首页 > 最新文献

Current Pharmaceutical Analysis最新文献

英文 中文
Protective Effect of Salvia cadmica on Fibroblast Cells from t-bhp-induced Oxidative Damage 丹参对成纤维细胞免受 t-bhp 诱导的氧化损伤的保护作用
IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-04-09 DOI: 10.2174/0115734129293569240327093703
Ceylan Hepokur, Sema Misir, Mehmet Cicek, Solomon Habtemariam, Javad Sharifi-Rad
Background:: Salvia species known as "Sage" are among the important aromatic plants used in the world. This study, it was investigated the antioxidant capacity of Salvia cadmica and to investigate its protective effect on oxidative damage in t-BHP-induced fibroblast cells. Methods:: Antioxidant activity and phenolic characterization of the extract were evaluated using DPPH, TPC, TFC, FRAP, and HPLC, respectively.TAS, TOS, MDA and 8-oxo-guanine, CAT, SOD, and GPx values were examined using enzyme-linked immunosorbent assay (ELISA). The antiproliferative and apoptosis effects of Salvia cadmica ethanolic extract were determined using MTT assay and fluorescent probes in fibroblast cells. Results:: As a result of GC-MS analysis of Salvia cadmica ethanolic extract, carvacrol content was found to be high. The IC50 value of the DPPH antioxidant assay of the Salvia cadmica ethanolic extract was 80 ± 0.51 μg/mL. TPC, TFC, and FRAP values were found to be 18.25 ± 0.64 (mg gallic acid/g powder), 1.691±0.314 (mg quercetin /g powder), 31.5 ± 0.10 (mg Trolox/g powder), respectively. Total antioxidant and TOS values were found to be 0.383±0.033 (mmol Trolox Equ L-1), 16.31±0.71 (μmol H2O2 L-1) for 0.25 mg/mL, and 0.725±0.05 (mmol Trolox Equ L-1), 12.02 ±0.56 (μmol H2O2 L-1) for 0.5 mg/mL. In addition, while CAT and GPx significantly decreased enzyme activities, no significant change was observed in SOD enzyme activity. Ethanolic Salvia cadmica extract exhibited apoptotic features compared to only the t-BHP group. Conclusion:: These results suggest that Salvica cadmica extract works through a free radical mechanism.
背景介绍被称为 "鼠尾草 "的丹参属植物是世界上常用的重要芳香植物之一。本研究调查了丹参的抗氧化能力,并研究其对 t-BHP 诱导的成纤维细胞氧化损伤的保护作用。方法::采用酶联免疫吸附法(ELISA)检测了丹参提取物的TAS、TOS、MDA和8-氧代鸟嘌呤、CAT、SOD和GPx值。使用 MTT 法和荧光探针测定了丹参乙醇提取物对成纤维细胞的抗增殖和凋亡作用。研究结果丹参乙醇提取物的气相色谱-质谱分析结果表明,丹参酚含量较高。丹参乙醇提取物 DPPH 抗氧化试验的 IC50 值为 80 ± 0.51 μg/mL。TPC 值、TFC 值和 FRAP 值分别为 18.25 ± 0.64(毫克没食子酸/克粉)、1.691±0.314(毫克槲皮素/克粉)和 31.5 ± 0.10(毫克曲安奈德/克粉)。0.25 mg/mL 的总抗氧化值和 TOS 值分别为 0.383±0.033(mmol Trolox Equ L-1)、16.31±0.71(μmol H2O2 L-1);0.5 mg/mL 的总抗氧化值和 TOS 值分别为 0.725±0.05(mmol Trolox Equ L-1)、12.02±0.56(μmol H2O2 L-1)。此外,CAT 和 GPx 的酶活性明显降低,而 SOD 的酶活性没有明显变化。与 t-BHP 组相比,丹参乙醇提取物具有凋亡特征。结论这些结果表明,丹参提取物通过自由基机制发挥作用。
{"title":"Protective Effect of Salvia cadmica on Fibroblast Cells from t-bhp-induced Oxidative Damage","authors":"Ceylan Hepokur, Sema Misir, Mehmet Cicek, Solomon Habtemariam, Javad Sharifi-Rad","doi":"10.2174/0115734129293569240327093703","DOIUrl":"https://doi.org/10.2174/0115734129293569240327093703","url":null,"abstract":"Background:: Salvia species known as \"Sage\" are among the important aromatic plants used in the world. This study, it was investigated the antioxidant capacity of Salvia cadmica and to investigate its protective effect on oxidative damage in t-BHP-induced fibroblast cells. Methods:: Antioxidant activity and phenolic characterization of the extract were evaluated using DPPH, TPC, TFC, FRAP, and HPLC, respectively.TAS, TOS, MDA and 8-oxo-guanine, CAT, SOD, and GPx values were examined using enzyme-linked immunosorbent assay (ELISA). The antiproliferative and apoptosis effects of Salvia cadmica ethanolic extract were determined using MTT assay and fluorescent probes in fibroblast cells. Results:: As a result of GC-MS analysis of Salvia cadmica ethanolic extract, carvacrol content was found to be high. The IC50 value of the DPPH antioxidant assay of the Salvia cadmica ethanolic extract was 80 ± 0.51 μg/mL. TPC, TFC, and FRAP values were found to be 18.25 ± 0.64 (mg gallic acid/g powder), 1.691±0.314 (mg quercetin /g powder), 31.5 ± 0.10 (mg Trolox/g powder), respectively. Total antioxidant and TOS values were found to be 0.383±0.033 (mmol Trolox Equ L-1), 16.31±0.71 (μmol H2O2 L-1) for 0.25 mg/mL, and 0.725±0.05 (mmol Trolox Equ L-1), 12.02 ±0.56 (μmol H2O2 L-1) for 0.5 mg/mL. In addition, while CAT and GPx significantly decreased enzyme activities, no significant change was observed in SOD enzyme activity. Ethanolic Salvia cadmica extract exhibited apoptotic features compared to only the t-BHP group. Conclusion:: These results suggest that Salvica cadmica extract works through a free radical mechanism.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"121 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140602916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Identification of the NF-κB Inhibition Peptides in Asthma from Pheretima aspergillum Decoction and Formula Granules Using Molecular Docking and Dynamics Simulations 利用分子对接和动力学模拟从天麻煎剂和配方颗粒中鉴定哮喘中的 NF-κB 抑制肽
IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-04-03 DOI: 10.2174/0115734129298587240322073956
Xiaotong Xiao, Yaxiong Liu, Yayang Huang, Wenjie Zeng, Zhuoya Luo
Background: The Pheretima aspergillum decoction is a traditional therapeutic form, while the formula granules are produced through traditional Chinese medicine decoctions. However, the active ingredients in Pheretima aspergillum have not been fully elucidated, and no published reports have investigated the differences between Pheretima aspergillum decoction and formula granules. Objective: The study aimed to explore the potential bioactive peptides in Pheretima aspergillum decoction and formula granules and investigate their potential pharmacological mechanisms in alleviating inflammation associated with asthma through interaction with the IκBβ/NF-κB p65 complex. Methods: μLC-Q Exactive MS combined with de novo sequencing technology was employed to identify potential bioactive peptides in Pheretima aspergillum decoction and formula granules. Deep learning models were utilized to evaluate the bioactivity and toxicity of these peptides. Further investigations included molecular docking studies aimed at uncovering the interactions between the selected peptides and the IκBβ/NF-κB p65 complex at affinity and critical residue sites. Molecular dynamics simulations were conducted to assess the stability of the peptide-receptor complexes. Results: A total of 2,235 peptides from the Pheretima aspergillum decoction and 1,424 peptides from the Pheretima aspergillum formula granules were identified. Deep learning models resulted in the identification of 298 bioactive and non-toxic peptides from the decoction and 145 from the formula granules. Molecular docking revealed that 160 peptides from the decoction and 63 from the formula granules exhibited a strong affinity for the IκBβ/NF-κB p65 complex. The results of molecular dynamics simulations supported the stability of the interactions involving the peptide EGPANFADLGK from the decoction and the peptide KAAVDFGVPGDAGALAHLK from the formula granules with the IκBβ/NF-κB p65 complex. In conclusion, potential bioactive peptides were identified in both Pheretima aspergillum decoction and formula granules. Conclusion: This study has investigated the potential pharmacological mechanisms of peptides derived from Pheretima aspergillum decoction and formula granules in alleviating inflammation associated with asthma through the interaction of the IκBβ/NF-κB p65 complex, providing a basis for elucidating the molecular mechanism of action for the treatment of asthma.
背景:Pheretima aspergillum煎剂是一种传统的治疗形式,而配方颗粒则是通过传统中药煎剂生产的。然而,白僵菌中的有效成分尚未完全阐明,也没有公开报道对白僵菌水煎剂和配方颗粒之间的差异进行研究。研究目的本研究旨在探索天麻煎剂和配方颗粒中潜在的生物活性肽,并研究其通过与 IκBβ/NF-κB p65 复合物相互作用来缓解哮喘相关炎症的潜在药理机制。方法:采用μLC-Q Exactive MS与全新测序技术相结合,鉴定天麻煎剂和配方颗粒中潜在的生物活性肽。利用深度学习模型评估了这些肽的生物活性和毒性。进一步的研究包括分子对接研究,旨在揭示所选多肽与 IκBβ/NF-κB p65 复合物在亲和力和关键残基位点上的相互作用。分子动力学模拟评估了肽受体复合物的稳定性。研究结果从天麻煎剂中鉴定出2235个肽段,从天麻配方颗粒中鉴定出1424个肽段。通过深度学习模型,从煎剂中鉴定出 298 种生物活性肽和无毒肽,从配方颗粒中鉴定出 145 种生物活性肽和无毒肽。分子对接显示,煎剂中的 160 种肽和配方颗粒中的 63 种肽与 IκBβ/NF-κB p65 复合物具有很强的亲和力。分子动力学模拟结果表明,煎剂中的肽 EGPANFADLGK 和配方颗粒中的肽 KAAVDFGVPGDAGALAHLK 与 IκBβ/NF-κB p65 复合物的相互作用具有稳定性。总之,在天麻煎剂和配方颗粒中都发现了潜在的生物活性肽。结论本研究通过 IκBβ/NF-κB p65 复合物的相互作用,探讨了从天麻煎剂和配方颗粒中提取的肽在缓解哮喘相关炎症方面的潜在药理机制,为阐明治疗哮喘的分子作用机制提供了依据。
{"title":"Identification of the NF-κB Inhibition Peptides in Asthma from Pheretima aspergillum Decoction and Formula Granules Using Molecular Docking and Dynamics Simulations","authors":"Xiaotong Xiao, Yaxiong Liu, Yayang Huang, Wenjie Zeng, Zhuoya Luo","doi":"10.2174/0115734129298587240322073956","DOIUrl":"https://doi.org/10.2174/0115734129298587240322073956","url":null,"abstract":"Background: The Pheretima aspergillum decoction is a traditional therapeutic form, while the formula granules are produced through traditional Chinese medicine decoctions. However, the active ingredients in Pheretima aspergillum have not been fully elucidated, and no published reports have investigated the differences between Pheretima aspergillum decoction and formula granules. Objective: The study aimed to explore the potential bioactive peptides in Pheretima aspergillum decoction and formula granules and investigate their potential pharmacological mechanisms in alleviating inflammation associated with asthma through interaction with the IκBβ/NF-κB p65 complex. Methods: μLC-Q Exactive MS combined with de novo sequencing technology was employed to identify potential bioactive peptides in Pheretima aspergillum decoction and formula granules. Deep learning models were utilized to evaluate the bioactivity and toxicity of these peptides. Further investigations included molecular docking studies aimed at uncovering the interactions between the selected peptides and the IκBβ/NF-κB p65 complex at affinity and critical residue sites. Molecular dynamics simulations were conducted to assess the stability of the peptide-receptor complexes. Results: A total of 2,235 peptides from the Pheretima aspergillum decoction and 1,424 peptides from the Pheretima aspergillum formula granules were identified. Deep learning models resulted in the identification of 298 bioactive and non-toxic peptides from the decoction and 145 from the formula granules. Molecular docking revealed that 160 peptides from the decoction and 63 from the formula granules exhibited a strong affinity for the IκBβ/NF-κB p65 complex. The results of molecular dynamics simulations supported the stability of the interactions involving the peptide EGPANFADLGK from the decoction and the peptide KAAVDFGVPGDAGALAHLK from the formula granules with the IκBβ/NF-κB p65 complex. In conclusion, potential bioactive peptides were identified in both Pheretima aspergillum decoction and formula granules. Conclusion: This study has investigated the potential pharmacological mechanisms of peptides derived from Pheretima aspergillum decoction and formula granules in alleviating inflammation associated with asthma through the interaction of the IκBβ/NF-κB p65 complex, providing a basis for elucidating the molecular mechanism of action for the treatment of asthma.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"6 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140593636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Analyzing Hair for Drug Traces: A Review of Electrochemical Approaches 分析头发中的药物痕迹:电化学方法综述
IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-03-26 DOI: 10.2174/0115734129293976240320090141
Jia Du, Li Fu, Xiaozhu Liu, Hassan Karimi-Maleh
Background:: Hair analysis plays a crucial role in forensic toxicology, offering a unique medium for long-term drug trace detection. This review emphasizes the evolution of electrochemical methods in analyzing hair for drug traces, underscoring their significance in forensic science. Methods:: We examined recent advancements in electrochemical techniques, including voltammetry, amperometry, and electrochemical impedance spectroscopy, and their application in drug trace analysis. The review also explores the development of novel electrode materials and surface modifications, which enhance the detection capabilities of these methods. Results:: Electrochemical methods have shown high sensitivity and specificity in detecting a range of drugs in hair. Innovations, like molecularly imprinted polymers and nanomaterials, have expanded the detectable substance range, offering more refined and accurate detection. Despite challenges, such as hair variability and external contamination, these methods have significantly improved the reliability of drug trace analysis. Conclusion:: Electrochemical approaches to hair analysis represent a significant advancement in forensic toxicology. Their ability to provide sensitive, specific, and non-invasive analysis makes them valuable tools. Future developments, including portable device creation and integration with other analytical techniques, hold promise for further enhancing the scope and accuracy of drug trace detection in hair.
背景毛发分析在法医毒理学中起着至关重要的作用,它为长期药物痕量检测提供了一种独特的媒介。本综述强调了电化学方法在分析毛发药物痕量方面的演变,突出了其在法医学中的重要意义。方法我们研究了电化学技术(包括伏安法、安培法和电化学阻抗光谱法)的最新进展及其在毒品痕量分析中的应用。综述还探讨了新型电极材料和表面改性的发展,这些材料和改性提高了这些方法的检测能力。研究结果电化学方法在检测头发中的一系列药物方面具有很高的灵敏度和特异性。分子印迹聚合物和纳米材料等创新技术扩大了可检测物质的范围,提供了更精细、更准确的检测。尽管存在毛发变异和外部污染等挑战,但这些方法大大提高了药物痕量分析的可靠性。结论毛发分析电化学方法是法医毒理学的一大进步。这些方法能够提供灵敏、特异和非侵入性的分析,是非常有价值的工具。未来的发展,包括便携式设备的创建和与其他分析技术的整合,有望进一步提高毛发中毒品痕量检测的范围和准确性。
{"title":"Analyzing Hair for Drug Traces: A Review of Electrochemical Approaches","authors":"Jia Du, Li Fu, Xiaozhu Liu, Hassan Karimi-Maleh","doi":"10.2174/0115734129293976240320090141","DOIUrl":"https://doi.org/10.2174/0115734129293976240320090141","url":null,"abstract":"Background:: Hair analysis plays a crucial role in forensic toxicology, offering a unique medium for long-term drug trace detection. This review emphasizes the evolution of electrochemical methods in analyzing hair for drug traces, underscoring their significance in forensic science. Methods:: We examined recent advancements in electrochemical techniques, including voltammetry, amperometry, and electrochemical impedance spectroscopy, and their application in drug trace analysis. The review also explores the development of novel electrode materials and surface modifications, which enhance the detection capabilities of these methods. Results:: Electrochemical methods have shown high sensitivity and specificity in detecting a range of drugs in hair. Innovations, like molecularly imprinted polymers and nanomaterials, have expanded the detectable substance range, offering more refined and accurate detection. Despite challenges, such as hair variability and external contamination, these methods have significantly improved the reliability of drug trace analysis. Conclusion:: Electrochemical approaches to hair analysis represent a significant advancement in forensic toxicology. Their ability to provide sensitive, specific, and non-invasive analysis makes them valuable tools. Future developments, including portable device creation and integration with other analytical techniques, hold promise for further enhancing the scope and accuracy of drug trace detection in hair.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"5 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140313882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Review on Working Principle and Advanced Applications of Fluorescence activated Cell Sorting Machine (FACS) 荧光激活细胞分拣机(FACS)工作原理及高级应用综述
IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-03-15 DOI: 10.2174/0115734129301463240306064929
Gurisha Garg, Preeti Patel, Ghanshyam Das Gupta, Balak Das Kurmi
: Various technologies, like flow cytometry and cell sorting, have been established in fields of biomedical research. Fluorescence-activated cell sorting is one of the most powerful techniques to witness advancement in these years. This article aims to provide an in-depth overview of the FACS applications, along with regulatory considerations and qualification parameters for the instrument. Moreover, specifications of instruments from different brands with specialized features are mentioned. FACS is a cornerstone in clinical diagnostics. This review highlights the current advancements and versatility of this indispensable technology, and the said information would be a focal paradigm for the upcoming biomedical and pharmaceutical research.
:流式细胞仪和细胞分拣等各种技术已在生物医学研究领域得到应用。荧光激活细胞分拣技术是近年来取得进步的最强大技术之一。本文旨在深入概述 FACS 的应用,以及仪器的监管注意事项和合格参数。此外,文章还提到了不同品牌、具有特殊功能的仪器规格。FACS 是临床诊断的基石。这篇综述重点介绍了这一不可或缺的技术目前的进展和多功能性,上述信息将成为即将开展的生物医学和制药研究的重点范例。
{"title":"A Review on Working Principle and Advanced Applications of Fluorescence activated Cell Sorting Machine (FACS)","authors":"Gurisha Garg, Preeti Patel, Ghanshyam Das Gupta, Balak Das Kurmi","doi":"10.2174/0115734129301463240306064929","DOIUrl":"https://doi.org/10.2174/0115734129301463240306064929","url":null,"abstract":": Various technologies, like flow cytometry and cell sorting, have been established in fields of biomedical research. Fluorescence-activated cell sorting is one of the most powerful techniques to witness advancement in these years. This article aims to provide an in-depth overview of the FACS applications, along with regulatory considerations and qualification parameters for the instrument. Moreover, specifications of instruments from different brands with specialized features are mentioned. FACS is a cornerstone in clinical diagnostics. This review highlights the current advancements and versatility of this indispensable technology, and the said information would be a focal paradigm for the upcoming biomedical and pharmaceutical research.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"20 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140153723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Enantioselective Recognition of Chiral Α-Phenylethanol by Β-Cyclodextrin and Characterization of its Inclusion Behaviour Based On 2D ROESY Β-环糊精对手性Α-苯乙醇的对映选择性识别及其基于二维 ROESY 的包合行为表征
IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-03-12 DOI: 10.2174/0115734129285978240222103045
Jian Chen, Qiulin Li, Yawen Yang, Liang Qi, Xiang Han, Nan Zhang, Bin Zheng, Fuxin Chen
Background:: α-phenylethanol and its derivatives are important intermediates for the synthesis of a variety of chiral drugs. Method:: The interaction mechanism of the two enantiomers of α-phenylethanol with β-CD was investigated using 1H-NMR and ROESY. The loading of β-cyclodextrin (β-CD) as the host with the chiral drug intermediate α-phenylethanol as the guest was investigated using high-resolution NMR in D2O and quantum chemical calculations. Results:: The results showed that both α-phenylethanol enantiomers were able to enter into the hydrophobic cavity of β-CD and undergo enantiospecific interactions, while the combination of 2D ROESY and quantum chemical calculations showed that the benzene ring of both R and S α- phenylethanol was inserted into the β-CD cavity toward the small-port end. However, the most stable poses of the two enantiomers were different, so the benzene ring of the S-enantiomer was oriented more toward the small-port end of β-CD than that of the R-enantiomer, which was reflected in the signals of 2D ROESY, which were obviously different. Conclusion:: β-CD can enantioselectively recognize the α-phenylethanol enantiomers, and the 2D ROESY method is a very direct and powerful tool in the recognition process of chiral host and guest research.
背景:α-苯乙醇及其衍生物是合成多种手性药物的重要中间体。方法:采用 1H-NMR 和 ROESY 方法研究了 α-苯乙醇的两种对映体与 β-CD 的相互作用机理。利用 D2O 中的高分辨率核磁共振和量子化学计算研究了以 β-环糊精(β-CD)为宿主,以手性药物中间体 α-苯乙醇为客体的负载情况。结果显示结果表明,两种α-苯乙醇对映体都能进入β-CD的疏水空腔并发生对映体特异性相互作用,而二维ROESY和量子化学计算的结合则表明,R和Sα-苯乙醇的苯环都向小端口端插入β-CD空腔。然而,两种对映体的最稳定位置不同,因此 S 对映体的苯环比 R 对映体的苯环更偏向于 β-CD 的小端口端,这反映在二维 ROESY 的信号上,两者有明显的不同。结论:β-CD能对映体选择性地识别α-苯乙醇对映体,二维ROESY方法是研究手性主客体识别过程中非常直接和有力的工具。
{"title":"Enantioselective Recognition of Chiral Α-Phenylethanol by Β-Cyclodextrin and Characterization of its Inclusion Behaviour Based On 2D ROESY","authors":"Jian Chen, Qiulin Li, Yawen Yang, Liang Qi, Xiang Han, Nan Zhang, Bin Zheng, Fuxin Chen","doi":"10.2174/0115734129285978240222103045","DOIUrl":"https://doi.org/10.2174/0115734129285978240222103045","url":null,"abstract":"Background:: α-phenylethanol and its derivatives are important intermediates for the synthesis of a variety of chiral drugs. Method:: The interaction mechanism of the two enantiomers of α-phenylethanol with β-CD was investigated using 1H-NMR and ROESY. The loading of β-cyclodextrin (β-CD) as the host with the chiral drug intermediate α-phenylethanol as the guest was investigated using high-resolution NMR in D2O and quantum chemical calculations. Results:: The results showed that both α-phenylethanol enantiomers were able to enter into the hydrophobic cavity of β-CD and undergo enantiospecific interactions, while the combination of 2D ROESY and quantum chemical calculations showed that the benzene ring of both R and S α- phenylethanol was inserted into the β-CD cavity toward the small-port end. However, the most stable poses of the two enantiomers were different, so the benzene ring of the S-enantiomer was oriented more toward the small-port end of β-CD than that of the R-enantiomer, which was reflected in the signals of 2D ROESY, which were obviously different. Conclusion:: β-CD can enantioselectively recognize the α-phenylethanol enantiomers, and the 2D ROESY method is a very direct and powerful tool in the recognition process of chiral host and guest research.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"101 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140115382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bionanofactories for the Environmental Friendly Fabrication of Silver Nanoparticles: Application to the Analysis of Antimicrobial Agents 以环保方式制造银纳米粒子的仿生工厂:应用于抗菌剂分析
IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-03-06 DOI: 10.2174/0115734129281373240214071815
Shatrudhan Prajapati, Shikha Yadav, Javed Khan
: The green synthesis of silver nanoparticles has garnered significant interest because of the unique physicochemical and biological properties they possess. These nanoparticles could have applications in a wide variety of fields, including biomedicine, cellular imaging, cosmetics, healthcare tourism, food and agriculture. The formation of nanoparticles is facilitated by the use of bionanofactories, or green synthesis processes, which utilise living organisms, biomolecules, and plant-based materials as bio reductive or bio sealing agents. Green chemistry is cost-effective in addition to being environmentally friendly, non-toxic, and biodegradable. By considering the results of recent studies using techniques like scanning electron microscopy, transmission electron microscopy, atomic force microscopy, ultraviolet/visible spectrophotometry, Fourier transform infrared spectroscopy or X-ray diffraction, we illuminate the most recent advances in green synthesis and the physicochemical properties of green silver nanoparticles. We also discuss the properties of silver nanoparticles that make them effective against bacteria, fungi, and parasites.
:银纳米粒子具有独特的物理化学和生物特性,因此绿色合成银纳米粒子备受关注。这些纳米粒子可应用于生物医学、细胞成像、化妆品、保健旅游、食品和农业等多个领域。利用生物有机体、生物大分子和植物性材料作为生物还原剂或生物密封剂的仿生工厂或绿色合成工艺,有助于纳米粒子的形成。绿色化学不仅环保、无毒、可生物降解,而且成本效益高。我们通过使用扫描电子显微镜、透射电子显微镜、原子力显微镜、紫外/可见分光光度计、傅立叶变换红外光谱或 X 射线衍射等技术的最新研究成果,阐明了绿色合成的最新进展以及绿色银纳米粒子的物理化学特性。我们还讨论了银纳米粒子有效对抗细菌、真菌和寄生虫的特性。
{"title":"Bionanofactories for the Environmental Friendly Fabrication of Silver Nanoparticles: Application to the Analysis of Antimicrobial Agents","authors":"Shatrudhan Prajapati, Shikha Yadav, Javed Khan","doi":"10.2174/0115734129281373240214071815","DOIUrl":"https://doi.org/10.2174/0115734129281373240214071815","url":null,"abstract":": The green synthesis of silver nanoparticles has garnered significant interest because of the unique physicochemical and biological properties they possess. These nanoparticles could have applications in a wide variety of fields, including biomedicine, cellular imaging, cosmetics, healthcare tourism, food and agriculture. The formation of nanoparticles is facilitated by the use of bionanofactories, or green synthesis processes, which utilise living organisms, biomolecules, and plant-based materials as bio reductive or bio sealing agents. Green chemistry is cost-effective in addition to being environmentally friendly, non-toxic, and biodegradable. By considering the results of recent studies using techniques like scanning electron microscopy, transmission electron microscopy, atomic force microscopy, ultraviolet/visible spectrophotometry, Fourier transform infrared spectroscopy or X-ray diffraction, we illuminate the most recent advances in green synthesis and the physicochemical properties of green silver nanoparticles. We also discuss the properties of silver nanoparticles that make them effective against bacteria, fungi, and parasites.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"51 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140055902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rapid Quantitation of Non-chromophoric Vigabatrin and Gabapentin by a Validated qNMR Method in Bulk Drug and Marketed Formulations 用经过验证的 qNMR 方法快速定量散装药物和上市制剂中的非色素维加溴铵和加巴喷丁
IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-02-22 DOI: 10.2174/0115734129283110240131044647
Pooja Bedage, Archana Sahu, Inder Pal Singh
Background:: Vigabatrin and gabapentin, commonly used antiepileptic drugs in clinics, lack a UV active chromophore and, therefore, require cumbersome derivatization methods for analysis by HPLC using fluorescence detection. This study demonstrated the use of NMR for their quantitative determination in pure form and their pharmaceutical formulations. Objective:: To develop a validated qNMR method for non-chromophoric drugs Vigabatrin and Gabapentin. Methods:: The signal of methine proton of vigabatrin at 3.67 ppm relative to the signal of maleic acid at 6.17 ppm and the methylene signal of gabapentin at 2.88 ppm relative to the signal of caffeine at 7.75 ppm was used for qNMR. The developed method was validated with respect to linearity, limits of detection and quantitation, accuracy, precision, specificity and solution state stability. Results:: Linearity range and r2 were found to be from 2.66 to 42.11 mg/mL and 0.9999. The limit of detection and quantification were 0.0129 mg/mL and 0.0391 mg/mL, respectively, for vigabatrin. This method was found to be linear (0.9998) and specific within the gabapentin concentration range from 1.07 to 34.24 mg/mL of D2O. The limits of detection and quantification were 0.0248 mg/mL and 0.0751 mg/mL, respectively. Conclusion:: Both methods were highly precise, with a calculated RSD of 0.60 % and 0.76 %, respectively. The robustness of the methods was revealed by changing pre and post-processing NMR parameters. The developed methods provide a simple and straight approach for the absolute determination of gabapentin and vigabatrin in bulk drugs and their marketed formulations without any pre-procedures.
背景::维加巴曲林和加巴喷丁是临床上常用的抗癫痫药物,它们缺乏紫外活性发色团,因此需要采用繁琐的衍生方法,利用荧光检测进行高效液相色谱分析。本研究展示了利用核磁共振对这两种药物的纯品及其药物制剂进行定量测定的方法。目标::为非色素药物维加巴曲林和加巴喷丁开发一种有效的 qNMR 方法。方法采用 qNMR 方法,维加巴曲林的甲基质子信号为 3.67 ppm,马来酸信号为 6.17 ppm;加巴喷丁的亚甲基信号为 2.88 ppm,咖啡因信号为 7.75 ppm。对所建立的方法进行了线性、检出限和定量限、准确度、精密度、特异性和溶液稳定性的验证。结果线性范围为 2.66 至 42.11 mg/mL,r2 为 0.9999。维加巴曲林的检出限和定量限分别为 0.0129 mg/mL 和 0.0391 mg/mL。该方法在加巴喷丁浓度为 1.07 至 34.24 毫克/毫升 D2O 的范围内线性关系良好(0.9998),特异性强。检出限和定量限分别为 0.0248 mg/mL 和 0.0751 mg/mL。结论两种方法的精确度都很高,计算的 RSD 分别为 0.60 % 和 0.76 %。通过改变核磁共振前处理和后处理参数,可以看出这两种方法的稳健性。所开发的方法提供了一种简单直接的方法,无需任何前处理即可绝对测定散装药物及其上市制剂中的加巴喷丁和维加巴曲林。
{"title":"Rapid Quantitation of Non-chromophoric Vigabatrin and Gabapentin by a Validated qNMR Method in Bulk Drug and Marketed Formulations","authors":"Pooja Bedage, Archana Sahu, Inder Pal Singh","doi":"10.2174/0115734129283110240131044647","DOIUrl":"https://doi.org/10.2174/0115734129283110240131044647","url":null,"abstract":"Background:: Vigabatrin and gabapentin, commonly used antiepileptic drugs in clinics, lack a UV active chromophore and, therefore, require cumbersome derivatization methods for analysis by HPLC using fluorescence detection. This study demonstrated the use of NMR for their quantitative determination in pure form and their pharmaceutical formulations. Objective:: To develop a validated qNMR method for non-chromophoric drugs Vigabatrin and Gabapentin. Methods:: The signal of methine proton of vigabatrin at 3.67 ppm relative to the signal of maleic acid at 6.17 ppm and the methylene signal of gabapentin at 2.88 ppm relative to the signal of caffeine at 7.75 ppm was used for qNMR. The developed method was validated with respect to linearity, limits of detection and quantitation, accuracy, precision, specificity and solution state stability. Results:: Linearity range and r2 were found to be from 2.66 to 42.11 mg/mL and 0.9999. The limit of detection and quantification were 0.0129 mg/mL and 0.0391 mg/mL, respectively, for vigabatrin. This method was found to be linear (0.9998) and specific within the gabapentin concentration range from 1.07 to 34.24 mg/mL of D2O. The limits of detection and quantification were 0.0248 mg/mL and 0.0751 mg/mL, respectively. Conclusion:: Both methods were highly precise, with a calculated RSD of 0.60 % and 0.76 %, respectively. The robustness of the methods was revealed by changing pre and post-processing NMR parameters. The developed methods provide a simple and straight approach for the absolute determination of gabapentin and vigabatrin in bulk drugs and their marketed formulations without any pre-procedures.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"29 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139948663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Molecular Absorption Scanning and Assay of Serotonin Reception Inhibitor Antidepressant Drugs 血清素接收抑制剂抗抑郁药物的分子吸收扫描与分析
IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-02-05 DOI: 10.2174/0115734129282354231226192406
Amanda Santana Silva, Victor Hugo Abreu de Paula, Lucas Gabriel dos Santos Xavier, Ludimila Nascimento da Silva, Ana Carolyne Silva Lucas, Aléxia Mariany Lourenço Alves, Fernando Machado dos Santos
Background:: Spectrophotometric techniques are based on the absorption of electromagnetic energy by the molecules of the substance analyzed and can be applied to drug analysis. Objective:: This study has been proposed to carry out molecular absorption scanning and assay in the ultraviolet region of generic antidepressant drugs of the serotonin reuptake inhibitor class produced by three Brazilian laboratories, addressing the importance of good manufacturing practices, drug quality control, and the use of qualitative and quantitative analytical techniques. Methods:: The physicochemical analyses were performed in a Marte Científica (580 UVP) UV-Vis spectrophotometer, and the result was evaluated according to the acceptance interval described in the Brazilian Pharmacopoeia. Results:: When calculating the dosage of the fluoxetine hydrochloride sample, the value of 90.95% was obtained and, therefore, the drug was approved for the dosage test. The dosage test for the drugs, citalopram hydrobromide and sertraline hydrochloride, was also approved, obtaining values of 102.4% and 98.2%, respectively. Conclusion:: The results presented provide future perspectives regarding the rigor of the need for good drug handling practices, maintenance and qualification of quality control laboratory equipment, and the guarantee of validation of analytical methodologies used in the pharmaceutical industries, contributing to the improvement of the quality of production and pharmaceutical products analysis.
背景::分光光度法基于被分析物质分子对电磁能量的吸收,可用于药物分析。目的::本研究拟对巴西三家实验室生产的 5-羟色胺再摄取抑制剂类抗抑郁剂仿制药进行分子吸收扫描和紫外光谱分析,探讨良好生产规范、药品质量控制以及定性和定量分析技术使用的重要性。方法使用 Marte Científica (580 UVP) 紫外可见分光光度计进行理化分析,并根据《巴西药典》规定的验收间隔对结果进行评估。结果在计算盐酸氟西汀样品的剂量时,得到的数值为 90.95%,因此,该药物获准进行剂量试验。药物氢溴酸西酞普兰和盐酸舍曲林的剂量测试也获得了批准,分别获得了 102.4% 和 98.2% 的数值。结论这些结果为今后严格执行良好的药品处理规范、维护和鉴定质量控制实验室设备以及保证验证制药行业使用的分析方法提供了参考,有助于提高生产和药品分析的质量。
{"title":"Molecular Absorption Scanning and Assay of Serotonin Reception Inhibitor Antidepressant Drugs","authors":"Amanda Santana Silva, Victor Hugo Abreu de Paula, Lucas Gabriel dos Santos Xavier, Ludimila Nascimento da Silva, Ana Carolyne Silva Lucas, Aléxia Mariany Lourenço Alves, Fernando Machado dos Santos","doi":"10.2174/0115734129282354231226192406","DOIUrl":"https://doi.org/10.2174/0115734129282354231226192406","url":null,"abstract":"Background:: Spectrophotometric techniques are based on the absorption of electromagnetic energy by the molecules of the substance analyzed and can be applied to drug analysis. Objective:: This study has been proposed to carry out molecular absorption scanning and assay in the ultraviolet region of generic antidepressant drugs of the serotonin reuptake inhibitor class produced by three Brazilian laboratories, addressing the importance of good manufacturing practices, drug quality control, and the use of qualitative and quantitative analytical techniques. Methods:: The physicochemical analyses were performed in a Marte Científica (580 UVP) UV-Vis spectrophotometer, and the result was evaluated according to the acceptance interval described in the Brazilian Pharmacopoeia. Results:: When calculating the dosage of the fluoxetine hydrochloride sample, the value of 90.95% was obtained and, therefore, the drug was approved for the dosage test. The dosage test for the drugs, citalopram hydrobromide and sertraline hydrochloride, was also approved, obtaining values of 102.4% and 98.2%, respectively. Conclusion:: The results presented provide future perspectives regarding the rigor of the need for good drug handling practices, maintenance and qualification of quality control laboratory equipment, and the guarantee of validation of analytical methodologies used in the pharmaceutical industries, contributing to the improvement of the quality of production and pharmaceutical products analysis.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"50 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139771023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality Evaluation of Banlangen Granule Based on Bioassays of Anti-influenzal and Anti-inflammatory Effects 基于抗流感和抗炎作用生物测定的板蓝根颗粒质量评价
IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-02-04 DOI: 10.2174/0115734129285820240108113029
Xiu-yu Qian, Ming-lu Zhang, Yan-Lin Wu, Shuang-cheng Ma, Jin-mei Liu, Yan-hui Kang, Li-xing Nie
Objective:: In order to control the quality better, this study aimed to develop two bioassay methods of Banlangen Granule (BLGG) based on its anti-influenza activity and antiinflammatory activity and to verify the necessity of established methods by relating the results tested by chemical methods. Method:: First, the bioassay methods for determining the biopotency of the anti-influenza effect and anti-inflammatory activity were established and applied, taking neuraminidase and cyclooxygenase- 2 as disease targets, respectively. Secondly, the ultra-high-performance liquid chromatography coupled photo-diode array detector (UPLC-PDA) technique was used to perform fingerprints and quantify chemical compounds. Finally, the correlation analysis was performed on the results of bioassay methods and chemical methods to assist in choosing the effective quality markers for the BLGG. Results:: Two accurate, stable, and repeatable bioassay methods were developed and applied to the determination of 57 batches of samples. The chemical fingerprints and contents of seven quality compounds were obtained based on UPLC-PDA methods. From the results of correlation analysis, the highest intensity correlation between these quality markers was medium with a r=0.495 (P<0.01), which indicates the need for establishing a bioassay method for BLGG. Conclusion:: This present work illuminated that bioassay methods can be a great means to evaluate the quality of BLGG effectively and also provided a paradigm case for the quality control of other traditional Chinese medicine preparations.
研究目的为了更好地控制质量,本研究旨在根据板蓝根颗粒(BLGG)的抗流感活性和抗炎活性开发两种生物测定方法,并通过化学方法测试的结果验证已建立方法的必要性。方法::首先,分别以神经氨酸酶和环氧合酶 2 为疾病靶点,建立并应用了测定抗流感作用和抗炎活性生物效价的生物测定方法。其次,采用超高效液相色谱-光电二极管阵列检测器(UPLC-PDA)技术对化合物进行指纹图谱和定量分析。最后,对生物测定方法和化学方法的结果进行了相关性分析,以帮助选择有效的 BLGG 质量标记。结果开发了两种准确、稳定、可重复的生物测定方法,并应用于 57 批样品的测定。基于 UPLC-PDA 方法获得了七种优质化合物的化学指纹图谱和含量。从相关性分析结果来看,这些质量标记物之间的相关强度最高,为中等,r=0.495(P<0.01),这表明有必要建立 BLGG 的生物测定方法。结论本研究表明,生物测定方法是有效评价 BLGG 质量的重要手段,也为其他中药制剂的质量控制提供了范例。
{"title":"Quality Evaluation of Banlangen Granule Based on Bioassays of Anti-influenzal and Anti-inflammatory Effects","authors":"Xiu-yu Qian, Ming-lu Zhang, Yan-Lin Wu, Shuang-cheng Ma, Jin-mei Liu, Yan-hui Kang, Li-xing Nie","doi":"10.2174/0115734129285820240108113029","DOIUrl":"https://doi.org/10.2174/0115734129285820240108113029","url":null,"abstract":"Objective:: In order to control the quality better, this study aimed to develop two bioassay methods of Banlangen Granule (BLGG) based on its anti-influenza activity and antiinflammatory activity and to verify the necessity of established methods by relating the results tested by chemical methods. Method:: First, the bioassay methods for determining the biopotency of the anti-influenza effect and anti-inflammatory activity were established and applied, taking neuraminidase and cyclooxygenase- 2 as disease targets, respectively. Secondly, the ultra-high-performance liquid chromatography coupled photo-diode array detector (UPLC-PDA) technique was used to perform fingerprints and quantify chemical compounds. Finally, the correlation analysis was performed on the results of bioassay methods and chemical methods to assist in choosing the effective quality markers for the BLGG. Results:: Two accurate, stable, and repeatable bioassay methods were developed and applied to the determination of 57 batches of samples. The chemical fingerprints and contents of seven quality compounds were obtained based on UPLC-PDA methods. From the results of correlation analysis, the highest intensity correlation between these quality markers was medium with a r=0.495 (P&lt;0.01), which indicates the need for establishing a bioassay method for BLGG. Conclusion:: This present work illuminated that bioassay methods can be a great means to evaluate the quality of BLGG effectively and also provided a paradigm case for the quality control of other traditional Chinese medicine preparations.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"70 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139689853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Review on N-nitrosamine Impurity 关于 N-亚硝胺杂质的综述
IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-02-04 DOI: 10.2174/0115734129271377231222100236
Debangana Pal, Babu B.
: Nitrosamines are a category of substances that have a nitroso group linked to an amino group in their molecular structure. They are a category of carcinogens developed as a by-product of drug synthesis and also constituted in the presence of sodium nitrite or nitric acid and secondary amines (like dimethyl amines and diethyl amine) that must be monitored in drug production. In mid-June 2018, the Food and Drug Administration and the European Medicines Agency became aware of the existence of an impurity called N-nitrosamine in some frequently used medications, such as those for blood pressure, antacids, and diabetes. N-nitrosamines are of major concern because the ICH M7 (R1)2 guideline categorizes them as Class 1 impurities or mutagenic carcinogens, and the International Agency for Cancer Research categorizes them as potential carcinogens. The existence of N-nitrosamines in pharmaceutical drugs must be minimized to the greatest extent possible and must be at or below the threshold based on ICH M7(R1)2 fundamentals for materials in the "cohort of concern" described in this guideline and measured based on lifetime constant exposure.
:亚硝胺是一类在分子结构中含有与氨基相连的亚硝基的物质。它们是药物合成过程中产生的一类致癌物质,也是亚硝酸钠或硝酸以及仲胺(如二甲基胺和二乙胺)存在时的致癌物质,在药物生产过程中必须受到监控。2018 年 6 月中旬,美国食品和药物管理局和欧洲药品管理局意识到,在一些常用药物(如治疗血压、抗酸剂和糖尿病的药物)中存在一种名为 N-亚硝胺的杂质。N-亚硝胺之所以备受关注,是因为 ICH M7 (R1)2 准则将其归类为 1 级杂质或诱变致癌物,而国际癌症研究机构则将其归类为潜在致癌物。必须尽最大可能减少 N-亚硝胺在药品中的存在,其含量必须达到或低于 ICH M7(R1)2 准则中所述 "关注人群 "材料的基本阈值,并根据终生持续接触进行测量。
{"title":"A Review on N-nitrosamine Impurity","authors":"Debangana Pal, Babu B.","doi":"10.2174/0115734129271377231222100236","DOIUrl":"https://doi.org/10.2174/0115734129271377231222100236","url":null,"abstract":": Nitrosamines are a category of substances that have a nitroso group linked to an amino group in their molecular structure. They are a category of carcinogens developed as a by-product of drug synthesis and also constituted in the presence of sodium nitrite or nitric acid and secondary amines (like dimethyl amines and diethyl amine) that must be monitored in drug production. In mid-June 2018, the Food and Drug Administration and the European Medicines Agency became aware of the existence of an impurity called N-nitrosamine in some frequently used medications, such as those for blood pressure, antacids, and diabetes. N-nitrosamines are of major concern because the ICH M7 (R1)2 guideline categorizes them as Class 1 impurities or mutagenic carcinogens, and the International Agency for Cancer Research categorizes them as potential carcinogens. The existence of N-nitrosamines in pharmaceutical drugs must be minimized to the greatest extent possible and must be at or below the threshold based on ICH M7(R1)2 fundamentals for materials in the \"cohort of concern\" described in this guideline and measured based on lifetime constant exposure.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"8 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139690147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Current Pharmaceutical Analysis
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1