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Glycopeptide Antibiotic Derivatives Against Resistant Bacteria 抗耐药细菌的糖肽抗生素衍生物
Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.173-174
Ilona Bereczki, Z. Szűcs, Erzsébet Rőth, E. Lőrincz, M. Milánkovits, E. Ostorházi, Zsuzsanna Dombrádi, A. Borbás, P. Herczegh
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引用次数: 0
Complement Activation-Related Pseudoallergy (CARPA) in Rats: The Example of Liposomal Amphotericin-B (AmBisome) 补体激活相关的大鼠假过敏(CARPA):以两性霉素b脂质体(AmBisome)为例
Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.175-176
Tamás Bakos, Erik Őrfi, T. Mészáros, Gergely Milosevits, Domonkos Csukás, L. Rosivall, P. Hamar, L. Dézsi, J. Szebeni, G. Szénási
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引用次数: 0
Alpha-1-Acid Glycoprotein as a Diagnostic Biomarker for Malignant Melanoma α -1-酸性糖蛋白作为恶性黑色素瘤的诊断生物标志物
Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.332-333
Dávid Virág, T. Kremmer, K. Lőrincz, Norbeert Kiss, S. Bozsányi, A. Jobbágy, N. Wikonkál, B. Dalmadi Kiss, I. Klebovich, K. Ludányi
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引用次数: 0
Determination of the Anorexigenic Drug Sibutramine in Biologically Active Dietary Supplements 生物活性膳食补充剂中厌氧药物西布曲明的测定
Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.220-221
V. I. Gegechkori, A. M. Sukhanova, G. M. Rodionova
Overweight is currently a common problem in modern society. People from all over the world are in search of the easiest and fastest, as well as the most effective ways to lose weight [1].To solve this problem, people turn to various fitness routines, but most people resort to taking anorexigenic biologically active dietary supplements, as well as medications. The most effective drug on the pharmaceutical market is sibutramine. It is included in the list of potent and toxic substances and is prescription-only, which makes it difficult to buy sibutramine in a pharmacy; therefore, people often prefer herbal supplements. Sibutramine has been banned in the United States, as well as the European Union, since 2010 following the decision of the Food and Drug Administration (FDA). However, some unscrupulous manufacturers add sibutramine to anorexigenic dietary supplements to increase their effectiveness [2]. Thusthere is a need to develop analytical methods for quality control of food additives, to detect cases of fraud on the pharmaceutical market in a timely manner.
超重是现代社会普遍存在的问题。世界各地的人们都在寻找最简单、最快速、最有效的减肥方法[1]。为了解决这个问题,人们转向各种健身程序,但大多数人求助于服用厌氧性生物活性膳食补充剂,以及药物。医药市场上最有效的药物是西布曲明。它被列入强效和有毒物质清单,并且只能凭处方购买,这使得在药房购买西布曲明变得困难;因此,人们往往更喜欢草药补充剂。根据美国食品和药物管理局(FDA)的决定,西布曲明自2010年起在美国和欧盟被禁止使用。然而,一些不道德的制造商将西布曲明添加到厌氧性膳食补充剂中以提高其有效性[2]。因此,有必要开发食品添加剂质量控制的分析方法,及时发现药品市场上的欺诈案件。
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引用次数: 0
Formulation of Apigenin-Loaded Liposomes for Pulmonary Delivery 肺给药芹菜素脂质体的制备
Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.268-269
Sabrina Magramane, Z. Pápay, Anna Kovács, R. Zelkó, I. Antal
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引用次数: 0
Formulation and Physicochemical Characterization of NLC–miRNA Complexes NLC-miRNA复合物的制备及理化性质研究
Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.334-336
Amina Tucak-Smajić, E. Vranić, M. Sirbubalo, Lamija Hindija, O. Rahić, J. Hadžiabdić, I. Klebovich, A. Zimmer
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引用次数: 0
Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic Method for the Determination of Domperidone in Bulk and Pharmaceutical Dosage Forms 稳定性指示高效液相色谱法测定多潘立酮原料药和制剂制剂含量的建立与验证
Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.191-192
Fateme Chavoshy, Niloofar Nejati, A. Mohammadi, N. Adib, Azam Sadat Montazeri
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引用次数: 0
Characteristics and Mechanisms of the Hypersensitivity Reactions Caused by Nanodrugs in Mice 纳米药物致小鼠超敏反应的特点及机制
Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.284-286
Erik Őrfi, T. Mészáros, László Hricisák, L. Dézsi, P. Hamar, L. Rosivall, Z. Benyó, J. Szebeni, G. Szénási
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引用次数: 0
Vaccine Development in Global Pandemic Time 全球大流行时期的疫苗开发
Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.95-96
Tibor Fabó
Introduction Pfizer-BioNTech collaboration started in 2018 in order to develop mRNA flu vaccine. Because of the covid19 pandemic the two companies started to focus on mRNA vaccine development for the prevention of covid19 infection. In March they signed the Letters of Intent. Initially there were four vaccine candidates including unmodified mRNA, nucleoside-modified mRNA and self-amplifying mRNA. For further development the nucleoside- modified mRNA was chosen. In April Phase 1/2 study was completed in Germany and in May in the USA. Two 30 μg doses 3 weeks apart induced neutralizing antibody titers comparable to natural infection and strong CD4+ and CD8+ Tcell responses were observed. Phase 2b/3 clinical trial started in July involving more than 43.000 participants in 153 sites. The result showed 95% efficacy with mild and moderate local and systemic events. For safety reason all participants will be followed for 2 years after the second dose. Based on rolling review regulatory agencies were able to approve within a short period of time in December 2020, first MHRA in UK, then FDA authorized for Emergency Use and EMA granted Conditional Marketing Authorization on 21 December 2021 for 16 years old and older. The first shipments were sent all European countries on 27 December. Direct shipments to vaccination centers on ultra-low temperature (minus 9060 degree of centigrade) using dry ice. Each thermal shipping container has a temperature monitoring device. All shipments are tracked via GPS monitoring device to ensure end-to-end distribution within required temperatures. In May EMA granted an extension of indication for covid-19 vaccine to include in children aged 12-15. The effect of vaccine was investigated in 2260 children aged 12-15, about half of them received dummy injection. Of the 1,005 children receiving the vaccine, none developed COVID-19 compared to 16 children out of the 978 who received the dummy injection. This means that, in this study, the vaccine was 100% effective at preventing COVID-19. The most common side effects in children aged 12 to 15 are similar like those in people aged 16 and above. They include pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever. These effects are usually mild or moderate and improve within a few days from the vaccination. EMA granted approval for booster dose (third dose) for immune weakened people 28 days after the second dose, and 6 months after the second dose for 18 years of age and older. Approval is based on the clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of covid-19 vaccine. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to mo
辉瑞与biontech的合作始于2018年,目的是开发mRNA流感疫苗。由于新冠肺炎大流行,两家公司开始专注于预防新冠病毒感染的mRNA疫苗的开发。3月,他们签署了意向书。最初有四种候选疫苗,包括未修饰的mRNA、核苷修饰的mRNA和自我扩增的mRNA。为了进一步发展,我们选择了核苷修饰的mRNA。4月在德国完成1/2期研究,5月在美国完成。两次30 μg剂量,间隔3周,诱导的中和抗体滴度与自然感染相当,并观察到强烈的CD4+和CD8+ t细胞反应。2b/3期临床试验于7月开始,涉及153个站点的43,000多名参与者。结果显示,轻度和中度局部和全身事件的有效率为95%。出于安全考虑,所有参与者在第二次注射后将被随访2年。根据滚动审查,监管机构能够在2020年12月的短时间内批准,首先是英国的MHRA,然后是FDA授权紧急使用,EMA于2021年12月21日授予16岁及以上人群的有条件上市许可。第一批货物于12月27日发往所有欧洲国家。使用干冰在超低温(零下9060摄氏度)下直接运送到疫苗接种中心。每个热集装箱都有一个温度监控装置。所有货物都通过GPS监控设备进行跟踪,以确保在要求的温度下进行端到端配送。5月,EMA批准将covid-19疫苗的适应症延长至12-15岁儿童。对2260名12-15岁的儿童进行了疫苗效果调查,其中约一半接受了假体注射。在接种疫苗的1005名儿童中,没有人患上COVID-19,而在接受假疫苗注射的978名儿童中,有16名儿童患上了COVID-19。这意味着,在这项研究中,疫苗对预防COVID-19的有效性为100%。12至15岁儿童最常见的副作用与16岁及以上人群相似。这些症状包括注射部位疼痛、疲劳、头痛、肌肉和关节疼痛、发冷和发烧。这些影响通常是轻微或中度的,并在接种疫苗后几天内改善。EMA批准免疫衰弱人群的加强剂(第三剂)在第二剂后28天,18岁及以上人群在第二剂后6个月。批准是基于临床项目评估covid-19疫苗加强剂的安全性、耐受性和免疫原性。与两剂初级系列疫苗接种后观察到的水平相比,加强剂量疫苗可显著提高针对初始SARS-CoV-2病毒(野生型)以及Beta和Delta变体的中和抗体滴度。强化剂量后7天内的反应性一般为轻度至中度,反应频率与第二次剂量后相似或更低。这个试验的有效性是95.6%。2021年10月,FDA批准对5至111岁儿童紧急使用covid-19。对于这一年龄组,疫苗将分为两剂,每剂10 μg (0.2 ml),间隔21天接种。临床数据支持EUA,显示在Delta流行毒株期间,5至11岁儿童具有良好的安全性和90.7%的高疫苗效力。到2021年9月底,我们已经向146个国家分发了18b剂疫苗。在2022年,我们计划分发4B剂。(图)。
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引用次数: 0
Flowability of Pharmaceutical Powders: Impact of Humidity 药粉的流动性:湿度的影响
Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.340-341
Daniela Ehgartner, H. Weingrill, Timothy Aschl, D. Schuetz
Surrounding conditions impact the behavior of many powders. Depending on the geographical location, bulk solids exhibit differing flowability due to different environmental conditions, e.g. Caracas (30°C, 80 %rH) vs. Boulder/Colorado (25°C, 35 %rH). The powder adjusts dynamically to its environmental condition until reaching saturation at a certain point (1). Besides that, many powders show a “sticky point”. At this point, a significant change in flow and adhesion behavior has been reported (2). Granular media generally tend to increase their cohesive character when surrounded by moisture. This is attributed to several mechanisms whereas formation of adhesive films on the grain surface, liquid bridging between the grains, or if the cohesive behavior decreases, a “lubrication” of the interstitials between grains are considered as the main underlying mechanisms (3). The investigated powder is a pharmaceutical cold and flu hot drink which comprises high amounts of vitamin C, citric acid, sugar and pharmaceutically active materials. The powder exhibits a tendency to cake and time consolidate. This is most likely due to a partial dissolution in condensed water as Groen et al. suggests for a pure citric acid (2). This partial dissolution is desired as the powder is supposed to dissolve in water. As the investigated powder contains a large amount of citric acid as well, a similar “sticky point” is expected. However, this property results in the forming of knots and clumps which is problematic for storage and processing. Thus, the aim of the presented work is to investigate changes in the powder’s flowability behavior after exposure to different relative humidity levels as well as to investigate the difference between consolidated and non-consolidated samples with the help of powder shear cell measurements. 2. Methods
周围条件影响许多粉末的性能。根据地理位置的不同,散装固体在不同的环境条件下表现出不同的流动性,例如加拉加斯(30°C, 80% rH)与科罗拉多州博尔德(25°C, 35% rH)。粉末动态地适应环境条件,直到达到饱和点(1)。此外,许多粉末还存在“粘点”。在这一点上,已经报道了流动和粘附行为的显著变化(2)。颗粒介质在被水分包围时通常倾向于增加其粘性。这归因于几种机制,而在颗粒表面形成粘附膜,颗粒之间的液体桥接,或者如果粘性行为减少,颗粒之间间隙的“润滑”被认为是主要的潜在机制(3)。所研究的粉末是一种药物感冒和流感热饮,含有大量的维生素C,柠檬酸,糖和药用活性物质。粉末有结块和时间固化的倾向。这很可能是由于在凝结水中部分溶解,正如Groen等人对纯柠檬酸的建议(2)。这种部分溶解是理想的,因为粉末应该溶于水。由于所研究的粉末也含有大量的柠檬酸,因此预计会出现类似的“粘点”。然而,这种特性会导致结和团块的形成,这对存储和处理来说是有问题的。因此,本文的目的是研究暴露于不同相对湿度水平后粉末流动性行为的变化,以及在粉末剪切室测量的帮助下研究固结和非固结样品之间的差异。2. 方法
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Acta pharmaceutica Hungarica
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