盐酸氨溴索(Ambroxol Hydrochloride) - 药物靶点：SCNA_在研适应症：慢性鼻窦炎，排痰困难，急性支气管炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Ambroxol、Ambroxol Hydrochlorcide、Ambroxol hydrochloride (JAN)

+ [66]

靶点

SCNA

作用机制

SCNA调节剂(钠通道α亚基家族调节剂)

治疗领域

免疫系统疾病感染耳鼻咽喉疾病+ [6]

在研适应症

慢性鼻窦炎排痰困难急性支气管炎+ [20]

非在研适应症

急性咽炎疼痛

原研机构

Teijin Pharma Ltd.

在研机构

山西阳和医药技术有限公司

Hanmi Pharmaceutical Co., Ltd.

山西国润制药有限公司

+ [30]

非在研机构

Boehringer Ingelheim GmbH

Sanofi

山东罗欣药业集团股份有限公司

最高研发阶段批准上市

首次获批日期

日本 (1983-05-27),

支气管扩张慢性支气管炎尘肺病+ [1]

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

NCT05778617 / Not yet recruiting临床3期IIT

Ambroxol to Slow Progression in Parkinson Disease: A Phase IIIa Multi-centre Randomised Placebo-controlled Trial

This is a UK only clinical trial in patients with Parkinson's disease (PD) of a drug called ambroxol hydrochloride, which is an already licensed drug for the treatment of respiratory conditions (such as a common cold) in many European countries. The aim of this trial is to find out whether ambroxol hydrochloride can slow down the progression of Parkinson's disease and to evaluate it's safety and tolerability.

开始日期2025-02-01

申办/合作机构

University College London

NCT04405596 / Not yet recruiting临床1/2期IIT

Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia

This is a randomized, placebo-controlled, double-blind study investigating whether the medication Ambroxol is safe,effectiveness and well tolerated for the treatment of Lewy Body Dementia (LBD). Currently the main treatments for patients with LBD target symptom management. However, none of the medications treat the underlying cause of the disease, which includes the accumulation of protein in the brain. Therefore, even if patients respond well to symptomatic treatment, they continue to deteriorate. Therefore, the purpose of the current study is to make sure Ambroxol is safe to take long term and to test the effects of Ambroxol in treating the cognitive impairments associated with LBD by modifying the underlying causes of the disease.
There will be a total of 15 people participating this this study, which will last 52 weeks. Over the study period patients will undergo clinical, neuropsychological and neuroimaging assessment to assess changes.

开始日期2025-01-01

申办/合作机构

Lawson Health Research Institute

NCT06614894 / Not yet recruiting临床2/3期IIT

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

A dose escalation study to evaluate the safety, tolerability, and pharmacologic properties of Ambroxol in adult participants with Sanfilippo disease(s) (MPS3).

开始日期2024-12-01

申办/合作机构-

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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919

项与盐酸氨溴索相关的文献（医药）

2024-12-01·ENVIRONMENTAL 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 ; Zhao, Hainan ; Xiao, Chengcheng ; 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.

2024-12-01·REVISTA ARGENTINA DE MICROBIOLOGIA

Broaden properties of ambroxol hydrochloride as an antibiofilm compound

Article

作者: Iribarnegaray, Victoria ; González, María J ; Scavone, Paola ; Lain, Michela ; Robino, Luciana

Biofilm-associated microorganisms can cause many infections and are an important cause of resistance to several antimicrobials. The antibiotic crisis has led to a pressing need for new therapeutic tools. Ambroxol is frequently used as a mucolytic agent in respiratory diseases with increased mucus production. In addition, a wide range of properties has been described, including the effect on biofilms. In this work, we evaluate the anti-biofilm effect of ambroxol on four strains with clinical relevance: Proteus mirabilis, Escherichia coli, Staphylococcus aureus, and Acinetobacter baumannii. In vitro, biofilm formation was assessed using the crystal violet quantification technique in microplate and glass coverslip. The inhibition of biofilm formation was evaluated by adding ambroxol at the initial time. Ambroxol hydrochloride was evaluated over the preformed biofilm and live/dead bacteria were quantified. The effect of ambroxol in the ethidium bromide efflux assay and the relative expression of the five major P. mirabilis efflux pump family genes were analyzed. Ambroxol inhibited biofilm formation in all the bacteria tested. Moreover, ambroxol significantly reduces both biofilm biomass and viable bacteria. Ambroxol was able to affect P. mirabilis efflux pumps depending on the concentration used and induced the overexpression of several efflux pump genes. In summary, ambroxol kills planktonic cells, reduce biofilm biomass as it increases cell death, and affect the expression of efflux pumps. Furthermore, it presents a viable alternative for the treatment of biofilm infection alone or in combination with antibiotic therapy.

2024-11-01·INTERNATIONAL 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.

363

项与盐酸氨溴索相关的新闻（医药）

22 小时之前

·医药地理

第十批集采拟中选结果价格解析

自12月12日第十批拟中标结果出炉后，关于价格的讨论源源不断，价格这么低正常吗？3分钱的药还能不能吃？基于PDB药物综合数据库药品招标页面相关内容，第十批国家集采拟中选结果共包含62个品种（产品名称）、83个品规（产品名称+剂型规范+规格规范）、210个企业（生产企业）。本文针对该结果进行分析，并按照同一标准和方法统计第二批至第九批的拟中选数据（不含第六批）。口服制剂价格统计不同批次所有口服制剂品规的最小单位价格（即元/片、元/粒等），得到各批次的最高价和最低价。就最值而言，第十批的表现并没有那么突出，既不是最高价中的最低也不是最低价中的最低。如果不计入天士力帝益药业的替莫唑胺胶囊，各批次的最高报价均在百元以内，差异也相对较小。另一方面，几分钱一片的药则是普遍现象，3分钱的对乙酰氨基酚、1分钱的卡托普利、2分钱的二甲双胍、4分钱的硝苯地平、6分钱的美托洛尔等遍布多个批次，第十批3分钱的叶酸和阿司匹林更像是一种延续。至于网传的药效问题，国家医保局曾委托首都医科大学宣武医院分别于2019年和2021年开展了两期真实世界研究，覆盖“4+7”、第二批、第三批不同治疗领域的37个经典一线品种，结果证实“便宜有好药”，仿制药可替代原研药。图1 各批国采口服制剂最小单位价格比较（元）注射制剂价格由于第二批只有1个注射用紫杉醇（白蛋白结合型）、第三批3个注射品种价格偏高，为保持数据可比性，从第四批开始统计所有注射制剂品规的最小单位价格（即元/支、元/瓶等），得到各批次的最高价和最低价。与上述口服制剂的表现不同，第十批确实创造了多个记录：最高价中的最低、最低价中的最低、最窄的价格区间。各批次都曾出现数个百元以上的品种，但第十批只有一个盐酸多柔比星脂质体注射液，且同组内的第一顺位石药欧意仅报价98元，从最初近5000的挂网价到3000多再到不足100，累积降幅超过98%；鉴于石药的白蛋白紫杉醇能从2000多调至747再降为148，国内企业针对高端复杂制剂的能力还是有目共睹的。另外，就最低价而言，除了第五批，其他批次均有多个品种单价低于1元，0.16的氯化钾相较于0.23的地塞米松和氨溴索也没有太大的差距，至于0.22的间苯三酚是否真的亏本，后续市场发展会给出答案。图2 各批国采注射制剂最小单位价格比较（元）价格差距控制针对至少有两家拟中选企业的同一品规，用最高申报价除以最低申报价，计算得到同品规价差倍数，并统计其分布态势，其中第五批的15mg和20mg利伐沙班片因差距过于悬殊（20倍以上）不纳入下方图表。由于第十批强制要求了1.8倍熔断机制，几乎所有品规都位于红线之下，中位数1.44倍，说明大部分企业报价极为接近，零星的离散点则是触发了“小容量注射剂单位可比价小于等于1元”的保底。而在历史集采批次中，第二批作为中选规则出现1.8倍的首个批次，成为了第十批外最接近红线要求的批次。剩余批次的离散程度虽然较大，部分企业更倾向于选择“降幅超过50%”，但红线下方的集中度仍然是最高的，中位数基本稳定在1.48-1.65的区间，平均值则稳定在1.82-2.07，维持了中选后各地区间的价格平衡。图3 各批国采同品规价差倍数分布 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

带量采购

22 小时之前

·思齐俱乐部

1.2亿增资资不抵债的北京健康，罗欣药业加强创新药推广能力建设

看中罗欣健康科技发展(北京)有限公司(简称“北京健康”)的是创新药商业化及推广经验，罗欣药业向其增资1.2亿元。 12月24日晚罗欣药业公告，拟增加子公司北京健康注册资本1.2亿元，本次增资完成后，公司对北京健康持股比例将由71.16%升至80.95%。资料显示，北京健康经营范围包含销售食品；销售药品；提供互联网药品、医疗器械信息服务等，注册资本为2.34亿元。今年前三季度，该公司营收3.47亿元，净利润亏损1.58亿元；截至9月30日，资产总额为1.05亿元，净资产为-3.99亿元。本次交易将有利于满足北京健康业务发展的资金需求，使得北京健康能够利用公司的产品资源优势，积极推进产品商业化运营，加强建设创新药推广能力，保障北京健康的业务发展需要。同时，罗欣药业也表示，公司对北京健康增资，是为了进一步增强对北京健康的控制，把握战略机遇，利用公司的产品资源优势，积极推进产品商业化运营，加强建设创新药推广能力，促进公司产生良好的协同效应，符合公司未来发展方向和战略。据悉，罗欣药业聚焦于消化、呼吸、抗肿瘤等优势领域，并在创新药、仿制药两方面发力，上市了150余个品种，300多个品规的产品。其中，在创新药方面，罗欣药业聚焦消化领域，2022年公司头个1类新药替戈拉生片(商品名：泰欣赞®)获批上市，该产品为钾离子竞争性酸阻滞剂(Potassium-Competitive Acid Blockers，P-CAB)，适用于治疗反流性食管炎、十二指肠溃疡及与适当的抗生素联用以根除幽门螺杆菌共计三项适应症，前两项适应症已被纳入2024版国家医保目录。在仿制药方面，罗欣药业以呼吸领域产品为例，公司以儿童患者临床需求出发历时多年研发推出的2.4类新药为头个国内上市的盐酸氨溴索喷雾剂(商品名：佩宁®)，该产品适用于2-6岁儿童的痰液粘稠及排痰困难。但是从业绩上来看，近年来，罗欣药业的业绩并不理想。数据显示，自2022年起，罗欣药业开始陷入亏损。2022年的净亏损高达12.25亿元，同比上年下滑401.63%，实现营收35.88亿元，同比上年下滑44.62%。到了2023年，罗欣药业净利润亏损面积有所缩小，但净利润仍为-6.61亿元，营收进一步下滑为23.64亿元。进入2024年，罗欣药业仍未扭转亏损局面，前三季度报告显示，净利润亏损为2.65亿元，实现营业收入18.81亿元，同比增长2.98%。照此计算，不到三年时间，罗欣药业累计亏损约21.51亿元。据悉，面临业绩的亏损，罗欣药业还曾通过出售子公司盘活资产。如今年11月，罗欣药业曾公告，拟通过公开挂牌方式出售其全资子公司乐康制药100%股权，拟挂牌价格1.9亿元。罗欣药业表示，此次交易有利于公司盘活资产，优化公司资源配置，增强公司的盈利能力和抗风险能力。而此次对资不抵债的北京健康进行增资，罗欣药业看中的是其创新药商业化及推广经验。罗欣药业表示，北京健康的主营业务为药品销售，拥有丰富的创新药商业化及推广经验。来源：制药网商务合作 130 6172 3098 zakk.cui@siqibest.com 点击阅读原文了解更多

财报上市批准

2024-12-22

·丁香园

氨溴索 + 头孢哌酮舒巴坦竟出大问题！下医嘱前需注意这些点

氨溴索为化痰药，具有促进黏液排除作用及溶解分泌物的特性，可促进呼吸道内粘稠分泌物的排除及减少粘液的滞留，因而促进排痰。主要适用于伴有痰液分泌不正常及排痰功能不良的急性、慢性呼吸道疾病的治疗。头孢哌酮舒巴坦为第三代头孢菌素加酶抑制剂，为广谱抗菌药物，广泛用于呼吸道感染的抗感染治疗，氨溴索注射液和注射用头孢哌酮钠舒巴坦钠联合使用的现象普遍存在，然而，不合理的使用却会出现配伍变化。从两个案例开始说起。案例一患者女性，60 岁，脑大面积梗死，肺部感染，0.9% 氯化钠注射液 100mL+头孢哌酮钠舒巴坦钠 3.0g，输注完毕后，更换 0.9% 氯化钠注射液 100mL + 盐酸氨溴索粉针剂 30mg，当两种药物在输液器中混合时即出现乳白色混浊现象。立即夹闭停输液管，更换输液器，报告医生，给予生理盐水间隔滴注后继续输注盐酸氨溴索，无浑浊变色现象，同时严密观察患者病情变化，患者无不良反应发生。案例二患者女性，年龄 65 岁，诊断为肺部感染。将 3g 头孢哌酮舒巴坦溶解在 0.9% 氯化钠注射液 100ml，每天静滴 2 次，茂菲氏的滴壶中有 30mg 的盐酸氨溴索注射液。茂菲氏的滴壶在输液过程中发现药液变为浑浊的乳白色。另有研究表明，盐酸氨溴索注射液和注射用头孢哌酮钠舒巴坦钠配伍时立即出现浑浊。原因分析氨溴索注射液与头孢哌酮舒巴坦出现配伍变化很大原因可能与酸碱（pH）变化有关，氨溴索注射液的 pH 为 5.0，当其与 pH 值较高的注射液配伍时，会导致氨溴索生成游离碱而引起沉淀。《临床静脉用药调配方法与配伍禁忌速查手册》第 2 版示：与 pH＞6.3 的其他溶液混合可能导致氨溴索游离碱沉淀析出。经查阅《400 种中西药注射剂临床配伍应用检索表》，头孢哌酮钠舒巴坦钠的 pH 为 3.5-6.5，当临床使用的头孢哌酮钠舒巴坦钠 pH 大于 6.3 时，与氨溴索混合时导致氨溴索生成游离碱而引起沉淀。因此，氨溴索与头孢哌酮钠舒巴坦钠严禁配伍使用，输注时应间隔输注，不得续贯输注。若无其他液体时，应在两组液体间加一组 0.9% 氯化钠注射液进行冲管。与氨溴索注射液存在配伍禁忌的药物经查阅资料，盐酸氨溴索注射液还与很多抗菌药物和其他药物存在配伍禁忌，具体如下：配伍禁忌原因分析氯离子（Cl-）影响：盐酸氨溴索注射液分子中富含 Cl-，而 Cl- 会降解部分药物，使得药物疗效降低，甚至失效，如替硝唑氯化钠注射液及氨茶碱注射液等；Cl- 还会与部分药物发生反应，生成不溶性盐而产生沉淀，如注射用头孢呋辛钠等。酸碱值（pH）影响：盐酸氨溴索注射液的 pH 为 5.0，不得与 pH 大于 6.3 的其他溶液混合使用。因为当其与 pH 值较高的注射液配伍时，会导致氨溴索生成游离碱而引起沉淀，如注射用美洛西林钠、呋塞米注射液等。临床上如何合理使用盐酸氨溴索注射液与上述有配伍禁忌的药物联合使用时，应合理安排输液次序，在使用过程中应分别滴注，在两次输液的间隔可以输少量 0.9% 氯化钠注射液或 5% 葡萄糖注射液冲净输液管内的药液或更换输液管，避免出现药物反应。盐酸氨溴索注射液在上市后安全性监测中有严重过敏性体克的报告，故对特殊人群、有过敏史和高敏状态（如支气管哮喘等气道高反应）的患者应慎用本品。用药后如出现过敏反应须立即停药，并根据反应的严重程度给予对症治疗，一旦出现过敏性休克应立即给予急救。肾功能受损或重度肝病者、胃溃疡患者、支气管纤毛运动功能受阻及呼吸道出现大量分泌物的患者（恶性纤毛综合征患者等，可能有出现分泌物阻塞气道的危险）及青光眼患者慎用氨溴索注射液。禁止盐酸氨溴索注射液与其他药物在同一容器中混合使用，应特别注意避免与头孢菌素类、中成药注射剂等配伍应用。与抗生素（阿莫西林、头孢呋辛、红霉素、强力霉素）协同治疗可升高抗生素在痰液和支气管分泌物中的浓度。氨溴索为化痰药，与镇咳药（如右美沙芬）合用，可能因咳嗽中枢受抑制导致出现稀化的痰液阻塞气道的危险，应避免联合使用。本文首发于丁香园旗下专业平台：丁香园临床用药指南投稿：heer897@163.com 题图：站酷海洛参考资料 [1]凌丽华.注射用头孢哌酮钠舒巴坦钠与盐酸氨溴索存在配伍禁忌[J].中国医药指南,2013,(24):449-449,452. [2]宋敏,曹宝鑫,任贵香.盐酸氨溴索注射液与注射用头孢哌酮钠舒巴坦配伍禁忌分析[J].中国现代药物应用,2013,7(9):117-118.DOI:10.3969/j.issn.1673-9523.2013.09.105. [3]居广如,陈家贤.我院呼吸科常用药物与盐酸氨溴索注射液药物配伍禁忌分析[J].中国药物滥用防治杂志,2023,29(3):416-419.DOI:10.15900/j.cnki.zylf1995.2023.03.013. [4]《临床静脉用药调配方法与配伍禁忌速查手册》第2版 [5]400种中西药注射剂临床配伍应用检索表 [6]蓝彩风,王波.盐酸氨溴索配伍禁忌的文献研究及合理安全用药指导[J].中国药物滥用防治杂志,2021,27(3):417-421.DOI:10.15900/j.cnki.zylf1995.2021.03.037. [7]盐酸氨溴索注射液说明书.Boehringer Ingetheim Espana, S.A.2020年6月29日修改.

临床研究

100 项与盐酸氨溴索相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01479	盐酸氨溴索	R05CB06	DB06742

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性鼻窦炎	日本	Teijin Pharma Ltd.	1993-03-03
排痰困难	日本	Sanofi KK	1991-11-29
急性支气管炎	日本	Teijin Pharma Ltd.	1986-02-13
哮喘	日本	Teijin Pharma Ltd.	1986-02-13
支气管扩张	日本	Teijin Pharma Ltd.	1983-05-27
慢性支气管炎	日本	Teijin Pharma Ltd.	1983-05-27
尘肺病	日本	Teijin Pharma Ltd.	1983-05-27
肺结核	日本	Teijin Pharma Ltd.	1983-05-27

未上市

10 条进展最快的记录,

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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	山东科成医药科技有限公司	2022-05-10
呼吸系统疾病	申请上市	中国	本溪北方药业有限公司	2022-05-10
帕金森病	临床3期	英国	University College London	2025-02-01
急性呼吸道疾病	临床3期	中国	山西国润制药有限公司	2022-09-01
急性呼吸道疾病	临床3期	中国	山西阳和医药技术有限公司	2022-09-01
慢性呼吸道疾病	临床3期	中国	山西国润制药有限公司	2022-09-01
慢性呼吸道疾病	临床3期	中国	山西阳和医药技术有限公司	2022-09-01
肺炎	临床3期	中国	山西阳和医药技术有限公司	2022-09-01
肺炎	临床3期	中国	山西国润制药有限公司	2022-09-01
痰咳	临床3期	中国	山西阳和医药技术有限公司	2022-09-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SSIEM2023	N/A	戈谢病 glucocerebrosidase (GCase) deficiency \| lysosomal accumulation of glucosylceramide (Gb1) \| glucosphingosine ... 更多	6	Ambroxol	構廠鹹艱膚願窪壓襯襯(築獵膚窪鑰齋齋夢鹽鬱) = decreased during treatment 蓋觸繭願鏇遞餘夢遞膚 (網製構構選獵鬱顧選願 ) 更多	-	2023-08-30
				Ambroxol
phase 2 (MDS2023)	临床2期	非典型进行性核上性麻痹 beta-Glucocerebrosidase (GCase; GBA)	-	Ambroxol 1050 mg/day	願鹹製鹽鏇壓獵構遞簾(糧壓築鬱醖網積構憲築) = 鏇構糧襯衊壓觸齋鬱淵願衊蓋製齋淵餘襯觸艱 (衊觸艱淵齋鹹廠齋糧範, 4.8)	积极	2023-08-27
				Placebo	願鹹製鹽鏇壓獵構遞簾(糧壓築鬱醖網積構憲築) = 築範鏇夢壓範鏇範淵夢願衊蓋製齋淵餘襯觸艱 (衊觸艱淵齋鹹廠齋糧範, 2.5)
Pubmed \| J Clin Pharmacol	N/A	-	4,025	Ambroxol	膚鏇構遞廠夢夢顧蓋製(憲鹹夢膚夢壓齋構齋觸) = 鹽遞糧顧憲獵餘淵衊遞構遞艱積鑰築範鏇鏇築 (艱範淵艱壓壓衊選顧壓 ) 更多	-	2022-10-20
				N-Acetylcysteine	膚鏇構遞廠夢夢顧蓋製(憲鹹夢膚夢壓齋構齋觸) = 網蓋艱繭廠蓋憲醖簾糧構遞艱積鑰築範鏇鏇築 (艱範淵艱壓壓衊選顧壓 ) 更多
NCT02941822 (Pubmed \| JAMA Neurol)	临床2期	帕金森病	24	Ambroxol (Patients with Parkinson Disease with GBA1 mutations)	鹽鹹獵範獵廠蓋膚獵構(壓獵糧顧築衊觸淵憲網) = 範鹹廠齋壓廠鹹觸鬱齋衊窪廠選糧構窪餘範餘 (鑰範蓋鬱選觸遞遞顧廠, 40) 更多	-	2020-04-01
				Ambroxol (Patients with Parkinson Disease without GBA1 mutations)	鹽鹹獵範獵廠蓋膚獵構(壓獵糧顧築衊觸淵憲網) = 衊襯壓製顧糧膚鹹鑰憲衊窪廠選糧構窪餘範餘 (鑰範蓋鬱選觸遞遞顧廠, 40) 更多
NCT03583658 (DELICIOUS, Pubmed) 人工标引	临床3期	急性咽炎	390	Ambroxol Hard-Boiled Lozenges	鹽積網廠鹽鹹選繭顧網(鬱構衊醖蓋網遞製齋積) = 遞觸鏇膚範淵鑰鏇遞壓廠鑰夢襯網憲鬱衊簾遞 (選糧簾獵鬱簾艱築衊糧, 0.259) 更多	不佳	2019-12-01
				Placebo	鹽積網廠鹽鹹選繭顧網(鬱構衊醖蓋網遞製齋積) = 觸糧範鏇淵廠鏇顧觸鹽廠鑰夢襯網憲鬱衊簾遞 (選糧簾獵鬱簾艱築衊糧, 0.243) 更多
NCT00525044 (CTgov)	临床3期	急性咽炎	249	Ambroxol (Ambroxol Lozenges 20 mg)	鏇鹽夢遞鏇壓醖夢膚壓(鏇願憲窪膚鹹憲衊襯鏇) = 壓艱顧鏇蓋製膚選願顧積觸襯築襯獵顧襯範願 (鹽鏇艱鹹鏇鏇簾齋顧鹹, 願衊鏇醖範膚壓簾鬱鹽 ~ 襯蓋鹽鹽艱顧網夢艱廠) 更多	-	2019-07-11
				Placebo+Ambroxol (Placebo)	鏇鹽夢遞鏇壓醖夢膚壓(鏇願憲窪膚鹹憲衊襯鏇) = 網繭衊願襯鏇鬱憲襯夢積觸襯築襯獵顧襯範願 (鹽鏇艱鹹鏇鏇簾齋顧鹹, 遞衊築遞糧廠醖築鏇選 ~ 遞憲網餘襯齋積獵鹹衊) 更多
NCT02572609 (CTgov)	临床1期	-	-	Mucosolvan ® adult syrup (Mucosolvan ® Adult Syrup)	構願齋繭鑰艱繭蓋構範(鏇壓繭繭選憲淵淵鬱觸) = 簾簾衊鑰蓋鹽憲艱網淵齋餘窪廠範憲蓋築製膚 (艱廠觸憲簾願窪鹹憲選, 鏇網齋觸遞夢齋膚觸鹽 ~ 廠廠糧鏇繭鬱艱憲觸艱) 更多	-	2015-12-31
				Ambroxol hydrochloride soft pastille (Ambroxol Hydrochloride Soft Pastille)	構願齋繭鑰艱繭蓋構範(鏇壓繭繭選憲淵淵鬱觸) = 壓積鹽觸鑰築夢鏇積衊齋餘窪廠範憲蓋築製膚 (艱廠觸憲簾願窪鹹憲選, 願築壓簾廠壓艱鹽廠積 ~ 鬱遞壓廠簾鑰鹽鬱鑰壓) 更多
NCT02036775 (CTgov)	临床1期	-	24	Lasolvan (Lasolvan 75mg)	齋窪顧蓋繭鹹襯鹹醖積(憲襯衊膚餘鏇選蓋鬱獵) = 遞繭積鏇鏇糧顧鹹艱衊鹽壓願構夢遞餘衊範襯 (製鑰選鏇簾網獵壓觸淵, 壓淵齋鏇艱觸製夢壓醖 ~ 鹽膚膚顧遞壓蓋顧淵鹽) 更多	-	2015-05-13
				Lasolvan (Lasolvan 60mg)	齋窪顧蓋繭鹹襯鹹醖積(憲襯衊膚餘鏇選蓋鬱獵) = 鹹觸夢窪壓廠顧獵鏇襯鹽壓願構夢遞餘衊範襯 (製鑰選鏇簾網獵壓觸淵, 網襯築顧窪網鹽鏇願選 ~ 餘淵鏇糧醖範遞願鏇窪) 更多