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Extemporaneous preparation as the last resort for drug shortage during covid-19 pandemic-lessons learned 作为covid-19大流行期间药物短缺的最后手段的临时准备——经验教训
Pub Date : 2021-01-01 DOI: 10.35841/2249-622X.71.17464
Ayman M Al-Qaaneh, Fuad H. Al-Ghamdi
COVID-19, as a newly emerged pandemic caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), attacked almost 17 million patients with more than 668 thousand fatalities (8%) as of today July 30, 2020 (https://coronavirus.jhu.edu/map. html), Created a significant strain on the pharmaceutical industries as well as pharmaceutical supply chains in terms of drug availability and delivery to the requested countries. This stain referred to many reasons, including but not a limited to; the Vast number of patients in a short period that increased demands, locked-down strategies adopted by some countries as a precautionary measure which limited the drug Import/Export process, shifting some pharmaceutical manufacturers their production lines to produce certain drugs in high demands, e.g., Intensive care and different antiviral drugs.
COVID-19是由严重急性呼吸综合征冠状病毒-2 (SARS-CoV-2)引起的新出现的大流行,截至2020年7月30日,已有近1700万患者感染,超过66.8万人死亡(8%)(https://coronavirus.jhu.edu/map)。html),在药物供应和向请求国家的运送方面,对制药业和药品供应链造成了重大压力。这一污点涉及许多原因,包括但不限于;大量患者在短时间内增加了需求,一些国家采取了封锁战略作为一项预防措施,限制了药物进出口过程,将一些制药商的生产线转移到生产某些高需求药物,例如重症监护和不同的抗病毒药物。
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引用次数: 0
A unique combination of Alchornea cordifolia and Pterocarpus santalinoides in the management of multi-drug resistant diarrhoegenic bacterial infection. 在多重耐药腹泻性细菌感染的管理中,堇青花和山蕨的独特组合。
Pub Date : 2020-01-01 DOI: 10.35841/2249-622X.69.5059
M. Obaji, I. Enweani, A. Oli
Background: Traditionally, diarrhoea in our locality has often been managed using herbs. Multi-drugresistant organisms refer tomicrobes that areresistant to the effects of antimicrobial drugs to which they were previously susceptible at therapeutic range. Objectives: This study investigates the combined effects of Alchornea cordifolia and Pterocarpus santalinoides leaves extracts against selected multi-drug resistant diarrhoegenic bacteria. Methods: Fresh plant seeds were collected from the plants, shade-dried, pulverized and extracted with methanol in a Soxhlet apparatus. Antibacterial activities of these plants were investigated using agarwell diffusion assay. The MIC and FIC of the extracts against test isolates were determined using agar well diffusion method and checkerboard assay respectively. The bactericidal effects of the extracts against the isolates were evaluated using Time-Kill Assay. Results: MIC values of methanolic extracts against drug resistant strains of Salmonella typhi , Shigella dysenteriae , Escherichia coli and Staphylococcus aureusranges from 6.25 µg/mL to 12.5 µg/mL. The combination of Alchornea cordifolia and Pterocarpus santalinoides extracts showed synergy at 8:2 and 4:6 combinations against S. aureus, Salmonella typhi and E. coli; at 7:3 combinations against E. coli ; at 6:4 and 3:7 combinations against S. aureus, Salmonella typhi , S. dysenteriae ; at 5:5 combinations against all the test isolates; at 2:8 combinations against S. aureus , S. dysenteriae and E. coli but additive against Salmonella organisms; at 1:9 combinations against S. aureus and Salmonella organism. Conclusion: The methanol extracts of the plants at combinations 5:5 is synergistic against all the tested multi-drug resistant diarrhoegenic bacteria. Combination of Salmonellaand A. cordifolia showed potentials of synergism against the test isolates. The detection of synergy suggests presence of antibiotic resistance modifying compounds in those extracts.
背景:传统上,我们当地的腹泻通常使用草药治疗。多重耐药生物是指对抗菌药物产生耐药性的微生物,而这些微生物以前在治疗范围内是敏感的。目的:研究菖蒲叶提取物联合抗多种耐药腹泻菌的作用。方法:采集新鲜植物种子,在索氏装置中遮荫干燥、粉碎、甲醇提取。用琼脂扩散法研究了这些植物的抑菌活性。分别用琼脂孔扩散法和棋盘法测定提取物对分离株的MIC和FIC。采用时间杀伤法评价提取物对分离菌株的杀菌效果。结果:甲醇提取物对伤寒沙门氏菌、痢疾志贺氏菌、大肠杆菌和金黄色葡萄球菌耐药菌株的MIC值在6.25µg/mL ~ 12.5µg/mL之间。菖蒲提取物与山菖蒲提取物联合对金黄色葡萄球菌、伤寒沙门氏菌和大肠杆菌的协同作用分别为8:2和4:6;对大肠杆菌的联合作用为7:3;金黄色葡萄球菌、伤寒沙门氏菌、痢疾沙门氏菌分别为6:4和3:7;针对所有测试分离株的组合比例为5:5;抗金黄色葡萄球菌、痢疾葡萄球菌和大肠杆菌的组合比例为2:8,但抗沙门氏菌的添加剂比例为2:8;金黄色葡萄球菌和沙门氏菌的比例为1:9。结论:组合5:5的甲醇提取物对所有耐多药腹泻菌均有协同作用。沙门氏菌与cordifolia联合对试验分离株具有协同作用。协同作用的检测表明这些提取物中存在抗生素抗性修饰化合物。
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引用次数: 1
In vivo and in vitro healing potential of aqueous extract ointment Ageratum conyzoïdes Linn. applied to excision and incision wounds induced in Wistar rat and human cells 藿香水浸膏的体内和体外愈合潜力conyzoïdes。适用于Wistar大鼠和人细胞的切除和切口创面
Pub Date : 2020-01-01 DOI: 10.35841/2249-622X.70.10227
Christelle B.D. Kouloungous Bafila, Nadège Okémy Andissa, S. U. Moussoungou, B. Moulari, A. Abena
The healing effect of the aqueous extract and ointment at 4 and 8 g/kg doses of Ageratum conyzoides Linn. on tracing and excision-induced wounds in the Wistar rat was the subject of our study. We used the classical tests described by some authors to carry out pharmacological work and organoleptic and toxicological analyses of the extract and formulation of this plant. The results, derived from this methodology, show that this ointment is homogeneous, weakly aromatic and acidic (pH : 5,6), rich in dissolved and mineral substances, no lethality was observed up to the dose of 3200 mg/kg in acute. Also, the aqueous extract of this plant has an abundance of Flavonoids. In addition, the healing effect of Ageratum conyzoides L. ointment was evaluated on deep wounds in Wistar rats. The planimetry results and measurements made over twentysix (26) days proved that the ointment at 4 and 8 g/rat weight; Madecassol® at 400 mg/kg (reference product) significantly reduced the mean area of the deep wounds in Wistar rats compared to the negative controls. In addition, the aqueous extract of Ageratum conyzoides L. at the dose of 5,5 ml/kg administered in vitro on cell model wounds created by scraping the cell web, significantly reduces the wound in 24 hours. In addition, at the dose of 11 ml/kg this scarring is complete, there is no visible wound trace. This reflects the presence of a cell thrust at the level of the scratch compared to the control lot, whose wound remained almost gaping. Thus, are confirmed the data of literature and traditional medicine on spa summarized efficacy.
以4、8 g/kg剂量的鹰嘴藤水提液和软膏对其愈合效果的影响。我们的研究对象是Wistar大鼠的追踪和切除性伤口。我们使用一些作者描述的经典试验对该植物的提取物和配方进行药理学工作和感官和毒理学分析。该方法得出的结果表明,该药膏均匀,弱芳香,呈酸性(pH值:5,6),富含溶解性和矿物质,急性剂量达3200mg /kg时未见致死性。此外,这种植物的水提取物含有丰富的黄酮类化合物。此外,还评价了鹰嘴草软膏对Wistar大鼠深创面的愈合作用。平面测量结果和测量超过二十六(26)天证明,药膏在4和8 g/大鼠体重;与阴性对照相比,400 mg/kg(参考产品)的Madecassol®显著减少了Wistar大鼠的平均深创面面积。此外,以5、5 ml/kg剂量给药于体外刮网细胞模型创面,24小时内可显著减少创面。此外,在剂量为11 ml/kg时,瘢痕形成完全,没有可见的伤口痕迹。这反映了与对照组相比,在划痕的水平上存在细胞推力,对照组的伤口几乎是张开的。由此,证实了文献资料和传统医学对spa的疗效总结。
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引用次数: 0
Could covid-19 virus be airborne? covid-19病毒会通过空气传播吗?
Pub Date : 2020-01-01 DOI: 10.35841/2249-622x.70.e
F. López-Muñoz
As we know that COVID-19 is a transferable disease initiated by a newly discovered virus called corona virus. This cause fever and common cold to more severe diseases called Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). A nCoV is an strain that is first time identified in humans. Some studies described that MERS-CoV was initially spread through dromedary camels to humans and SARS-CoV was firstly spread from civet cats to humans. Covid -19 outbreak was first acknowledged in Wuhan City as an breathing illness. After china the virus rapidly spread globally counting to the United States. Thousands of individuals have become sick and community health officials are keeping a close watch on how the virus is spreading. It was primarily stated to the WHO on December 31, 2019. On January 30, 2020, the WHO declared the COVID- 19 epidemic a worldwide health emergency. On March 11, 2020, the WHO stated COVID-19 a global pandemic.
众所周知,COVID-19是一种可转移疾病,由一种新发现的冠状病毒引发。这会导致发烧和普通感冒,进而引发更严重的疾病,即中东呼吸综合征(MERS-CoV)和严重急性呼吸综合征(SARS-CoV)。新型冠状病毒是首次在人类中发现的毒株。一些研究描述,MERS-CoV最初通过单峰骆驼传播给人类,SARS-CoV最初由果子狸传播给人类。新冠肺炎疫情首先在武汉市被确认为呼吸系统疾病。在中国之后,病毒迅速传播到全球,包括美国。成千上万的人已经生病,社区卫生官员正在密切关注病毒如何传播。这主要是在2019年12月31日向世卫组织声明的。2020年1月30日,世卫组织宣布COVID- 19疫情为全球突发卫生事件。2020年3月11日,世界卫生组织宣布新冠肺炎为全球大流行。
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引用次数: 0
Simple spectrophotometric method for estimation of drugs using chloraminet and indigo caramine dye couple 氯胺和靛蓝焦胺染料偶联分光光度法测定药物含量
Pub Date : 2020-01-01 DOI: 10.35841/2249-622X.69.6498
Sailaja Battu, G. Venkateshwarlu, B. P. Nenavathu
The five drugs viz., GEM, PHE, TRD, IMT, VRP were estimated using a simple, specific, accurate and precise UV–visible spectrophotometric method. These methods involve the addition of a known nexcess of Chloramine-T to the drugs in acid medium followed by estimation of residual Chloramine-T by reacting with a fixed amount of Indigo caramine dye and measuring the absorbance of the dye at 608 nm. The calibration curves obeyed Beer’s law over the concentration range of 3.0,5.5,6.5 μg mL-1 of GEM; 2.5,3.69,5.01 μg mL-1 of PHE ; 2.0,3.5,7.5 μg mL-1 of TRD; 3.0,4.5,7.0 μg mL- 1 of IMT; and 4.2,5.5,7.0 μg mL-1 of VRP were chosen. The methods that are developed were found to be suitable for the estimation of these drugs in bulk and their formulations. Several parameters such as linearity, accuracy, and precision, Limit of detection and Limit of quantification were considered for the analysis of results of the drugs and their corresponding validation were carried out statistically.
采用简单、特异、准确、精密的紫外可见分光光度法对5种药物GEM、PHE、TRD、IMT、VRP进行测定。这些方法包括在酸性介质中向药物中加入已知过量的氯胺- t,然后通过与一定量的靛蓝焦胺染料反应并测量染料在608 nm处的吸光度来估计氯胺- t的残留量。GEM在3.0、5.5、6.5 μ mL-1浓度范围内的校准曲线符合比尔定律;PHE分别为2.5、3.69、5.01 μ mL-1;TRD 2.0、3.5、7.5 μg mL-1;3.0、4.5、7.0 μ mL- 1的IMT;VRP浓度分别为4.2、5.5、7.0 μ mL-1。发现所开发的方法适用于这些散装药物及其制剂的估计。考虑线性、准确度、精密度、检出限、定量限等参数对药物结果进行分析,并对其进行统计验证。
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引用次数: 1
Potential mechanisms for vitamin D protective effect for COVID-19 morbidity and mortality. 维生素D保护COVID-19发病率和死亡率的潜在机制。
Pub Date : 2020-01-01 DOI: 10.35841/2249-622X.70.13470
P. Ilie, S. Stefanescu, Lee Smith
Ilie et al. have described a correlation between the mean levels of vitamin D with the number of cases of COVID-19 and the mortality per million caused by this disease in several European countries. Other studies have subsequently reported similar findings. The present short commentary aims to discuss the potential mechanisms behind the potential vitamin D protective role for COVID-19.
Ilie等人描述了在几个欧洲国家,维生素D的平均水平与COVID-19病例数和由该疾病引起的每百万人死亡率之间的相关性。其他研究随后也报告了类似的发现。本文旨在讨论维生素D对COVID-19的潜在保护作用背后的潜在机制。
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引用次数: 0
Early ambulatory multidrug therapy for SARS-CoV-2 (COVID-19) infection. SARS-CoV-2 (COVID-19)感染的早期门诊多药治疗
Pub Date : 2020-01-01 DOI: 10.35841/2249-622X.72.21860
P. McCullough
SARS-CoV-2 infection (COVID-19) illness involves viral mediated organ damage, cytokine storm, and thrombosis. Once ill, the only method of reducing the risk of hospitalization and death is medical treatment in the ambulatory phase using the same principles for hospitalized patients. Early therapy that has a reasonable chance of success and an acceptable safety profile includes: 1) combination antiviral therapy, 2) corticosteroids, 3) antiplatelet agents/antithrombotics, 4) supportive care including supplemental oxygen, monitoring, and telemedicine. The current rates of hospitalization and death are unacceptably high under the present paradigm of contagion control and watchful waiting for a vaccine.
SARS-CoV-2感染(COVID-19)疾病涉及病毒介导的器官损伤、细胞因子风暴和血栓形成。一旦生病,减少住院和死亡风险的唯一方法是在门诊阶段使用与住院病人相同的原则进行医疗治疗。早期治疗具有合理的成功机会和可接受的安全性,包括:1)联合抗病毒治疗,2)皮质类固醇,3)抗血小板药物/抗血栓药物,4)支持性治疗,包括补充氧气,监测和远程医疗。在目前传染病控制和警惕等待疫苗的模式下,目前的住院率和死亡率高得令人无法接受。
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引用次数: 0
Review on comprehensive understanding of building an analytical quality by design for drug manufacturing process. 对药品生产过程分析质量设计的综合认识综述。
Pub Date : 2020-01-01 DOI: 10.35841/2249-622x.70.8911
Sai Prasad, Kolpana Diwekar, A Anite
When knowledge based on pure scientific understanding and quality risk management is applied to product and process learning with regulation on process control along with a systematic approach for development of predefined objectives in analytical field then it is called as quality by design or QBD it follow ICH guidelines for quality in pharmaceutical product concept of QBD also extends to analytical methods, it is mandatory process in QBD to define a goal. A protocol for the method which will continue monitoring the process throughout in a systematic way and working on alternate methods as well to get optimal performance, the methods given are carefully analyzed in structured pattern for risks and is put for a challenge of the validity of method which later on can be taken for the criteria, benefit of these studies. The performances can be improved as well as clearly understood along with the risk management and desired performance methods which can also be validated later on, the review briefly gives an inside view of application of analytical QBD in industries and its current status with examples and principles of analytical methods in HPTLC ,titration for moisture content, determination of toxic impurities in mixtures, quantative colour measurement and various spectroscopic method for identification of chemical moiety. QBD developed spectroscopic and chromatographic method is usually done as per ICH Q8 R2, the critical parameters are compared to principle observation and analysis, the HPTLC method employs solvent usage and detection of absorbance and wavelength comparison.
当基于纯科学理解和质量风险管理的知识应用于产品和工艺学习,并与过程控制法规以及系统的方法一起开发分析领域的预定义目标时,它被称为质量设计或QBD。它遵循ICH药品质量指南,QBD概念也扩展到分析方法,它是QBD中定义目标的强制性过程。该方法的协议将以系统的方式继续监控整个过程,并研究替代方法以获得最佳性能,给出的方法以结构化模式仔细分析风险,并对方法的有效性提出挑战,这些方法稍后可以作为这些研究的标准和益处。本文简要介绍了分析QBD在工业中的应用及其现状,包括HPTLC分析方法、水分滴定法、混合物中有毒杂质的测定方法的实例和原理。化学成分的定量颜色测定和各种光谱鉴定方法。QBD开发的光谱和色谱方法通常按照ICH Q8 R2完成,对关键参数进行原理对比观察和分析,HPTLC方法采用溶剂用量和检测吸光度和波长对比。
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引用次数: 1
Point of view about biologic therapy in covid-19 关于covid-19生物治疗的观点
Pub Date : 2020-01-01 DOI: 10.35841/2249-622X.71.19036
S. Castañeda, J. Ancochea, B. Atienza-Mateo, M. González-Gay
COVID-19 (COronaVIrus Disease firstly reported in December 2019) is a complex and heterogeneous disease whose clinical spectrum ranges from asymptomatic cases or with mild symptoms to severe acute respiratory distress syndrome, with/without heart and kidney involvement, especially in people with comorbidities. Treatment we use today is quite empirical, depending on the severity of the disease, associated risk factors and access to medication. In severe cases, a combination of potent anti-cytokine monoclonal antibodies associated to low-dose dexamethasone and remdesivir and/or favipiravir is recommended. Here, we review the clinical evidence and indications of main biologic therapy in the treatment of COVID-19 patients.
2019年12月首次报道的COVID-19(冠状病毒病)是一种复杂的异质性疾病,其临床谱范围从无症状或轻度症状到严重急性呼吸窘迫综合征,伴/不伴心脏和肾脏受累,特别是在有合并症的人群中。我们今天使用的治疗是相当经验性的,取决于疾病的严重程度、相关的风险因素和获得药物的途径。在严重病例中,建议联合使用低剂量地塞米松、瑞德西韦和/或法匹拉韦联合使用强效抗细胞因子单克隆抗体。现就主要生物疗法治疗新冠肺炎的临床证据及适应证进行综述。
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引用次数: 0
First phenotypic and molecular characterization of clinical isolates of drug resistant Providencia rettgeri in Imo state, South-Eastern Nigeria. 尼日利亚东南部伊莫州耐药雷氏普罗维登菌临床分离株的首次表型和分子特征分析
Pub Date : 2020-01-01 DOI: 10.35841/2249-622x.70.12507
M. Ugwu, L. U. Ndunagu, Chika P Ejikwugwu, C. Esimone
Background: Nosocomial outbreak of drug resistant Enterobacteriaceae including those mediated by Providencia species has become a serious public health challenge across the globe – owing to the difficulty in selecting antibiotics for proper treatment especially in the face of resistance. The morbidity and mortality rate of bacteremia due to Providencia species could be high, especially among the elderly and those with pre-existing medical conditions. This study was aimed at determining the occurrence of multidrug resistance phenotypes in clinical isolates of Providencia rettgeri using both phenotypic and genotypic techniques. Methods: Clinical isolates were identified to be isolates of P. rettgeri using standard microbiological and biochemical techniques; and these were characterized with respect to antibiotic resistant patterns. Overall, 143 clinical isolates of non-duplicate P. rettgeri isolates were bacteriologically recovered from the clinical specimens which included blood/wound swab samples (n=108) and swabs from surgical instruments and suction devices (n=35). Antimicrobial susceptibility test (AST) was done using the modified Kirby-Bauer disk diffusion techniques as per the Clinical Laboratory Standard Institute (CLSI) criteria. The isolates were tested phenotypically for ESBL production by the double disk synergy test (DDST) method and the β-lactamase genes were identified using polymerase chain reaction. The strains were sequenced with ABI3500XL analyzer with a 50 cm array, using POP7. Sequences data generated were analyzed with Geneious version 9. 0. 5. Results: The result of AST showed that Providencia rettgeri isolates were resistant to ceftazidime, cefotaxime, ampicillin and tetracycline. Based on the DDST method, some of the Providencia rettgeri isolates were phenotypically confirmed to be ESBL positive (11%) and MBL positive (6%). The results of the molecular analysis showed that the P. rettgeri isolates harbored SHV genes (n=6; 12. 5%) which mediates ESBL production. However, none of the isolates harboured the CTX-M or TEM gene. Conclusion: Our study shows that the P. rettgeri isolates analyzed were multidrug resistant, and they also harbour some important phenotypes and/or genotypes that mediate the production of ESBL (extended spectrum beta-lactamase). This is the first report of ESBL detection in clinical isolates of P. rettgeri in Imo state, southeast Nigeria.
背景:包括由普罗维登菌介导的耐药肠杆菌科的院内暴发已成为全球范围内严重的公共卫生挑战-由于难以选择适当的抗生素治疗,特别是面对耐药性。由普罗维登斯菌引起的菌血症的发病率和死亡率可能很高,特别是在老年人和已有疾病的人中。本研究旨在利用表型和基因型技术确定临床分离的雷氏普罗维登菌多药耐药表型的发生情况。方法:采用标准微生物学和生化技术对临床分离的雷氏假单胞菌进行鉴定;这些都是抗生素耐药模式的特征。总体而言,从临床标本(包括血液/伤口拭子样本(n=108)和手术器械和吸引装置拭子样本(n=35))中回收了143株非重复的雷氏假体临床分离株。按照临床实验室标准协会(CLSI)标准,采用改良的Kirby-Bauer纸片扩散技术进行抗菌药敏试验(AST)。采用双盘协同试验(DDST)对分离株进行ESBL表型检测,采用聚合酶链反应对其β-内酰胺酶基因进行鉴定。采用ABI3500XL分析仪,50 cm阵列,采用POP7进行测序。生成的序列数据用geneeversion 9进行分析。0. 5. 结果:AST检测结果显示,雷氏普罗维登菌分离株对头孢他啶、头孢噻肟、氨苄西林和四环素耐药。基于DDST方法,部分雷氏普罗维登菌分离株表型证实为ESBL阳性(11%)和MBL阳性(6%)。分子分析结果表明,雷氏假单胞菌分离株携带SHV基因(n=6;12. 5%),介导ESBL的产生。然而,没有一个分离物含有CTX-M或TEM基因。结论:我们的研究表明,分析的P. rettgeri分离株具有多重耐药,并且它们还具有介导ESBL(扩展谱β -内酰胺酶)产生的重要表型和/或基因型。这是尼日利亚东南部伊莫州首次报告在临床分离的雷氏疟原虫中检测到ESBL。
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引用次数: 0
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Asian Journal of Biomedical and Pharmaceutical Sciences
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