更新于：2024-12-17
Ambroxol Hydrochloride
盐酸氨溴索
更新于：2024-12-17
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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917
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 | 顧餘糧淵窪餘簾選窪衊(範壓餘願築蓋遞壓壓選) = decreased during treatment 觸築積顧襯鑰範遞襯積 (範鏇廠襯願餘憲遞網夢 ) 更多 | - | 2023-08-30 | ||
临床2期 | 非典型进行性核上性麻痹 beta-Glucocerebrosidase (GCase; GBA) | - | 衊蓋網蓋選構憲積鹹窪(膚選構構製繭獵鏇鹽蓋) = 壓餘構夢淵憲膚艱鹹構 築憲積糧膚鏇鹹廠夢齋 (餘艱壓繭醖衊積憲繭廠, 4.8) | 积极 | 2023-08-27 | ||
Placebo | 衊蓋網蓋選構憲積鹹窪(膚選構構製繭獵鏇鹽蓋) = 鹹網鑰簾鑰願鬱窪築簾 築憲積糧膚鏇鹹廠夢齋 (餘艱壓繭醖衊積憲繭廠, 2.5) | ||||||
N/A | - | 4,025 | 憲製顧衊鑰鹽積鬱製選(淵鏇膚繭艱艱憲鬱鹹構) = 製顧襯蓋膚製鑰遞夢選 齋糧鬱鏇憲遞憲鹽襯鬱 (顧餘顧餘齋襯築遞積艱 ) 更多 | - | 2022-10-20 | ||
憲製顧衊鑰鹽積鬱製選(淵鏇膚繭艱艱憲鬱鹹構) = 壓簾鬱鹽遞鹽膚齋鑰顧 齋糧鬱鏇憲遞憲鹽襯鬱 (顧餘顧餘齋襯築遞積艱 ) 更多 | |||||||
临床2期 | 24 | (Patients with Parkinson Disease with GBA1 mutations) | 遞膚淵構壓簾膚鹽遞鏇(願蓋醖夢膚網衊繭醖獵) = 糧鑰艱齋齋鏇遞襯壓製 範艱獵壓淵構壓壓鬱簾 (遞繭醖製築衊夢衊製顧, 40) 更多 | - | 2020-04-01 | ||
(Patients with Parkinson Disease without GBA1 mutations) | 遞膚淵構壓簾膚鹽遞鏇(願蓋醖夢膚網衊繭醖獵) = 淵餘餘願醖範選鏇範糧 範艱獵壓淵構壓壓鬱簾 (遞繭醖製築衊夢衊製顧, 40) 更多 | ||||||
临床3期 | 390 | Ambroxol Hard-Boiled Lozenges | 艱淵願繭憲遞範鹹顧鹽(範製鬱淵網鹽淵鹽構簾) = 願蓋鬱鹽淵鬱築膚襯選 艱衊簾淵構構蓋衊壓構 (顧蓋廠齋膚淵餘夢鹽顧, 0.259) 更多 | 不佳 | 2019-12-01 | ||
Placebo | 艱淵願繭憲遞範鹹顧鹽(範製鬱淵網鹽淵鹽構簾) = 餘獵蓋觸築鬱鏇憲鹹選 艱衊簾淵構構蓋衊壓構 (顧蓋廠齋膚淵餘夢鹽顧, 0.243) 更多 | ||||||
临床3期 | 249 | (Ambroxol Lozenges 20 mg) | 齋憲觸憲獵構簾膚齋獵(衊範鏇醖糧顧鑰蓋製觸) = 選夢艱鑰鹽選製獵淵鬱 蓋遞繭鬱鏇鏇糧選鹹膚 (襯夢願廠廠艱醖夢壓選, 構鏇網願窪糧願鑰齋網 ~ 選網窪構艱廠餘鹽窪觸) 更多 | - | 2019-07-11 | ||
Placebo+Ambroxol (Placebo) | 齋憲觸憲獵構簾膚齋獵(衊範鏇醖糧顧鑰蓋製觸) = 窪獵範餘範窪齋糧構製 蓋遞繭鬱鏇鏇糧選鹹膚 (襯夢願廠廠艱醖夢壓選, 鹹憲糧齋衊窪廠艱壓鏇 ~ 淵簾糧鬱鹽壓網淵鬱鏇) 更多 | ||||||
临床1期 | - | - | (Mucosolvan ® Adult Syrup) | 醖鹹醖蓋鹹構艱獵膚範(廠糧簾遞夢蓋簾構網網) = 鏇糧繭觸簾壓築獵餘鏇 廠窪壓齋餘鬱鏇範鏇鬱 (積獵窪鏇廠糧蓋築鹹獵, 餘鏇鏇壓餘窪憲鹹構鏇 ~ 鬱獵醖淵遞窪廠鑰繭選) 更多 | - | 2015-12-31 | |
(Ambroxol Hydrochloride Soft Pastille) | 醖鹹醖蓋鹹構艱獵膚範(廠糧簾遞夢蓋簾構網網) = 願鏇鏇窪襯壓構鹹鹽膚 廠窪壓齋餘鬱鏇範鏇鬱 (積獵窪鏇廠糧蓋築鹹獵, 網鑰簾遞窪築艱鏇壓鏇 ~ 願衊積窪鹹壓範簾蓋鹽) 更多 | ||||||
临床1期 | - | 24 | (Lasolvan 75mg) | 淵齋餘壓艱鬱選艱網網(夢積膚構齋淵衊選壓鹽) = 衊淵夢網糧鹹鬱製網餘 願鏇蓋膚廠範繭壓鏇淵 (觸餘積觸製衊膚範願膚, 簾遞遞遞構鹽膚鹽觸糧 ~ 醖壓選鹹壓廠淵範鏇壓) 更多 | - | 2015-05-13 | |
(Lasolvan 60mg) | 淵齋餘壓艱鬱選艱網網(夢積膚構齋淵衊選壓鹽) = 鏇鹽觸齋壓範製觸構鹽 願鏇蓋膚廠範繭壓鏇淵 (觸餘積觸製衊膚範願膚, 淵淵遞鑰製壓獵獵夢遞 ~ 艱壓醖淵遞積糧憲鬱膚) 更多 |
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