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Estimation of Gallic Acid in Triphala Using Enzymatic Hydrolysis 酶解法测定三倍子中没食子酸的含量
Pub Date : 2022-06-15 DOI: 10.18579/jopcr/v21i1.ms21.53
R. Pallavi, S. Jha
A well-known Ayurvedic formulation, Triphala has numerous health benefits like appetite stimulation, controls diabetes, reduces cholesterol, relieves stress, alleviates inflammation and treats a variety of bacterial and fungal infections along with digestive problems. The phytoconstituents flavonoids, tannins, polyphenols and many chemical compounds are responsible for its claimed health benefits. One of the very significant compounds is gallic acid, which is reported to possess hepatoprotective, anti-inflammatory, antineoplastic and antioxidant properties that are beneficial in treatment of several diseases. In the present work using gallic acid as a marker, an attempt has been made to extract gallic acid from tannins present in Triphala by enzymatic hydrolysis and subsequent estimation of total gallic acid content by high performance thin layer chromatography (HPTLC). Rhizopus oryzae fungus is cultured for the production of enzyme tannase, which converts tannins into gallic acid. The extracted gallic acid is estimated in the biocatalyzed sample at optimal process parameters by high performance thin layer chromatography (HPTLC) method. The gallic acid content after treatment with enzyme was found to be doubled 0.296 ± 0.018 mg/ml, Rf value 0.37 at 254nm which was 0.197 ± 0.008 mg/ml and Rf value was 0.37 prior to enzymatic treatment. Gallic acid in Triphala is present in free form as well as the constituent of tannins. There is a remarkable yield of gallic acid from tannins using the enzyme Tannase in the conversion process. Application of such advanced technology increases the gallic acid yield from response surfaces in herbal and ayurvedic products containing gallic acid. The extraction condition of phenolic compounds can be optimised using enzyme hydrolysis. The effective factors including the solid to solvent ratio, enzyme concentration, particle size and extraction time can be optimised. Keywords: Triphala, Gallic acid, Tannin, Rhizopus oryzae, Tannase, HPTLC
Triphala是一种著名的阿育吠陀配方,具有许多健康益处,如刺激食欲,控制糖尿病,降低胆固醇,缓解压力,减轻炎症,治疗各种细菌和真菌感染以及消化问题。植物成分类黄酮,单宁,多酚和许多化合物是其声称的健康益处的原因。其中一种非常重要的化合物是没食子酸,据报道,它具有保护肝脏、抗炎、抗肿瘤和抗氧化的特性,对治疗多种疾病有益。本文以没食子酸为标记物,采用酶解法从三倍子单宁中提取没食子酸,并用高效薄层色谱法测定了总没食子酸的含量。培养米根霉真菌生产单宁酶,将单宁转化为没食子酸。在最佳工艺参数下,用高效薄层色谱法对生物催化样品中没食子酸的含量进行了测定。酶处理后没食子酸含量增加了一倍(0.296±0.018 mg/ml),在254nm处的Rf值为0.37(0.197±0.008 mg/ml),酶处理前的Rf值为0.37。Triphala中的没食子酸以自由形式存在,同时也是单宁的组成部分。在单宁转化过程中,利用单宁酶生产没食子酸的产量显著。这种先进技术的应用提高了含没食子酸的草药和阿育吠陀产品的反应面没食子酸的产量。利用酶解法优化酚类化合物的提取条件。对固液比、酶浓度、粒径和提取时间等影响因素进行了优化。关键词:tritria,没食子酸,单宁,米根霉,单宁酶,HPTLC
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引用次数: 0
A Statistical Study on Anti-Breast Cancer Drug Screening 抗乳腺癌症药物筛选的统计研究
Pub Date : 2022-01-20 DOI: 10.33140/jpr.07.01.01
Breast cancer is one of the most lethal cancers, estrogen receptor α Subtype (ERα) is an important target. The compounds that able to fight ERα active may be candidates for treatment of breast cancer. The drug discovery process is a very large and complex process that often requires one selected from a large number of compounds. This paper considers the independence, coupling, and relevance of bioactivity descriptors, selects the 15 most potentially valuable bioactivity descriptors from 729 bioactivity descriptors. An optimized back propagation neural network is used for ERα, the pharmacokinetics and safety of 15 selected bioactivity descriptors were verified by gradient lifting algorithm. The results showed that these 15 biological activity descriptors could not only fit well with the nonlinear relationship of ERα activity can also accurately predict its pharmacokinetic characteristics and safety, with an average accuracy of 89.92~94.80%. Therefore, these biological activity descriptors have great medical research value.
癌症是最致命的癌症之一,雌激素受体α亚型(ERα)是其重要靶点。能够对抗ERα活性的化合物可能是治疗癌症的候选化合物。药物发现过程是一个非常庞大和复杂的过程,通常需要从大量化合物中选择一种。本文考虑了生物活性描述符的独立性、耦合性和相关性,从729个生物活性描述符中选择了15个最具潜在价值的生物活性描述符。将优化的反向传播神经网络用于ERα,通过梯度提升算法验证了所选15个生物活性描述符的药代动力学和安全性。结果表明,这15个生物活性描述符不仅能很好地拟合ERα活性的非线性关系,而且能准确预测其药代动力学特性和安全性,平均准确率为89.92~94.80%,具有很高的医学研究价值。
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引用次数: 0
A Review On: Herbal, Pharmacognostical and Pharmacological Studies on Guggulu 骨骨露的本草、生药学和药理学研究综述
Pub Date : 2022-01-20 DOI: 10.33140/jpr.07.01.04
Guggulu is an oleogum resin (oleo resin) that spontaneously emerges from the bark of Commiphora mukul Hook. ex Stocks, which belongs to the Burseraceae family. It has a long ethnomedicinal history and is a phytochemical repository of heuristic medical qualities. Guggulu is one of the constituents in several Ayurvedic formulations, the majority of which are titled with the suffix ‘guggulu.’ Guggulsterone is the principal active ingredient in gugulipid, a C. mukul extract used to treat a range of human illnesses. Massive work was expended in this review to assemble the data about guggulu and its undiscovered Ayurvedic formulations utilised in the Ayurvedic System of Medicines. Purified guggulu has been found to be useful in a variety of guggulu formulations for a variety of illness problems, with or without particular anupana. In Ayurveda, the formulation concept of guggulu is characterized by improved pharmacokinetic and polyvalent effects with multiple mechanisms of drug action. As a result, it is necessary in the modern period to undertake preclinical and clinical trials to validate the medicinal effectiveness of Guggulu formulations referenced in ancient literatures.
Guggulu是一种油胶树脂(油胶树脂),从Commiphora mukul Hook的树皮中自发产生。属粘液科。它具有悠久的民族医学史,是启发式医学品质的植物化学资源库。古古鲁是几种阿育吠陀配方中的成分之一,其中大多数都以后缀“古古鲁”命名。gugugulsterone是gugugul脂的主要活性成分,gugugul脂是一种用于治疗一系列人类疾病的C. mukul提取物。在这篇综述中花费了大量的工作来收集有关guggulu及其未被发现的阿育吠陀药物系统中使用的阿育吠陀配方的数据。纯化的guguulu已被发现在各种guguulu配方中对各种疾病问题有用,有或没有特别的anupana。在阿育吠陀中,古古鲁的配方概念以改善药代动力学和多价效应为特征,具有多种药物作用机制。因此,现代有必要进行临床前和临床试验来验证古代文献中引用的咕咕咕方的疗效。
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引用次数: 0
The Combination of Double Pigtail Plastic Stent, Nasocystic Tube and Percutaneous Catheter in Endoscopic Ultrasound-Guided Transluminal Drainage for Peripancreatic Fluid Collection 双纤尾塑料支架、鼻囊管和经皮导管联合应用于内镜超声引导下胰周液腔内引流
Pub Date : 2022-01-20 DOI: 10.33140/jpr.07.01.05
Background: Endoscopic ultrasound-guided drainage is first-line treatment of Pancreatic fluid collection. The invention of metallic stents has provided a safer and more efficient approach route for internal drainage. But because of the high cost of metal stents, a large number of patients still choose plastic stents, which can help them from the disease with much lower cost. Patients and Methods: Between March to December in 2017, 20 patients with Peripancreatic fluid collections were prospectively enrolled to receive the double pigtail plastic stent with nasocystic tube and/or percutaneous catheter. Results: There were 20 cases of pseudocyst including 4 cases of infected pseudocyst. The causes of the PFC were mainly gallstones (60%), followed with alcohol (30%) and hyperlipoidemia (10%). Technical success was achieved in 100% of the cases. All patients were completely resolved with the evidence of CT scan and clinical evaluation. The mean time for resolution was 15±20 days. The mean follow-up was 3 months. Conclusion: The combination drainage of double pigtail plastic stent with nasocystic tube and/or percutaneous catheter of pancreatic pseudocyst is feasible and efficacious to most patients. Using a titanium clip could prevent migration occurrence. With the economic benefits of plastic stents, they are still wildly used in developing countries.
背景:超声内镜引导下引流是胰液收集的一线治疗方法。金属支架的发明为内引流提供了一种更安全、更有效的入路。但由于金属支架的成本较高,大量患者仍然选择塑料支架,塑料支架可以帮助他们以更低的成本摆脱疾病。患者和方法:2017年3月至12月,前瞻性纳入20例胰周积液患者,接受鼻囊管和/或经皮导管双辫状塑料支架。结果:假性囊肿20例,其中感染假性囊肿4例。PFC的病因以胆结石为主(60%),其次为酒精(30%)和高脂血症(10%)。100%的病例在技术上取得了成功。所有患者均通过CT扫描和临床评价得到彻底解决。平均溶解时间为15±20天。平均随访3个月。结论:双纤尾塑料支架联合鼻囊管和/或经皮导管引流胰腺假囊肿对大多数患者是可行且有效的。使用钛夹子可以防止迁移的发生。由于塑料支架的经济效益,在发展中国家仍被广泛使用。
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引用次数: 0
A Cross Sectional Study on Prescription Pattern and Combination Drug Therapy in Hypertension Among Patients Visiting Alka Hospital Kathmandu 加德满都Alka医院高血压患者处方模式及联合用药的横断面研究
Pub Date : 2022-01-20 DOI: 10.33140/jpr.07.01.02
Background: The sources of drug usage data vary from country to country depending on the level of sophistication of medical record keeping, data collection, data analysis, reporting and the operational considerations of the health care system. In the majority of the countries, different physicians’ prescribing patterns for anti-hypertensive medications widely differ from the established standards. Objective: The objective of this study was to assess the prescription pattern and practice of combination drug therapy of anti-hypertensive medicines in Alka Hospital, Kathmandu. Method: The medical record of patients who received anti-hypertensive drugs during their treatment periods were reviewed. Data entry was done in MS Excel data sheet and data were analyzed in SPSS. The total number of prescriptions analyzed was 112. Results: The maximum percentage of males and females with hypertension was found in the age group of 40-60 years. As mono therapy Angiotensin II Receptor Blockers (ARBs) (39.28%) were the most commonly prescribed anti-hypertensive followed by Calcium Channel Blockers (CCBs) (8.92%) and Angiotensin Converting Enzyme Inhibitors (ACEIs) (0.89%). In combination therapy often two drugs combination was prescribed. The most common combination was ARBs + CCBs (24.1%), followed by ARBs + Diuretics (6.25%). Conclusion: The prevalent prescribing pattern of antihypertensive in Alka Hospital seems to be in compliance with Joint National Committee VIII (JNC VIII) guidelines.
背景:药物使用数据的来源因国家而异,这取决于医疗记录保存、数据收集、数据分析、报告的复杂程度以及医疗保健系统的操作考虑因素。在大多数国家,不同医生的抗高血压药物处方模式与既定标准大相径庭。目的:本研究旨在评估加德满都阿尔卡医院抗高血压药物的处方模式和联合用药治疗实践。方法:对接受降压药物治疗的患者的病历资料进行回顾性分析。在MS Excel数据表中进行数据录入,并在SPSS中进行数据分析。分析的处方总数为112张。结果:男性和女性高血压患者的比例最大的年龄组是40-60岁。在单药治疗中,血管紧张素II受体阻滞剂(ARBs)(39.28%)是最常见的降压药,其次是钙通道阻滞剂(CCB)(8.92%)和血管紧张素转换酶抑制剂(ACEIs)(0.89%)。最常见的组合是ARBs+CCB(24.1%),其次是ARBs+利尿剂(6.25%)。
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引用次数: 0
Ventilator-Associated Pneumonia Bundle of Care Training of Nursing Officers Using Simulation and Its Impact on Their Knowledge and Incidence of Ventilator-Associated Pneumonia: A Quasi-Experimental Study. 使用模拟技术对护理人员进行呼吸机相关肺炎捆绑护理培训及其对护理人员呼吸机相关肺炎知识和发病率的影响:一项准实验研究。
IF 0.5 Pub Date : 2021-12-16 eCollection Date: 2024-06-01 DOI: 10.1055/s-0041-1740589
Ravi Kumar Jeengar, Bharat Choudhary, Daisy Khera, Simranjeet Singh, Suray Prakash Purohit, Kuldeep Singh

The objective of this study was to assess the effectiveness of simulation-based training (SBT) of a ventilator-associated pneumonia (VAP) bundle of care on the knowledge and practice of nursing officers working in the pediatric intensive care unit (PICU) and its impact on the incidence of VAP. This study was a single-center, pre- and postsimulation-based educational interventional tool conducted in a six-bed PICU located in Western Rajasthan, India. Thirty nursing officers working in the PICU participated in the study. Baseline knowledge and practice regarding VAP bundle of care were assessed using a questionnaire and practice checklist. It was followed by 1:1 SBT of the VAP bundle of care following which all participants were immediately reassessed and then again at 3 months postintervention. The incidence of VAP (events/1,000 ventilation days) was subsequently compared both at 6 months pre- and postintervention. Thirty nursing officers participated in the study of which 63% were male. Baseline knowledge and practice increased significantly immediately after the VAP bundle of care training and then again at 3 months in comparison to preintervention testing (baseline 20.27 ± 4.51, immediate postintervention 26.0 ± 3.67, 3 months postintervention 23.97 ± 4.69). The incidence of VAP showed a declining trend from 46.1 to 36.5/1,000 ventilation days; however, this finding was not statistically significant ( p  = 0.22). The simulation-based teaching program significantly enhanced nursing officers' knowledge and practice toward utilization of a preventive VAP bundle of care. There was decay in knowledge with time indicating that repetitive sessions are required at regular intervals to sustain this effect.

本研究旨在评估呼吸机相关性肺炎(VAP)捆绑护理模拟培训(SBT)对儿科重症监护病房(PICU)护理人员知识和实践的影响,以及对 VAP 发生率的影响。这项研究是在印度西拉贾斯坦邦一家拥有六张病床的儿童重症监护病房开展的一项单中心、基于模拟前和模拟后的教育干预工具。30 名在 PICU 工作的护理人员参与了研究。研究人员使用调查问卷和实践清单评估了有关 VAP 护理包的基线知识和实践。随后对所有参与者进行了 1:1 的 VAP 护理包 SBT,之后立即进行了重新评估,并在干预后 3 个月再次进行了评估。随后,对干预前后 6 个月的 VAP 发生率(事件/1,000 通气天数)进行了比较。30 名护理人员参与了研究,其中 63% 为男性。与干预前的测试相比,VAP 护理捆绑培训后的基线知识和实践立即有了明显增加,3 个月后再次增加(基线为 20.27 ± 4.51,干预后为 26.0 ± 3.67,干预后 3 个月为 23.97 ± 4.69)。VAP 发生率呈下降趋势,从 46.1 降至 36.5/1000通气天;但这一结果并无统计学意义(P = 0.22)。模拟教学项目大大增强了护理人员对使用预防性 VAP 护理包的认识和实践。随着时间的推移,护理人员的知识水平会有所下降,这表明需要定期进行重复培训才能保持这种效果。
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引用次数: 0
Knowledge, Attitude and Practice about a Newer Class of Antidiabetic Drug (Glucagon-like peptide-1 receptor agonist) Among the Health Care Professionals of Qassim University, Saudi Arabia 沙特阿拉伯卡西姆大学医护人员对一类新型降糖药(胰高血糖素样肽-1受体激动剂)的认识、态度和实践
Pub Date : 2021-12-15 DOI: 10.18579/jopcr/v20i4.ms21083
Alwaleed Yousef Aldhobaib, S. Rabbani, M. Mobark
Glucagon-like peptide-1 receptor agonist (GLP-1RA) is a newer class of drugs used in the treatment of adult type-2 diabetes mellitus. The use of the drugs needs appropriate methods of administration including precautions and carry some potential risks such as pancreatitis and thyroid cell neoplasia. In this cross-sectional study, a pre-validated questionnaire with fixed-answers was used to assess the medical practitioner’s response towards recently approved drugs. Their replies were recorded in an excel sheet. The data was subjected to statistical analysis using one-way ANOVA and post-hoc tests to determine the significant value. p<0.05 was used to indicate the significance of the results. The data from the study indicated that 107 health care professionals such as physicians, nurses and pharmacists with differences in age, gender, nationality, qualification and experience took part in the survey. The overall correct response to the questions of knowledge domain was found to be 73.5%, attitude – 78.5% and practice – 80.3%. However, some critical information about the method of administration, precautions and possible risks associated with the therapy is lacking among the participants. A significant variation (P<0.05) was found for some of the demographic variables such as profession, qualification and age of the participants. The finding from the study suggests that the medical professionals have good knowledge, better attitude and proper practice about the GLP-1RA that is being approved for the treatment of type-2 diabetes mellitus. However, some of the vital aspects of the medication need update. Continuing medical education programs could be one of the most suitable strategies suggested for enlightening the information on the recent additions to the therapy. Keywords Knowledge, Attitude, Practice, Medical professionals, Type­2 diabetes, GLP­1RA
胰高血糖素样肽-1受体激动剂(GLP-1RA)是一类用于治疗成人2型糖尿病的新型药物。药物的使用需要适当的给药方法,包括预防措施,并具有一些潜在的风险,如胰腺炎和甲状腺细胞瘤。在这项横断面研究中,使用了一份具有固定答案的预验证问卷来评估医生对最近批准的药物的反应。他们的答复被记录在excel表格中。使用单因素方差分析和事后检验对数据进行统计分析,以确定显著值。p<0.05表示结果的显著性。研究数据显示,107名年龄、性别、国籍、资格和经验不同的医生、护士和药剂师等医疗保健专业人员参加了调查。对知识领域问题的总体正确回答为73.5%,态度为78.5%,实践为80.3%。然而,参与者缺乏有关给药方法、预防措施和与治疗相关的可能风险的一些关键信息。参与者的职业、资格和年龄等一些人口统计学变量存在显著差异(P<0.05)。研究结果表明,医学专业人员对GLP-1RA有良好的知识、态度和正确的实践,该药物正被批准用于治疗2型糖尿病。然而,药物的一些重要方面需要更新。继续医学教育计划可能是最合适的策略之一,可以启发有关最近增加的治疗信息。知识、态度、实践、医学专业人员、2型糖尿病、GLP 1RA
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引用次数: 0
Association of Mucormycosis in Covid-19 and its Epidemiologic Study 毛霉病与Covid-19的关系及其流行病学研究
Pub Date : 2021-12-15 DOI: 10.18579/jopcr/v20i4.ms21073
Suchismita Mishra, S. Suman, Akshat Gupta, N. Mishra
Mucormycosis, also known as Zygomycosis or Black Fungus, is an infection caused in humans via various causative agents from the Zygomycetes class. Several countries including India is afflicted by the covid-19 virus, which has infected approximately 3.7 million people across the country. Some of the corona-positive patients suffer from another fatal infection, Mucormycosis, commonly known as Black Fungus. The strategy should be to administer an effective antifungal drug as soon as possible at the optimum dose. However, India being an epicenter of Diabetes with enormous 80 million diabetics, is of particular importance in the present scenario of the COVID pandemic. COVID therapy with Steroids and immune suppressants has increased the chances of infection in various individuals within the country with weaker immune system responses. The main purpose of this paper is to enlighten the community about the involvement of mucormycosis in covid-19 affected population and basic insights of its invasion. Keywords Mucormycosis, Black Fungus, Covid-19, Diabetes Mellitus, Amphotericin B, Immunosuppression, Apophysomyces, Renal Failure, Corticosteroids
毛霉菌病,也称为结霉菌病或黑真菌,是一种通过结霉菌类的各种病原体在人类中引起的感染。包括印度在内的几个国家都受到新冠肺炎病毒的影响,该病毒已感染全国约370万人。一些电晕阳性患者患有另一种致命的感染,毛霉菌病,通常被称为黑真菌。策略应该是尽快以最佳剂量给予有效的抗真菌药物。然而,印度是糖尿病的中心,有8000万糖尿病患者,在当前的新冠肺炎疫情中尤为重要。类固醇和免疫抑制剂的新冠肺炎治疗增加了国内免疫系统反应较弱的各种人感染的机会。本文的主要目的是让社区了解新冠肺炎感染人群中毛霉菌病的发病情况及其侵袭的基本见解。毛霉菌病,黑真菌,新冠肺炎,糖尿病,两性霉素B,免疫抑制,Apophysomyces,肾衰竭,皮质类固醇
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引用次数: 0
Antidiabetic and Antihyperlipidemic Effects of Calamus rotang L leaves (Arecaceae) in Streptozotocin-Nicotinamide Induced Diabetic Model 槟榔科菖蒲叶在链脲佐菌素-烟酰胺诱导的糖尿病模型中的降糖、降血脂作用
Pub Date : 2021-12-15 DOI: 10.18579/jopcr/v20i4.kishore
V. K. Kumar, K. Lalitha, R. S. Kumar
Background: Calamus rotang L (Asteraceae), also known as Pirampu in India, has long been employed in Ayurvedic medicinal formulations. It has been used to cure diabetes in folklore medicine for centuries. Aim: This Study evaluated the antidiabetic and antihyperlipidemic effects of Calamus rotang L leaves in streptozotocin-nicotinamide (STZ-NC) induced diabetic model. Methods: Estimation of fasting blood glucose, glycosylated haemoglobin, total haemoglobin, lipid profiles, lipoproteins, hepatic marker enzyme activity, and pancreas histopathology was performed in STZ-NC induced diabetic rats after receiving ethanol extract of C. rotang L leaves (100 & 200 mg/kg) for 28 days orally. The data were statistically analysed using one-way analysis (ANOVA) and post hoc multiple comparison tests. Results: The ethanol extract of C. rotang L leaves was given at doses of 100 and 200 mg/kg showed a substantial drop in fasting blood glucose levels and an increase in body weight. HbA1C, TC, TG, LDL, VLDL, AST, ALT, and ALP levels were dramatically lowered by the ethanol extract of the leaves of C. rotang L, whereas Hb, HDL cholesterol levels were significantly increased. Furthermore, in STZ-NC induced diabetes, the C. rotang L leaves ethanol extract has a positive impact on pancreas histological alterations. Conclusions: For the first time, these findings show that the C. rotang L leaves ethanol extract has significant antidiabetic and antihyperlipidemic potential, bolstering the plant's claimed application in the treatment of diabetes and its complications. Keywords Calamus rotang L leaves, Antidiabetic, Antihyperlipidemic, Glibenclamide
背景:菖蒲(Asteraceae),在印度也被称为Pirampu,长期以来一直被用于阿育吠陀药物配方。几个世纪以来,民间医学一直用它来治疗糖尿病。目的:研究菖蒲叶在链脲唑素-烟酰胺(STZ-NC)诱导的糖尿病模型中的降糖、降血脂作用。方法:采用STZ-NC诱导的糖尿病大鼠,口服罗唐叶乙醇提取物(100和200 mg/kg) 28 d,测定空腹血糖、糖化血红蛋白、总血红蛋白、脂质谱、脂蛋白、肝脏标记酶活性和胰腺组织病理学。采用单因素分析(ANOVA)和事后多重比较检验对数据进行统计学分析。结果:以100和200 mg/kg剂量给药后,大鼠空腹血糖水平明显下降,体重明显增加。粗唐叶乙醇提取物显著降低HbA1C、TC、TG、LDL、VLDL、AST、ALT和ALP水平,显著升高Hb、HDL胆固醇水平。此外,在STZ-NC诱导的糖尿病中,苦参叶乙醇提取物对胰腺组织学改变有积极影响。结论:这些发现首次表明,罗唐叶乙醇提取物具有显著的抗糖尿病和降血脂的潜力,支持了该植物在治疗糖尿病及其并发症方面的应用。菖蒲叶;抗糖尿病;降血脂
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引用次数: 1
Quantification and Validation of a HPLC-UV Method for Simultaneous Analysis of Nitrosoamine Impurities (NDMA, NDEA and NDIPA) in Losartan HPLC-UV法同时分析氯沙坦中硝基索胺杂质(NDMA、NDEA和NDIPA)的定量和验证
Pub Date : 2021-12-15 DOI: 10.18579/jopcr/v20i4.ms21084
S. Patil, Rajeev Chadar, A. Prasad, Poonam Koppula, Santhosh Koppula
Impurity profiling is an important aspect in drug therapy for its safety and efficacy. The study of impurities of sartans, the first line antihypertensive drugs, has become critical due to presence of cancer causing N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and N-nitrosodiisopropylamine (NDIPA) in them, resulting from production and degradation process. These impurities have led to worldwide recall of products. Hence, a simple and accurate method has been developed and validated for simultaneous detection of NDMA, NDEA and NDIPA in Losartan using High Performance Liquid Chromatography - Ultra violet (HPLC - UV) system. The impurities were analyzed on Inertsil ODS 3V (250mm × 4.6mm, 5.0µm) analytical column by using water:methanol (60:40) as the mobile phase at a flow rate of 1.0 mL/min, with a run time of 30 mins. The method was developed for the acceptance limit of 0.64 ppm for NDMA, 0.177 ppm for NDEA and NDIPA respectively. On comparison with existing approaches, the developed method is fast, ideal for routine screening and is suitable for both laboratory and industrial uses. Keywords: Losartan, HPLC - UV, N-nitrosodimethylamine, N-nitrosodiethylamine, N-nitrosodiisopropylamine
杂质分析是药物治疗的一个重要方面,因为其安全性和有效性。作为一线抗高血压药物的缬沙坦,由于其在生产和降解过程中存在引起癌症的N-亚硝基二甲胺(NDMA)、N-亚硝基二乙胺(NDEA)和N-亚硝基异丙胺(NDIPA),因此对其杂质的研究变得至关重要。这些杂质导致产品在全球范围内被召回。因此,采用高效液相色谱-紫外(HPLC-UV)系统建立并验证了一种简单准确的同时检测氯沙坦中NDMA、NDEA和NDIPA的方法。杂质在Inertsil ODS 3V(250mm×4.6mm,5.0µm)分析柱上以水:甲醇(60:40)为流动相,流速为1.0mL/min,运行时间为30分钟。该方法的NDMA、NDEA和NDIPA的验收限分别为0.64 ppm、0.177 ppm。与现有方法相比,所开发的方法快速,是常规筛查的理想方法,适用于实验室和工业用途。关键词:氯沙坦,高效液相色谱-紫外,N-亚硝基二甲胺,N-亚硝酸二乙胺,N-亚硝二异丙胺
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Journal of Pharmaceutical Research
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