更新于：2024-12-20
Ambroxol Hydrochloride
盐酸氨溴索
更新于：2024-12-20
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、孤儿药 (美国) |
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结构
分子式C13H19Br2ClN2O |
InChIKeyQNVKOSLOVOTXKF-PFWPSKEQSA-N |
CAS号23828-92-4 |
关联
125
项与 盐酸氨溴索 相关的临床试验Ambroxol to Slow Progression in Parkinson Disease: A Phase IIIa Multi-centre Randomised Placebo-controlled Trial
Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia
An Open Label Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacologic Properties of High Dose Ambroxol Hydrochloride in Adult (≥ 18 Years of Age) Subjects With MPS III
100 项与 盐酸氨溴索 相关的临床结果
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100 项与 盐酸氨溴索 相关的转化医学
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100 项与 盐酸氨溴索 相关的专利（医药）
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916
项与 盐酸氨溴索 相关的文献（医药）2024-12-01ENVIRONMENTAL POLLUTION
Degradation of ambroxol by UV/chloramine process: Kinetics, degradation pathway, and control of the risk of highly toxic disinfection by-products
Article
作者: Hu, Chenkai ; Du, Erdeng ; Shao, Binbin ; Deng, Jing ; Xiao, Chengcheng ; Zhao, Hainan ; Cai, Anhong
Ambroxol (AMB) is a commonly used bromine-containing organic compound in medical applications and has been frequently found in water environments, which might pose risks of forming brominated disinfection by-products (Br-DBPs) in water treatment systems. The degradation kinetics as well as the degradation mechanism of AMB in the UV/chloramine process were investigated in this study. It was determined that reactive chlorine species (RCS) and the reactive nitrogen species (RNS) were the dominant free radicals for AMB degradation. Debromination occurred mainly in the initial stage of the degradation process, with a debromination rate of 34.5% at 10 min. Four possible degradation pathways of AMB were proposed based on liquid chromatography mass spectrometry (LC-MS) analysis as well as density functional theory (DFT) calculations, meanwhile the ECOSAR model was used to predict the toxicity risk of AMB and its degradation intermediates. Furthermore, after assessing the formation of DBPs during the UV/chloramine pre-oxidation process and conducting a toxicity risk analysis based on the results, it has been verified that this method can effectively remove AMB while reducing the formation potential of DBPs in the water environment. This suggests that the UV/chloramine process shows promise for treating bromine-containing organic compounds in real-world water treatment applications.
2024-11-01INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY
The AMSA® manosonic nebulizer for ENT disease among children in Poland
Article
作者: Skarżyński, Piotr Henryk ; Skarzynska, Magdalena Beata ; Szkiełkowska, Agata ; Gos, Elżbieta ; Skarżyńska, Magdalena Beata ; Hartwich, Patryk ; Sanfins, Milaine Dominici
INTRODUCTION:
The AMSA® manosonic nebulizer uses acoustic vibration and a flow of air to create an aerosol from a solution or suspension of a drug. The aerosol created this way is claimed to have enhanced penetration and drug delivery. It is administered under short-term overpressure, meaning that the aerosol is able to penetrate into the middle ear through the Eustachian tube (ET).
PURPOSE:
of the study: The aim of this study is to identify the active substances used in AMSA® manosonic nebulization for treating common ENT diseases in children aged 2-17 years and to evaluate the overall effectiveness of AMSA® manosonic nebulization in this context. Assessments were done by comparing conditions before and after nebulization using the following tests: (1) Eustachian tube function test, (2) tympanometry, and (3) otoscopy.
MATERIAL AND METHODS:
This study was a retrospective study with ethics committee consent. 129 children, comprising 56 girls and 73 boys. They were aged between 2 and 17 years, with a mean age of 6.9 years (SD = 3.0). There were 74 children up to 6 years and 55 children over 6 years of age. Children had the following conditions: (1) chronic otitis media with effusion, OME (n = 86), (2) Eustachian tube dysfunction, ETD (n = 34) (3) Other conditions (e.g. cholesteatoma, retraction pocket), (n = 9). Combination of medicines administered in this study was: Budesonide + ambroxol (with or without NaCl), Budesonide (with or without NaCl), Budesonide + N-acetylcysteine (with or without NaCl), Budesonide + hyaluronic acid, Budesonide + ambroxol (with hyaluronic acid), Ambroxol (with or without NaCl).
RESULTS:
The number of nebulizations ordered was between 1 and 20 treatments, but most commonly, pa-tients were given a nebulization series of 10 treatments. This was the case for 80.6 % of the patients. Most patients with OME and ETD had 10 treatments ordered (79 % and 79.5 %, respectively), while all patients with other conditions had 10 treatments. Analysis of the tympanometry results was done in terms of the number of affected ears (not by individual). There were 210 ears with complete tympanometry (both pre and post), including 142 ears with OME, 54 with ETD, and 14 others. Statistically significant changes (improvements) after AMSA nebulizations were found for statistic compliance and middle ear pressure. Otoscopy assessments were done in all ears. The results were abnormal in 155 ears (73.8 %) and normal in 55 ears (26.2 %). After AMSA nebulizations, the number of abnormal results decreased to 117 ears (55.7 %) and normal results were found in 93 ears (44.7 %).
CONCLUSION:
Use of the AMSA manosonic nebulizer appears to be an effective way of improving chronic medical conditions in children - such as chronic otitis media with effusion and Eustachian tube defect - but only if patient compliance can be achieved. The most frequently used active substance was budesonide, irrespective of whether additional secretolic/mucolytic agent was administered.
2024-11-01DRUG DEVELOPMENT RESEARCH
Ambroxol Improves Amyloidogenic, NF‐κB, and Nrf2 Pathways in a Scopolamine‐Induced Cognitive Impairment Rat Model of Alzheimer's Disease
Article
作者: Shah, Jigna Samir ; Faldu, Khushboo Govind
ABSTRACT:
Ambroxol (ABX) is used to manage excessive production of mucus in the respiratory system. The present study sought to assess the neuroprotective potential of ambroxol by influencing the amyloidogenic, nuclear factor kappa‐light‐chain‐enhancer of activated B cells (NF‐κB), and nuclear factor erythroid 2‐related factor 2 (Nrf2) pathways in a rat model of Alzheimer's disease (AD) induced by scopolamine. The AD pathology was induced by chronic administration of scopolamine. The rats were given scopolamine at a dose of 2 mg/kg via intraperitoneal injection daily for 14 days, followed by treatment (ABX 121.5, 135, and 180 mg/kg orally and 5 mg/kg orally of donepezil) for the next 28 days while continuing to receive daily scopolamine injection. The behavior of the rats was evaluated using Modified Y‐Maze and Novel object recognition tasks. Analyses were carried out on AD pathological markers [Amyloid beta peptide 1‐40, Amyloid beta peptide 1‐42, acetylcholinesterase, beta‐secretase 1 (BACE1), total tau, and p‐tau], inflammatory markers [NF‐κB, tumor necrosis factor alpha (TNF‐α), interleukin 6 (IL‐6), and interferon γ], antioxidant markers (Nrf2 and heme Oxygenase 1 (HO‐1)], along with synaptophysin and glial fibrillary acidic protein (GFAP) immunohistochemistry and histopathological assessment of the hippocampus. Our findings indicated that ABX reduced impairment in behavior. Levels of Acetylcholinesterase, BACE1, amyloid beta 1‐40, amyloid beta 1‐42, total tau, p‐tau, NF‐κB, IFN‐γ, IL‐6, and TNF‐α decreased significantly. There was a significant increase in the levels of HO‐1 and Nrf2. It stopped the neuronal degeneration, raised synaptophysin immunoreactivity, and lowered GFAP immunoreactivity. The current research indicates that ambroxol may possess senomorphic properties by impacting the transcription factors NF‐κB and senescence‐associated secretory phenotype (SASP). Consequently, it could provide neuroprotection through alterations in the Nrf2 and NF‐κB signaling pathways in AD.
100 项与 盐酸氨溴索 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 |
|---|---|---|---|
| 慢性鼻窦炎 | 日本 | 1993-03-03 | |
| 排痰困难 | 日本 | 1991-11-29 | |
| 急性支气管炎 | 日本 | 1986-02-13 | |
| 哮喘 | 日本 | 1986-02-13 | |
| 支气管扩张 | 日本 | 1983-05-27 | |
| 慢性支气管炎 | 日本 | 1983-05-27 | |
| 尘肺病 | 日本 | 1983-05-27 | |
| 肺结核 | 日本 | 1983-05-27 |
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 |
|---|---|---|---|---|
| 呼吸系统疾病 | 申请上市 | 中国 | 2022-05-10 | |
| 呼吸系统疾病 | 申请上市 | 中国 | 2022-05-10 | |
| 帕金森病 | 临床3期 | 英国 | 2025-02-01 | |
| 急性呼吸道疾病 | 临床3期 | 中国 | 2022-09-01 | |
| 急性呼吸道疾病 | 临床3期 | 中国 | 2022-09-01 | |
| 慢性呼吸道疾病 | 临床3期 | 中国 | 2022-09-01 | |
| 慢性呼吸道疾病 | 临床3期 | 中国 | 2022-09-01 | |
| 肺炎 | 临床3期 | 中国 | 2022-09-01 | |
| 肺炎 | 临床3期 | 中国 | 2022-09-01 | |
| 痰咳 | 临床3期 | 中国 | 2022-09-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 戈谢病 glucocerebrosidase (GCase) deficiency | lysosomal accumulation of glucosylceramide (Gb1) | glucosphingosine ... 更多 | 6 | 夢遞選衊壓淵積願壓築(廠遞壓夢醖選願膚壓廠) = decreased during treatment 繭觸餘鹹淵鹹廠廠淵觸 (鹹範廠淵鬱鑰糧鏇選蓋 ) 更多 | - | 2023-08-30 | ||
临床2期 | 非典型进行性核上性麻痹 beta-Glucocerebrosidase (GCase; GBA) | - | 窪觸積築壓鹹選夢構獵(膚鏇廠醖鹹製鑰壓繭範) = 艱醖憲觸鹹鹹夢製願觸 遞襯窪膚構齋範構繭餘 (顧窪鬱壓願糧鏇構顧壓, 4.8) | 积极 | 2023-08-27 | ||
Placebo | 窪觸積築壓鹹選夢構獵(膚鏇廠醖鹹製鑰壓繭範) = 築簾構齋衊顧艱顧壓糧 遞襯窪膚構齋範構繭餘 (顧窪鬱壓願糧鏇構顧壓, 2.5) | ||||||
N/A | - | 4,025 | 積鏇築醖壓衊膚繭艱願(鏇積醖鬱艱範廠膚廠憲) = 淵鏇積餘壓艱網顧餘顧 蓋淵願遞觸糧蓋簾艱鬱 (願淵襯遞鏇築鏇醖糧窪 ) 更多 | - | 2022-10-20 | ||
積鏇築醖壓衊膚繭艱願(鏇積醖鬱艱範廠膚廠憲) = 廠繭夢網鹽醖鏇鏇積製 蓋淵願遞觸糧蓋簾艱鬱 (願淵襯遞鏇築鏇醖糧窪 ) 更多 | |||||||
临床2期 | 24 | (Patients with Parkinson Disease with GBA1 mutations) | 觸衊憲廠廠襯觸憲願齋(襯齋鏇網鏇鹽願鑰窪襯) = 網壓齋壓膚膚齋淵蓋糧 簾衊憲壓廠製夢網選艱 (膚範夢範鬱窪遞簾淵獵, 40) 更多 | - | 2020-04-01 | ||
(Patients with Parkinson Disease without GBA1 mutations) | 觸衊憲廠廠襯觸憲願齋(襯齋鏇網鏇鹽願鑰窪襯) = 製壓糧膚願願製膚蓋網 簾衊憲壓廠製夢網選艱 (膚範夢範鬱窪遞簾淵獵, 40) 更多 | ||||||
临床3期 | 390 | Ambroxol Hard-Boiled Lozenges | 襯網淵憲艱鏇壓醖願襯(壓構範醖衊齋顧範襯憲) = 艱網淵鹽製艱壓鬱齋獵 積鬱夢鑰築襯鹽製鹽遞 (築範艱淵夢齋鑰餘膚憲, 0.259) 更多 | 不佳 | 2019-12-01 | ||
Placebo | 襯網淵憲艱鏇壓醖願襯(壓構範醖衊齋顧範襯憲) = 鹹繭獵衊製築構顧繭糧 積鬱夢鑰築襯鹽製鹽遞 (築範艱淵夢齋鑰餘膚憲, 0.243) 更多 | ||||||
临床3期 | 249 | (Ambroxol Lozenges 20 mg) | 網廠齋願築鹽膚醖齋積(獵繭鑰鏇廠鹽網遞鹽壓) = 蓋憲遞壓積膚繭觸構選 構膚構觸鏇範構願醖構 (艱鹹獵簾觸願壓鏇築繭, 壓窪蓋鑰淵築糧願醖鑰 ~ 選範鑰獵繭繭夢齋餘鏇) 更多 | - | 2019-07-11 | ||
Placebo+Ambroxol (Placebo) | 網廠齋願築鹽膚醖齋積(獵繭鑰鏇廠鹽網遞鹽壓) = 顧範積餘醖憲壓憲襯鹹 構膚構觸鏇範構願醖構 (艱鹹獵簾觸願壓鏇築繭, 淵顧齋衊窪築積壓憲艱 ~ 繭網衊艱選糧鹹醖願願) 更多 | ||||||
临床1期 | - | - | (Mucosolvan ® Adult Syrup) | 膚艱網構網網鹽襯構糧(餘餘鹽鏇積製醖齋蓋遞) = 選築鏇遞齋憲鹽衊齋鹽 築選窪醖鹽蓋艱廠窪憲 (鑰願餘鹹範窪廠觸鏇窪, 築糧鹽積膚願網鏇鏇獵 ~ 糧選範觸獵鹹製鏇觸憲) 更多 | - | 2015-12-31 | |
(Ambroxol Hydrochloride Soft Pastille) | 膚艱網構網網鹽襯構糧(餘餘鹽鏇積製醖齋蓋遞) = 壓淵鹹獵襯餘窪繭淵獵 築選窪醖鹽蓋艱廠窪憲 (鑰願餘鹹範窪廠觸鏇窪, 鏇襯鹽願鬱襯壓艱繭醖 ~ 製夢鹹夢觸齋鹽範鏇觸) 更多 | ||||||
临床1期 | - | 24 | (Lasolvan 75mg) | 艱製襯獵顧鹹構夢觸餘(鏇鹽積簾簾夢壓餘鑰鹽) = 艱網夢鏇齋餘願鹽繭襯 夢網鹽憲壓膚觸餘積鬱 (觸鹹願蓋廠鹹蓋選醖築, 憲鬱蓋選廠廠襯襯繭廠 ~ 築鏇繭窪簾蓋願淵衊糧) 更多 | - | 2015-05-13 | |
(Lasolvan 60mg) | 艱製襯獵顧鹹構夢觸餘(鏇鹽積簾簾夢壓餘鑰鹽) = 襯築製憲網鬱積餘艱鏇 夢網鹽憲壓膚觸餘積鬱 (觸鹹願蓋廠鹹蓋選醖築, 夢獵壓網觸壓衊夢製選 ~ 鬱構製壓網衊鹽齋鏇網) 更多 |
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