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Exploration of Physicochemical, Phytochemical, and HPTLC Analysis of Arputha Mathirai: A Siddha Herbo Mineral Formulation for Poly Cystic Ovarian Syndrome (PCOS) 治疗多囊卵巢综合征(PCOS)的Siddha草药矿物制剂Arputha Mathirai的理化、植物化学及HPTLC分析
Pub Date : 2023-07-20 DOI: 10.9734/jpri/2023/v35i197397
G. Begum, N. Anbu
Aim: The aim of this study was to explore the physicochemical, phytochemical and HPTLC analysis of the Siddha herbomineral formulation, Arputha Mathirai (AM), in tablet form, for its potential in treating PCOS (Poly Cystic Ovarian Syndrome). The objective was to analyze the tablet and assess its physicochemical properties, as well as the presence of bioactive compounds derived from plant sources. Place of Study: The physicochemical and phytochemical analysis was conducted at The Tamilnadu Dr.MGR Medical University, located at No.69, Anna Salai, Guindy, Chennai – 600 032. The High-Performance Thin Layer Chromatography (HPTLC) was carried out at Noble Research Solutions in Kolathur, Chennai – 600 099. Materials and Methods: Arputha Mathirai, the Siddha herbomineral formulation, was prepared in compliance with Good Manufacturing Practices (GMP) guidelines. The formulation underwent a thorough analysis of its physicochemical and phytochemical properties at The Tamilnadu Dr.MGR Medical university, Guindy, Chennai. The analysis was conducted following the standards set by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) in accordance with the guidelines established by AYUSH (Ayurveda, Yoga, Unani, Siddha, Homoeopathy), the governing body for traditional health systems in India. HPTLC was peformed at Noble Research Solutions, Kolathur, Chennai – 600 099. Results: Physico-chemical analysis of AM showed 10.08% of loss on drying at 1050 C, 15.39% total ash value, 2.45% acid-insoluble ash, 12.18% water-soluble ash, 20.55% water-soluble extraction, and 8.46% alcohol-soluble extraction. According to the phytochemical analysis of AM, alkaloids, carbohydrates, saponins, flavonoids, diterpenes, gum, and mucilage were all found in the sample. Additionally, it demonstrated the absence of quinones, tannins, and phenols. HPTLC finger printing analysis of the sample revealed the presence of five prominent peaks corresponding to the presence of five versatile phytocomponents present with in it. Rf value of the peaks ranged from 0.02 to 0.56. Conclusion: The findings of this study provided a comprehensive understanding of the physicochemical properties, bio active phytochemicals and phytocomponents of Arputha Mathirai (AM). These results contribute to establishing the nature of the formulation's composition and its safety profile. Moreover, the standardization of the tablet formulation based on these parameters supports its suitability for therapeutic use in the treatment of PCOS. These outcomes validate the quality and potential effectiveness of AM in addressing PCOS, enhancing its credibility as a viable treatment option.
目的:本研究的目的是探讨西达草药制剂阿普塔·玛蒂莱(AM)片剂治疗多囊卵巢综合征(PCOS)的理化、植物化学和HPTLC分析。目的是分析片剂并评估其物理化学性质,以及来自植物来源的生物活性化合物的存在。研究地点:理化和植物化学分析在泰米尔纳德邦mgr博士医科大学进行,该大学位于No.69, Anna Salai, Guindy, Chennai - 600032。高效薄层色谱(HPTLC)在Noble Research Solutions进行,位于金奈Kolathur - 600099。材料和方法:Arputha Mathirai, Siddha草药制剂,按照良好生产规范(GMP)制备。该配方在位于金奈Guindy的泰米尔纳德邦医科大学进行了物理化学和植物化学特性的彻底分析。该分析是根据印度传统卫生系统管理机构AYUSH(阿育吠陀、瑜伽、乌纳尼、悉达、顺势疗法)制定的指南,按照印度药物药典实验室(PLIM)制定的标准进行的。HPTLC在Noble Research Solutions, Kolathur, Chennai - 600099进行。结果:AM在1050℃干燥时损失10.08%,总灰分15.39%,酸不溶灰分2.45%,水溶性灰分12.18%,水溶性萃取物20.55%,醇溶萃取物8.46%。根据AM的植物化学分析,样品中均含有生物碱、碳水化合物、皂苷、类黄酮、二萜、树胶和粘液。此外,它还证明了不含醌、单宁和酚。HPTLC指纹图谱分析显示,样品中存在五个突出的峰,对应于其中存在五种多功能植物成分。峰的Rf值在0.02 ~ 0.56之间。结论:本研究为全面了解阿普塔·马提莱(Arputha Mathirai, AM)的理化性质、生物活性化学物质和植物成分提供了基础。这些结果有助于确定配方成分的性质及其安全性。此外,基于这些参数的片剂配方的标准化支持其在多囊卵巢综合征治疗中的适用性。这些结果验证了AM治疗PCOS的质量和潜在有效性,提高了其作为可行治疗选择的可信度。
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引用次数: 0
Antimicrobial Resistance Profile of Different Clinical Isolates against Augmentin, Imipenem and Ceftriaxone 不同临床分离株对Augmentin、亚胺培南和头孢曲松的耐药性分析
Pub Date : 2023-07-20 DOI: 10.9734/jpri/2023/v35i197398
Miftah S. M. Nag, N. M. Al-Awkally, Ahmed Abouserwel, F. M. Senossi, Sara El-Warred, M. A. Ali
Background: Antibiotic resistance is a growing global public health concern because it jeopardizes the effective control and treatment of bacterial infections. The purpose of this study was to determine the bacterial profiles and susceptibility patterns to Imipenem, Augmentin, and Ceftriaxone in various clinical specimens from Al Saleem laboratory in Benghazi, Libya. Methods: Two separate studies were carried out. Each experiment lasted three months. The patients' clinical samples included wound swabs, urine, sperm, blood, high vaginal swabs, and cerebrospinal fluid. Bacterial species were isolated and identified using standard microbiological methods in each study. Kirby-Bauer disc diffusion was used to conduct antimicrobial susceptibility tests from September 2020 to November 2020. Results: There were 711 isolates obtained from 535 female and 503 male patients. The most common organisms isolated from specimens were E. coli spp, Klebsiella spp, and Staph aureus. Conclusion: Bacterial resistance levels to various antibiotics varied greatly. We found that Augmentin has less activity against gram negative bacteria isolated from clinical specimens, whereas Imipenem has a much stronger effect on isolates than Augmentin. Appropriate monitoring of prevalent pathogenic organisms and their sensitivities will assist clinicians in making appropriate antibiotic treatment choices to avoid the spread of antimicrobial resistance.
背景:抗生素耐药性是一个日益严重的全球公共卫生问题,因为它危及细菌感染的有效控制和治疗。本研究的目的是确定来自利比亚班加西Al-Saleem实验室的各种临床标本中的细菌谱和对亚胺培南、Augmentin和头孢曲松的易感性模式。方法:进行两项单独的研究。每个实验持续三个月。患者的临床样本包括伤口拭子、尿液、精子、血液、高位阴道拭子和脑脊液。在每项研究中使用标准微生物学方法分离和鉴定细菌种类。从2020年9月到2020年11月,使用Kirby-Bauer椎间盘扩散法进行抗菌药物敏感性测试。结果:从535名女性和503名男性患者中获得711个分离株。从标本中分离出的最常见的生物体是大肠杆菌、克雷伯菌和金黄色葡萄球菌。结论:细菌对各种抗生素的耐药性水平差异较大。我们发现Augmentin对临床标本中分离的革兰氏阴性菌的活性较低,而亚胺培南对分离物的作用比Augmentin强得多。对流行病原菌及其敏感性的适当监测将有助于临床医生做出适当的抗生素治疗选择,以避免抗微生物耐药性的传播。
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引用次数: 0
In-vitro and In-silico Inhibitory Action of Methanol Extract of Rhynchosia beddomei Whole Plant on α-Glucosidase and α-Amylase 花首乌全株甲醇提取物对α-葡萄糖苷酶和α-淀粉酶的体外和体外抑制作用
Pub Date : 2023-07-15 DOI: 10.9734/jpri/2023/v35i197395
N. Reddy, M. Raju, M. Mamatha, M. L. Madhuri
The goal of the current study was to identify potential bioactive components that may be responsible for Rhynchosia beddomei's antidiabetic activity through in silico docking study and to investigate potential mechanisms by which Rhynchosia beddomei may be helpful in managing diabetes and its associated complications.  In vitro anti-diabetic assays showed that this plant's high efficiency to inhibit α-amylase (62.13%) and α-glucosidase (59.9%) enzymatic activity, which are well-established targets for the management of diabetes, is responsible for its anti-hyperglycaemic activity. Soxhlet extraction produced an extractive yield of 35.43%.  Additionally, we hypothesised that flavonoids including rutin, lucenin, orientin, rhynchosin, and isooreintin contained in this plant may be accountable for the antidiabetic characteristics through docking experiments. The traditional usage of this herb as an antidiabetic is supported scientifically by these findings.  By reducing dietary glucose intake, it may help slow the course of diabetic complications and control diabetes. The therapy of hyperglycaemia requires further screening of predicted antidiabetic compounds.
本研究的目的是通过计算机对接研究,确定可能导致床支Rhynchosia beddomei抗糖尿病活性的潜在生物活性成分,并研究床支Rhyn chosia beddomei可能有助于治疗糖尿病及其相关并发症的潜在机制。体外抗糖尿病试验表明,这种植物对α-淀粉酶(62.13%)和α-葡萄糖苷酶(59.9%)酶活性的高效抑制是其抗高血糖活性的原因。索氏提取的提取率为35.43%。此外,我们通过对接实验推测,该植物中含有的黄酮类化合物,包括芦丁、lucenin、orientin、rhinchosin和异oreintin,可能是其抗糖尿病特性的原因。这些发现在科学上支持了这种草药作为抗糖尿病药物的传统用法。通过减少饮食中葡萄糖的摄入,它可能有助于减缓糖尿病并发症的进程并控制糖尿病。治疗高血糖需要进一步筛选预测的抗糖尿病化合物。
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引用次数: 0
Surface-Decorated Nanocarrier as a Targeted Drug Delivery Cargo to Folate Receptor-Overexpressing Cells for Enhancing Anti-cancer and Anti-inflammatory Activity 表面修饰纳米载体作为叶酸受体过表达细胞的靶向药物递送货物增强抗癌和抗炎活性
Pub Date : 2023-07-10 DOI: 10.9734/jpri/2023/v35i187393
Yomna Adel Gabr, G. Girgis, H. El-Sabbagh
Aims: Folate receptor (FR) is overexpressed in most cancer cells and activated macrophages entailed in rheumatoid arthritis (RA). The aim of the current study was the fabrication of FR-targeted nanocarrier loaded with methotrexate (MTX) to magnify its therapeutic efficacy and limit its toxicity. Methodology: Folic acid-chitosan (FA-CS) conjugate was synthesized and characterized. MTX loaded poly(d,l-lactide-co-glycolide) (PLGA) nanoparticles (NPs) were prepared, optimized and coated with different concentrations of FA-CS conjugate. The selected FA-CS coated MTX NPs formulation (F10) was evaluated via in vitro and in vivo studies. Results: F10 had satisfactory encapsulation efficiency (76.2%), homogenous particle size (278.6 nm) and positive zeta potential (34.0 mV) and displayed biphasic drug release pattern in different pH media. Further characterization of F10 cinched MTX incorporation in the polymeric matrix of the targeted nanocarrier. In vitro cytotoxicity assay to FR-positive and FR-negative cancer cells revealed the improved anticancer effect of F10 to FR-positive cancer cells, which was absent in FR-negative cells, compared to free MTX or uncoated MTX NPs (F2). F10 showed appropriate storage stability at refrigerated temperature up to 3 months.  Moreover, oral administration of F10 in the treatment of complete Freund’s adjuvant (CFA)-induced RA in BALB/c mice conferred prodigious therapeutic outcomes and declined systemic toxicity compared to oral treatment with conventional pure MTX or commercial MTX tablets. Conclusion: The fabricated targeted nanocarrier could enhance the anticancer activity of MTX to FR-overexpressing cancer cells and could be a promising novel approach for oral administration of MTX in the treatment of RA or other inflammatory conditions associated with FR-overexpressing activated macrophages.
目的:叶酸受体(FR)在类风湿关节炎(RA)的大多数癌细胞和活化的巨噬细胞中过度表达。本研究的目的是制备装载甲氨蝶呤(MTX)的fr靶向纳米载体,以扩大其治疗效果并限制其毒性。方法:合成叶酸-壳聚糖(FA-CS)缀合物并对其进行表征。制备了负载MTX的聚(d,l-丙交酯-羟基乙酸酯)(PLGA)纳米颗粒(NPs),并对其进行了优化和包被不同浓度的FA-CS共轭物。选定的FA-CS包被MTX NPs配方(F10)通过体外和体内研究进行评价。结果:F10包封率为76.2%,粒径均匀(278.6 nm), zeta电位为34.0 mV,且在不同pH介质中呈双相释药模式。F10进一步表征了MTX在目标纳米载体聚合物基质中的掺入。对fr阳性和fr阴性癌细胞的体外细胞毒性试验显示,与游离MTX或未包被MTX NPs相比,F10对fr阳性癌细胞的抗癌作用增强,而这在fr阴性细胞中是不存在的(F2)。F10在冷藏温度下表现出良好的储存稳定性,最长可达3个月。此外,口服F10治疗完全弗氏佐剂(CFA)诱导的BALB/c小鼠RA获得了惊人的治疗效果,与传统纯MTX或商业MTX片口服治疗相比,降低了全身毒性。结论:制备的靶向纳米载体可以增强MTX对过表达fr的癌细胞的抗癌活性,可能是口服MTX治疗RA或其他与fr过表达活化巨噬细胞相关的炎症的一种有希望的新方法。
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引用次数: 0
The Importance of Good Manufacturing Practices (GMP) in the Healthcare Industry 良好生产规范(GMP)在医疗保健行业中的重要性
Pub Date : 2023-07-10 DOI: 10.9734/jpri/2023/v35i187394
Akash Sharma, Vriti Gamta, G. Luthra
In the healthcare industry, maintaining high-quality standards is crucial to ensure the safety and efficacy of medical products. Good Manufacturing Practices (GMP) provide a set of guidelines and regulations that help ensure the consistent production, control, and quality assurance of pharmaceuticals, medical devices, and other healthcare products. This paper explores the significance of GMP in the healthcare industry, highlighting its background, objectives, role in safeguarding patient health and maintaining public trust. It examines the key principles of GMP, its regulatory framework, and its impact on various aspects of the healthcare sector, including drug manufacturing, quality control, product safety, and regulatory compliance. Furthermore, the paper discusses the challenges and future perspectives of GMP implementation, emphasizing the need for ongoing advancements to meet the evolving demands of the industry. To summarize, adherence to GMP standards is crucial for the healthcare industry to produce high-quality, safe, and effective healthcare products. GMP compliance promotes patient safety, regulatory compliance, and innovation in the pharmaceutical industry.
在医疗保健行业,保持高质量的标准对于确保医疗产品的安全性和有效性至关重要。良好生产规范(GMP)提供了一套指导方针和法规,有助于确保药品、医疗器械和其他医疗保健产品的一致生产、控制和质量保证。本文探讨了GMP在医疗保健行业的意义,强调了其背景、目标、在保障患者健康和维护公众信任方面的作用。它审查了GMP的关键原则、监管框架及其对医疗保健部门各个方面的影响,包括药品生产、质量控制、产品安全和监管合规性。此外,本文讨论了GMP实施的挑战和未来前景,强调了不断进步以满足行业不断变化的需求的必要性。总之,遵守GMP标准对于医疗保健行业生产高质量、安全有效的医疗保健产品至关重要。GMP合规促进了制药行业的患者安全、法规合规和创新。
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引用次数: 0
Development and Validation of a UV Spectroscopy Absorption Ratio Method for Simultaneous Estimation of Nitrendipine and Hydrochlorothiazide 同时测定尼群地平和氢氯噻嗪的紫外光谱吸收比法的建立和验证
Pub Date : 2023-07-09 DOI: 10.9734/jpri/2023/v35i187392
A. Soni, Muskan Sharma, C. Kumari
A novel UV-spectroscopic method, characterized by its novelty, simplicity, accuracy, precision, linearity, and sensitivity, has been successfully developed and validated for the simultaneous estimation of Nitrendipine and Hydrochlorothiazide in pharmaceutical tablet dosage form. The method relied on the absorption factor approach, employing the analysis of isosbestic points within the zero-order absorption spectra. Specifically, the isoabsorptive points at a wavelength of 282 nm were employed for the determination of Nitrendipine and Hydrochlorothiazide. The absorbance corresponding to each compound at the isoabsorptive point of 282 nm was calculated using the absorbance factor, derived as the average absorbance of various concentrations of pure Nitrendipine utilizing the isoabsorptive point at 282 nm. Subsequently, the developed method underwent a comprehensive validation process, adhering to the guidelines established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The linearity range was determined based on their respective λ max at the isoabsorptive point of 282 nm. The culmination of these results leads to the conclusion that the present research is characterized by novelty, accuracy, efficiency, precision, rapidity, reproducibility, simplicity, and sensitivity. Consequently, the proposed method is deemed suitable for the successful estimation of Nitrendipine and Hydrochlorothiazide in pharmaceutical tablet dosage form.
成功开发并验证了一种新的紫外光谱法同时测定片剂中尼群地平和氢氯噻嗪的含量,该方法具有新颖、简便、准确、精密、线性和灵敏度等特点,采用对零阶吸收光谱内的同位点的分析。具体而言,采用282nm波长的等吸收点测定尼群地平和氢氯噻嗪。使用吸光度因子计算每种化合物在282nm的等吸收点处的吸光度,该吸光度因子导出为利用282nm的同吸收点的各种浓度的纯尼群地平的平均吸光度。随后,根据国际人类药物技术要求协调理事会(ICH)制定的指南,对开发的方法进行了全面的验证。线性范围是基于它们在282nm的等吸收点处各自的λmax来确定的。这些结果的结果表明,本研究具有新颖性、准确性、有效性、精密性、快速性、再现性、简单性和敏感性。因此,所提出的方法被认为适用于成功估算片剂剂型中尼群地平和氢氯噻嗪的含量。
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引用次数: 0
Understanding Healthcare Regulation in Canada: Strategies for Ensuring Quality and Accessibility 了解加拿大的医疗监管:确保质量和可及性的策略
Pub Date : 2023-07-09 DOI: 10.9734/jpri/2023/v35i187391
Akash Sharma, Vriti Gamta, G. Luthra
Healthcare regulation plays a crucial role in ensuring the quality and accessibility of healthcare services in Canada. This article provides an overview of the healthcare regulatory landscape in Canada, focusing on federal and provincial/territorial regulations. The federal level regulations, overseen by Health Canada, encompass drug and medical device regulations, health information privacy and security, and food safety and nutrition regulations. Provincial and territorial regulations, implemented by respective healthcare authorities, address licensing and regulation of healthcare professionals, healthcare facility regulation, and allocation of healthcare resources. The article discusses the importance of health information privacy and security regulations in the digital age and highlights the safeguards and best practices to protect personal health information. By understanding and navigating these healthcare regulations, stakeholders can contribute to a healthcare system that ensures quality and accessibility for all Canadians.
医疗保健监管在确保加拿大医疗保健服务的质量和可及性方面发挥着至关重要的作用。本文概述了加拿大的医疗监管格局,重点介绍了联邦和省/地区法规。由加拿大卫生部监督的联邦级法规包括药品和医疗器械法规、健康信息隐私和安全以及食品安全和营养法规。省和地区法规由各自的医疗保健机构实施,涉及医疗保健专业人员的许可和监管、医疗保健设施监管以及医疗保健资源的分配。文章讨论了数字时代健康信息隐私和安全法规的重要性,并强调了保护个人健康信息的保障措施和最佳实践。通过了解和指导这些医疗法规,利益相关者可以为确保所有加拿大人的质量和可及性的医疗体系做出贡献。
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引用次数: 0
Ensuring Patient Safety and Trust: The Critical Importance of Regulatory Compliance in Healthcare 确保患者安全和信任:医疗保健中法规遵从性的关键重要性
Pub Date : 2023-07-07 DOI: 10.9734/jpri/2023/v35i187390
Akash Sharma, Vriti Gamta, G. Luthra
Regulatory compliance plays a pivotal role in the healthcare industry by ensuring patient safety, maintaining quality standards, and fostering trust between healthcare providers and patients. This research article aims to highlight the significance of regulatory compliance in healthcare, examining its impact on patient outcomes, organizational performance, and legal implications. Drawing upon existing literature and empirical evidence, this article underscores the need for robust compliance frameworks, effective monitoring systems, and continuous education to ensure adherence to regulatory requirements. By addressing key challenges and outlining best practices, this article provides valuable insights for healthcare organizations to enhance their compliance efforts and ultimately promote a safer and more reliable healthcare system.
法规遵从性在医疗保健行业中发挥着关键作用,可确保患者安全、维护质量标准以及促进医疗保健提供者和患者之间的信任。本文旨在强调医疗保健中的法规遵从性的重要性,并检查其对患者结果、组织绩效和法律含义的影响。根据现有文献和经验证据,本文强调需要健全的法规遵循框架、有效的监控系统和持续的教育,以确保遵守法规要求。通过解决关键挑战和概述最佳实践,本文为医疗保健组织提供了有价值的见解,以增强其遵从性工作,并最终促进更安全、更可靠的医疗保健系统。
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引用次数: 0
Preformulation Studies of Varenicline for Formulation and Development of a Novel Orally Disintegrating Film 一种新型口腔崩解膜的制备与研制
Pub Date : 2023-07-07 DOI: 10.9734/jpri/2023/v35i177388
Prakruti Amin, Manish Patel
Objective: The major goal of pre-formulation research is to create a drug delivery system that is stable, elegant, safe, and effective by determining the drug's kinetic profile, the formulation's compatibility with various excipients, and the physico-chemical characteristics of new drug molecules. This could offer crucial support for executing formulation design or the need for the molecular change. Therefore, in the current study, studies on Varenicline (VAR)'s appropriateness for oral formulation were conducted. Similar to cytisine, VAR functions as a partial nicotine receptor agonist. It blocks alpha-4-beta-2 nicotinic acetylcholine receptor subtypes and is a partial agonist. Through partial agonism, VAR reduces the urge and withdrawal symptoms associated with quitting efforts by inhibiting the dopaminergic activation brought on by smoking. It stops nicotine from stimulating the mesolimbic dopamine pathway, which is linked to nicotine addiction. Methods: The authenticity of VAR was established by DSC and FTIR spectra. A UV spectrophotometric method was employed for determination of VAR in bulk and active pharmaceutical ingredient (API). Results: The authenticity of VAR was established by DSC and FTIR spectra. For the determination of VAR in bulk API (active pharmaceutical ingredient), a UV spectrophotometric approach was used. In the concentration range of 5–40 g/ml, the UV technique was linear. The lower% CV values of intraday and interday variability indicate the proposed methodology's robustness. The higher regression coefficient value(0.999) indicates the methodology is robust. Conclusions: The outcome of the physico-chemical experiments of drug molecule indicates suitability of oral route. Additionally, at different conditions like solid as well as liquid state, the drugmoleculewasobservedstable.
目的:制剂前研究的主要目标是通过确定药物的动力学特性、制剂与各种赋形剂的兼容性以及新药分子的物理化学特性,建立一种稳定、优雅、安全、有效的给药系统。这可以为执行配方设计或分子改变的需要提供关键支持。因此,在本研究中,对缬氨酸(VAR)用于口服制剂的适宜性进行了研究。与胞嘧啶类似,VAR作为部分尼古丁受体激动剂发挥作用。它阻断α-4-β-2烟碱型乙酰胆碱受体亚型,是一种部分激动剂。通过部分激动,VAR通过抑制吸烟引起的多巴胺能激活来减少与戒烟相关的冲动和戒断症状。它阻止尼古丁刺激与尼古丁成瘾有关的中边缘多巴胺通路。方法:通过DSC和FTIR光谱分析,验证VAR的真实性。采用紫外分光光度法测定API原料药中VAR的含量。结果:通过DSC和FTIR光谱验证了VAR的真实性。采用紫外分光光度法测定原料药API中的VAR。在5–40 g/ml的浓度范围内,紫外线技术是线性的。日内和日间变异性的较低%CV值表明了所提出的方法的稳健性。较高的回归系数值(0.999)表明该方法是稳健的。结论:药物分子的理化实验结果表明口服途径是合适的。此外,在固态和液态等不同条件下,药物分子是稳定的。
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引用次数: 0
Regulatory Compliance in the United States: A Comprehensive Analysis of USFDA Guidelines and Implementation Strategies 美国的法规遵从:美国食品药品监督管理局指南和实施策略的综合分析
Pub Date : 2023-07-07 DOI: 10.9734/jpri/2023/v35i177389
Akash Sharma, Vriti Gamta, G. Luthra
This research paper aims to provide a comprehensive analysis of regulatory compliance in the United States, with a specific focus on the guidelines set forth by the United States Food and Drug Administration (USFDA). Regulatory compliance plays a crucial role in ensuring the safety and efficacy of pharmaceutical products, medical devices, and food and beverages in the US market. This paper discusses the regulatory framework, key requirements, challenges faced by companies, and effective implementation strategies to achieve and maintain compliance with USFDA regulations. The findings of this research provide valuable insights for businesses operating in regulated industries and contribute to the understanding of the importance of regulatory compliance in the US.
本研究论文旨在对美国的法规遵从性进行全面分析,特别关注美国食品和药物管理局(USFDA)制定的指导方针。法规遵从性在确保美国市场上药品、医疗器械、食品和饮料的安全性和有效性方面起着至关重要的作用。本文讨论了监管框架、关键要求、公司面临的挑战,以及实现和保持遵守USFDA法规的有效实施策略。本研究的结果为在受监管行业运营的企业提供了有价值的见解,并有助于理解美国监管合规的重要性。
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引用次数: 0
期刊
Journal of Pharmaceutical Research International
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