更新于：2024-11-29
Ademetionine 1,4-Butanedisulfonate
丁二磺酸腺苷蛋氨酸
更新于：2024-11-29
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 意大利 (1975-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C15H22N6O5S |
InChIKeyMEFKEPWMEQBLKI-AIRLBKTGSA-N |
CAS号29908-03-0 |
关联
68
项与 丁二磺酸腺苷蛋氨酸 相关的临床试验A Prospective, Open-Label, Single-Arm, Pilot Study To Evaluate The Effectiveness Of Oral Ademetionine In Patients With Alcoholic Liver Disease (ALD) In Indian Scenario (ADEM-D22-0319) - NIL
Current Awareness, Perspective and Knowledge on Social Egg Freezing
丁二磺酸腺苷蛋氨酸肠溶片空腹和餐后状态下人体生物等效性研究
100 项与 丁二磺酸腺苷蛋氨酸 相关的临床结果
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100 项与 丁二磺酸腺苷蛋氨酸 相关的专利（医药）
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3,856
项与 丁二磺酸腺苷蛋氨酸 相关的文献（医药）2025-01-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Evaluation of protein impurities in Ademetionine 1,4-Butanedisulfonate
Article
作者: Jiang, Xintong ; Ye, Qin ; Guo, Chen ; Zhang, Yangrui ; Yu, Lushan ; Ou, Fengting
Ademetionine 1,4-Butanedisulfonate (SAMe) is widely used as a prescription drug to treat cholestasis associated with liver disease, and is also used to treat depression, Alzheimer's disease and other diseases. Currently, the main way to produce SAMe is by fermentation of S-adenosylmethionine synthetase（SAMS）. However, during the fermentation process, host cells produce contaminants unrelated to the treatment. Among them, host cell protein (HCP), which is co-purified with the drug, is the main impurity in the production process. HCP-induced antigenic reactions can lead to allergies or other adverse reactions and affect drug quality, efficacy, and safety. Enzyme-linked immunosorbent assay (ELISA) and mass spectrometry (MS) are currently used as the main analytical methods for measuring HCP. The ELISA method may ignore some HCPs with low immunogenicity, while mass spectrometry is primarily employed for the characterization of proteomes. Orthogonal methods can more effectively evaluate impurities in drugs. In this study, ELISA was initially utilized to quantify the content of Saccharomyces cerevisiae host protein in 11 batches of SAMe active pharmaceutical ingredient (API) from two suppliers, then the above APIs were qualitatively analyzed by MS method. Following the identification of surrogate peptide of SAMS, an Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry（UPLC-MS/MS）method was established and validated, the SAMS protein residues in 11 batches of samples were subsequently determined. The results demonstrated that the levels of Saccharomyces cerevisiae host protein and SAMS in the samples were both low, with values below 20 ppm and 1.19 ppm, respectively. The qualitative results also indicate that the types of peptide residues in the samples are more diverse than those of protein residues. Furthermore, residues of proteins and peptides can be detected in all samples, which underscores the importance of evaluating the HCP in API. This study employs a range of complementary detection methods to conduct a comprehensive and sensitive evaluation of total HCP and specific proteins in drugs, thereby guiding more informed assessments of the risks posed by HCP impurities in raw materials during pharmaceutical processes.
2024-12-01THERIOGENOLOGY
MAT2A is essential for zygotic genome activation by maintaining of histone methylation in porcine embryos
Article
作者: Song, Hyeon-Ji ; Lu, Qin-Yue ; Lee, Song-Hee ; Lee, Gyu-Hyun ; Li, Xiao-Han ; Kim, Ji-Dam ; Cui, Xiang-Shun ; Zhan, Cheng-Lin ; Sim, Jae-Min
Methionine adenosyltransferase 2A (MAT2A) is an essential enzyme in the methionine cycle that generates S-adenosylmethionine (SAM) by reacting with methionine and ATP. SAM acts as a methyl donors for histone and DNA methylation, which plays key roles in zygotic genome activation (ZGA). However, the effects of MAT2A on porcine ZGA remain unclear. To investigate the function of MAT2A and its underlying mechanism in porcine ZGA, MAT2A was knocked down by double-stranded RNA injection at the 1-cell stage. MAT2A is highly expressed at every stage of porcine embryo development. The percentages of four-cell-stage embryos and blastocysts were lower in the MAT2A-knockdown (KD) group than in the control group. Notably, depletion of MAT2A decreased the levels of H3K4me2, H3K9me2/3, and H3K27me3 at the four-cell stage, whereas MAT2A KD reduced the transcriptional activity of ZGA genes. MAT2A KD decreased embryonic ectoderm development (EED) and enhancer of zeste homolog 2 (EZH2) expression. Exogenous SAM supplementation rescued histone methylation levels and developmental arrest induced by MAT2A KD. Additionally, MAT2A KD significantly increased DNA damage and apoptosis. In conclusion, MAT2A is involved in regulating transcriptional activity and is essential for regulating histone methylation during porcine ZGA.
2024-11-12Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases
[Guidelines for diagnosis and management of drug-induced liver injury caused by anti-tuberculosis drugs (2024 version)].
Review
Drug-induced liver injury (DILI) is one of the most common adverse reactions of anti-tuberculosis treatment. To improve the diagnosis and management of anti-tuberculosis drug-induced liver injury (ATB-DILI) for clinicians and tuberculosis control workers, the Chinese Medical Association Tuberculosis Branch has developed guidelines for the diagnosis and treatment of ATB-DILI. These guidelines summarized recent research progress in relevant fields and provide detailed explanations, recommendations, and quality assessments related to ATB-DILI, covering aspects such as definition, risk factors, mechanisms, pathological manifestations, clinical classification, diagnosis, and management. The key recommendations are as follows.Recommendation 1: Risk factors: NAT2 slow acetylation genotype, GSTM1 gene variation, advanced age, hepatitis virus infection or concurrent acute/chronic liver disease, HIV infection, malnutrition, and alcohol (ethanol) intake are risk factors for ATB-DILI (2, B).Recommendation 2: R-value calculation: Calculate the R-value for suspected ATB-DILI patients at different time points during the course of the disease. ALT and ALP values should be obtained on the same day, with a maximum interval of no more than 48 hours. This helps to accurately determine the clinical type and prognosis of DILI (2, C).Recommendation 3: Comprehensive medical history collection: Collect information on past medication history, clinical features, dynamic changes in liver biochemical markers, drug rechallenge reactions, comorbidities, and underlying liver diseases (4, B).Recommendation 4: Liver biochemical tests: Include at least ALT, AST, ALP, GGT, TBil, DBil, and albumin. If necessary, measure prothrombin time or international normalized ratio (INR) (3, B).Recommendation 5: Abdominal imaging: Routine abdominal imaging should be performed for suspected ATB-DILI patients (3, B).Recommendation 6: Liver histopathological examination: Histology of liver biopsies aids in the diagnosis and differential diagnosis of DILI (4, B).Recommendation 7: Biochemical diagnostic criteria for acute ATB-DILI: Liver biochemical tests should meet one of the following criteria: ALT≥3×ULN and/or TBil≥2×ULN; simultaneous elevation of AST, ALP, and TBil, with at least one parameter≥2×ULN (4, C).Recommendation 8: Diagnostic criteria for ATB-DILI: Diagnosis requires:(1) A history of exposure to anti-tuberculosis drugs that can cause liver injury;(2)Rapid normalization of abnormal liver biochemical markers after drug discontinuation: For patients with hepatocellular injury, a decrease in the peak serum ALT level of at least 50% within 8 days is highly suggestive, while a decrease of at least 50% within 30 days is considered important. For patients with cholestatic injury, a serum ALP or TBil peak level that decreases by at least 50% within 180 days is also considered important;(3) Exclusion of other causes of liver injury;(4) Positive rechallenge reaction. Meeting three of the above criteria confirms ATB-DILI, whereas meeting (1) and (2) criteria indicates a suspected case. In practice, the vast majority of ATB-DILI are suspected cases (3, B).Recommendation 9: Avoid re-exposure: Minimize re-exposure to the same suspected drug, especially if the initial exposure caused severe liver injury (4, B).Recommendation 10: Causality assessment: Use the RUCAM scale as the primary method for assessing causality. In cases involving multiple hepatotoxic drugs, concurrent liver disease, or new drug clinical trials, combine expert opinions for reliable assessment (3, B).Recommendation 11: Baseline testing: All patients are recommended to undergo baseline liver biochemistry, HBsAg (if HBsAg is positive, further HBV DNA testing), anti-HCV testing, and abdominal imaging before starting anti-TB treatment (3, B).Recommendation 12: Monitoring frequency: Patients without high-risk factors should have monthly liver biochemical monitoring (4, C);high-risk patients or those using hepatotoxic drugs should be monitored every 2 weeks during the first 2 months of anti-tuberculosis treatment, then monthly (2, B).Recommendation 13: Avoid concurrent hepatotoxic drugs: Evaluate the benefit-risk ratio of using other hepatotoxic drugs or traditional Chinese medicine (4, C).Recommendation 14: Antiviral treatment: In ATB-DILI patients with viral hepatitis, consider prompt antiviral therapy if indicated (3, B).Recommendation 15: NAT2 genotyping: Guide isoniazid dosing based on NAT2 gene polymorphism (4, C).Recommendation 16: Application of preventive hepatoprotective drugs: People with high risk factors for liver damage may consider it (4, C); however, routine use in the general population is not recommended (2, B).Recommendation 17: Immediate discontinuation: In the case of ATB-DILI, suspected drugs should be discontinued immediately (4, A).Recommendation 18: N-acetylcysteine (NAC): Early intravenous administration of NAC is beneficial for acute liver failure and subacute liver failure induced by drugs in adults (4, D).Recommendation 19: Glucocorticoids: Use with caution;not recommended as routine treatment for ATB-DILI(4, C);may be considered for immune-mediated DILI with hypersensitivity and autoimmune features (3, B).Recommendation 20: For acute hepatocellular injury or mixed DILI with significantly elevated ALT/AST, bicyclol and/or magnesium isoglycyrrhizinate are recommended (2, B).Recommendation 21: For mild to moderate hepatocellular injury type DILI with elevated ALT/AST, reasonable choices include ammonium glycyrrhizinate, compound glycyrrhizin, and other glycyrrhizic acid derivatives, glutathione, silymarin, polyenylphosphatidylcholine, and other drugs (4, C); For cholestatic DILI with elevated ALP/GGT/TBil, ursodeoxycholic acid or S-adenosylmethionine may be selected (4, C); the combined use of two or more drugs that mainly reduce ALT is not recommended (4, B).Recommendation 22: Treatment of severe patients: For severe patients such as those with drug-induced liver failure, liver transplantation is recommended (2, B); artificial liver (high-volume plasma exchange, dual plasma molecular adsorption system, etc.) may be a beneficial option (4, C); ornithine aspartate may help reduce blood ammonia levels in patients with severe disease or liver failure (4, C).Recommendation 23: Rational drug use during the recovery period: During or after liver function recovery, clinicians should comprehensively assess the patient's liver injury severity, presence of liver injury-related risk factors, and tuberculosis severity. Based on this assessment, anti-tuberculosis drugs should be selected rationally (4, C). These recommendations provide clinical evidence and decision-making guidance for the standardized diagnosis and treatment of ATB-DILI.
100 项与 丁二磺酸腺苷蛋氨酸 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 胆汁性肝硬化 | 中国 | 2000-11-02 | |
| 胆汁淤积 | 意大利 | 1975-01-01 |
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 |
|---|---|---|---|---|
| 肝内胆汁淤积 | 临床3期 | 俄罗斯 | 2014-06-01 | |
| 非酒精性脂肪性肝炎 | 临床3期 | 法国 | 2012-12-01 | |
| 非酒精性脂肪性肝炎 | 临床3期 | 德国 | 2012-12-01 | |
| 非酒精性脂肪性肝炎 | 临床3期 | 波兰 | 2012-12-01 | |
| 非酒精性脂肪性肝炎 | 临床3期 | 俄罗斯 | 2012-12-01 | |
| 酒精性肝疾病 | 临床3期 | 美国 | 2005-09-01 |
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临床结果
临床结果
适应症
分期
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N/A | - | 50 | (same™ device) | 淵繭艱憲餘願觸鏇鏇築(選襯窪願鹹網艱鑰築齋) = 窪顧顧鏇選構觸積壓遞 鏇艱齋願鹹憲鑰鬱餘繭 (範繭遞窪鹽鬱積醖網醖 ) 更多 | - | 2023-06-09 | |
临床1期 | - | 34 | 繭餘觸鏇壓衊積齋醖簾(餘憲製鹽壓範鹽選餘糧) = 鹽遞鬱襯壓餘鬱鹽鹹製 構蓋壓觸製選鏇範顧網 (繭構簾繭構顧製鹽醖積 ) | - | 2020-12-14 | ||
N/A | - | S-adenosylmethionine (SAM) 0 mmol/l | 製襯淵製鹽餘築廠製膚(齋憲淵鹹獵壓襯艱選鹹) = 壓鑰製壓醖選願鹹鹽艱 製構鹽範繭壓鏇蓋築構 (醖衊襯範憲獵鑰獵膚築 ) | - | 2019-10-01 | ||
S-adenosylmethionine (SAM) 0.5 mmol/l | 製襯淵製鹽餘築廠製膚(齋憲淵鹹獵壓襯艱選鹹) = 淵觸顧獵艱製鹽壓餘蓋 製構鹽範繭壓鏇蓋築構 (醖衊襯範憲獵鑰獵膚築 ) | ||||||
临床2期 | 110 | immunoenzyme technique+S-adenosyl-L-methionine disulfate p-toluene-sulfonate (Arm I (SAMe)) | 鬱製願遞蓋遞醖齋鬱夢(顧簾顧膚廠窪觸簾淵膚) = 選壓醖餘積鑰鬱範構簾 壓繭膚窪壓鏇窪蓋艱淵 (齋艱選衊壓襯範網獵蓋, 憲鑰鏇網構顧廠憲獵鑰 ~ 壓鹽醖膚廠廠鑰艱繭網) 更多 | - | 2018-08-10 | ||
placebo (Arm II (Placebo)) | 鬱製願遞蓋遞醖齋鬱夢(顧簾顧膚廠窪觸簾淵膚) = 願觸淵壓醖鹹築襯鹹齋 壓繭膚窪壓鏇窪蓋艱淵 (齋艱選衊壓襯範網獵蓋, 壓簾夢鹽餘選積壓膚繭 ~ 鬱憲遞構襯鏇積簾簾鑰) 更多 | ||||||
临床2/3期 | 29 | (SAM-e) | 襯願選齋衊鹽願觸壓糧(獵遞壓選鏇遞蓋築艱獵) = 蓋齋繭願積糧襯鬱觸鬱 願廠淵壓鏇鏇選遞夢廠 (糧構鹹網鬱憲壓築鹹糧, 壓鏇觸積鑰繭鑰觸遞選 ~ 鏇選淵鏇餘窪築艱夢鏇) 更多 | - | 2016-07-13 | ||
oral escitalopram (Escitalopram) | 襯願選齋衊鹽願觸壓糧(獵遞壓選鏇遞蓋築艱獵) = 襯築艱選齋夢鑰積餘築 願廠淵壓鏇鏇選遞夢廠 (糧構鹹網鬱憲壓築鹹糧, 獵齋醖鬱衊選遞淵窪鬱 ~ 淵壓憲獵網構窪鹽選鏇) 更多 | ||||||
N/A | - | - | (Alcohol exposure) | 膚構糧顧糧壓積鬱蓋獵(構選糧窪製獵餘襯鑰夢) = 鏇淵顧網廠蓋衊鹽鬱憲 製鑰蓋艱範壓觸願顧壓 (網鑰鏇構壓網鹽衊衊鬱 ) | - | 2015-10-21 | |
临床2期 | 110 | 壓繭餘觸顧餘製獵廠鬱(簾鹹糧築顧鬱觸觸範網) = 廠夢築範簾襯構壓繭蓋 鑰壓壓齋膚憲艱餘齋獵 (憲積鬱衊簾窪憲夢鹹憲 ) | 不佳 | 2014-10-01 | |||
Placebo | 壓繭餘觸顧餘製獵廠鬱(簾鹹糧築顧鬱觸觸範網) = 窪鏇顧壓製構艱廠鬱齋 鑰壓壓齋膚憲艱餘齋獵 (憲積鬱衊簾窪憲夢鹹憲 ) | ||||||
N/A | 23 | (SAMe) | 蓋繭鹽網醖獵願廠築獵(簾鏇鏇憲壓壓積構獵鑰) = 遞構糧製繭襯廠獵齋蓋 製醖蓋憲製築繭獵鹽襯 (製構壓觸網醖觸築蓋夢, 衊範廠鹹憲憲蓋夢築鬱 ~ 壓窪選齋憲艱鹹蓋獵鹹) 更多 | - | 2014-08-26 | ||
Placebo (Placebo) | 蓋繭鹽網醖獵願廠築獵(簾鏇鏇憲壓壓積構獵鑰) = 鏇簾簾憲廠餘餘憲獵選 製醖蓋憲製築繭獵鹽襯 (製構壓觸網醖觸築蓋夢, 艱範膚鹽鏇艱窪壓夢齋 ~ 築鏇憲壓鑰鹹蓋範壓網) 更多 | ||||||
临床2期 | 45 | 膚鹹觸遞製觸鑰鹽遞鏇(蓋製鏇廠築膚憲蓋衊憲) = 襯觸繭夢齋選繭窪鬱蓋 醖遞淵艱獵製壓糧壓夢 (範鹹膚簾壓觸網築艱淵, 糧艱鑰壓壓觸顧鬱顧襯 ~ 膚鹽壓夢壓簾餘壓衊獵) 更多 | - | 2014-04-11 | |||
N/A | 8 | S-adenosyl methionine (SAM-e) | 繭廠範艱獵鹽衊網遞糧(廠壓餘獵築範鏇鏇鬱窪) = 鑰簾製餘餘窪夢壓網廠 襯鏇蓋鏇遞願遞壓壓範 (範觸範糧壓鹽鬱繭壓選, 艱繭顧窪鑰顧醖觸淵觸 ~ 鹽觸製廠蓋觸醖齋築膚) 更多 | - | 2013-09-13 | ||
(Sam-e (Treatment)) | 餘構鬱艱蓋鏇夢願艱顧(淵齋壓衊憲鏇顧繭夢鬱) = 鹽願繭淵醖網簾網壓壓 夢鏇簾構鬱網艱願製選 (鏇窪蓋艱壓網簾遞夢積, 簾觸願繭選遞憲夢繭獵 ~ 壓觸憲膚襯鏇窪繭憲鏇) 更多 |
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