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Assurance of quality, safety and efficacy of vaccines through compliance of quality management processes 通过遵守质量管理程序保证疫苗的质量、安全性和有效性
Pub Date : 2019-01-01 DOI: 10.15406/japlr.2019.08.00337
M. Taj, S. Adeel, M. W. Malik, Amina Najam, K. Batool
Immunization is one of the most rewarding effective and economical health interventions known to mankind to-date. Since last 50 years successful vaccination campaigns has resulted in extermination of small pox, dropped global polio incidence by 99% and had efficaciously reduced the disability, illness and morbidity caused by the vaccine preventable diseases. Immunization is a crucial constituent behind the efforts taken to meet millennium development goals reducing the mortality in children under-five by over 50 percent, decreasing from 90 to 43 deaths per 1,000 live births between 1990 and 2015.1 To ensure continuous positive results from immunization WHO has stressed upon the need of stringent quality assurance measures which is dependent upon control / monitoring of raw materials; adequacy of production processes, suitability quality control methods and specifications, and control / monitoring of final finished products. The present paper assesses all the essential tools required for the development of a quality biological product. These factors safeguard the safety, efficacy, integrity and quality of vaccines; a result of adequate quality management system which is based upon quality risk management approach (validations, consistency of production, vendor qualifications, independent lot release etc). Efficacy of vaccines
免疫接种是迄今为止人类已知的最有效和最经济的卫生干预措施之一。50年来,成功的疫苗接种运动消灭了天花,使全球脊髓灰质炎发病率下降了99%,并有效地减少了由疫苗可预防疾病引起的残疾、疾病和发病率。免疫接种是为实现千年发展目标所作努力的关键组成部分,这些目标将五岁以下儿童死亡率降低50%以上,在1990年至2015年期间将每千名活产婴儿的死亡人数从90人减少到43人。为确保免疫接种取得持续的积极成果,世卫组织强调需要采取严格的质量保证措施,这取决于对原材料的控制/监测;生产过程的充分性,质量控制方法和规范的适用性,以及最终成品的控制/监控。本文评估了开发高质量生物制品所需的所有基本工具。这些因素保障了疫苗的安全性、有效性、完整性和质量;基于质量风险管理方法的充分质量管理体系的结果(验证、生产一致性、供应商资格、独立批号放行等)。疫苗的功效
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引用次数: 0
Anxiolytic effect of olive leaf tea on mice 橄榄叶茶对小鼠的抗焦虑作用
Pub Date : 2019-01-01 DOI: 10.15406/japlr.2019.08.00338
S. Sarfaraz, T. Bano, Aimen Zafar, Anoosha atique, Areesha rashid
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引用次数: 1
Anti-genotoxic and anti-inflammatory effects of ethanol extract of stoechospermum marginatum (c. agardh) kutzing in rat 苦姜乙醇提取物对大鼠的抗遗传毒性和抗炎作用
Pub Date : 2019-01-01 DOI: 10.15406/japlr.2019.08.00332
P. Arumugam, K. Arunkumar, M. Murugan, K. Murugan
Marine organisms are having rich source biologically active metabolites and there are many reports of macro algae-derived compounds that posses a broad range of biological functions, such as antibiotic, antiviral, antioxidant, antifouling, anti-inflammatory, cytotoxic, and anti-mitotic activities.1,2 Some of the marco algaederived bioactive compounds are amino acids, terpenoids, phlorotannins, steroids, alkaloids, polyketides, glycerols, cyclic peptide, polysaccharides, phenolic compounds, fatty acids, and acrylic acid.3,4 These bioactive potential of seaweeds are mainly used as a human food sources in Asian countries. Particularly, brown seaweed (Phaephyceae) is most complex group of algae and they are broadly distributed from tropical to polar zones of ocean in the world.5 Stoechospermum marginatum (C. Agardh) Kutzing belongs to brown algae and distributed from Indian Ocean to Australian ocean.6 It quiet effortlessly collected from the Gulf of Mannar near Mandapam coast (9o16 ́N,79o12 ́E) of Tamilnadu, India. Currently, this brown seaweed utilized for various aspects like used as a food in salads, fresh meal for breeding animals, manure for cultivation of vegetable and raw material for production of alginic acid and mannitol.7 Different essential oils along with methanolic and dichloromethane (1:1) extract of S. marginatum possessed antioxidant and antibacterial potential were also documented.3 Recent report revealed that the secondary metabolites present in S. marginatum were noticed to be boosted the activities of peroxidase, phenyl alanine lyase, catalyse, and poly phenol oxidase.8 Spatane derivatives from S. marginatum were well established regarding their biological activity.4 However, bioactive composition was differed depending on the geographical distribution, habitats including environmental conditions: water, temperature, salinity, light, and nutrients.9 In the present novel study was seems to be lacking based on the review of literature and therefore in the present pragmatic study intended to evaluate the anti-genotoxic and anti-inflammatory effects of Stoechospermum marginatum ethanol extract in rat model.
海洋生物具有丰富的生物活性代谢物来源,有许多报道称,大型藻类衍生的化合物具有广泛的生物功能,如抗生素、抗病毒、抗氧化、抗污染、抗炎、细胞毒性和抗有丝分裂活性。一些海藻衍生的生物活性化合物是氨基酸、萜类、绿藻单宁、类固醇、生物碱、聚酮、甘油、环肽、多糖、酚类化合物、脂肪酸和丙烯酸。3,4这些具有生物活性的海藻在亚洲国家主要被用作人类的食物来源。特别是褐藻(Phaephyceae)是藻类中最复杂的一类,广泛分布于全球从热带到极地的海洋5 . Stoechospermum marginatum (C. Agardh) Kutzing属褐藻,分布于印度洋至澳大利亚海域它是在印度泰米尔纳德邦曼达帕姆海岸(9016°N, 7912°E)附近的马纳尔湾轻松收集的。目前,这种褐藻被用于各种方面,如用作沙拉的食物,饲养动物的新鲜饲料,种植蔬菜的肥料和生产褐藻酸和甘露醇的原料结果表明,不同精油与甲醇和二氯甲烷(1:1)提取物均具有抗氧化和抗菌作用近年来有研究发现,边草次生代谢物能提高过氧化物酶、苯丙氨酸裂解酶、酶和多酚氧化酶的活性3 .边角草的烷类衍生物的生物活性已得到证实然而,生物活性成分因地理分布、生境(包括环境条件:水、温度、盐度、光和营养)而异基于文献回顾,本研究似乎缺乏新颖的研究,因此,本实用研究拟在大鼠模型上评价毛茛乙醇提取物的抗遗传毒性和抗炎作用。
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引用次数: 0
Pharmacologically relevant drug interactions of Glucagon-like peptide-1 receptor agonists 胰高血糖素样肽-1受体激动剂的药理学相关药物相互作用
Pub Date : 2019-01-01 DOI: 10.15406/japlr.2019.08.00310
N. Maideen
Glucagon-like peptide-1 (GLP-1) receptor agonists are incretin mimetics and they are useful in the treatment of type 2 diabetes mellitus (Type 2 DM). The drugs such as Exenatide, Liraglutide, Lixisenatide, Albiglutide, Dulaglutide and Semaglutide are approved as GLP-1 agonists and administered subcutaneously to manage fasting and postprandial blood glucose.1 The antidiabetic effect of GLP1 agonists occurs through many mechanisms including increased glucose-dependent insulin secretion, suppressed glucagon levels, delayed gastric emptying and reduced food intake.2
胰高血糖素样肽-1 (GLP-1)受体激动剂是模拟肠促胰岛素的药物,它们在治疗2型糖尿病(2型糖尿病)中很有用。艾塞那肽、利拉鲁肽、利昔那肽、阿比格鲁肽、杜拉鲁肽和Semaglutide等药物被批准为GLP-1激动剂,并被皮下施用以控制空腹和餐后血糖GLP1激动剂的降糖作用通过多种机制发生,包括增加葡萄糖依赖型胰岛素分泌、抑制胰高血糖素水平、延迟胃排空和减少食物摄入
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引用次数: 1
Brief review on most advanced detection methods used for Clostridium botulinum neurotoxins (BoNTs) analysis 肉毒杆菌神经毒素分析的最新检测方法综述
Pub Date : 2019-01-01 DOI: 10.15406/japlr.2019.08.00322
K. Rani
Botulism is neuroparalytic disease which affects human and animal population. It is caused neurotoxins called botulinum neurotoxins (BoNTs) which produced by gram positive, anaerobic, spore-forming microbes named Clostridium botulinum. It causes flaccid paralysis in infected animals and human population. Because of its bio-warfare agent and potent toxin BoNTs causes disorder in living beings.1 BoNTs infection commonly occurs via the ingestion of contaminated food and water due to poor hygiene and may occur from infected weapons in military areas which can cause muscle paralysis or even death in exposed animals and humans.2,3 There are no as such geographical boundaries for botulism because of its infrequent occurrence of outbreaks. Reported main route of transmission is by oral ingestion and exposure of wounds with spores of Clostridium botulinum. Clinical symptoms of botulism occur within 24 hour of exposure that lasts up to 17 days in the exposed and susceptible population. Botulinum neurotoxins (BoNTs) contains zinc endopeptidase which blocks binding of vesicles of acetylcholine with the terminal membrane of the motor neuron that lead to flaccid muscle paralysis with lateral recumbency due to muscle weakness and dysphagia. And, in severe cases, it becomes lethal and results in death due to respiratory arrest and pharyngeal paralysis.4,5 Botulinum neurotoxin has simple dichain polypeptide that consists of a 100kDa heavy chain joined by a single disulfide bond to a 50kDa light chain. The toxin’s light chain has zinc-containing endopeptidase that blocks acetylcholine-containing vesicles from fusing with the terminal membrane of the motor neuron, resulting in flaccid muscle paralysis. Botulism can be classified into a number of groups; depending on the route the toxin enters the body like food borne botulism, infant botulism, wound botulism, hidden botulism, inadvertent botulism, and inhalational botulism. There were 197 outbreaks reported between 1920 and 2014.5,6 The goldstandard method has been proposed for BoNT/A detection in the mouse bioassay for studying its lethality test and it performed by injecting potential toxin-containing sample into live mice followed by observation for signs of botulinic paralysis or death.7–9 Other reported methods were also well known for detecting BoNTs have been reported, such as ELISA, surface plasma resonance (SPR) immunoassay , and electrochemical luminescence immunoassay.8–12 Among them, immunoassays method is more reliable for its lowest detection limit but require complicated operations and cumbersome instrumentation for achieving signal readouts.13–18 In recent years, electrochemical detection methods and Enzyme based biosensor based methods have proposed as most predominant analytical techniques for the easy quantification and simple instrumentation which designed or evolved for achieving most effective BoNTs detection in biological samples.19–23
肉毒杆菌中毒是一种影响人类和动物的神经麻痹性疾病。它是由一种叫做肉毒杆菌神经毒素(BoNTs)的神经毒素引起的,这种神经毒素是由一种叫做肉毒杆菌的革兰氏阳性、厌氧、孢子形成的微生物产生的。它在受感染的动物和人群中引起弛缓性麻痹。由于其生物战剂和强效毒素,BoNTs会引起生物的紊乱由于卫生条件差,bont的感染通常是通过摄入受污染的食物和水发生的,也可能来自军事地区受感染的武器,这可能导致接触的动物和人类肌肉麻痹甚至死亡。2,3由于肉毒杆菌中毒不经常爆发,因此没有这样的地理界限。据报道,主要传播途径是通过口服摄入和伤口接触肉毒杆菌孢子。肉毒杆菌中毒的临床症状在接触后24小时内出现,在接触和易感人群中持续长达17天。肉毒杆菌神经毒素(BoNTs)含有锌内肽酶,可阻断乙酰胆碱囊泡与运动神经元终膜的结合,从而导致肌肉无力和吞咽困难引起的侧卧肌弛缓性麻痹。在严重的情况下,它会变得致命,并因呼吸停止和咽麻痹而导致死亡。4,5肉毒杆菌神经毒素是一种简单的二链多肽,由一条100kDa的重链和一条50kDa的轻链通过单键二硫键连接而成。这种毒素的轻链含有含锌的内肽酶,可以阻止含有乙酰胆碱的囊泡与运动神经元的末端膜融合,从而导致弛缓性肌肉麻痹。肉毒中毒可分为几类;根据毒素进入人体的途径,如食源性肉毒杆菌中毒、婴儿肉毒杆菌中毒、伤口肉毒杆菌中毒、隐性肉毒杆菌中毒、无意肉毒杆菌中毒和吸入性肉毒杆菌中毒。在1920年至2014年期间,共报告了197次暴发,6在小鼠生物测定中提出了检测BoNT/A的金标准方法,以研究其致死性试验,方法是将可能含有毒素的样品注射到活小鼠中,然后观察肉毒杆菌麻痹或死亡的迹象。其他已知的检测bont的方法也有报道,如ELISA、表面等离子体共振(SPR)免疫分析法和电化学发光免疫分析法。8-12其中,免疫分析法检测限最低,可靠性较高,但操作复杂,仪器繁琐,难以实现信号读出。13-18近年来,电化学检测方法和基于酶的生物传感器方法被认为是最主要的分析技术,它们易于定量和简单的仪器设计或发展,以实现最有效的生物样品中bont的检测
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引用次数: 0
Hepatic morphological alterations in lopinavir/ ritonavir–intoxicated rats were abrogated by melatonin and α lipoic acidElias 褪黑素和α硫辛酸可消除洛匹那韦/利托那韦中毒大鼠的肝脏形态学改变
Pub Date : 2019-01-01 DOI: 10.15406/japlr.2019.08.00324
Elias Adikwu, B. Nelson, W. Obianime
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引用次数: 0
Spotting the sensory preferences of artichokes to improve the consumption of this functional food 发现洋蓟的感官偏好,以改善这种功能食品的消费
Pub Date : 2019-01-01 DOI: 10.15406/japlr.2019.08.00316
Gatti Mb, Mondino Mc, García Ciappini Mc
- Given the greater varietal supply of the globe artichoke and evaluating its use for human consumption, it is important to carry out market positioning work, including the recognition of the newly available cultivars. Sensory analysis comes up as an important instrument to assess the potential of insertion of artichoke into the market. Within this perspective, the aim of the present study was to determine the sensorial quality characteristics of three globe artichoke cultivars produced in the Rosario´s Horticultural Belt and associated with the preference of consumers. The cultivars were Opal, Madrigal and Romanesco. For sensory evaluation, the method called CATA (Check All That Apply) was used. The results of the CATA test were analyzed using multivariate statistics, applying the Correspondence Analysis. The most distinguishing elements between artichokes were the color and aroma. When associating these results with which was the artichoke that consumers liked the most, it was observed that the Romanesco obtained the best rating. Consumers preferred sweet and tender artichokes. This information could guide the production strategies of the horticulturists to offer cultivars that meet these characteristics.
-鉴于全球洋蓟品种供应的增加和评估其供人类消费的用途,开展市场定位工作,包括对新品种的认可是很重要的。感官分析是评估洋蓟进入市场潜力的重要工具。从这个角度来看,本研究的目的是确定在罗萨里奥园艺带生产的三种全球洋蓟品种的感官品质特征,并与消费者的偏好相关。品种为欧泊、牧歌和罗马。感官评价,称为CATA(检查所有适用)的方法被使用。对CATA检验结果进行多元统计分析,采用对应分析。洋蓟最显著的特点是颜色和香气。当将这些结果与消费者最喜欢的洋蓟联系起来时,可以观察到罗马esco获得了最好的评级。消费者更喜欢又甜又嫩的洋蓟。这些信息可以指导园艺师的生产策略,以提供符合这些特征的品种。
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引用次数: 0
Formulation development and in vitro evaluation of oral disintegrating tablets for newer anticonvulsant agent 新型抗惊厥药口服崩解片的配方研制及体外评价
Pub Date : 2019-01-01 DOI: 10.15406/japlr.2019.08.00318
R. Gunda, Prasada Rao Manchineni, Chaikam Gopi Reddy, K. Divya, D. Alekhya, Ekula Jyoshna
Objective: The main objective of current research work is to formulate the Levetiracetam oral disintegrating tablets. Levetiracetam, a newer anti convulsant and used to treat epilepsy and chronic seizures. Methods: The oral disintegrating tablets of Levetiracetam were prepared employing various proportions of Crospovidone and Croscarmellose sodium as a Superdisintegrants by Direct Compression technique. 9 formulations were developed and are evaluated for various finished product quality assurance methods. Results: Results reveals that all the formulation was found to be within the Pharmacopoeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters were determined. Conclusion: Formulation (F 5 ) containing 37.5mg of Crospovidone and 37.5mg of Croscarmellose, is ideal formulation (similarity factor f 2 = 82.676, dissimilarity factor f 1 =2.049 & No significant difference, t=0.0456) to marketed product ( SPRITAM-250 ). Formulation (F 5 ) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion (n=0.666).
目的:研制左乙拉西坦口腔崩解片。左乙拉西坦,一种新的抗惊厥药,用于治疗癫痫和慢性发作。方法:采用直接压缩法,以不同比例的交联维酮和交联蜜糖钠为强力崩解剂,制备左乙拉西坦口腔崩解片。开发了9种配方,并对各种成品质量保证方法进行了评估。结果:所有制剂均在药典限定范围内,并拟合了不同动力学模型的体外溶出度分布,确定了各制剂的统计参数。结论:含37.5mg交叉维酮和37.5mg交叉卡蜜糖的配方(f5)与市售产品SPRITAM-250的相似因子F 2 = 82.676,不同因子F 1 =2.049,无显著差异(t=0.0456),为理想配方。配方(f5)符合一级动力学,药物释放机制为非菲克扩散(n=0.666)。
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引用次数: 4
Homeopathy: synopsis 顺势疗法:剧情简介
Pub Date : 2019-01-01 DOI: 10.15406/japlr.2019.08.00319
A. G. Arias 
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引用次数: 0
Cytotoxic effects of S-(+)-Carvone on selected human cancer cell lines S-(+)-香芹酮对选定的人类癌细胞系的细胞毒性作用
Pub Date : 2019-01-01 DOI: 10.15406/japlr.2019.08.00330
A. Mehanna, Enas A Alasmari
Herbalism, one of the oldest systems of medicine humans have ever known, is the practice of making or prescribing plant-based herbal medicines.1 Over the past centuries, medicinal herbs were of great importance. Looking back in time, people were healthier and more competent against diseases compared to people at the present time. The reason behind this is thought to be partly due to the healthy diet and lifestyle they had which depends mainly on traditional herbal remedies and alternative medicine. It is worth mentioning that alternative and herbal medicine has also contributed significantly in the development of useful synthetic chemotherapeutic drugs. So far, the discovery of anticancer and chemotherapeutic treatments throughout the years has been successful, in terms of effectiveness and cancer remission.2 However, chemotherapeutic drugs are not devoid of serious toxic side effects. Due to the high toxicity associated with anticancer treatments, efforts have been directed toward the use of herbal medicines and anticancer products derived from plants. Currently, there are four classes of plant-based compounds that exhibit anticancer activity and they include: vinca alkaloids, taxanes, epipodophyllotoxins, and camptothecin derivatives. 2 All of these plants have demonstrated significant inhibition on cancer growth. Furthermore, natural products still have enormous potential to provide promising chemo preventive and anticancer therapeutic compounds.
草药学是人类所知的最古老的医学体系之一,是一种制作或处方植物性草药的实践在过去的几个世纪里,草药非常重要。回顾过去,与现在的人相比,人们更健康,更有能力对抗疾病。这背后的原因被认为部分是由于他们的健康饮食和生活方式,主要依赖于传统的草药疗法和替代药物。值得一提的是,替代药物和草药在开发有用的合成化疗药物方面也作出了重大贡献。到目前为止,多年来抗癌和化疗疗法的发现在有效性和癌症缓解方面都是成功的然而,化疗药物并非没有严重的毒副作用。由于与抗癌治疗相关的高毒性,人们一直致力于使用草药和从植物中提取的抗癌产品。目前,有四类基于植物的化合物具有抗癌活性,它们包括:长春花生物碱、紫杉烷、表观叶绿素毒素和喜树碱衍生物。所有这些植物都显示出对癌症生长的显著抑制作用。此外,天然产物仍有巨大的潜力提供有前途的化学预防和抗癌治疗化合物。
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引用次数: 4
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Journal of analytical & pharmaceutical research
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