Development and validation of LC-MS/MS method for quantitation of sodium oligomannate in human plasma, urine and feces
文献类型：期刊论文
| 作者 | Zhang, Zhenqing6,7; Yang, Xing5; Zhang, Lu5; Zhu, Haizhong5; Huang, Biao5; Chen, Qian3,4; Wang, Yijun3,4; Yu, Chen3,4; Bi, Luke5; Geng, Meiyu2
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| 刊名 | BIOANALYSIS
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| 出版日期 | 2023-04-01 |
| 卷号 | 15期号:7页码:371-390 |
| 关键词 | Alzheimer's disease excretion LC-MS/MS pharmacokinetics phase I clinical trial sodium oligomannate |
| DOI | 10.4155/bio-2023-0026 |
| 文献子类 | Article |
| 英文摘要 | Background: Sodium oligomannate was approved for marketing by the National Medical Products Administration of China in 2019 for improving cognitive functions in mild-to-moderate Alzheimer's disease patients. Method: LC-MS/MS methods were established and validated for the quantitation of sodium oligomannate in human plasma, urine and feces to support clinical development studies. Samples were prepared using liquid-liquid extraction and analyzed by ion-pair reversed-phase LC-MS/MS with calibration standard curve ranges of 25.0-5000 ng/ml, 0.500-100 mu g/ml and 100-10,000 mu g/g in plasma, urine and feces, respectively. Results & conclusion: All validation parameters met the respective acceptance criteria established by US FDA and International Council for Harmonisation of Technical Requirements for Human Use guidelines. The validated methods were applied to a pharmacokinetics and excretion study in healthy Chinese subjects. |
| WOS关键词 | OLIGOSACCHARIDE SUGAR CHAIN ; ACIDIC OLIGOSACCHARIDE ; TIGHT JUNCTIONS |
| WOS研究方向 | Biochemistry & Molecular Biology ; Chemistry |
| 语种 | 英语 |
| 出版者 | Newlands Press Ltd |
| WOS记录号 | WOS:000971977200001 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/309641]  |
| 专题 | 新药研究国家重点实验室 |
| 通讯作者 | Zhang, Zhenqing; Li, Liang |
| 作者单位 | 1.Green Valley Shanghai Pharmaceut Co Ltd, Carbohydrate based Drug Res Ctr, Shanghai 201203, Peoples R China 2.Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, Shanghai 201203, Peoples R China; 3.Shanghai Engn Res Ctr Phase I Clin Res & Qual Cons, Shanghai 200031, Peoples R China; 4.Fudan Univ, Shanghai Xuhui Cent Hosp, Zhongshan Xuhui Hosp, Drug Clin Trial Ctr, Shanghai 200031, Peoples R China; 5.Labcorp Pharmaceut R&D, Chem Solut, Shanghai 201203, Peoples R China; 6.Soochow Univ, Coll Pharmaceut Sci, Suzhou 215021, Jiangsu, Peoples R China; 7.Soochow Univ, Jiangsu Key Lab Translat Res & Therapy Neuropsycho, Suzhou 215021, Jiangsu, Peoples R China; |
| 推荐引用方式 GB/T 7714 | Zhang, Zhenqing,Yang, Xing,Zhang, Lu,et al. Development and validation of LC-MS/MS method for quantitation of sodium oligomannate in human plasma, urine and feces[J]. BIOANALYSIS,2023,15(7):371-390. |
| APA | Zhang, Zhenqing.,Yang, Xing.,Zhang, Lu.,Zhu, Haizhong.,Huang, Biao.,...&Li, Liang.(2023).Development and validation of LC-MS/MS method for quantitation of sodium oligomannate in human plasma, urine and feces.BIOANALYSIS,15(7),371-390. |
| MLA | Zhang, Zhenqing,et al."Development and validation of LC-MS/MS method for quantitation of sodium oligomannate in human plasma, urine and feces".BIOANALYSIS 15.7(2023):371-390. |
入库方式： OAI收割
来源：上海药物研究所
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