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A Comparative Study on the Review and Evaluation of the Regulatory Process of Spurious and not Standard Quality Drugs in Different Countries 不同国家伪劣药品监管审查与评价的比较研究
Pub Date : 2023-10-20 DOI: 10.26452/fjphs.v3i4.513
Rajasekhar Sreerama, Somu Ashok Kumar, Audi Narayana Nelavala
To protect the public's health, the pharmaceutical business must first ensure the efficacy and safety of its products. In this comparative study, the regulatory frameworks for fake and inferior-quality medicines in India and the United States are analysed and contrasted. The study uses a mixed-approaches methodology, combining qualitative and quantitative research methods. Interviews with important figures from pharmaceutical corporations, healthcare organisations, and regulatory authorities are used to collect primary data. These interviews are combined with a thorough analysis of the literature, laws, and case studies that have already been published. We evaluate the efficacy of corrective measures implemented by regulatory bodies to reduce the dangers associated with fake and subpar medications. The comparative research identifies the regulatory frameworks of each nation's strong and weak points, revealing possible areas for development. Suggestions are made for improving inter-agency communication, streamlining inspection processes, and implementing cutting-edge technologies for improved surveillance.In the end, this study contributes to the global conversation on drug regulation and public health by illuminating the obstacles and opportunities that India and the USA must overcome in their fight against fake and subpar medications. Policy makers, regulatory bodies, and stakeholders in both nations are likely to benefit from the research's findings, which will help create a more effective and flexible regulatory framework for pharmaceuticals.
为了保护公众的健康,医药企业必须首先确保其产品的有效性和安全性。在这项比较研究中,对印度和美国的假药和劣质药品的监管框架进行了分析和对比。本研究采用定性与定量研究相结合的混合方法。对来自制药公司、医疗保健组织和监管机构的重要人物的访谈用于收集原始数据。这些访谈结合了对文献、法律和已经发表的案例研究的彻底分析。我们评估了监管机构实施的纠正措施的有效性,以减少与假药和劣药相关的危险。比较研究确定了每个国家的监管框架的长处和弱点,揭示了可能的发展领域。提出了改善机构间沟通、简化检查程序和采用尖端技术以改进监测的建议。最后,本研究通过阐明印度和美国在打击假药和劣药方面必须克服的障碍和机会,为全球药物监管和公共卫生对话做出了贡献。两国的政策制定者、监管机构和利益相关者都可能从这项研究的发现中受益,这将有助于建立一个更有效、更灵活的药品监管框架。
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引用次数: 0
A Review of Alstrom Syndrome Alstrom综合征研究综述
Pub Date : 2023-10-18 DOI: 10.26452/fjphs.v3i4.512
Borra Sandhya
Alström disease is a condition of autosomal recessive trait disorders that are characterized. At the same time, cone-rod spinal muscular atrophy, hearing impairment, adolescent upper abdominal overweight, insulin sensitivity but also insulin production, insulin-dependent, hypercholesterolemia, present approximately through sexual maturity, myocardial infarction, but also accelerated respiratory, hepatic, but also renal failure to thrive. A multitude of interesting alternative strand management functionality. alms1 protein is present through the centromere, metabolic rate organization, and intracellular space of any connective tissue infected with the disease. Identifying alms1 as little more than a pupillary transcription factor helps explain its variety like witnessed phenotypic expression and their resemblance from those of someone else ciliopathies, including such burden-field disorder. Experiments conducted by mouse models and cell membrane model types like alström disorder have made available an understanding of the staphylococcus aureus mechanisms that underlie obesity in children, hyperglycemia, and many other diagnostic and therapeutic significant issues. Inevitably, data analysis into pathophysiology like alström disorder could perhaps translate to more vital organization and coverings for people and also have crucially substantial potential consequences for these other relatively uncommon ciliopathies, along with more frequent symptoms like obesity and heart disease, as well as other circumstances prevalent inside the overall population.
Alström疾病是一种常染色体隐性性状疾病,其特征是。同时,锥杆脊髓性肌肉萎缩、听力障碍、青少年上腹部超重、胰岛素敏感但也产生胰岛素、胰岛素依赖、高胆固醇血症,现约通过性成熟、心肌梗塞,但也加速呼吸、肝、肾衰茁壮成长。大量有趣的可选链管理功能。Alms1蛋白通过感染此病的任何结缔组织的着丝粒、代谢率组织和细胞内间隙存在。确定alms1仅仅是一个瞳孔转录因子,有助于解释其多样性,如目击表型表达,以及它们与其他纤毛病(包括负担场障碍)的相似性。通过小鼠模型和细胞膜模型类型(如alström紊乱)进行的实验,可以了解金黄色葡萄球菌的机制,该机制是儿童肥胖、高血糖和许多其他诊断和治疗重大问题的基础。不可避免的是,对病理生理学的数据分析,如alström紊乱,可能会转化为人们更重要的组织和覆盖物,也会对其他相对不常见的纤毛病,以及更常见的症状,如肥胖和心脏病,以及其他在总人口中普遍存在的情况,产生至关重要的潜在影响。
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引用次数: 0
A Review of Parkinson’s Disease: Diagnosis and Treatment 帕金森病的诊断和治疗综述
Pub Date : 2023-10-11 DOI: 10.26452/fjphs.v3i4.510
Gautham Chakra R, Naveen T G, Abdul Rahem Sk, Harshitha A, Aravind Goud K
One of the most frequent diseases is Parkinson's disease (PD). Recent years have seen notable improvements in the understanding of the disease's in terms of prevalence and incidence. Additionally, there has been a growing understanding that, in addition to the more well acknowledged difficulties, the disorder may also be linked to important causes and disturbances. Despite accumulating suggestive evidence, it has not yet been determined which of the Parkinson's disease treatments possess a effect. There are numerous therapy options available, but there is no known cure for Parkinson's disease. As the illness worsens, additional treatments are available, but managing the symptoms of PD is still difficult and will benefit from more clinical study.
最常见的疾病之一是帕金森病(PD)。近年来,人们对该病的患病率和发病率的了解有了显著提高。此外,人们越来越认识到,除了公认的困难之外,这种障碍也可能与重要的原因和干扰有关。尽管积累了大量具有启发性的证据,但目前还没有确定哪种帕金森病治疗方法具有效果。有许多可用的治疗方案,但目前还没有已知的治愈帕金森病的方法。随着病情的恶化,有更多的治疗方法可用,但控制帕金森病的症状仍然很困难,将受益于更多的临床研究。
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引用次数: 0
Development and Validation of Breast cancer and Breast self-examination scale to assess the Knowledge and attitude towards Breast cancer and Breast self-examination 乳腺癌和乳房自检量表的编制与验证,以评估对乳腺癌和乳房自检的知识和态度
Pub Date : 2023-10-11 DOI: 10.26452/fjphs.v3i4.509
Chandana B, Thanushree D R, Kumaraswamy M, Robin George
The second most prevalent type of cancer after lung cancer, breast cancer affects women more frequently than any other type.BSE is a screening method that women can use at home to find breast cancer early on. Whether female college students are sufficiently informed about breast cancer. They can aid in reducing the prevalence of breast cancer in their neighbourhood and assist in cancer prevention for themselves. As the nation's future mothers, they ought to be at least somewhat knowledgeable about breast cancer. The secondary objective was to perform its reliability and validity. Apart from referring to previous existing scales, were also considered while developing the scale. The scale was administered to a total of 1006 participants, from pharmacy, medical, nursing, and BSC &MSC with ages ranging from 18-33 years. The participants did not report any difficulty in understanding the questions. The final scale consists of (21-items development and validation of breast cancer and breast self-examination scale) with a content validity index (CVI=1), Pearson's 'r' value (0.96), Cronbach's Alpha (0.923). Hence (21-items development and validation of breast cancer and breast self-examination scale) turned out to be a reliable and valid tool in assessing knowledge, attitude about breast cancer and breast self-examination among female college students. The (21-items development and validation of breast cancer and breast self-examination scale) is expected to aid in the clinical evaluation and research the field.
乳腺癌是仅次于肺癌的第二大常见癌症,对女性的影响比任何其他类型的癌症都要大。疯牛病是一种筛查方法,女性可以在家中使用这种方法来早期发现乳腺癌。女大学生是否充分了解乳腺癌。她们可以帮助减少她们所在社区的乳腺癌发病率,并帮助她们自己预防癌症。作为这个国家未来的母亲,她们至少应该对乳腺癌有所了解。次要目标是验证其信度和效度。除了参考以前的现有比额表外,我们在制定比额表时也考虑了这些因素。该量表共有1006名参与者参与,他们来自药学、医学、护理和理学士和理学硕士,年龄从18-33岁不等。参与者没有报告在理解问题上有任何困难。最终量表由(21项乳腺癌发展与验证及乳房自检量表)组成,内容效度指数(CVI=1), Pearson' r'值为0.96,Cronbach's Alpha值为0.923。因此(21项乳腺癌及乳房自检量表的编制与验证)是评估女大学生乳腺癌及乳房自检知识、态度的可靠有效的工具。该项目(21项乳腺癌及乳房自检量表的开发和验证)有望为该领域的临床评价和研究提供帮助。
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引用次数: 0
A Case Report on Alcohol Dependence Syndrome with Relation to Insomnia 酒精依赖综合征伴失眠1例报告
Pub Date : 2023-10-06 DOI: 10.26452/fjphs.v3i4.508
Fiza S H, Prajnesh J Shetty, Robin George
Alcohol dependence is a pattern of substance use, leading to clinically significant impairment or distress; chronic alcohol abuse has been known to disrupt the normal sleep cycle and lead to sleep disorders, including sleep terror disorder. A male patient of age 42 years was a known alcoholic for 24 years, and the patient does not have any previous psychiatric history. Then, he stopped drinking for four days and developed insomnia. The patient gave an account of emotional outbreaks from 2 days; vital signs included blood pressure 14090 , pulse rate 81 bpm, respiratory rate 20 , and oxygen saturation 97%@RA and the patient's GRBS level was 210 mg, and the patient was immediately given with medication in. 4mg (IV), . (2 amp in 100 ml NS, BD), . Panto 40mg (IV), the same drug, was continued for three days, and there was no complaint of visual hallucinations. The patient felt symptomatically better and was discharged on the 4th day with no fresh complaints. The patient was advised to continue Tab. 2mg for three days. The preliminary case investigation evaluated the link between insomnia and alcohol dependence syndrome (ADS).
酒精依赖是一种物质使用模式,导致临床显著损害或痛苦;众所周知,长期酗酒会扰乱正常的睡眠周期,导致睡眠障碍,包括睡眠恐怖症。患者男,42岁,酗酒24年,既往无精神病史。之后,他连续4天不喝酒,出现了失眠。患者叙述了2天内情绪爆发的情况;生命体征为血压14090,脉率81 bpm,呼吸频率20,血氧饱和度97%@RA, GRBS水平210 mg,立即给予药物治疗。4mg (IV),。(2安培100ml NS, BD),Panto 40mg (IV),同样的药物,持续3天,没有视觉幻觉的抱怨。患者症状好转,第4天出院,无新的主诉。建议患者继续服用2mg,连续3天。初步病例调查评估了失眠与酒精依赖综合征(ADS)之间的联系。
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引用次数: 0
Hydroalcoholic Extraction of Ipomoea pes caprae Leaf Extract of Antifungal Activity Against Candida albicans 水醇提取茯苓叶提取物抗白色念珠菌活性的研究
Pub Date : 2023-08-21 DOI: 10.26452/fjphs.v3i3.505
Salma Shaik, K. Baba, Katakam Pavana Narasimha, Mohammed Arshiya Rehamath, P. Dharani, Polisetty Harshavardhan, Poori Kusuma Kumari
The current study is to prepare hydroalcoholic extraction of ipomea pes caprae leaf extract of antifungal activity against candida albicans. Ipomoea pes caprae leaves are extracted using a hydroalcoholic solvent in a 1:9 ratio, which consists of 1 part water as well as 9 parts of the alcohol. These plant extracts are used to treat antifungal diseases. The antifungal activity of ipomoea pes-caprae leaf extract and their respective zone of inhibitions were evaluated. From the results, it was confirmed that the hydroalcoholic extract obtained from the leaves of the ipomoea pes caprae demonstrated exceptional activity as compared to that of a typical medication.
本研究旨在制备对白色念珠菌具有抗真菌活性的水醇提取液。用1:9比例的水酒精溶剂提取卡普拉叶,该溶剂由1份水和9份酒精组成。这些植物提取物被用来治疗抗真菌疾病。研究了甘薯叶提取物的抑菌活性及其抑菌区。从结果中可以证实,与典型药物相比,从甘露叶中提取的水酒精提取物具有特殊的活性。
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引用次数: 0
Development of Stable Injectable Formulation by Freeze Drying Technique 用冷冻干燥技术研制稳定注射制剂
Pub Date : 2023-08-14 DOI: 10.26452/fjphs.v3i3.500
Rajni K, Naresh Kalra, Hunny Dabas
Drug stability is a significant problem that affects drug quality. Freeze drying is one of the techniques that can be used to develop stable drugs. This paper presents a new technique for developing regular drugs by a freeze-drying process with the potential for various applications in and the pharmaceutical industry. This review aims to improve the current systems from unstable to stable by freeze drying technique. systems are dangerous, which leads to the degradation of the drug. The freeze-drying process can be used for sound systems. Characteristics of proteins and peptides are the primary concern of the pharmaceutical industry. Freeze drying provides a new, safe, and effective way to preserve these substances without refrigeration or freezing. In the pharmaceutical industry, many efforts have been made to improve current protein formulations for injection. A new technique called freeze drying is emerging as a potential solution. This paper will explore the characteristics of freeze-drying and its possibilities for developing stable drugs in more detail. Especially complex protein-based drugs present significant challenges to manufacturers because their stability is low, and they often have harsh conditions that need to be stored such as being kept frozen or cooled on ice at all times.
药物稳定性是影响药品质量的重要问题。冷冻干燥是一种可用于开发稳定药物的技术。本文介绍了一种利用冷冻干燥法制备常规药物的新技术,在医药工业中具有广泛的应用前景。本综述旨在通过冷冻干燥技术将现有的不稳定系统改善为稳定系统。系统是危险的,这会导致药物的降解。冷冻干燥工艺可用于音响系统。蛋白质和多肽的特性是制药工业最关心的问题。冷冻干燥提供了一种新的、安全的、有效的方法来保存这些物质,而不需要冷藏或冷冻。在制药行业,许多努力已经作出了改善目前的注射用蛋白质配方。一种被称为冷冻干燥的新技术正在成为一种潜在的解决方案。本文将更详细地探讨冷冻干燥的特点及其开发稳定药物的可能性。尤其是复杂的蛋白质类药物,它们的稳定性很低,而且通常需要在恶劣的条件下储存,比如一直冷冻或在冰上冷却,这给制造商带来了巨大的挑战。
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引用次数: 0
To develop and evaluate the in-vitro anti oxidant and anti-inflammatory activity of polyherbal Gel 目的:开发并评价中药凝胶的体外抗氧化和抗炎活性
Pub Date : 2023-08-12 DOI: 10.26452/fjphs.v3i3.496
Suchitra M, Harinadha Baba K, Yamini R, S. P, Surekha G, P. T, Sakshi Jain
Herbal medicines are used for their safety, efficacy, cultural acceptability and lesser side effects. The chemical constituents present in plants are a part of the physiological functions of living system and hence they are believed to have better compatibility with the human body. These drugs are made from renewable resources of raw materials by eco-friendly processes and will bring economic prosperity. An herb is a plant or plant part used for its scent, flavor, or therapeutic properties. They are sold as tablets, capsules, powders, teas, extracts, and fresh or dried plants. People use herbal medicines to try to maintain or improve their health. Products made from botanicals, or plants, that are used to treat diseases or to maintain health are called herbal products, botanical products, or phytomedicines. A product made from plants and used solely for internal use is called an herbal supplement.
草药因其安全性、有效性、文化可接受性和较小的副作用而被使用。植物中的化学成分是生命系统生理功能的一部分,因此被认为与人体具有更好的相容性。这些药物是由可再生资源的原料,通过环保的过程,将带来经济繁荣。草本植物是一种植物或植物的一部分,因其气味、味道或治疗特性而被使用。它们以片剂、胶囊、粉末、茶、提取物以及新鲜或干燥植物的形式出售。人们使用草药来维持或改善他们的健康。由植物制成的用于治疗疾病或保持健康的产品被称为草药产品、植物产品或植物药。由植物制成并仅供内部使用的产品称为草药补充剂。
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引用次数: 1
The perspective of herbal mineral formulation Kaalamega Narayana Chendhooram (KMNC) as an anti-microbiological, anti-oral carcinoma, anti-tumor evaluations (A Siddha medicine for oral cancer, lung cancer) in in-vitro studies
Pub Date : 2023-07-31 DOI: 10.26452/fjphs.v3i3.494
S. C, B. S, K. D, A. R
Leukaemia, one of the most lethal illnesses of the twentieth century, is becoming one of the most common illnesses of the twenty-first. The most common carcinoma among those under the mandatory age of 20 is oral also tumor cancer. Siddha herbal mineral formulation's perspective this study aims to assess the anti-microbiological, anti-oral cancer, and anti-tumor activities of Kaalamega Narayana Chendhooram in vitro experiments. As well as to measure anti-tumor activity against KB cell lines as well as anti-cancer activity (MTT assay) and validate the therapeutic effects of KMNC in order to evaluate the therapeutic effects of KMNC. In the modern medical setting, oral cancer must be effectively treated. The percentage of KB cell viability in the MTT experiment was 69.46%, 55.06%, 51.67%, 40.33%, and 35.34% at concentrations of 62.5 µg/mL, 12.5 µg/mL, 25 µg/mL, 50 µg/mL, and 100 µg/mL, respectively. The results of the present study support the anti-cancer activity of the formulation KMNC. The results of the present study support the anti-cancer activity of the formulation KMNC. KMNC is demonstrating its effectiveness as a tumor and oral carcinoma cancer prevention. Numerous pharmacological actions, including as antibacterial and anticancer properties, are present. This cancer treatment is inexpensive and doesn't have any negative side effects. The anticancer properties of KMNC have been documented in scientific journals. In this paper, the anticancer activity of KMNC is discussed in the context of several in-vitro researches.
白血病,二十世纪最致命的疾病之一,正在成为二十一世纪最常见的疾病之一。在法定年龄20岁以下的人中,最常见的癌症是口腔癌和肿瘤。本研究旨在通过体外实验,评价喀拉拉木的抗微生物、抗口腔癌和抗肿瘤活性。以及测定KMNC对KB细胞系的抗肿瘤活性和抗癌活性(MTT法),验证KMNC的治疗效果,以评价KMNC的治疗效果。在现代医疗环境中,口腔癌必须得到有效治疗。MTT实验中,62.5µg/mL、12.5µg/mL、25µg/mL、50µg/mL和100µg/mL浓度下,KB细胞存活率分别为69.46%、55.06%、51.67%、40.33%和35.34%。本研究结果支持复方KMNC的抗癌活性。本研究结果支持复方KMNC的抗癌活性。KMNC在肿瘤和口腔癌预防方面的有效性正在得到证实。许多药理作用,包括抗菌和抗癌特性,都存在。这种治疗癌症的方法不贵,而且没有任何副作用。KMNC的抗癌特性已在科学期刊上得到证实。本文结合几项体外研究,对KMNC的抗癌活性进行了讨论。
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引用次数: 0
Formulation and Evaluation of Transdermal Patches of Clotrimazole 氯霉唑透皮贴剂的研制与评价
Pub Date : 2023-07-31 DOI: 10.26452/fjphs.v3i3.492
Yelamanda Jagadeesh, Hari Kiran, Reddy Naveena B, Chandra Prakash D, Bhagya Lakshmi G, Vaishnavi P, Varshini S, Vadamala Prudhvi Raj
The aim of the present research work was to formulate Transdermal patches of Clotrimazole and to enhance effectiveness and to avoid side effects of the drug. Transdermal patch of clotrimazole was prepared with EC and HPMC in different ratios in order to improve the drug diffusion. Clotrimazole has formulated Transdermal patches were prepared by solvent evaporation technique. Drug and polymers has been characterized by FT-IR. The FTIR spectra of formulation shows that no interaction between drug and excipient. The evaluation of Transdermal patches of Clotrimazole were performed mainly for their Physical parameters such as Weight variation, Thickness, Folding endurance test And also for their Drug content and In-vitro Drug diffusion studies. The patch prepared by solvent evaporation technique passes the prepared patch were found to be non irritant, weight variation was found in the range of 39±5.81 to 48±2.90mg, thickness in the range of 0.08±0.09 to 0.04±0.08 mm, Folding endurance of patches was found to be in the range of 98 ±0.57 to 128±0.59, The tensile strength of the patches was ranging from 1.95±1.2to 3.98±1.9, The percentage elongation ranges from 10.6 to 18.6, drug content uniformity was in between 78.25 to 89.76 %. The in-vitro drug diffusion profiles of the formulations in pH 7.4 show differences depending on their composition. A Tran’s dermal patches of all the preparations were observed by the diffusion test. It was also observed that F6 showed highest drug release.
本研究的目的是研制氯霉唑透皮贴剂,以提高药物的有效性和避免药物的副作用。以不同比例的EC和HPMC制备氯霉唑透皮贴剂,以改善药物的扩散。采用溶剂蒸发法制备了氯霉唑透皮贴剂。用傅里叶变换红外光谱对药物和聚合物进行了表征。FTIR光谱表明,制剂与辅料无相互作用。对氯曲霉唑透皮贴剂的评价主要包括质量变化、厚度、耐折试验等物理参数,以及药物含量和体外药物扩散研究。补丁由溶剂蒸发技术通过准备补丁被发现非刺激物,重量差异被发现在39±5.81 48±2.90毫克,厚度在0.08±0.09,0.04±0.08毫米,耐折度的补丁被发现在98年到128±0.57±0.59,补丁的抗拉强度从1.95±1.2,3.98±1.9,伸长率范围从10.6到18.6,药物含量均匀度在78.25 - 89.76%之间。在pH 7.4条件下,制剂的体外药物扩散曲线因其组成而异。通过扩散试验观察各制剂的A Tran皮肤斑块。同时观察到F6的药物释放最高。
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引用次数: 0
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Future Journal of Pharmaceuticals and Health Sciences
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