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Pharmacokinetic Properties of Baitouweng Decoction in Bama Miniature Pigs: Implications for Clinical Application in Humans 白头翁煎剂在巴马小型猪体内的药代动力学特性:对人类临床应用的启示
IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL Pub Date : 2024-05-10 DOI: 10.1155/2024/5535752
Qianqian Xu, Huilan Gao, Fuqiang Zhu, Wenliang Xu, Yubo Wang, Jinwen Xie, Guangjun Guo, Limei Yang, Li Ma, Zhiqiang Shen, Jichang Li
Traditional Chinese medicine (TCM) serves as a significant adjunct to chemical treatment for chronic diseases. For instance, the administration of Baitouweng decoction (BTWD) has proven effective in the treatment of ulcerative colitis. However, the limited understanding of its pharmacokinetics (PK) has impeded its widespread use. Chinese Bama miniature pigs possess anatomical and physiological similarities to the human body, making them a valuable model for investigating PK properties. Consequently, the identification of PK properties in Bama miniature pigs can provide valuable insights for guiding the clinical application of BTWD in humans. To facilitate this research, a rapid and sensitive UPLC-MS/MS method has been developed for the simultaneous quantification of eleven active ingredients of BTWD in plasma. Chromatographic separation was conducted using an Acquity UPLC HSS T3 C18 column and a gradient mobile phase comprising acetonitrile and water (containing 0.1% acetic acid). The methodology was validated in accordance with the FDA Bioanalytical Method Validation Guidance for Industry. The lower limit of quantitation fell within the range of 0.60–2.01 ng/mL. Pharmacokinetic studies indicated that coptisine chloride, berberine, columbamine, phellodendrine, and obacunone exhibited low , while fraxetin, esculin, fraxin, and pulchinenoside were rapidly absorbed and eliminated from the plasma. These findings have implications for the development of effective components in BTWD and the adjustment of clinical dosage regimens.
传统中医药是慢性疾病化学疗法的重要辅助手段。例如,服用白头翁煎剂(BTWD)已被证明对治疗溃疡性结肠炎有效。然而,由于对其药代动力学(PK)的了解有限,阻碍了其广泛应用。中国巴马小型猪的解剖和生理结构与人体相似,因此是研究 PK 特性的宝贵模型。因此,鉴定巴马小型猪的 PK 特性可为指导 BTWD 在人体中的临床应用提供有价值的见解。为了促进这项研究,我们开发了一种快速灵敏的 UPLC-MS/MS 方法,用于同时定量测定血浆中 BTWD 的 11 种有效成分。色谱分离采用 Acquity UPLC HSS T3 C18 色谱柱和乙腈-水(含 0.1% 乙酸)梯度流动相。该方法根据 FDA 生物分析方法验证指南进行了验证。定量下限为 0.60-2.01 纳克/毫升。药代动力学研究表明,氯化黄连碱、小檗碱、秋水仙碱、黄柏碱和欧巴农甙在血浆中的吸收和清除率较低,而枸杞子苷、枸杞子素、枸杞子苷和蒲公英苷在血浆中的吸收和清除率较快。这些发现对开发 BTWD 的有效成分和调整临床剂量方案具有重要意义。
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引用次数: 0
The Analysis of Leontopodium leontopodioides (Willd.) Beauv. Chemical Composition by GC/MS and UPLC-Q-Orbitrap MS 利用气相色谱/质谱和超高效液相色谱-质谱联用技术分析Leontopodium leontopodioides (Willd.) Beauv.GC/MS 和 UPLC-Q-Orbitrap MS 的化学成分分析
IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL Pub Date : 2024-05-07 DOI: 10.1155/2024/3525212
Yuanyuan Chen, Yu Dong, Lin Song, Changxi Bai, Buhechaolu Wang, Chula Sa
Leontopodium leontopodioides (Willd.) Beauv. (L. leontopodioides.) has been used to treat lung diseases in traditional Chinese medicine (TCM). However, a systematic analysis of its chemical components has not been reported so far. In this study, UPLC-Q-Orbitrap MS and GC-MS were applied to investigate the chemical composition of the water extracts and essential oils of L. leontopodioides. UPLC-Q-Orbitrap MS adopts a heating electrospray ionization source, collecting primary and secondary mass spectrometry data in positive and negative ions, respectively, and uses Compound Discoverer 3.2 software to analyze the collected raw data. As a result, a total of 39 compounds were identified from their high-resolution mass spectra in both positive and negative ionization modes, including 13 flavonoids and their glycosides, 15 phenolic acids, 4 oligosaccharides and glycosides, 4 pentacyclic triterpenoids, and 3 other compounds. Among them, 18 chemical components have not been reported in L. leontopodioides. In the GC-MS section, two common organic solvents (n-hexane and diethyl ether) were used to extract essential oils, and the mass spectra were recorded at 70 eV (electron impact) and scanned in the range of 35∼450 m/z. Compounds were identified using NIST (version 2017), and the peak area normalization method was used to calculate their relative amounts. Finally, 17 components were identified in the volatile oil extracted with n-hexane, accounting for 80.38% of the total volatile oil, including monoterpenoids, phenylpropene, fatty acids, and aliphatic hydrocarbons. In the volatile oil extracted with diethyl ether, 16 components were identified, accounting for 73.50% of the total volatile oil, including phenylpropene, aliphatic hydrocarbons, monoterpenoids, fatty acids, and esters. This study was the first to conduct a comprehensive analysis of the chemical composition of the L. leontopodioides water extract and its essential oil, and a comprehensive chemical composition spectrum was constructed, to lay a foundation for its further pharmacodynamic material basis and quality evaluation.
Leontopodium leontopodioides (Willd.) Beauv.(L. leontopodioides.)在传统中医中被用于治疗肺部疾病。然而,迄今为止尚未有对其化学成分进行系统分析的报道。本研究采用 UPLC-Q-Orbitrap MS 和 GC-MS 法研究了亮菌甲藻水提取物和精油的化学成分。UPLC-Q-Orbitrap MS采用加热电喷雾离子源,分别采集正离子和负离子的一级和二级质谱数据,并使用Compound Discoverer 3.2软件对采集的原始数据进行分析。结果,通过正、负离子高分辨率质谱共鉴定出 39 种化合物,包括 13 种黄酮类化合物及其苷类化合物、15 种酚酸类化合物、4 种低聚糖及苷类化合物、4 种五环三萜类化合物和 3 种其他化合物。其中,18 种化学成分在 L. leontopodioides 中未见报道。在气相色谱-质谱部分,使用两种常见的有机溶剂(正己烷和二乙醚)提取精油,在 70 eV(电子碰撞)下记录质谱,扫描范围为 35∼450 m/z。使用 NIST(2017 版)对化合物进行鉴定,并采用峰面积归一化方法计算其相对含量。最后,在用正己烷萃取的挥发油中鉴定出 17 种成分,占挥发油总量的 80.38%,包括单萜、苯丙 烯、脂肪酸和脂肪烃。在用二乙醚提取的挥发油中,鉴定出 16 种成分,占挥发油总量的 73.50%,包括苯丙烯、脂肪烃、单萜、脂肪酸和酯类。该研究首次对L. leontopodioides水提取物及其精油的化学成分进行了全面分析,构建了全面的化学成分谱,为其进一步的药效物质基础和质量评价奠定了基础。
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引用次数: 0
Exploiting of Green Synthesized Metal Oxide Nanoparticles in the Potentiometric Determination of Metformin Hydrochloride in Pharmaceutical Products 利用绿色合成的金属氧化物纳米粒子进行药品中盐酸二甲双胍的电位测定
IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL Pub Date : 2024-04-12 DOI: 10.1155/2024/8354311
Shikhah Almutairi, Nawal A. Alarfaj, Adibah M. Almutairi, Maha F. El-Tohamy
The advanced and highly functional properties of Al2O3 and NiO nanoparticles promote the widespread use of metal oxides as remarkable electroactive materials for sensing and electrochemical applications. The proposed study describes a comparison of the sensitivity and selectivity of two modified wire membrane sensors enriched with Al2O3 and NiO nanoparticles with conventional wire membranes for the quantification of the antidiabetic drug metformin hydrochloride (MTF). The results show linear relationships of the enriched Al2O3 and NiO nanosensors over the concentration ranges 1.0 × 10−10–1.0 × 10−2 mol L−1 and 1.0 × 10−6–1.0 × 10−2 M for both the modified sensors and the conventional coated wire membrane sensors. The regression equations were  = (52.1 ± 0.5) log (MTF) + 729 for enriched nanometallic oxides,  = (57.04 ± 0.4) log (MTF) + 890.66, and  = (58.27 ± 0.7) log (MTF) + 843.27 with correlation coefficients of 0.9991, 0.9997, and 0.9998 for the aforementioned sensors, respectively. The proposed method was fully validated with respect to the recommendations of the International Union of Pure and Applied Chemistry (IUPAC). The newly functionalized sensors have been successfully used for the determination of MTF in its commercial products.
Al2O3 和 NiO 纳米粒子具有先进的高功能特性,促进了金属氧化物作为非凡电活性材料在传感和电化学应用中的广泛应用。本研究描述了富含 Al2O3 和 NiO 纳米粒子的两种改性金属丝膜传感器与传统金属丝膜在定量检测抗糖尿病药物盐酸二甲双胍 (MTF) 的灵敏度和选择性方面的比较。结果表明,在 1.0 × 10-10-1.0 × 10-2 mol L-1 和 1.0 × 10-6-1.0 × 10-2 M 的浓度范围内,富集的 Al2O3 和 NiO 纳米传感器与传统的涂覆金属丝膜传感器均呈线性关系。富集纳米金属氧化物的回归方程分别为 = (52.1 ± 0.5) log (MTF) + 729、= (57.04 ± 0.4) log (MTF) + 890.66 和 = (58.27 ± 0.7) log (MTF) + 843.27,相关系数分别为 0.9991、0.9997 和 0.9998。所提出的方法完全符合国际纯粹与应用化学联合会(IUPAC)的建议。新功能化的传感器已成功用于测定商业产品中的 MTF。
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引用次数: 0
Urine Test Strip Quantitative Assay with a Smartphone Camera 利用智能手机摄像头进行尿液试纸定量检测
IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL Pub Date : 2024-03-18 DOI: 10.1155/2024/6004970
Miroslav Pohanka, Jitka Zakova
Urine test strips for urinalysis are a common diagnostic tool with minimal costs and are used in various situations including homecare and hospitalization. The coloration scaled by the naked eye is simple, but it is suitable for semiquantitative analysis only. In this paper, a colorimetric assay is developed based on a smartphone digital camera and urine test strips. Assays of pH, albumin, glucose, and lipase activity were performed as a tool for the diagnosis of aciduria, alkaluria, glycosuria, proteinuria, and leukocyturia. The RGB color channels were analyzed in the colorimetric assay, and the assay exerted good sensitivity, and all the particular diagnoses proved to be reliable. The limits of detection for glucose (0.11 mmol/L), albumin (0.15 g/L), and lipase (2.50 U/μL) were low enough to cover the expected physiological concentration, and the range for pH was also satisfactory. The urine test strips with a camera as an output detector proved applicability to spiked urine samples, and the results were also well in comparison to the standard assays which confirms the practical relevance of the presented findings.
用于尿液分析的尿试纸是一种常见的诊断工具,成本极低,可用于家庭护理和住院治疗等各种情况。肉眼显色虽然简单,但只适用于半定量分析。本文以智能手机数码相机和尿液试纸为基础,开发了一种比色测定法。作为诊断酸尿、碱尿、糖尿、蛋白尿和白细胞尿的工具,对 pH 值、白蛋白、葡萄糖和脂肪酶活性进行了测定。在比色测定中对 RGB 颜色通道进行了分析,该测定具有良好的灵敏度,所有特定诊断均证明是可靠的。葡萄糖(0.11 mmol/L)、白蛋白(0.15 g/L)和脂肪酶(2.50 U/μL)的检测限很低,足以涵盖预期的生理浓度,pH 值的检测范围也令人满意。事实证明,用照相机作为输出检测器的尿液试纸适用于添加剂的尿样,其结果与标准测定结果相比也很好,这证实了本文研究结果的实用性。
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引用次数: 0
A Simple and Rapid LC-MS/MS Method for the Quantification of Nirmatrelvir/Ritonavir in Plasma of Patients with COVID-19 用于定量检测 COVID-19 患者血浆中尼马瑞韦/利托那韦的简便快速 LC-MS/MS 方法
IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL Pub Date : 2024-03-06 DOI: 10.1155/2024/6139928
Xiujing Zhu, Lin Li, Bin Dai, Zhijun Liu, Zhipeng Wang, Lili Cui, Shouhong Gao, Wansheng Chen, Xia Tao, Deduo Xu
The combined prescriptions of nirmatrelvir/ritonavir and other drugs are limited due to potential drug-drug interactions, so therapeutic drug monitoring (TDM) becomes particularly important. In this study, a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was established for determination of the nirmatrelvir/ritonavir in plasma of patients with COVID-19, providing technical and theoretical support for the TDM. Plasma samples were processed by protein precipitation using acetonitrile, and analytes were separated on an Agilent Poroshell 120 SB-C18 (2.1 × 75 mm, 2.7 μm) column at 35°C. Acetonitrile and 0.1% formic acid in water (52 : 48) were utilized as the mobile phases at a flow rate of 0.3 mL/min. In the multiple reaction monitoring (MRM) mode, nirmatrelvir and ritonavir were monitored using precursor/product ions: m/z 500.2/110.1 and 721.3/296.1, respectively, with selinexor as the internal standard. The linear range of both analytes was 2.0 ng/mL to 5000 ng/mL with good inter- and intraday precision and accuracy, and the recovery was 92.0%–107% for nirmatrelvir and 85.7%–106% for ritonavir. Finally, this method was successfully applied to monitor the exposure levels of nirmatrelvir/ritonavir in plasma samples from hemodialysis patients.
由于潜在的药物相互作用,尼马瑞韦/利托那韦与其他药物的联合处方受到限制,因此治疗药物监测(TDM)变得尤为重要。本研究建立了一种液相色谱-串联质谱(LC-MS/MS)测定COVID-19患者血浆中尼瑞韦酯/利托那韦的方法,为TDM提供了技术和理论支持。血浆样品经乙腈蛋白沉淀处理后,用 Agilent Poroshell 120 SB-C18 (2.1 × 75 mm, 2.7 μm)色谱柱在 35°C 下分离。流动相为乙腈和 0.1%甲酸水溶液(52:48),流速为 0.3 mL/min。在多反应监测(MRM)模式下,使用前体/产物离子监测尼马瑞韦和利托那韦,前体/产物离子分别为 m/z 500.2/110.1 和 721.3/296.1,内标为西利奈德。两种分析物的线性范围为2.0 ng/mL至5000 ng/mL,日间和日内精密度和准确度良好,尼马瑞韦的回收率为92.0%-107%,利托那韦的回收率为85.7%-106%。最后,该方法被成功地应用于监测血液透析患者血浆样本中尼马瑞韦/利托那韦的暴露水平。
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引用次数: 0
Pharmacokinetics of Ziyuglycoside I and Ziyuglycoside II in Rat Plasma by UPLC-MS/MS 通过 UPLC-MS/MS 测定大鼠血浆中紫玉糖苷 I 和紫玉糖苷 II 的药代动力学
IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL Pub Date : 2024-03-01 DOI: 10.1155/2024/7971021
Xiuwei Shen, Ziyue Wang, Wenting Li, Shenshen Mei, Shunjun Ma, Xianqin Wang, Congcong Wen, Fan Chen, Guojun Zheng
Ziyuglycoside I and ziyuglycoside II are important active components of Sanguisorba officinalis L., which have excellent pharmacological effects, such as antioxidant and anticancer effects. However, the bioavailability of ziyuglycoside I and ziyuglycoside II has not been reported. This work aims to establish a UPLC-MS/MS method to study the pharmacokinetics of ziyuglycoside I and ziyuglycoside II in rats under different administration routes (intragastric and intravenous administration) and to calculate the bioavailability. The concentration of ziyuglycoside I and ziyuglycoside II in rat plasma in the range of 2–2000 ng/mL showed a good linear relationship (r > 0.99). The intra-day accuracies of ziyuglycoside I and ziyuglycoside II ranged from 87% to 110%, and the inter-day accuracies ranged from 97% to 109%. The intra-day precision was less than 15% and the inter-day precision was less than 14%. The matrix effects ranged from 88% to 113%. The recoveries were all above 84%. The developed UPLC-MS/MS method for the determination of ziyuglycoside I and ziyuglycoside II in rat plasma was applied to pharmacokinetics. The bioavailability of ziyuglycoside I and ziyuglycoside II was measured at 2.6% and 4.6%, respectively.
紫玉糖苷 I 和紫玉糖苷 II 是山银花的重要活性成分,具有很好的药理作用,如抗氧化和抗癌作用。然而,关于紫杉糖苷 I 和紫杉糖苷 II 的生物利用度尚未见报道。本研究旨在建立一种 UPLC-MS/MS 方法,以研究不同给药途径(胃内给药和静脉给药)下紫玉糖苷 I 和紫玉糖苷 II 在大鼠体内的药代动力学,并计算其生物利用度。大鼠血浆中齐尤甙 I 和齐尤甙 II 的浓度在 2-2000 纳克/毫升范围内呈良好的线性关系(r > 0.99)。ziyuglycoside I 和 ziyuglycoside II 的日内准确度为 87% 至 110%,日间准确度为 97% 至 109%。日内精确度低于 15%,日间精确度低于 14%。基质效应为 88% 至 113%。回收率均高于 84%。应用所建立的 UPLC-MS/MS 方法测定了大鼠血浆中齐尤糖苷 I 和齐尤糖苷 II 的药代动力学。结果表明,紫杉甙 I 和紫杉甙 II 的生物利用度分别为 2.6% 和 4.6%。
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引用次数: 0
Development of a Novel Multiplex PCR Method for the Rapid Detection of SARS-CoV-2, Influenza A Virus, and Influenza B Virus 开发用于快速检测 SARS-CoV-2、甲型流感病毒和乙型流感病毒的新型多重 PCR 方法
IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL Pub Date : 2024-02-29 DOI: 10.1155/2024/4950391
Liang Ma, Haoyan Zhu, Yongwei Jiang, Xiaomu Kong, Peng Gao, Yi Liu, Meimei Zhao, Guoxiong Deng, Yongtong Cao
Objective. A sensitive and specific multiplex fluorescence rapid detection method was established for simultaneous detection of SARS-CoV-2, influenza A virus, and influenza B virus in a self-made device within 30 min, with a minimum detection limit of 200 copies/mL. Methods. Based on the genome sequences of SARS-CoV-2, influenza A virus (FluA), and influenza B virus (FluB) with reference to the Chinese Center for Disease Control and Prevention and related literature, specific primers were designed, and a multiplex fluorescent PCR system was established. The simultaneous and rapid detection of SARS-CoV-2, FluA, and FluB was achieved by optimizing the concentrations of Taq DNA polymerase as well as primers, probes, and Mg2+. The minimum detection limits of the nucleic acid rapid detection system for SARS-CoV-2, FluA, and FluB were evaluated. Results. By optimizing the amplification system, the N enzyme with the best amplification performance was selected, and the optimal concentration of Mg2+ in the multiamplification system was 3 mmol/L; the final concentrations of SARS-CoV-2 NP probe and primer were 0.15 μmol/L and 0.2 μmol/L, respectively; the final concentrations of SARS-CoV-2 ORF probe and primer were both 0.15 μmol/L; the final concentrations of FluA probe and primer were 0.2 μmol/L and 0.3 μmol/L, respectively; the final concentrations of FluB probe and primer were 0.15 μmol/L and 0.25 μmol/L, respectively. Conclusion. A multiplex real-time quantitative fluorescence RT-PCR system for three respiratory viruses of SARS-CoV-2, FluA, and FluB was established with a high amplification efficiency and sensitivity reaching 200 copies/mL for all samples. Combined with the automated microfluidic nucleic acid detection system, the system can achieve rapid detection in 30 minutes.
目的建立一种灵敏、特异的多重荧光快速检测方法,利用自制装置在 30 分钟内同时检测 SARS-CoV-2、甲型流感病毒和乙型流感病毒,最低检测限为 200 拷贝/毫升。检测方法根据 SARS-CoV-2、甲型流感病毒(FluA)和乙型流感病毒(FluB)的基因组序列,参考中国疾病预防控制中心及相关文献,设计了特异性引物,建立了多重荧光 PCR 系统。通过优化 Taq DNA 聚合酶、引物、探针和 Mg2+ 的浓度,实现了对 SARS-CoV-2、FluA 和 FluB 的同时快速检测。评估了核酸快速检测系统对 SARS-CoV-2、FluA 和 FluB 的最低检测限。结果显示通过优化扩增系统,选择了扩增性能最好的 N 酶,多重扩增系统中 Mg2+ 的最佳浓度为 3 mmol/L;SARS-CoV-2 NP 探针和引物的最终浓度分别为 0.15 μmol/L 和 0.2 μmol/L;SARS-CoV-2 ORF探针和引物的最终浓度均为0.15 μmol/L;FluA探针和引物的最终浓度分别为0.2 μmol/L和0.3 μmol/L;FluB探针和引物的最终浓度分别为0.15 μmol/L和0.25 μmol/L。结论建立了一种针对 SARS-CoV-2、FluA 和 FluB 三种呼吸道病毒的多重实时荧光定量 RT-PCR 系统,其扩增效率高,所有样本的灵敏度均达到 200 拷贝/毫升。该系统与自动化微流控核酸检测系统相结合,可在 30 分钟内实现快速检测。
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引用次数: 0
Validation and Application of Screen-Printed Microchip for Potentiometric Determination of Metformin Hydrochloride in Tablet Dosage Form 用于片剂盐酸二甲双胍电位测定的丝网印刷微芯片的验证与应用
IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL Pub Date : 2024-02-27 DOI: 10.1155/2024/8664723
Mohammed Alqarni, Abdullah A. Alshehri, Hassan Arida
Metformin is an oral biguanides hypoglycaemic agent, which used to lower the blood glucose levels in people with type 2 diabetes mellitus. Many analytical techniques have been used to quantify the drug in different pharmaceutical dosage forms; however, most of these methods have limited throughput in the quality control application. A disposable potentiometric microsensor responsive to metformin has recently been reported. For the first time, herein, this method of analysis has been validated according to IUPAC recommendations and successfully applied in the determination of metformin drug in some dosage form. Different drug formulations of metformin hydrochloride have been collected from the local pharmaceutical stores in Saudi Arabia and analysed using the validated microchip-based method of analysis. Subsequently, the results of this study showed that the validated method was linear, specific, precise, and accurate. The linear range was 1 × 10−1–1 × 10−5 mol L−1 and the correlation coefficient was 0.999. The limit of detection was 2.89 × 10−6 mol L−1, and the limit of quantification was 8.77 × 10−6 mol L−1. This method demonstrated high precision, with an RSD% of less than 2.22%. The accuracy of this method was obtained by comparing the recovery percentage with percentage values less than 5%. The results obtained showed that there was no significant difference between the references, label, and recovery of less than 5%.
二甲双胍是一种口服双胍类降血糖药,用于降低 2 型糖尿病患者的血糖水平。许多分析技术已被用于定量分析不同药物剂型中的二甲双胍,但大多数方法在质量控制应用中的通量有限。最近有报道称,一种一次性电位微传感器对二甲双胍有反应。本文首次根据国际理论化学和应用化学联合会(IUPAC)的建议对该分析方法进行了验证,并将其成功应用于某些剂型中二甲双胍药物的测定。我们从沙特阿拉伯当地的药店收集了盐酸二甲双胍的不同药物制剂,并使用经过验证的微芯片分析方法进行了分析。研究结果表明,该方法线性、特异、精密、准确。线性范围为 1 × 10-1-1 × 10-5 mol L-1,相关系数为 0.999。检出限为 2.89 × 10-6 mol L-1,定量限为 8.77 × 10-6 mol L-1。该方法的精密度高,RSD%小于 2.22%。该方法的准确度是通过比较回收率与小于 5%的百分比值得出的。结果表明,参照物、标签和小于 5%的回收率之间没有显著差异。
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引用次数: 0
Method Development for Simultaneously Determining Indomethacin and Nicotinamide in New Combination in Oral Dosage Formulations and Co-Amorphous Systems Using Three UV Spectrophotometric Techniques 利用三种紫外分光光度法同时测定口服制剂和共晶体系中新组合吲哚美辛和烟酰胺的方法开发
IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL Pub Date : 2024-02-20 DOI: 10.1155/2024/2035824
Nazira Sarkis, Abdulkader Sawan
This research aims to develop methods for simultaneously determining indomethacin (IND) and nicotinamide (NCT) in binary mixtures, immediate-release capsules, sustained-release capsules, and co-amorphous systems, which were designed in 2021 to improve the solubility, dissolution rate, and stability of the amorphous state of indomethacin. Moreover, this new combination may have also other possible medical benefits. Therefore, there is a need to have simple, sensitive, and precise developed methods for simultaneous quantification analysis of IND/NCT in several different ratios. Three UV-spectrophotometry techniques were deployed: zero-crossing point in the second-order derivative, dual-wavelength in the first-order derivative, and ratio subtraction coupled with spectrum subtraction. The limit of detection and the limit of quantifications (LOD and LOQ) for IND were 0.41 and 1.25, 0.55 and 1.66, and 0.53 and 1.62 μg/mL, respectively, while for NCT were 0.53 and 1.59, 0.38 and 1.14, and 0.36 and 1.08 μg/mL, respectively. All methods were linear at least in the range of 2.5–40.0 μg/mL. All proposed methods were validated according to ICH guidelines and their application on the dosage formulations was carried out. Finally, the proposed methods were compared to a reference method for each IND and NCT, and no significant statistical variance was found.
这项研究旨在开发同时测定二元混合物、速释胶囊、缓释胶囊和共无定形系统中吲哚美辛(IND)和烟酰胺(NCT)含量的方法。此外,这种新的组合还可能具有其他医疗益处。因此,需要开发出简单、灵敏、精确的方法,用于同时定量分析几种不同比例的吲哚美辛/NCT。我们采用了三种紫外分光光度法:二阶导数中的零交叉点法、一阶导数中的双波长法以及比率减法与光谱减法相结合的方法。IND 的检出限和定量限(LOD 和 LOQ)分别为 0.41 和 1.25、0.55 和 1.66 以及 0.53 和 1.62 μg/mL,而 NCT 的检出限和定量限(LOD 和 LOQ)分别为 0.53 和 1.59、0.38 和 1.14 以及 0.36 和 1.08 μg/mL。所有方法至少在 2.5-40.0 μg/mL 范围内线性良好。所有建议的方法都根据 ICH 指南进行了验证,并在制剂中进行了应用。最后,将所提出的方法与每种 IND 和 NCT 的参照方法进行了比较,未发现明显的统计差异。
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引用次数: 0
Analysis of Quality Differences in Radix Dipsaci before and after Processing with Salt Based on Quantitative Control of HPLC Multi-Indicator Components Combined with Chemometrics. 基于 HPLC 多指标成分定量控制结合化学计量学的地肤子加盐加工前后的质量差异分析。
IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL Pub Date : 2024-02-07 eCollection Date: 2024-01-01 DOI: 10.1155/2024/2109127
Hangsha Wu, Yue Lv, Rui Tang, Mingfang Zhao, Yafei Li, Feiyang Wei, Changyu Li, Weihong Ge, Weifeng Du

Radix Dipsaci (RD) is the dry root of the Dipsacus asper Wall. ex DC., which is commonly used for tonifying the kidney and strengthening bone. The purpose of this study was to analyze the difference between raw and salt-processed RD from the chemical composition comprehensively. The fingerprints of raw and salt-processed RD were established by HPLC-DAD to determine the contents of loganin (LN), asperosaponin VI (AVI), caffeic acid (CaA), dipsanoside A (DA), dipsanoside B (DB), chlorogenic acid (CA), loganic acid (LA), isochlorogenic acid A (IA), isochlorogenic acid B (IB), and isochlorogenic acid C (IC). The results showed that after processing with salt, the components with increased contents were LA, CaA, DA, and AVI, and the components with decreased contents were CA, LN, IB, IA, IC, and DB. Then, the chemometric methods such as principal component analysis (PCA) and fisher discriminant analysis (FDA) were used to evaluate the quality of raw and salt-processed RD. In the classification of raw and salt-processed RD, the order of importance of each chemical component was LA > DB > IA > IC > IB > LN > CA > DA > AVI > CaA. These integrated methods successfully assessed the quality of raw and salt-processed RD, which will provide guidance for the development of RD as a clinical medication.

地骨皮(Radix Dipsaci,RD)是地骨皮的干燥根,常用于补肾壮骨。本研究的目的是从化学成分全面分析生地黄和盐渍地黄的区别。采用高效液相色谱-反相色谱法(HPLC-DAD)测定了生猕猴桃苷(LN)、天冬皂苷Ⅵ(AVI)、咖啡酸(CaA)、地黄苷A(DA)、地黄苷B(DB)、绿原酸(CA)、猕猴桃酸(LA)、异绿原酸A(IA)、异绿原酸B(IB)和异绿原酸C(IC)的含量,建立了生猕猴桃苷和盐加工猕猴桃苷的指纹图谱。结果表明,用盐加工后,含量增加的成分有 LA、CaA、DA 和 AVI,含量减少的成分有 CA、LN、IB、IA、IC 和 DB。然后,采用主成分分析法(PCA)和渔夫判别分析法(FDA)等化学计量学方法来评价生鲜和盐渍加工 RD 的质量。在生鲜和盐加工 RD 的分类中,各化学成分的重要程度依次为 LA > DB > IA > IC > IB > LN > CA > DA > AVI > CaA。这些综合方法成功地评估了未加工和盐加工 RD 的质量,将为 RD 作为临床药物的开发提供指导。
{"title":"Analysis of Quality Differences in Radix Dipsaci before and after Processing with Salt Based on Quantitative Control of HPLC Multi-Indicator Components Combined with Chemometrics.","authors":"Hangsha Wu, Yue Lv, Rui Tang, Mingfang Zhao, Yafei Li, Feiyang Wei, Changyu Li, Weihong Ge, Weifeng Du","doi":"10.1155/2024/2109127","DOIUrl":"10.1155/2024/2109127","url":null,"abstract":"<p><p>Radix Dipsaci (RD) is the dry root of the <i>Dipsacus asper</i> Wall. ex DC., which is commonly used for tonifying the kidney and strengthening bone. The purpose of this study was to analyze the difference between raw and salt-processed RD from the chemical composition comprehensively. The fingerprints of raw and salt-processed RD were established by HPLC-DAD to determine the contents of loganin (LN), asperosaponin VI (AVI), caffeic acid (CaA), dipsanoside A (DA), dipsanoside B (DB), chlorogenic acid (CA), loganic acid (LA), isochlorogenic acid A (IA), isochlorogenic acid B (IB), and isochlorogenic acid C (IC). The results showed that after processing with salt, the components with increased contents were LA, CaA, DA, and AVI, and the components with decreased contents were CA, LN, IB, IA, IC, and DB. Then, the chemometric methods such as principal component analysis (PCA) and fisher discriminant analysis (FDA) were used to evaluate the quality of raw and salt-processed RD. In the classification of raw and salt-processed RD, the order of importance of each chemical component was LA > DB > IA > IC > IB > LN > CA > DA > AVI > CaA. These integrated methods successfully assessed the quality of raw and salt-processed RD, which will provide guidance for the development of RD as a clinical medication.</p>","PeriodicalId":13888,"journal":{"name":"International Journal of Analytical Chemistry","volume":"2024 ","pages":"2109127"},"PeriodicalIF":1.8,"publicationDate":"2024-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10866631/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139735136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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International Journal of Analytical Chemistry
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