响因素研究
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.84
N. Andrienko
Aim. To study the theoretical foundations of the socio-psychological climate of a pharmacy institution and determine the factors affecting it.Materials and methods. The methods of generalization, analysis and synthesis, content analysis were used in the study. An expert survey was used to determine the factors affecting the socio-psychological climate in the pharmacy. All members of the staff working in the pharmacy took part in the survey. The total number of respondents who participated in the expert study was 563 pharmacists. The study covered all regions of Ukraine. The results of the survey are significant and consistent.Results and discussion. The approaches to defining the essence of the “socio-psychological climate” concept have been studied. The generalized definition of “socio-psychological climate of a pharmacy institution” can be defined as the mood and relationships developed in the labor collective and manifested as a set of psychological conditionsthat promote or hinder joint activities and the personal development of each employee. Factors affecting the sociopsychological climate in the labor collective of the pharmacy have been studied.Conclusions. The socio-psychological climate is the result of joint activities of members of the labor collective and their interpersonal interaction; it is manifested itself in the mood and opinions of the team, well-being and assessments of the pharmacist’s living conditions in the team and expressed in relationships related to work and the solution of common tasks.
的目标。研究医药机构社会心理氛围的理论基础,确定影响因素。材料和方法。研究采用了归纳、分析综合、内容分析等方法。通过专家调查来确定影响药房社会心理气候的因素。所有在药房工作的员工都参加了调查。参与专家调查的受访药师总数为563名。这项研究涵盖了乌克兰的所有地区。调查的结果是显著和一致的。结果和讨论。研究了界定“社会心理气候”概念本质的方法。“医药机构社会心理气候”的广义定义可以定义为劳动集体中发展起来的情绪和关系,表现为促进或阻碍每个员工共同活动和个人发展的一组心理条件。对影响药店劳动集体社会心理气氛的因素进行了研究。社会心理气候是劳动集体成员共同活动及其人际互动的结果;它表现在团队的情绪和意见,幸福感和对药剂师在团队中的生活状况的评估,以及与工作相关的关系和共同任务的解决。
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引用次数: 1
The fatty acid composition of the raw material from sea buckthorn 沙棘原料的脂肪酸组成
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.52
L. Naumenko, N. .. Popova
Today, the relevance of studying medicinal plants and creating medicines based on them occupies a special place in medicine and pharmacy. Interest in the study of already known and new medicinal plants of the domestic flora is growing. On their basis, new herbal medicines and dietary supplements are created, which due to their unique compositionhave a mild therapeutic and complex effect on the organs and systems of the human body. They are virtually devoid of side effects, and they do not develop addiction.Aim. To study the qualitative composition and the content of fatty acids in the medicinal plant raw material from sea buckthorn using the chromatographic method; to determine the specific feature of the fatty acid composition for identification of the sea buckthorn raw material.Materials and methods. The study objects were leaves, fruit pulp, seeds and bark of sea buckthorn harvested at the pharmacopoeial garden of the National University of Pharmacy (2018). The analysis was performed using gas chromatography-mass spectrometry (GC/MS).Results and discussion. The results of the analysis indicate that the medicinal plant raw material from sea buckthorn has a rich diverse composition of saturated and unsaturated fatty acids, namely: in the leaves of sea buckthorn there are significant amounts of fatty acids. Among saturated fatty acids there are palmitic (55.33 mg/g), behenic (1.07 mg/g),stearic (1.03 mg/g), arachinic (0.91 mg/g), lignocerinic (0.78 mg/g), margaric (0.32 mg/g), myristic (0.28 mg/g) acids; among unsaturated fatty acids – oleic (7.79 mg/g), linoleic (2.42 mg/g). Fatty acids of the sea buckthorn bark are representedby saturated arachidonic (20.85 mg/g), palmitic (2.14 mg/g), erucic (2.09 mg/g), heneukocylic (1.87 mg/g),behenic (1.38 mg/g) acids and unsaturated oleic (5.75 mg/g) and linoleic (4.86 m/g) fatty acids. In the pulp of sea buckthorn fruits 9 fatty acids have been identified. Palmitic acid (23.55 mg/g) is contained in large quantities, there are also stearic acid (2.68 mg/g), myristic acid (1.36 mg/g), arachinic acid (0.87 mg/g). Among unsaturated acids, oleic acid (44.42 mg/g), linoleic acid (12.49 mg/g), linolenic acid (5.96 mg/g), palmitoleic acid (5.16 mg/g) and vaccenic acid (3.79 mg/g) have been identified. The seeds of sea buckthorn contain 8 fatty acids. Three of them are saturated: palmitic (15.89 mg/g), stearic (2.51 mg/g), myristic (0.71 mg/g), and there are five unsaturated acids: oleic (31.41 mg/g), linoleic (27.03 mg/g),linolenic (17.00 mg/g), vaccenic (2.86 mg/g) and palmitoleic (2.56 mg/g).Conclusions. The results of the analysis show a rich fatty acid composition of the medicinal plant raw material from sea buckthorn. It has been determined that the specific feature is the presence and the ratio of palmitoleic and vaccenic acid in the pulp and seeds; this feature is characteristic when identifying the sea buckthorn raw material. Thus, this raw material can be promising for the creation of medicines and d
今天,研究药用植物和以它们为基础制造药物的相关性在医学和药学中占有特殊的地位。对国内植物区系中已知和新的药用植物的研究兴趣正在增长。在此基础上,新的草药和膳食补充剂被创造出来,由于它们独特的成分,对人体的器官和系统有轻微的治疗和复杂的作用。它们几乎没有副作用,也不会让人上瘾。采用色谱法研究沙棘药用植物原料的定性组成及脂肪酸含量;测定沙棘原料脂肪酸组成的具体特征,用于沙棘原料的鉴别。材料和方法。研究对象为国家药学院药典园(2018)采收的沙棘叶、果肉、种子和树皮。采用气相色谱-质谱法(GC/MS)进行分析。结果和讨论。分析结果表明,沙棘药用植物原料具有丰富多样的饱和和不饱和脂肪酸组成,即:沙棘叶中含有大量的脂肪酸。饱和脂肪酸中有棕榈酸(55.33 mg/g)、白石酸(1.07 mg/g)、硬脂酸(1.03 mg/g)、花生酸(0.91 mg/g)、木质素酸(0.78 mg/g)、人造黄油酸(0.32 mg/g)、肉豆蔻酸(0.28 mg/g);在不饱和脂肪酸中,油酸(7.79毫克/克)、亚油酸(2.42毫克/克)。沙棘树皮的脂肪酸主要为饱和花生四烯酸(20.85 mg/g)、棕榈酸(2.14 mg/g)、芥子酸(2.09 mg/g)、四烯酸(1.87 mg/g)、白酸(1.38 mg/g)和不饱和油酸(5.75 mg/g)和亚油酸(4.86 m/g)。在沙棘果肉中鉴定出9种脂肪酸。棕榈酸(23.55 mg/g)含量较多,还有硬脂酸(2.68 mg/g)、肉豆蔻酸(1.36 mg/g)、花生二酸(0.87 mg/g)。在不饱和酸中,鉴定出油酸(44.42 mg/g)、亚油酸(12.49 mg/g)、亚麻酸(5.96 mg/g)、棕榈油酸(5.16 mg/g)和异丙酸(3.79 mg/g)。沙棘的种子含有8种脂肪酸。其中3种是饱和酸:棕榈酸(15.89 mg/g)、硬脂酸(2.51 mg/g)、肉豆蔻酸(0.71 mg/g),还有5种不饱和酸:油酸(31.41 mg/g)、亚油酸(27.03 mg/g)、亚麻酸(17.00 mg/g)、亚麻酸(2.86 mg/g)和棕榈酸(2.56 mg/g)。分析结果表明,沙棘药用植物原料具有丰富的脂肪酸组成。确定了其具体特征是棕榈烯酸和异丙酸在果肉和种子中的存在和比例;这是沙棘原料鉴别的特点。因此,这种原料有望用于制造基于它的药物和膳食补充剂,用于治疗和预防各种疾病。
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引用次数: 0
Development of conditions for Pyrazidol identification in the urine in the presence of its biotransformation products by thin layer chromatography and mass spectrometry 用薄层色谱和质谱法鉴定尿液中吡嗪醇生物转化产物的条件
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.78
S. V. Baiurka, S. A. Karpushyna
For the analytical diagnosis of drug poisoning, it is important to develop conditions for the detection of both native compounds and products of their biotransformation in biological samples.Aim. To develop a method for isolating the antidepressant drug Pyrazidol from the human urine in the presence of its biotransformation products and determine the conditions that are suitable for analytical diagnostics of thymoleptic intoxication for their detection by thin layer chromatography.Materials and methods. The study was conducted with the human urine samples collected after taking a single therapeutic dose of Pyrazidol. The urine was subjected to the acid hydrolysis, and the antidepressant and its metabolites were extracted from the hydrolysate with chloroform from an alkaline medium at pH 8-9. Concomitant endogenous admixtures were removed by extraction with diethyl ether from an acidic medium at pH 1. For the chromatographic study of the extracts, four mobile phases recommended by the International Association of Forensic Toxicologists for TLC screening of drugs, and Merck chromatographic plates were used. Color reactions were performed on pieces of chromatographic plates with a number of chromogenic reagents most commonly used in chemico-toxicological analysis. Metabolites were identified by electron impact mass spectrometry.Results and discussion. The native substance and dehydropyrazidol were detected in the urine hydrolysates by TLC, their chromatographic mobility parameters in four TLC screening systems, as well as the results of their color reactions with the chromogenic reagents were determined.Conclusions. Conditions for isolating Pyrazidol and its biotransformation product from the urine have been proposed. The method for detecting the native compound and dehydropyrazidol in the urine extracts by TLC and mass spectrometry after taking a single therapeutic dose of the drug has been developed. The method is recommended for use in the practice of forensic and clinical toxicology.
在药物中毒的分析诊断中,建立检测生物样品中天然化合物及其生物转化产物的条件是十分重要的。建立一种从人尿中分离抗抑郁药物吡嗪醇生物转化产物的方法,并确定适用于胸腺中毒分析诊断的薄层色谱检测条件。材料和方法。该研究是在服用单剂量吡嗪醇治疗后收集的人类尿液样本进行的。将尿液进行酸水解,在pH为8-9的碱性培养基中用氯仿从水解物中提取抗抑郁药及其代谢物。在pH为1的酸性培养基中,用乙醚萃取去除伴随的内源外加剂。提取物的色谱研究采用国际法医毒理学家协会推荐的四种TLC筛选药物的流动相和默克色谱板。用化学毒理学分析中最常用的显色试剂在色谱板上进行显色反应。代谢物用电子冲击质谱法鉴定。结果和讨论。用薄层色谱法测定了尿水解液中的天然物质和脱氢吡嗪醇,测定了它们在4种薄层色谱筛选体系中的色谱迁移率参数,并测定了它们与显色剂的显色反应结果。提出了从尿液中分离吡嗪醇及其生物转化产物的条件。建立了单次用药后用薄层色谱和质谱法检测尿提取物中天然化合物和脱氢吡嗪醇的方法。建议在法医和临床毒理学实践中使用该方法。
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引用次数: 0
Development the composition and technology for obtaining a dietary supplement “Cachinol” with the antioxidant activity in the form of granules used in the polycystic ovary syndrome 开发了一种膳食补充剂“Cachinol”的组合物和技术,其抗氧化活性以颗粒形式用于多囊卵巢综合征
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.77
O. Maslov, S. Kolisnyk, M. Komisarenko, T. A. Kostina, K. Dynnyk
Aim. To develop the composition and technology for obtaining a dietary supplement “Cachinol” with the antioxidant activity in the form of granules used in the polycystic ovary syndrome.Materials and methods. To achieve the goal, physical, physicochemical, pharmacotechnological and statistical research methods, as well as generally accepted research methods of the State Pharmacopoeia of Ukraine (SPhU) 2.0 were used in the work.Results and discussion. The rational dosage form is granules. The green tea leaf extract and myo-inositol were chosen as the active pharmaceutical ingredients of granules. For 3 batches of granules, the following parameters were determined: the fractional composition ranging from 13.2 to 17.9 % for 3-2 mm, from 45.3 to 56.2 % for 2-1 mm, from 20.1 to 26.1 % for 1-0.5 mm, from 8.1-12.4 for 0.5-0.25 mm, from 2.95-4.6 % for < 0.25 mm; the moisture content of granules ranging from 2.80-3.10 %; the bulk density – from 0.49 to 0.52 g/cm3, the tapped density – from 0.54 to 0.58 g/cm3; the flowability was in the range of 8.00-8.25 g/s; the angle of repose – from 30 to 33°; disintegration – from 41 to 45 s.Conclusions. The flowchart for obtaining granules in industrial conditions has been developed. The technological process for obtaining granules consists of 8 technological stages. The studies of the technological parameters of granules have been performed in accordance with the requirements of the SPhU 2.0. It has been found that the granules developed meet the requirements of the SPhU 2.0 and can be recommended for further research.
的目标。开发一种用于多囊卵巢综合征的具有抗氧化活性颗粒的膳食补充剂“Cachinol”的组合物和工艺。材料和方法。为了达到这个目标,工作中使用了物理、物理化学、药理学和统计学的研究方法,以及乌克兰国家药典(SPhU) 2.0中公认的研究方法。结果和讨论。合理剂型为颗粒剂。选择绿茶叶提取物和肌醇作为颗粒的有效药物成分。对于3批颗粒剂,确定了以下参数:3-2 mm为13.2 ~ 17.9%,2-1 mm为45.3% ~ 56.2%,1-0.5 mm为20.1% ~ 26.1%,0.5-0.25 mm为8.1 ~ 12.4%,< 0.25 mm为2.95 ~ 4.6%;颗粒含水量为2.80 ~ 3.10%;堆积密度-从0.49到0.52 g/cm3,抽头密度-从0.54到0.58 g/cm3;流动度范围为8.00 ~ 8.25 g/s;休止角- 30 ~ 33°;解体-从41到45。制定了在工业条件下获得颗粒的流程图。获得颗粒的工艺过程包括8个工艺阶段。按照SPhU 2.0的要求对颗粒的工艺参数进行了研究。结果表明,制备的颗粒符合SPhU 2.0的要求,可作为进一步研究的推荐材料。
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引用次数: 1
Improvement of the pharmacopoeial identification of burr marigold herb by macro- and microscopic characteristics 金盏花药材宏显微鉴别方法的改进
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.72
S. Kotov, T. Gontova, О. Sokolova
Aim. To improve the national monograph of burr marigold (Bidens tripartita L.) herb on macro- and microscopic characteristics of the raw material. To achieve this goal, a comparative macroscopic analysis of various species of burr marigold and an extended microscopic analysis of all parts of the plant that are part of the raw material were carried out.Materials and methods. The study objects were 7 samples of the medicinal plant raw material of Bidens tripartita L. identified and registered at the premises of the State Enterprise “Pharmacopoeia Center”. They were provided by various domestic manufacturers; a sample of the whole raw material of B. frondosa L. collected in the Akhtyrsky district ofthe Sumy region; a sample of the whole raw material of B. cernua L. provided by a domestic pharmaceutical enterprise. The raw material was harvested in the period of budding and the beginning of flowering. The dry raw material wassubject to the macroscopic analysis. The microscopic analysis was performed on the powder of the raw material sifted through a sieve with a hole diameter of 355 since according to the requirements of the European Pharmacopoeia and the State Pharmacopoeia of Ukraine this was a standardized procedure for determining the diagnostic signs of the medicinal plant raw material by microscopy.Results and discussion. As a result of the macroscopic analysis, it has been found that the raw material of Bidens tripartita L. is a mixture of the whole or fragmented stems with leaves, leaves, anthodia, and achenes. Stems are green or greenish-purple, round-oval, longitudinally grooved. Leaves are green or brownish-green, with a dentateserrated edge, opposite, with a 3-5-parted lamina with lanceolate lobes narrowed into short, slightly winged petioles. Inflorescences are erect anthodia, their width is almost equal to the height. Fruits are flattened achenes, at the apex with 2 or 3 awns, twice as short as the achene. The awns and lateral ribs of the achenes are covered with bristles, which tips are directed downwards. As a result of the microscopic analysis of Bidens tripartita L. powder, diagnosticsigns of all parts of the raw material have been found, namely: fragments of the lamina with veins, along which secretory channels with reddish-brown contents pass; fragments of the lamina from the upper or lower epidermis with the basic cells with sinuous walls, stomata anomocytic type, covering caterpillar form trichomes of 9–18 thin-walled cells, rarely thick-walled covering trichomes of 2-13 cells; fragments of the stem epidermis of rectangular elongated cells with thickened walls; fragments of the epidermis of the inner leaves of the involucres of elongated rectangular thin-walled cells and articulated branched secretory channels; fragments of epidermis of tubular flowers from polygonal cells with rounded papillary outgrowths; rounded pollen grains with spinous exine; fragments of the testa with pigmented darkbrown cells of the hypodermis and the
的目标。对毛莨属药材的宏观和微观特征进行完善。为了实现这一目标,对毛刺万寿菊的各种物种进行了比较宏观分析,并对作为原材料一部分的植物的所有部分进行了扩展的微观分析。材料和方法。研究对象为在国家企业“药典中心”鉴定注册的7份药用植物原料白刺草样品。它们由国内各种制造商提供;在苏梅地区Akhtyrsky地区采集的灰树花全原料样品;国内某制药企业提供的全药材样品。原料是在萌芽期和开花初期收获的。对干燥原料进行宏观分析。根据欧洲药典和乌克兰国家药典的要求,对原料粉末进行显微镜分析,筛孔直径为355,这是通过显微镜确定药用植物原料诊断体征的标准化程序。结果和讨论。通过宏观分析发现,三棱拜登的原料为整茎或碎块茎与叶、叶、刺骨和瘦果的混合。茎绿色或绿紫色,圆形椭圆形,纵槽。叶绿色或棕绿色,具具齿锯齿的边缘,对生,具3-5分片具披针形裂片狭窄成短,稍具翅叶柄。花序直立,呈菱形,其宽度几乎等于高度。果扁平瘦果,在先端具2或3个芒,短于瘦果的两倍。瘦果的芒和侧肋被刚毛覆盖,刚毛的尖端向下。通过对三叶拜登粉末的显微分析,发现了该原料各部分的诊断征象,即:带有静脉的薄片碎片,其分泌通道呈红褐色;上表皮或下表皮的薄片碎片与具有弯曲壁的基本细胞,气孔无形型,覆盖9-18薄壁细胞的毛虫状毛状体,很少厚壁覆盖2-13细胞的毛状体;矩形细长细胞的茎表皮碎片,细胞壁增厚;细长的矩形薄壁细胞的总苞内叶表皮碎片和铰接的分枝分泌通道;管状花由多角形细胞产生的表皮碎片,具圆形乳头状突起;圆形花粉粒具刺状外壁;有色素沉着的深棕色细胞的睾丸碎片和相邻的下层细长的淡黄色硬膜。对SPhU 2.2国家专著“毛莨药材bn”的“鉴定A、B”部分(原料的宏观和微观标志)进行了改进,可以更准确地鉴定药用植物原料的各个部位。开发的补充内容包含在SPhU 2.5的专著“毛茛金盏花草药”的文本中。
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引用次数: 0
Development of a methodological approach to determine regression equations in the study of the technology for manufacturing tablets based on quercetin 在槲皮素片剂生产工艺研究中建立回归方程的方法学方法
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.79
O. Kutova, I. Kovalevska, N. Demchenko
When developing the technology of tablets and tablet masses one of the tasks is to determine the amounts of excipients required to obtain pharmaco-technological quality indicators that meet the requirements of the State Pharmacopoeiaof Ukraine (SPhU).Aim. To develop an algorithm for determining the type of three-factor mathematical models with dependent variables.Materials and methods. The study object was experimental observations of the quantitative effect of excipients in the tablet composition based on a solid dispersion of quercetin on the pharmacopeial characteristics of this dosage form, in particular on its flowability. The experimental data were processed by the planned experiment using Mathcad 15 and MS Excel software according to the algorithm proposed.Results and discussion. It has been found that the identification of mathematical models in pharmaceutical studies with three dependent factors, which total value is determined by the quantitative composition of the dosage formand fixed at a certain level, is difficult to perform due to the difficulty of interpreting the multiple regression parameters as characteristics of factors in isolation through their correlability. It has been proven that the replacement of variablesleads to the determination of a mathematical model that does not reveal the mechanism of the factors’ action and is a static description of their overall impact on the indicator studied.Conclusions. As a result of the research conducted, regression equations were found to determine the effect of the amount of these excipients on the tablet flowability. It has been found that the most influential role in determining the target in the factor space studied is played by the interaction of factors. The algorithm for determining the mathematical description of the dependence with three variables has been proposed. Based on the fact that the research is conditioned by strict conditions in the quantitative composition, the chosen mathematical model of the dependence of the quadratic equation with two factors, for which there are limitations, has no correlation. The model determined is characterized by the possibility of providing the graphical interpretation and simplification of analysis and can be used for forecasting and optimization.
在片剂和片剂质量的工艺开发中,其中一项任务是确定所需辅料的用量,以获得符合乌克兰国家药典(SPhU)要求的药学技术质量指标。开发一种确定具有因变量的三因素数学模型类型的算法。材料和方法。研究对象是实验观察槲皮素固体分散片中辅料对该剂型药典特性的定量影响,特别是对其流动性的影响。根据提出的算法,使用Mathcad 15和MS Excel软件对实验数据进行计划实验处理。结果和讨论。研究发现,在药物研究中,由于难以通过相关性将多元回归参数解释为孤立因素的特征,因此具有三个依赖因素的数学模型的识别是困难的,这些依赖因素的总价值由剂型的定量组成决定并固定在一定水平上。已经证明,变量的替换导致数学模型的确定,该模型不能揭示因素作用的机制,并且是对其对所研究指标的总体影响的静态描述。通过研究,找到了回归方程来确定这些辅料的用量对片剂流动性的影响。研究发现,在所研究的因子空间中,对目标确定影响最大的是因子间的相互作用。提出了确定三变量相关性数学描述的算法。由于本研究在定量组成上有严格的条件限制,所选择的二次方程与两因素的相关性数学模型存在局限性,不具有相关性。所确定的模型具有图形化解释和简化分析的可能性,可用于预测和优化。
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引用次数: 1
Determination of the optimal concentration of the thyme essential oil in a cosmetic cream for the treatment of skin diseases 治疗皮肤病的美容霜中百里香精油的最佳浓度的测定
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.80
L. O. Puchkan, L. Fukleva, D. Romanina
Aim. To determine the optimal concentration of the thyme essential oil in the cream for the treatment of scalp diseases as part of the first stage of the development of the composition of this remedy.Materials and methods. The study object was model ointment compositions on the vaseline-lanolin base with different concentrations of the thyme essential oil. The antimicrobial and antifungal activities of the essential oil components were determined in the microbiological studies using agar diffusion. The reliability of the effect of the concentration of the thyme essential oil on the microbiological activity was determined by the method of mathematical planning of the experiment with a repeated number of tests.Results and discussion. Using Duncan’s multiple rank test, the ointment compositions with different content of the thyme essential oil (0,5 %, 1 %, 2 %, 3 %, 5 %, 7 %, 10 %) made on a vaseline-lanolin base (7 : 3) were ranked by the effect of the concentration of the thyme essential oil on the microbiological activity. According to the results obtained, the best indicators of the microbiological activity were observed in the samples containing 10 %, 7 % and 5 % thyme essential oil, and they had practically the same activity of their concentrations. In order to save the thyme essential oil, it was decided to focus on its minimum concentration (5 %), which provided the maximum antibacterial effect.Conclusions. The results of the studies allowed us to state the reliable effect of the concentration of the thyme essential oil on the microbiological activity of the ointment. The optimal concentration of the thyme essential oil, which is 5 %, has been determined. It will be used in the future to develop the optimal composition of a cosmetic cream.
的目标。确定用于治疗头皮疾病的乳膏中百里香精油的最佳浓度,作为该药物组合物开发的第一阶段的一部分。材料和方法。以不同浓度百里香精油在凡士林-羊毛脂基础上的膏体组成为研究对象。用琼脂扩散法测定了精油成分的抑菌活性和抑菌活性。通过反复试验的数学规划方法确定百里香精油浓度对微生物活性影响的可靠性。结果和讨论。采用Duncan多重秩检验,以凡士林-羊毛脂(7:3)为基料,对不同百里香精油含量(0、5%、1%、2%、3%、5%、7%、10%)的软膏进行了微生物活性排序。结果表明,百里香精油浓度为10%、7%和5%时,其微生物活性指标最佳,且浓度基本相同。为节约百里香精油,确定其最低浓度(5%)为最佳抑菌效果。研究结果使我们能够确定百里香精油浓度对软膏微生物活性的可靠影响。确定了百里香精油的最佳浓度为5%。它将在未来用于开发化妆品霜的最佳成分。
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引用次数: 1
Technological aspects of the “Probioskin” emulgel development “益生菌皮肤”乳剂开发的技术方面
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.88
A. Soloviova, O. Kaliuzhnaia
Aim. To develop a rational technology of a new semisolid preparation for skin application with a probiotic component in the form of an emulgel under the conditional name “Probioskin”.Materials and methods. When developing the technology the study objects were emulgel samples with selected substances – a lyophilized biomass of lactobacilli, dexpanthenol, lactic acid, and excipients – Aristoflex AVC gelling agent, propylene glycol, polysorbate-80, tocopherol, peach oil. To control the quality of the samples, the requirements of the monograph of the SPhU 2.4 on dosage forms “Semi-solid preparations for dermal use” and the general monograph of the SPhU 2.5 “Viable biotherapeutic drugs for human use” were observed.Results and discussion. The process of production of the “Probioskin” drug developed is carried out in the premises of purity class C according to the standard flowchart: the stage of auxiliary works, the stage of the main technological process, the stage of packaging, labeling and shipment of the finished product. The sequence of the technological stages in accordance with the technology of production of a semisolid preparation for skin application – the “Probioskin” emulgel consists of 8 stages: preparation of the raw material, preparation of an oil concentrate of a probiotic component, preparation of an aqueous concentrate of active substances, preparation of a gel base, preparation of an emulsion, packaging of tubes in packs, packaging of packs in group container. The specification for the “Probioskin” drug includes the following sections: “Description”, “Identification”, “pH”, “Uniformity”, “Mass of packaging contents”, “Microbiologicalpurity”, “Assay”. The results of control of the finished product meet the requirements of the MQC.Conclusions. Based on the complex of physicochemical, microbiological, biopharmaceutical, technological, rheological studies, a rational technology of a semisolid preparation for skin application under the conditional name “Probioskin”in the form of an emulgel has been developed. The indicators of quality, permissible norms, methods of control and critical parameters of production of the product developed have been determined.
的目标。开发一种新的用于皮肤应用的半固体制剂的合理技术,其中含有乳剂形式的益生菌成分,条件名称为“益生菌皮肤”。材料和方法。在开发该技术时,研究对象是选定物质的凝胶样品-乳酸菌,dexpanthenol,乳酸和辅料- Aristoflex AVC胶凝剂,丙二醇,聚山梨酸酯-80,生育酚,桃油。为控制样品质量,观察SPhU 2.4各论《皮肤用半固体制剂》和SPhU 2.5通用各论《人用活性生物治疗药物》对剂型的要求。结果和讨论。所开发的“益生菌皮”药物的生产过程在纯度C级的前提下按照标准流程图进行:辅助工作阶段、主要工艺流程阶段、成品包装、贴标和出货阶段。按照生产用于皮肤的半固体制剂-“益生菌皮肤”乳凝胶的技术顺序,技术阶段包括8个阶段:原料制备,益生菌成分油浓缩物制备,活性物质水浓缩物制备,凝胶基制备,乳液制备,袋装管包装,袋装组容器包装。“益生菌皮”药物的说明书包括以下部分:“描述”、“鉴定”、“pH值”、“均匀性”、“包装内容物质量”、“微生物纯度”、“测定”。成品的控制结果符合mqc的要求。结论。基于物理化学、微生物学、生物制药、技术、流变学的综合研究,开发了一种以乳状体形式应用于皮肤的半固体制剂,条件名称为“益生菌皮肤”。确定了所开发产品的质量指标、允许标准、控制方法和关键生产参数。
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引用次数: 0
The study of the anatomical structure of Cercis siliquastrum L. leaves 茜草叶片解剖结构的研究
Pub Date : 2022-02-07 DOI: 10.24959/nphj.22.73
O. Demeshko, I. Batiuchenko, S. V. Kovalev, O. V. Krivoruchko, S. Romanova
Aim. To study the anatomical structure of Cercis siliquastrum L. leaves.Materials and methods. The study objects were leaves of Judas tree collected in the Botanical garden of the National University of Pharmacy in June, 2021. Micropreparations were made of fresh, dried material and fixed with a mixture of 96 % ethanol, water and glycerin (1 : 1: 1). Micropreparations were prepared and examined according to the methodsof the SPhU using a Granum microscope (Austria). A Canon PC1251 camera was used for photographing.Results and discussion. The type of the leaf blade is dorsoventral, hypostomatic, there are cells with the orange content. There are numerous stomata of anocytic (sometimes anisocytic) type. Simple multicellular hairs with a weakly warty cuticle were found on the lower and upper epidermis. A 2-3-layered collenchymatous parenchyma is located above the central vein. The bundle sheath is crystalliferous. On the xylem side, 5-6 layers of the sclerenchyma are observed. The petiole has an oval shape, slightly ribbed near the leaf blade. In the middle of the petiole there are three bundles: two radial on the sides and one central with two additional bundles. All bundles are surrounded by a common sclerenchymal ring. There are cells with the orange content in the parenchyma. On the abaxial side there is a layer of cells with calcium oxalate drusens under the sclerenchyma. The petiole is rounded, slightly ribbed. The bundle has a crescent shape in the center. The xylem rays are with the brown content. The sclerenchyma is well developed. There are drusens in the parenchyma of the petiole.Conclusions. The main anatomical features of Judas tree leaves have been determined; it will allow identifying and standardizing the plant raw material. The data obtained are necessary for the development of Drug Quality Control Methods (DQCM) for the medicinal raw material.
的目标。目的:研究茜草叶片的解剖结构。材料和方法。研究对象为国立药学院植物园于2021年6月采集的犹大树叶子。用新鲜、干燥的材料制备微制剂,用96%乙醇、水和甘油(1:1:1)的混合物固定。用Granum显微镜(奥地利)按照SPhU方法制备微制剂并进行检测。使用佳能PC1251相机进行拍摄。结果和讨论。叶片类型为背腹状,下气孔,有细胞,含橙色。有许多无细胞(有时是各细胞)型气孔。下表皮和上表皮上可见简单的多细胞毛,具弱疣状角质层。2-3层厚壁实质位于中央静脉上方。束鞘是结晶的。木质部一侧有5-6层厚壁组织。叶柄有椭圆形,在叶片附近稍具棱。叶柄中部有三束:两束在叶柄两侧呈放射状,一束在叶柄中央,另外还有两束。所有束被一个共同的厚壁细胞环包围。薄壁组织中有含有橙色的细胞。背面厚壁组织下有一层草酸钙膜细胞。叶柄圆形,稍具棱。束的中心呈新月形。木质部射线含有棕色成分。厚壁组织发育良好。叶柄薄壁中有胆鞘。确定了犹大树叶片的主要解剖特征;它将允许识别和标准化植物原料。所获得的数据为药材质量控制方法的制定提供了必要的依据。
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引用次数: 0
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News of Pharmacy
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