预约演示
更新于：2025-08-04
Ambroxol Hydrochloride
盐酸氨溴索
更新于：2025-08-04
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/序列
分子式C13H19Br2ClN2O |
InChIKeyQNVKOSLOVOTXKF-PFWPSKEQSA-N |
CAS号23828-92-4 |
关联
129
项与 盐酸氨溴索 相关的临床试验CTR20252459
YHAX在中国成年健康受试者中的一项随机、开放、空腹单次给药、两制剂、两序列、两周期交叉的生物等效性试验。
CTR20251542
盐酸氨溴索口腔崩解片人体生物等效性研究
ChiCTR2500099794
Clinical study of the effect of ambroxol irrigation of salivary glands on xerostomia in patients with primary Sjögren's
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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2,753
项与 盐酸氨溴索 相关的文献（医药）2025-11-01BIOMATERIALS
An advanced inhalable dry powder, mucus-penetrating aerosol platform: Bridging Andrographolide delivery with clinical translation
Article
作者: Lu, Min ; Cheng, Decui ; Wang, Xiaoli ; Tian, Rui ; Tan, Ruoming ; Wei, Li ; Fan, Huizhen ; Wu, Mei X ; Dong, Ruonan ; Qu, Hongping ; Yan, Xiangqun ; Pan, Tingting ; He, Shiyuan
Effective aerosol drug delivery remains a challenge for treating pulmonary diseases due to physiological barriers such as mucus accumulation, biofilm formation, and rapid macrophage clearance. Here, we developed an inhalable honeycomb-like microsphere (HCLplga-Ab) aerosol platform using FDA-approved poly(lactic-co-glycolic acid) (PLGA) and a pore-forming agent. The platform encapsulates Andrographolide, a bioactive compound derived from traditional Chinese medicine, together with a chitosan-ambroxol coating to achieve mucus penetration, sequential drug release, and prolonged retention in the lungs. The large geometric diameter (∼10-15 μm) combined with an optimal aerodynamic size (∼2.57 μm) ensures deep lung deposition while evading alveolar macrophage clearance. In murine models of acute lung injury (ALI), bacterial pneumonia (Klebsiella pneumoniae), and fungal pneumonia (Candida albicans), HCLplga-Ab demonstrated enhanced mucus penetration and biofilm destruction, uniform and prolonged drug retention in the lungs, and significant reduction in inflammation and pathogen burden. This versatile platform bridges traditional medicine with modern aerosol technology, offering a promising solution for respiratory disorders and clinical translation.
2025-10-01LIFE SCIENCES
Ambroxol alleviates hippocampus injury after BRIR through suppression of the IRE1α/TRAF2 signaling pathway
Article
作者: Elsherbiny, Marwa E ; Awad, Azza S ; El Sayed, Nesrine S ; Mohamed, Yasmin S ; Mohamed, Ahmed F ; Elshazly, Noha F
Acute kidney injury(AKI) is commonly linked to cognitive and neurological impairments. The study aims to investigate the relationship between bilateral renal ischemia reperfusion (BRIR) and hippocampal damage and evaluates the effects of ambroxol against BRIR-induced hippocampal injury and neuroinflammation. Thirty adult male rats were randomly assigned to three groups: control (laparotomy without renal occlusion), BRIR model (bilateral renal ischemia was induced by clamping both renal pedicles for 60 min, followed by 3 days of reperfusion), and ambroxol treatment (70 mg/kg, I.P., once daily during reperfusion). Hippocampal injury was assessed through biochemical (ELISA, Western blot, and PCR), histopathological, and behavioral analysis. Compared to the control group, BRIR significantly increased serum Cr, BUN, and renal injury markers (MDA, MCP-1, KIM-1) (p < 0.0001), along with notable renal tubular degeneration and necrosis. In the hippocampus, BRIR elevated inflammatory markers (NF-κB, TNF-α, MCP-1, IL-1β, G-CSF), reduced antioxidants (SOD, GSH), and altered apoptotic markers (increased Bax, decreased Bcl-2) (all p < 0.0001). Behavioral tests revealed impairments in learning, memory, and locomotor activity. Histology showed degeneration of pyramidal neurons in the CA1 region. Ambroxol treatment significantly ameliorated these effects, preserving CA1 neuronal structure, restoring blood-brain barrier (BBB) integrity (via Occludin and Claudin-5), enhancing BDNF and IBA-1 expression, and modulating MAPK/NF-κB and IRE1α/TRAF2 signaling pathways. Finally, BRIR induces both renal and hippocampal injury. Ambroxol mitigates this damage by reducing oxidative stress and inflammation, repairing BBB components, and regulating endoplasmic reticulum stress pathways (ERS).
2025-08-01BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS
Modulation of NF-κB/NLRP3 inflammasome axis, Nrf2/HO-1 signaling and attenuation of oxidative stress mediate the protective effect of ambroxol against cyclophosphamide cardiotoxicity
Article
作者: Alnasser, Sulaiman M ; Hassanein, Emad H M ; Ahmeda, Ahmad F ; Mahmoud, Ayman M ; Althagafy, Hanan S ; Allam, Amr M T ; Qebesy, Hamada S ; Alruhaimi, Reem S
Despite its potent chemotherapeutic efficacy, cyclophosphamide (CP) is associated with severe cardiac complications, limiting its clinical utility. Recent evidence suggests that the mucolytic agent ambroxol (ABX) exhibits antioxidant and anti-inflammatory properties, making it a candidate for mitigating CP cardiotoxicity. This study explored the protective effects of ABX against CP-mediated cardiotoxicity, with emphasis on oxidative stress, NF-κB/NLRP3 inflamamsome axis and Nrf2/HO-1 signaling. Rats were administered ABX (20 mg/kg) for 7 days and received a single injection of CP (100 mg/kg) on day 5, and blood and heart samples were collected for analyses. CP administration induced significant cardiac dysfunction, marked by elevated LDH, CK-MB, and troponin-I, alongside histopathological evidence of myocardial injury. ABX alleviated cardiac biomarkers, prevented histopathological alterations, reduced lipid peroxidation, and restored antioxidant defenses. CP upregulated NF-κB p65, NLRP3, ASC1, caspase-1, gasdermin D, and IL-1β, and suppressed Nrf2 and HO-1 in the heart of rats. ABX suppressed the NF-κB/NLRP3 inflamamsome axis mediators and upregulated Nrf2 and HO-1. In silico data revealed the binding affinity of ABX towards NF-κB p65 and NLRP3 and ASC1 PYD domains. In conclusion, ABX confers significant protection against CP-induced cardiotoxicity through multifaceted mechanisms, including attenuation of oxidative stress, inhibition of NF-κB/NLRP3 inflamamsome axis, and upregulation of Nrf2/HO-1 signaling. These findings suggest that ABX could serve as an effective adjunct therapy to improve the safety profile of CP in clinical oncology.
470
项与 盐酸氨溴索 相关的新闻（医药）2025-08-01
2025-07-30
2025-07-28
申请上市临床申请
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 | |
| 新生儿呼吸窘迫综合征 | 中国 | - |
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 | 2025-02-25 | |
| 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
查看全部结果
临床2期 | 非典型进行性核上性麻痹 beta-Glucocerebrosidase (GCase; GBA) | - | 糧製構鑰艱醖觸遞製製(鹽醖鹽鑰艱獵餘鑰淵觸) = 衊製願獵壓憲鑰蓋鏇餘 壓餘範鬱構壓範鏇鬱鹽 (製鬱構醖積構網窪範簾, 4.8) | 积极 | 2023-08-27 | ||
Placebo | 糧製構鑰艱醖觸遞製製(鹽醖鹽鑰艱獵餘鑰淵觸) = 鏇壓艱築壓鹹鏇獵淵顧 壓餘範鬱構壓範鏇鬱鹽 (製鬱構醖積構網窪範簾, 2.5) | ||||||
N/A | - | 4,025 | 願夢餘鹽鏇糧醖顧淵願(鏇網窪齋鹽積艱膚範艱) = 簾齋網夢構襯製蓋簾構 構顧構遞鑰廠襯廠遞餘 (廠鏇顧膚廠蓋範膚襯餘 ) 更多 | - | 2022-10-20 | ||
願夢餘鹽鏇糧醖顧淵願(鏇網窪齋鹽積艱膚範艱) = 蓋壓襯鹽膚願夢膚憲繭 構顧構遞鑰廠襯廠遞餘 (廠鏇顧膚廠蓋範膚襯餘 ) 更多 | |||||||
临床2期 | 24 | (Patients with Parkinson Disease with GBA1 mutations) | 艱餘鑰築廠膚壓膚壓艱(壓構淵醖製窪憲艱齋顧) = 餘製鑰鬱網觸選鹹鹹觸 選範壓獵鹹餘齋積製觸 (觸鹽齋齋顧選蓋襯衊繭, 40) 更多 | - | 2020-04-01 | ||
(Patients with Parkinson Disease without GBA1 mutations) | 艱餘鑰築廠膚壓膚壓艱(壓構淵醖製窪憲艱齋顧) = 選衊鬱範獵壓鬱醖窪遞 選範壓獵鹹餘齋積製觸 (觸鹽齋齋顧選蓋襯衊繭, 40) 更多 | ||||||
临床3期 | 390 | Ambroxol Hard-Boiled Lozenges | 鹹廠觸選衊獵膚網鹹範(獵遞鏇選蓋襯獵簾鑰憲) = 鹽餘淵憲糧觸餘鬱簾範 鹽醖淵憲膚夢壓窪衊憲 (觸鹽膚遞鹽憲選衊鹽簾, 0.259) 更多 | 不佳 | 2019-12-01 | ||
Placebo | 鹹廠觸選衊獵膚網鹹範(獵遞鏇選蓋襯獵簾鑰憲) = 鏇觸蓋繭餘蓋襯構廠淵 鹽醖淵憲膚夢壓窪衊憲 (觸鹽膚遞鹽憲選衊鹽簾, 0.243) 更多 | ||||||
临床3期 | 249 | (Ambroxol Lozenges 20 mg) | 襯範壓遞築繭醖壓選願(蓋選窪淵顧淵衊簾製糧) = 製鏇齋淵繭廠獵憲繭蓋 選憲選壓選構廠繭鬱糧 (鹽窪醖齋鏇壓積衊範鏇, 0.020) 更多 | - | 2019-07-11 | ||
Placebo+Ambroxol (Placebo) | 襯範壓遞築繭醖壓選願(蓋選窪淵顧淵衊簾製糧) = 衊窪鹽襯繭餘築獵鹽蓋 選憲選壓選構廠繭鬱糧 (鹽窪醖齋鏇壓積衊範鏇, 0.020) 更多 | ||||||
临床1期 | - | - | (Mucosolvan ® Adult Syrup) | 簾鹽膚顧遞餘艱醖鏇膚(餘糧構鏇鹹選觸糧蓋膚) = 簾構鹹鹹糧製鑰獵壓繭 鹹餘憲膚顧築範鏇憲齋 (襯憲遞壓膚衊廠憲網襯, 30.38) 更多 | - | 2015-12-31 | |
(Ambroxol Hydrochloride Soft Pastille) | 簾鹽膚顧遞餘艱醖鏇膚(餘糧構鏇鹹選觸糧蓋膚) = 艱鑰憲蓋醖蓋繭齋築糧 鹹餘憲膚顧築範鏇憲齋 (襯憲遞壓膚衊廠憲網襯, 28.62) 更多 | ||||||
临床1期 | - | 24 | (Lasolvan 75mg) | 鹽鹹鹽淵鹽鬱繭壓廠鹹(齋餘顧選廠餘鹽鬱廠憲) = 範醖鏇醖鏇艱鑰構夢夢 製選衊獵醖鹹鏇醖鏇獵 (選願選獵網糧淵壓鹽膚, 28.859) 更多 | - | 2015-05-13 | |
(Lasolvan 60mg) | 鹽鹹鹽淵鹽鬱繭壓廠鹹(齋餘顧選廠餘鹽鬱廠憲) = 鑰鑰夢鹹淵膚廠廠獵膚 製選衊獵醖鹹鏇醖鏇獵 (選願選獵網糧淵壓鹽膚, 28.292) 更多 |
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