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Key Aspects of Analytical Method Development and Validation 分析方法开发和验证的关键方面
Pub Date : 2019-09-21 DOI: 10.52228/jrub.2018-31-1-6
Suman Shrivastava, Pooja Deshpande, S. Daharwal
Development of a method is crucial for discovery, development, and analysis of medicines in the pharmaceutical formulation. Method validation could also be thought to be one in all the foremost well-known areas in analytical chemistry as is reproduced within the substantial variety of articles submitted and presented in peer review journals every year. Validation of an analytical procedure is to demonstrate that it's appropriate for its intended purpose. Results from method validation are often wont to decide the quality, reliability and consistency of analytical results. Analytical methods need to be validated or revalidated. This review describes general approach towards validation process and validation parameters to be considered during validation of an analytical method. It also refers to various regulatory requirements like WHO, USFDA, EMEA, ICH, ISO/IEC. The parameters described here are according to ICH guidelines which include accuracy, precision, specificity, limit of detection, limit of quantification, linearity range and robustness.
开发一种方法对于药物配方中的药物的发现、开发和分析至关重要。方法验证也可以被认为是分析化学中所有最著名的领域之一,因为每年在同行评审期刊上提交和发表的大量文章中都有方法验证。分析方法的验证是证明它适合其预期目的。方法验证的结果往往决定分析结果的质量、可靠性和一致性。分析方法需要验证或再验证。本综述描述了验证过程的一般方法和在分析方法验证期间要考虑的验证参数。它还参考了各种法规要求,如WHO, USFDA, EMEA, ICH, ISO/IEC。这里描述的参数是根据ICH指南,包括准确性,精密度,特异性,检出限,定量限,线性范围和鲁棒性。
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引用次数: 5
Promising Phytoactives Candidates for Efficacious Treatment of Psoriasis and Other Skin Disorders 有希望的植物活性候选物有效治疗牛皮癣和其他皮肤疾病
Pub Date : 2019-09-21 DOI: 10.52228/jrub.2018-31-1-2
K. Yadav, J. Pawar, D. Singh, M. Singh
Psoriasis is a complex multifactor red blistering autoimmune skin disorder depicted by T-cell inception, neighbourhood vascular changes, abnormal keratinocyte extension, and neutrophil activation. The fabricated meds used to treat it are having undesired indications and it has been seen that some the synthetic medications have brutal impact on psoriasis. All things considered, the herbal phytoactives are promising choice, which is highly effective and consistently amazing with no side effect as of natural origin. In the present review a few plant sources have been contemplated in based on traditional learning and reports of various phyto investigations.
银屑病是一种复杂的多因素自身免疫性皮肤疾病,由t细胞开始、邻近血管改变、角化细胞异常延伸和中性粒细胞激活所描述。用于治疗牛皮癣的捏造药物有不良的适应症,并且已经看到一些合成药物对牛皮癣有残酷的影响。考虑到所有的事情,草药植物活性是有希望的选择,它是高效的,始终惊人的没有副作用的天然来源。本文在传统知识和各种植物调查报告的基础上,对几种植物来源进行了展望。
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引用次数: 10
Development of Three Row Self-Propelled Zero till Direct Seeded Rice Planter Cum Fertilizer Applicator 三排自行式零耕直播水稻播种机及施肥机的研制
Pub Date : 2019-05-01 DOI: 10.52228/JRUB.2019-32-1-8
Rashmi Anil Bangale
The agricultural operational holding in India is about 1.15 ha and 85.01 per cent belongs to marginal holdings (below 2 ha). This data shows an economic condition of the Indian farmer, which doesn’t allow him to adopt advanced agricultural machineries. Considering the situation of Indian farmer, we developed a prototype of three row self-propelled zero till direct seeded rice planter cum fertilizer applicator. This machine helps to plant a dry rice seed along with the fertilizer application with zero tillage condition. The machine includes inclined plate metering mechanism for seed; cup feed metering mechanism for fertilizer, seed cum fertilizer hopper, ground wheel, depth control wheels, inverted T furrow openers, 5 hp engine as a prime mover, power transmission system, adjustable handle, lever and rigid main frame to support all the parts and drive wheels. Machine is divided into two parts viz., prime mover part and planter cum fertilizer applicator part. Both parts can be separated from each other. The machine places the rice seed up to average depth of 25-40 mm and spacing between hills is observed to be 130-160 mm along with an average 20 cm of row spacing. The average field capacity at an average speed of 2.3 km.h-1 is observed to be 0.115 ha.h-1 for operating rice seeds. The field efficiency is observed to be 86.9 per cent. The operational cost is observed to be around 69.28 per cent less than the manual planting of rice seedling and also the man hour’s requirement is very less than the manual planting.
印度的农业经营面积约为1.15公顷,85.01%属于边际土地(低于2公顷)。这一数据表明印度农民的经济状况不允许他们采用先进的农业机械。考虑到印度农民的实际情况,我们研制了一种三排自行式零耕直播水稻播种机兼施肥机样机。该机器有助于种植干燥的水稻种子,并在免耕条件下施肥。本机包括斜板种子计量机构;杯形给料计量机构:肥料、种子及肥料料斗、地面轮、深度控制轮、倒T型开沟器、5马力发动机作为原动机、动力传动系统、可调手柄、杠杆和刚性主框架支撑所有部件和驱动轮。机器分为两部分,即原动机部分和播种机和施肥机部分。这两个部分可以相互分离。该机器播种水稻种子的平均深度为25-40毫米,垄间间距为130-160毫米,行距平均为20厘米。在2.3 km.h-1的平均速度下,稻田的平均运力为0.115 ha.h-1。田间效率为86.9%,作业成本比人工插秧低69.28%左右,所需工时也比人工插秧少得多。
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引用次数: 0
Development and Characterization of Quercetin Loaded Nanoparticle for Skin Cancer 槲皮素纳米粒子的制备与表征
Pub Date : 2019-05-01 DOI: 10.52228/jrub.2019-32-1-1
N. Verma
As a disease skin cancer has obtained different characteristics over the decades. Solar radiation that contains ultraviolet ray is the prime cause of skin cancer. In this present research, the nano-precipitation method was applied for preparing Quercetin loaded Nanoparticle (Qu-Nps) with much enhanced loading properties and improves incorporation of corresponding drugs. At the same time, the Quadratic model that takes help of the Response Surface Method was applied to observe the effects of some specific parameters maintained in the development of nanoparticle. Here, the sonication time was 20 min and delivery system F6 (with Drug: Polymer ratio of 1:45) provided optimum drug entrapment ability which is 70%. The optimized formulation for average size was almost 102.39 ±7.64 nm with zeta potential diameter averaging -28.43mV. Quercetin is a dietary flavonoid possessing multidimensional properties that is used in various other diseases including viral infection, bacterial infection, diabetes mellitus, and cancer. All outcomes support the view that Quercetin loaded nanoparticles (Qu-Nps) has high entrapment and drug loading abilities.
作为一种疾病,皮肤癌在过去的几十年里已经有了不同的特征。含有紫外线的太阳辐射是皮肤癌的主要原因。在本研究中,采用纳米沉淀法制备槲皮素负载纳米颗粒(q - nps),大大增强了负载性能,并改善了相应药物的掺入。同时,利用响应面法建立二次模型,观察纳米颗粒发育过程中保持的某些特定参数的影响。在这里,超声时间为20 min, F6(药聚合物比为1:45)提供了最佳的药物包封率,为70%。优化后的配方平均粒径约为102.39±7.64 nm, zeta电位直径平均为-28.43mV。槲皮素是一种具有多维特性的膳食类黄酮,用于各种其他疾病,包括病毒感染、细菌感染、糖尿病和癌症。所有结果都支持槲皮素负载纳米颗粒(q - nps)具有高包裹和载药能力的观点。
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引用次数: 0
Robotics Module in Enhancing Interactive Stem Education 加强互动Stem教育中的机器人模块
Pub Date : 2019-05-01 DOI: 10.52228/jrub.2019-32-1-7
A. Tiwari
Teaching robotics to young students can increase their ability to be creative, innovative thinkers and more productive members of society throughout their school years. Indian government have already recognized the importance of robotics in the classroom teaching and started ATAL tinkering lab to be included in school education system. By teaching the basics of robotics to the students, one can open up a whole new world for them and exciting opportunities which they wouldn't have access to. In traditional teaching methods of science and engineering, students lack experience in applying physical principles to the physical situation in real time. Students are not engaged in creating interest in interactive learning. To overcome above problem, this paper presents a new and versatile interactive learning tool using the Whizbrabo Robotic Education Module. This module describes the method of an educational tool based on robotics to study electrical component interfacing, pcb design, mechanical structure design and elementary programming skill. The module has been demonstrated to school students of higher secondary, and undergraduate student of various colleges. The key advantages of robotics in school education will enhance the level of programming, creativity and prepare them for the future, turn their frustration into innovation and promote inclusiveness. Robotics has a lot of educational potential.
向年轻学生教授机器人技术可以提高他们在整个学年中成为创造性、创新思考者和更有生产力的社会成员的能力。印度政府已经认识到机器人在课堂教学中的重要性,并启动了ATAL修补实验室,将其纳入学校教育体系。通过向学生教授机器人的基础知识,我们可以为他们打开一个全新的世界,以及他们以前无法接触到的令人兴奋的机会。在传统的理工科教学方法中,学生缺乏将物理原理实时应用于物理情境的经验。在互动式学习中,学生没有参与创造兴趣。为了克服上述问题,本文提出了一种使用Whizbrabo机器人教育模块的新型多功能交互式学习工具。本模块描述了一个基于机器人的教学工具的方法来学习电子元件接口,pcb设计,机械结构设计和基本的编程技巧。该模块已在高中学生和各院校的本科生中进行了演示。机器人在学校教育中的关键优势将提高他们的编程水平,创造力和为未来做准备,将他们的挫折转化为创新,促进包容性。机器人技术具有很大的教育潜力。
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引用次数: 1
Effect of Spironolactone on the Micellar Properties of Non-Ionic Surfactant: Assessment by Conductivity and Surface Tension Methods 螺内酯对非离子表面活性剂胶束性质的影响:电导率法和表面张力法评价
Pub Date : 2018-05-01 DOI: 10.52228/jrub.2018-31-1-4
M. Jain, S. Chatterjee, Manoj Jangde, Deepak Sina
An interaction of spironolactone (SPI) with octyl phenol ethoxylate (Triton-X-100 or TX-100) has been investigated by using conductometric and tensiometric measurement. The value of critical micellar concentration (CMC), degree of ionization (a) and thermodynamic parameters like standard enthalpy of micellization (?H°m), standard entropy of micellization (?S°m) and standard Gibb’s free energy (?G°m) were determined by conductivity data. The negative value of ?G°m shows spontaneity in the solubilization of drug. Various interfacial parameters such as maximum surface excess concentration (Gmax) and minimum area per molecule (Amin) was determined by surface tension measurement. All these parameters have been discussed in terms of drug-surfactant interactions. Based on the result it was found that variation in the presence of spironolactone in micellar properties of TX-100 increases with increase in concentration of drug. This study will help the pharmaceutical industries in the discovery of new drug and enhancement of their bioavailability.
用电导法和张力法研究了螺内酯(SPI)与辛烷基酚聚氧乙酸酯(Triton-X-100或TX-100)的相互作用。通过电导率数据测定了临界胶束浓度(CMC)、电离度(a)以及胶束标准焓(H°m)、胶束标准熵(S°m)和标准吉布自由能(G°m)等热力学参数。G°m为负值时,表明药物的溶解具有自发性。通过表面张力测量确定了各种界面参数,如最大表面过量浓度(Gmax)和每分子最小面积(Amin)。从药物-表面活性剂相互作用的角度讨论了所有这些参数。结果发现,随着药物浓度的增加,螺内酯的存在对TX-100胶束性质的影响也随之增加。该研究将有助于制药行业发现新药并提高其生物利用度。
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引用次数: 0
A Review on Plant Profile, Standardization Method and Pharmacological Activities of Tribulus Terristries (Gokhru) 蒺藜属植物概况、标准化方法及药理活性研究进展
Pub Date : 2018-05-01 DOI: 10.52228/jrub.2018-31-1-7
Pooja Deshpande, Suman Shrivastava, S. Daharwal
Tribulus terristries belongs to family zygophyllaceae and commonly known as Puncture vine, Tribulus including goat's-head, bindii, bullhead, burra gokharu, bhakhdi, caltrop, small caltrops, cat's-head, devil's eyelashes, devil's-thorn, devil's-weed, puncture vine, and tackweed. Found widely distributed warmer regions of the world, throughout in India, srilanka, west Tibet, consists of dried fully ripen fruits of plant. Fruits are used as Diuretics tonics and also in the treatment of calculous affections and painful micturation, they are also used as aphrodiasic and in gout. Standardization is a system ensuring predefined set of the quantity, quality and therapeutic effect of the constituents in each dose. It is an imperative stride in establishing a quality assurance plan for production and manufacturing thereby, curtailing batch to batch variation and reassuring acceptability, safety, quality and efficacy of the drug , Thin layer chromatography (TLC) and high performance thin layer chromatography (HPTLC) fingerprint profiles are used for ensuring the identity, transparency and potency of herbal formulations.
刺蒺藜属属刺蒺藜科,俗称刺蒺藜。刺蒺藜属包括羊头、刺蒺藜、牛头、刺蒺藜、刺蒺藜、鹿角、小鹿角、猫头、刺蒺藜、刺蒺藜和刺蒺藜。广泛分布于全球温暖地区,遍布印度、斯里兰卡、西藏西部,由干燥的、完全成熟的植物果实组成。水果被用作利尿剂、补品,也用于治疗结石和排尿疼痛,它们也被用作壮阳药和痛风。标准化是一个系统,确保预先设定的数量,质量和治疗效果的成分在每个剂量。建立生产制造的质量保证计划,从而减少批次之间的差异,保证药物的可接受性、安全性、质量和有效性是必不可少的一步。采用薄层色谱(TLC)和高效薄层色谱(HPTLC)指纹图谱来确保中药配方的身份、透明度和效价。
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引用次数: 0
UV-Visible Spectrophotometric Determination of Lambda-Cyhalothrin Insecticide in Vegetables, Soil and Water Samples 紫外可见分光光度法测定蔬菜、土壤和水样中高效氯氟氰菊酯杀虫剂
Pub Date : 2018-05-01 DOI: 10.52228/jrub.2018-31-1-1
D. Sahu, Joyce Rai, C. Bhatt, M. Rai, J. Goswami, A. Sahu, T. V. Singh, M. Nirmala, Kalpana Wani, P. Mundeja
In modern age pesticide is used widely in agriculture. Lambda-cyhalothrin (LCT) is one of the most used pesticides which are used as a insecticide to kill pest, tricks, flies etc in agricultural field and it is also used for crop production. We have developed new method to detect LCT insecticide in agriculture field and reduce its uses. In this method we found the maximum absorbance at 460 nm for yellow colour dye. We also calculated limit of detection and limit of quantification 0.001 mg kg-1 and 0.056 mg kg-1 respectively. Molar absorptivity and Sandell’s sensitivity was also calculated and obtained 1.782 ×107 mol-1 cm-1 and 9.996 ×10-6 µg cm-2 respectively. The obtained yellow colour dye obeyed Beer’s law limit range of 0.5 µg ml -1 to 16 µg ml-1 in 25 ml. This method is less time consuming, selective, simple, sensitive and low cost. Present method is successfully applied in various soil, water and vegetable samples.
在现代,农药在农业中被广泛使用。高效氯氟氰菊酯(LCT)是一种应用最广泛的农药,主要用于杀灭农田害虫、蝇类、蝇类等,也用于农作物生产。我们开发了一种新的方法来检测LCT杀虫剂,减少其在农业领域的使用。用该方法测定了黄色染料在460 nm处的最大吸光度。并计算出检出限0.001 mg kg-1,定量限0.056 mg kg-1。摩尔吸光度和桑德尔灵敏度分别为1.782 ×107 mol-1 cm-1和9.996 ×10-6µg cm-2。所得黄色染料在25 ml中符合Beer定律限定范围0.5µg ml-1 ~ 16µg ml-1。该方法耗时短,选择性好,操作简便,灵敏度高,成本低。该方法成功地应用于各种土壤、水和蔬菜样品。
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引用次数: 4
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Journal of Ravishankar University (PART-B)
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