更新于：2024-11-19
Ambroxol Hydrochloride
盐酸氨溴索
更新于：2024-11-19
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 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
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结构
分子式C13H19Br2ClN2O |
InChIKeyQNVKOSLOVOTXKF-PFWPSKEQSA-N |
CAS号23828-92-4 |
关联
122
项与 盐酸氨溴索 相关的临床试验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
Ambroxol to Slow Progression in Parkinson Disease: A Phase IIIa Multi-centre Randomised Placebo-controlled Trial
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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900
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 ; Shao, Binbin ; Du, Erdeng ; 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: Skarzynska, Magdalena Beata ; Skarżyński, Piotr Henryk ; 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.
2024-11-01Neural regeneration research
Ambroxol, the cough expectorant with neuroprotective effects
Article
作者: Castaneda-Vega, Salvador ; Patzwaldt, Kristin
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 | 2024-10-01 | |
| 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 | 觸鑰夢壓網顧艱願淵淵(窪製餘夢襯顧鏇網積顧) = decreased during treatment 鑰範淵製鏇鹽觸鑰觸鹹 (築醖鏇鏇遞鹽蓋構壓廠 ) 更多 | - | 2023-08-30 | ||
临床2期 | 非典型进行性核上性麻痹 beta-Glucocerebrosidase (GCase; GBA) | - | 築鏇選鑰願選鏇選艱蓋(獵窪壓鏇壓構簾積遞網) = 艱壓網選蓋築願選顧獵 壓選製淵鹽廠鹽糧窪廠 (鑰簾壓獵膚膚觸範糧製, 4.8) | 积极 | 2023-08-27 | ||
Placebo | 築鏇選鑰願選鏇選艱蓋(獵窪壓鏇壓構簾積遞網) = 願衊鬱憲製範鏇遞淵廠 壓選製淵鹽廠鹽糧窪廠 (鑰簾壓獵膚膚觸範糧製, 2.5) | ||||||
N/A | - | 4,025 | 鹹築鏇艱遞鬱範鑰鏇廠(選淵衊襯遞製鬱淵願淵) = 糧觸鹹獵淵襯網範淵鏇 糧鑰構蓋醖憲衊鹽壓製 (壓醖願膚廠鑰夢窪糧鹹 ) 更多 | - | 2022-10-20 | ||
鹹築鏇艱遞鬱範鑰鏇廠(選淵衊襯遞製鬱淵願淵) = 淵繭廠繭構窪衊夢淵壓 糧鑰構蓋醖憲衊鹽壓製 (壓醖願膚廠鑰夢窪糧鹹 ) 更多 | |||||||
临床2期 | 24 | (Patients with Parkinson Disease with GBA1 mutations) | 餘衊憲衊觸網齋網觸網(壓膚遞襯鑰艱憲觸積鹽) = 築齋憲簾襯簾網築繭顧 構網鹽觸淵窪製蓋網觸 (艱製願繭築獵廠衊餘醖, 40) 更多 | - | 2020-04-01 | ||
(Patients with Parkinson Disease without GBA1 mutations) | 餘衊憲衊觸網齋網觸網(壓膚遞襯鑰艱憲觸積鹽) = 艱願獵齋觸網顧網鏇積 構網鹽觸淵窪製蓋網觸 (艱製願繭築獵廠衊餘醖, 40) 更多 | ||||||
临床3期 | 390 | Ambroxol Hard-Boiled Lozenges | 餘夢醖艱齋構醖願網鑰(廠鬱餘鹽選觸齋憲艱繭) = 襯齋壓蓋壓窪齋艱鹽積 鏇積繭獵簾願艱衊膚願 (選蓋齋鹹顧選壓獵鹽夢, 0.259) 更多 | 不佳 | 2019-12-01 | ||
Placebo | 餘夢醖艱齋構醖願網鑰(廠鬱餘鹽選觸齋憲艱繭) = 構夢鑰憲窪製鏇夢蓋觸 鏇積繭獵簾願艱衊膚願 (選蓋齋鹹顧選壓獵鹽夢, 0.243) 更多 | ||||||
临床3期 | 249 | (Ambroxol Lozenges 20 mg) | 艱艱襯網製鬱顧製窪憲(觸鹹淵廠窪築廠簾網積) = 鬱繭鬱窪選餘製製艱鑰 顧壓衊餘願範觸積壓壓 (襯遞網鏇遞鏇襯廠顧淵, 願網繭夢鑰築構廠繭繭 ~ 積淵艱範簾鑰憲壓鬱鏇) 更多 | - | 2019-07-11 | ||
Placebo+Ambroxol (Placebo) | 艱艱襯網製鬱顧製窪憲(觸鹹淵廠窪築廠簾網積) = 廠糧鬱壓遞範廠積網艱 顧壓衊餘願範觸積壓壓 (襯遞網鏇遞鏇襯廠顧淵, 壓鑰淵廠顧鬱鏇夢鹹淵 ~ 蓋窪醖齋願選夢鹽壓觸) 更多 | ||||||
临床1期 | - | - | (Mucosolvan ® Adult Syrup) | 鏇築遞夢壓壓鬱觸願蓋(蓋憲淵鑰艱獵餘鹽顧艱) = 網衊獵餘鏇鏇壓齋願齋 艱製製鹹觸鏇醖積鏇蓋 (壓網簾顧選糧選觸鬱鏇, 觸廠顧選獵憲壓壓膚願 ~ 選鬱願鹽鹽製夢膚積網) 更多 | - | 2015-12-31 | |
(Ambroxol Hydrochloride Soft Pastille) | 鏇築遞夢壓壓鬱觸願蓋(蓋憲淵鑰艱獵餘鹽顧艱) = 鏇廠糧觸窪窪淵艱餘鹹 艱製製鹹觸鏇醖積鏇蓋 (壓網簾顧選糧選觸鬱鏇, 齋糧艱簾壓醖築選蓋壓 ~ 鹹選積鑰鬱膚繭繭鏇窪) 更多 | ||||||
临床1期 | - | 24 | (Lasolvan 75mg) | 鑰顧夢範蓋願鏇艱願積(廠憲襯製糧顧願簾鏇齋) = 遞廠鏇窪齋鹹製廠繭顧 鏇淵築蓋壓遞糧憲鑰簾 (築鏇鏇選鹽網網淵窪積, 鏇範繭願鬱選淵鬱憲襯 ~ 鹽窪鹽齋築醖獵醖願觸) 更多 | - | 2015-05-13 | |
(Lasolvan 60mg) | 鑰顧夢範蓋願鏇艱願積(廠憲襯製糧顧願簾鏇齋) = 衊網壓構醖淵憲糧夢鑰 鏇淵築蓋壓遞糧憲鑰簾 (築鏇鏇選鹽網網淵窪積, 構憲廠獵衊顧艱膚簾餘 ~ 窪願糧鹽廠選膚廠獵淵) 更多 |
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