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更新于：2025-05-12
Mycophenolate Sodium
麦考酚钠
更新于：2025-05-12
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 瑞士 (2002-10-24), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C17H20NaO6 |
InChIKeyXXFIICJIHVLJFB-JOKMOOFLSA-N |
CAS号37415-62-6 |
关联
168
项与 麦考酚钠 相关的临床试验ChiCTR2500099977
Enteric-Coated Mycophenolate Sodium (EC-MPS) Monotherapy for Renal Dysfunction after Liver Transplantation: a Prospective Trial
CTR20250663
麦考酚钠肠溶片在健康受试者中的单剂量、随机、开放、两制剂、重复交叉、四周期、空腹和餐后人体生物等效性试验
CTR20250065
麦考酚钠肠溶片空腹及餐后人体生物等效性研究
100 项与 麦考酚钠 相关的临床结果
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100 项与 麦考酚钠 相关的转化医学
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100 项与 麦考酚钠 相关的专利（医药）
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5,396
项与 麦考酚钠 相关的文献（医药）2025-07-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Analytical validation and pilot clinical application of a UPLC-MS/MS method for determining intracellular mycophenolic acid and metabolites in kidney transplant recipients
Article
作者: Xu, Huan ; Wang, Xueqaio ; Liu, Hanjing ; Bai, Yangjuan ; Chen, Chunxia ; Shi, Yunying ; Chen, Xiaomei ; Li, Yi ; Dai, Xinhua ; Zou, Yuangao
There is no consensus on the strategy for therapeutic drug monitoring of the immunosuppressive drug mycophenolic acid (MPA) in organ transplant recipients. The present study proposes the utilization of ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) for determining the concentrations of MPA and its metabolites: 7-O-mycophenolic acid glucuronide (MPAG) and acyl mycophenolic acid glucoside (AcMPAG) in peripheral blood mononuclear cells (PBMCs). We aimed to assess the potential application of monitoring MPA and its metabolite concentrations in PBMCs in the infection after transplantation in Chinese kidney transplant recipients (KTRs). The UPLC-MS/MS method we developed demonstrated good linearity in the quantitative ranges of 0.05-50.00 ng/mL for MPA, 0.50-50.00 ng/mL for MPAG, and 0.10-20.00 ng/mL for AcMPAG. AcMPAG in PBMCs was unstable, degrading significantly after 48 h of storage at -80°C or after 3 freeze-thaw cycles. MPA and MPAG concentrations in KTRs' PBMCs exhibited high inter-individual variability, and the MPA concentration in PBMCs was poorly correlated with that in plasma (rs = 0.206, p = 0.117). Compared with the stable group, the infected group had significantly higher MPA concentration in PBMCs at 2 and 4 h post-dosing and in plasma at 4 h post-dosing (p < 0.05). The receiver operating characteristic (ROC) analysis for post-transplantation infection revealed that PBMCs MPA-C4 and PBMCs-MPA-C2 possessed much better diagnostic efficiency than Plasma-MPA-C4. This method is easy-to-use and reliable, making it a promising clinical quantitative tool for MPA, MPAG, and AcMPAG in PBMCs. PBMC-MPA monitoring may be a potential biomarker for infection monitoring for KTRs.
2025-06-01FOOD CONTROL
Simultaneous broad-spectrum detection of over 50 mycotoxins in maize silage via liquid chromatography-tandem mass spectrometry: Method development and application
作者: Sun, Yucui ; Huang, Jin ; Yang, Hailin ; Feng, Shoushuai ; Luan, Yujing ; Zhou, Xueting ; Zhang, Dawei ; Sun, Bo
For a comprehensive assessment of mycotoxin contamination in maize silage, a novel method using high-performance liquid chromatog.-tandem mass spectrometry (LC-MS/MS) that can simultaneously detect 53 mycotoxins in maize silage was developed.The method streamlines the extraction and purification processes with a simplified dilute-and-shoot sample pretreatment step.After extraction with acetonitrile/water/formic acid (70:30:0.1, volume/volume/v) followed by the LC-MS/MS detection.Furthermore, isotope internal standards were employed to eliminate matrix effects.The method was validated by linearity, matrix effects, selectivity, recovery, repeatability, limits of detection (LOD), limits of quantification (LOQ) and measurement uncertainties.The LODs ranged from 0.3 to 162.2 μg/kg and the LOQs from 0.9 to 535.4 μg/kg.The method developed enables the effective quant. anal. of 51 out of 53 mycotoxins, with mean recoveries for 51 qual. determinable analytes applicable to this method ranging from 33.20% to 119.50% and relative standard deviations of less than 13.33%; all 53 mycotoxins could be qual. analyzed, and the method was successfully applied for analyzing 63 maize silage samples from China.Most of the mycotoxins detected were attributed to the Fusarium species. highlighting the prevalence of this genus in maize silage contamination.The developed LC-MS/MS method provides an excellent anal. performance for detecting multiple mycotoxins, marking it as the first report of such broad-spectrum detection in silage, and offers an effective tool for the accurate assessment of the true mycotoxin content in maize silage and the precise evaluation of feed quality.
2025-05-01FOOD CONTROL
Use of Penicillium roqueforti in plant-based veined-blue cheese: A source of mycotoxin hazards?
作者: Richard-Forget, Florence ; Gallegos, Nathalie ; Khireddine, Rayan ; Gauthier, Oriane ; Bernillon, Stephane ; Chassard, Christophe ; Callon, Cecile ; Saupique, Capucine
While the consumer demand for plant-based cheese is increasingly growing, there is insufficient knowledge to allow anticipating potential hazards related to mycotoxins in these new products and notably in plant-based blue veined cheese inoculated with Penicillium roqueforti.Actually plant-based matrixes, characterized by a higher C/N ratio than dairy milk, are likely to promote the yield of mycotoxins by P. roqueforti.This study aims to provide first scientific insights to fulfill this gap of knowledge.As a first step, the capacity of 15 P. roqueforti strains belonging to the Roquefort and Non-Roquefort populations to yield mycotoxins was assessed.The medium used allowed to evidence a significant higher production of roquefortine C and a lower yield of andrastin A by strains of the Non-Roquefort group compared to those of the Roquefort one.In a second step a microbiol. challenge testing approach was implemented using five matrixes of plant (almond, cashew and soy) and animal (cow and sheep) origin.Results suggested that animal matrixes were more prone to contamination with andrastin A while cashew and soy matrixes promoted the yield of roquefortine C and mycophenolic acid, and in a less extent of fumigaclavin A.Besides, while warning on the mycotoxin risk associated with some plant matrixes, our results also evidenced that the risk was strongly dependent on choice of the combination P. roqueforti strain/matrix.
100 项与 麦考酚钠 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 肾移植急性排斥反应 | 奥地利 | 2004-02-07 | |
| 肾移植急性排斥反应 | 比利时 | 2004-02-07 | |
| 肾移植急性排斥反应 | 塞浦路斯 | 2004-02-07 | |
| 肾移植急性排斥反应 | 捷克 | 2004-02-07 | |
| 肾移植急性排斥反应 | 丹麦 | 2004-02-07 | |
| 肾移植急性排斥反应 | 芬兰 | 2004-02-07 | |
| 肾移植急性排斥反应 | 法国 | 2004-02-07 | |
| 肾移植急性排斥反应 | 德国 | 2004-02-07 | |
| 肾移植急性排斥反应 | 希腊 | 2004-02-07 | |
| 肾移植急性排斥反应 | 匈牙利 | 2004-02-07 | |
| 肾移植急性排斥反应 | 冰岛 | 2004-02-07 | |
| 肾移植急性排斥反应 | 爱尔兰 | 2004-02-07 | |
| 肾移植急性排斥反应 | 意大利 | 2004-02-07 | |
| 肾移植急性排斥反应 | 卢森堡 | 2004-02-07 | |
| 肾移植急性排斥反应 | 马耳他 | 2004-02-07 | |
| 肾移植急性排斥反应 | 荷兰 | 2004-02-07 | |
| 肾移植急性排斥反应 | 挪威 | 2004-02-07 | |
| 肾移植急性排斥反应 | 波兰 | 2004-02-07 | |
| 肾移植急性排斥反应 | 葡萄牙 | 2004-02-07 | |
| 肾移植急性排斥反应 | 斯洛伐克 | 2004-02-07 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 中间葡萄膜炎 | 临床3期 | 德国 | 2010-03-01 | |
| 微小病变性肾病 | 临床3期 | 法国 | 2009-10-01 | |
| 肾病综合征 | 临床3期 | 法国 | 2009-10-01 | |
| 系统性红斑狼疮 | 临床3期 | 荷兰 | 2007-07-01 | |
| 消化系统体征和症状 | 临床3期 | 加拿大 | 2007-05-01 | |
| 慢性移植物抗宿主病 | 临床3期 | 法国 | 2006-09-01 | |
| 慢性移植物抗宿主病 | 临床3期 | 德国 | 2006-09-01 | |
| 慢性移植物抗宿主病 | 临床3期 | 意大利 | 2006-09-01 | |
| 慢性移植物抗宿主病 | 临床3期 | 荷兰 | 2006-09-01 | |
| 慢性移植物抗宿主病 | 临床3期 | 西班牙 | 2006-09-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 349 | (Mycophenolic Acid 0.1%) | 簾衊願醖積壓築鑰齋積 = 齋築顧衊壓襯窪餘遞鏇 糧範構製憲鬱壓蓋艱獵 (衊齋蓋淵願憲繭選範窪, 遞鏇蓋觸鑰夢選膚網夢 ~ 窪簾鹽齋糧顧淵遞糧淵) 更多 | - | 2025-03-18 | ||
(Mycophenolic Acid 0.3%) | 簾衊願醖積壓築鑰齋積 = 願選齋遞製蓋壓簾膚鏇 糧範構製憲鬱壓蓋艱獵 (衊齋蓋淵願憲繭選範窪, 網鏇構廠製鹹鬱築遞窪 ~ 醖蓋範簾壓願獵鑰憲蓋) 更多 | ||||||
N/A | - | 窪鹹醖餘壓艱憲壓膚齋(齋襯鬱選憲餘淵範憲製) = 廠鹽鹹鬱構觸鑰齋築蓋 顧顧淵齋膚積簾窪鹹淵 (獵糧憲遞鏇蓋壓築積簾 ) | - | 2024-06-05 | |||
N/A | - | 110 | 鹽鏇鹽餘願鬱艱鏇範廠(艱顧壓膚鏇醖鏇鏇選構) = 56% 構淵鹹鬱選觸積範範鑰 (壓壓簾鏇繭製簾壓繭餘 ) 更多 | 积极 | 2024-05-19 | ||
N/A | 251 | MMF cessation | 齋鑰繭淵窪壓壓願選鏇(遞鏇餘繭淵窪蓋積艱網) = 鑰糧廠獵鑰鏇窪齋醖醖 鬱鑰廠製鹹網夢夢壓網 (窪衊醖醖夢積遞遞簾鏇 ) 更多 | 不佳 | 2023-03-01 | ||
MMF reduction/no manipulation | 齋鑰繭淵窪壓壓願選鏇(遞鏇餘繭淵窪蓋積艱網) = 構壓餘觸壓顧衊鏇鬱餘 鬱鑰廠製鹹網夢夢壓網 (窪衊醖醖夢積遞遞簾鏇 ) 更多 | ||||||
N/A | - | 75 | 獵觸繭鑰窪觸觸遞範選(壓鬱範壓製膚淵餘範鬱): HR = 0.39 (95% CI, 0.16 ~ 0.94), P-Value = 0.037 | 积极 | 2023-02-01 | ||
N/A | - | - | 觸衊夢窪鹹鬱簾鑰蓋壓(膚積獵鹹鏇鹽襯餘鏇壓) = 範艱觸鹹構夢憲願遞餘 範淵構衊簾鹽構鬱夢壓 (鏇齋築夢獵築築襯獵觸 ) | 积极 | 2022-11-04 | ||
觸衊夢窪鹹鬱簾鑰蓋壓(膚積獵鹹鏇鹽襯餘鏇壓) = 壓衊壓鑰構積醖構襯網 範淵構衊簾鹽構鬱夢壓 (鏇齋築夢獵築築襯獵觸 ) | |||||||
N/A | 20 | Mycophenolate + Placebo | 壓衊鑰鏇醖願觸窪壓蓋(積網網築鹽獵遞壓選鬱) = 鹽構夢膚夢糧糧夢糧糧 鏇憲糧蓋願壓鏇願鑰範 (積網膚築艱淵艱壓範醖 ) 更多 | 积极 | 2022-11-03 | ||
壓衊鑰鏇醖願觸窪壓蓋(積網網築鹽獵遞壓選鬱) = 艱鹽選蓋醖鏇膚衊膚餘 鏇憲糧蓋願壓鏇願鑰範 (積網膚築艱淵艱壓範醖 ) 更多 | |||||||
N/A | - | Mycophenolate (MMF) | 築餘選網製鏇選淵衊願(獵壓獵鹹齋淵壓艱鏇鏇) = 5% of patients taking MMF experienced constitutional symptoms, which were also a common reason for medication discontinuation (14% of those who stopped MMF) 遞艱顧憲製艱憲鹹遞鹽 (淵鬱淵齋醖齋鏇鑰範鹽 ) 更多 | - | 2021-05-03 | ||
Azathioprine (AZA) | |||||||
N/A | - | 17 | 衊範築艱網餘築糧衊膚(蓋範窪齋膚範鹽繭窪簾) = 鹽鹹齋鬱觸鏇遞憲膚觸 構衊築憲夢襯積願夢糧 (築築淵獵鑰網衊壓衊鏇 ) 更多 | - | 2020-08-29 | ||
临床4期 | - | 11 | 蓋遞繭廠衊鏇齋積構艱(淵壓衊淵獵範鹽壓艱壓) = 遞構膚構築網網願鬱簾 夢衊簾鑰遞餘觸艱鑰糧 (構鏇膚壓鹽製網製網鏇, 15.49) 更多 | - | 2020-07-08 |
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