更新于：2024-06-20
Bromhexine Hydrochloride
盐酸溴己新
更新于：2024-06-20
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
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) |
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结构
分子式C14H21Br2ClN2 |
InChIKeyUCDKONUHZNTQPY-UHFFFAOYSA-N |
CAS号611-75-6 |
关联
38
项与 盐酸溴己新 相关的临床试验Fasted-state in vivo bioequivalence study of Bromhexine 8 mg tablet manufactured by AaniDarman compared with innovator product
盐酸溴己新颗粒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
The effect of inhaled bromhexine on clinical and laboratory symptoms and COVID-19
100 项与 盐酸溴己新 相关的临床结果
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100 项与 盐酸溴己新 相关的转化医学
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100 项与 盐酸溴己新 相关的专利（医药）
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504
项与 盐酸溴己新 相关的文献（医药）2024-02-01Revista clinica espanola
Evaluation of the efficacy of N-acetylcysteine and bromhexine compared with standard care in preventing hospitalization of outpatients with COVID-19: a double blind randomized clinical trial
Article
作者: Shahbazi, F ; Keramat, F ; Eslami Ghayour, A ; Eslami-Ghayour, A ; Nazari, S
INTRODUCTION AND AIM:
Since its emergence in December 2019, the coronavirus disease caused by the severe acute respiratory syndrome coronavirus 2 has become a global emergency, spreading rapidly worldwide. In response to the early referral of these patients to outpatient health centers, we decided to seek more effective treatments in the early stages of their referral. This study aims to prevent both the progression and deterioration of the physical conditions of COVID-19 patients, reduce the rate of referrals, and mitigate the risks of hospitalization and death.
MATERIAL AND METHODS:
Conducted at Dibaj Therapeutic Center, Hamadan City, Iran, a double-blind randomized controlled trial encompassed 225 COVID-19 patients from April to September 2022. Ethical approval was obtained from Hamadan University of Medical Sciences (Approval No.: IR.UMSHA.REC.1400.957), with the protocol registered in the Iranian Registry of Clinical Trials (Registration No. : IRCT20220302054167N1). In this study, we included patients who tested positive for COVID-19- PCR and were symptomatic, excluding those who were pregnant or had received a COVID-19 vaccine. Patients with oxygen saturation above 92% were allocated to three groups: Group A received N-acetylcysteine, Group B received Bromhexine, and Group C received standard care. Follow-ups on oxygen levels, symptoms, and hospitalization needs were conducted on days 7 and 14, with hospitalized patients monitored for one month post-hospitalization.
RESULTS:
The study found that both N-acetylcysteine and Bromhexine can effectively reduce hospitalization rates and mortality and shorten the duration of hospitalization. The third visit of patients who received N-acetylcysteine showed an increase of 1.33% in oxygen saturation compared to their first visit, and in patients who received Bromhexine, this increase was 1.19%. The mortality rate was 9.33% in the control group and zero in both groups of patients who received medication.
CONCLUSION:
In conclusion, the results of this study indicate that NAC and bromhexine may be effective in the treatment of patients with positive COVID-19, with a lower hospitalization rate, shorter hospitalization, faster recovery time, and reduced mortality compared to the control group.
2023-12-01Pharmaceutical research
Investigating the Impact of Co-processed Excipients on the Formulation of Bromhexine Hydrochloride Orally Disintegrating Tablets (ODTs)
Article
作者: Antosik-Rogóż, Agata ; Wojteczko, Kamil ; Haznar-Garbacz, Dorota ; Kurek, Mateusz ; Woyna-Orlewicz, Krzysztof ; Brniak, Witold ; Strzebońska, Magdalena ; Tatara, Wiktor ; Strózik, Mirosław ; Szafraniec-Szczęsny, Joanna ; Jachowicz, Renata ; Mendyk, Aleksander
Abstract:
Purpose:
Orodispersible tablets (orally disintegrating tablets, ODTs) have been used in pharmacotherapy for over 20 years since they overcome the problems with swallowing solid dosage forms. The successful formula manufactured by direct compression shall ensure acceptable mechanical strength and short disintegration time. Our research aimed to develop ODTs containing bromhexine hydrochloride suitable for registration in accordance with EMA requirements.
Methods:
We examined the performance of five multifunctional co-processed excipients, i.e., F-Melt® C, F-Melt® M, Ludiflash®, Pharmaburst® 500 and Prosolv® ODT G2 as well as self-prepared physical blend of directly compressible excipients. We tested powder flow, true density, compaction characteristics and tableting speed sensitivity.
Results:
The manufacturability studies confirmed that all the co-processed excipients are very effective as the ODT formula constituents. We noticed superior properties of both F-Melt’s®, expressed by good mechanical strength of tablets and short disintegration time. Ludiflash® showed excellent performance due to low works of plastic deformation, elastic recovery and ejection. However, the tablets released less than 30% of the drug. Also, the self-prepared blend of excipients was found sufficient for ODT application and successfully transferred to production scale. Outcome of the scale-up trial revealed that the tablets complied with compendial requirements for orodispersible tablets.
Conclusions:
We proved that the active ingredient cannot be absorbed in oral cavity and its dissolution profiles in media representing upper part of gastrointestinal tract are similar to marketed immediate release drug product. In our opinion, the developed formula is suitable for registration within the well-established use procedure without necessity of bioequivalence testing.
2023-10-01Chemical biology & drug design
Synthesis and preliminary evaluation of benzylaminoimidazoline derivatives as novel norepinephrine transporter ligands.
Article
作者: Zhou, Hang ; Lu, Jie ; Yao, Jingjing ; Zhao, Zuoquan
A series of benzylaminoimidazoline derivatives was synthesized and evaluated for norepinephrine transporter (NET) targeting. Among them, N-(3-iodobenzyl)-4,5-dihydro-1H-imidazol-2-amine (Compound 9) displayed the highest affinity for NET (IC50 = 5.65 ± 0.97 μM). The corresponding radiotracer [125 I]9 was further prepared by copper-mediated radioiodination and evaluated both in vitro and in vivo. The cellular uptake results suggested that [125 I]9 was specifically taken up by the NET-expressing SK-N-SH cell line. Biodistribution studies showed that [125 I]9 accumulated in the heart (5.54 ± 1.24 %ID/g at 5 min p.i. and 0.79 ± 0.08 %ID/g at 2 h p.i.) and adrenal gland (14.83 ± 3.47 %ID/g at 5 min p.i. and 3.87 ± 0.24 %ID/g at 2 h p.i.). The uptake in the heart and adrenal gland could be significantly inhibited by preinjection of desipramine (DMI). These results indicated that the benzylaminoimidazoline derivatives retained affinity for NET, which could provide structure-activity relationship data for further studies.
100 项与 盐酸溴己新 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 急性鼻窦炎 | 临床3期 | 中国 | 2021-07-06 | |
| 慢性支气管疾病 | 临床3期 | 中国 | 2021-07-06 | |
| 慢性鼻窦炎 | 临床3期 | 中国 | 2021-07-06 | |
| 下呼吸道感染 | 临床3期 | 中国 | 2021-07-06 | |
| 气管支气管炎 | 临床3期 | 中国 | 2021-07-06 | |
| 支气管扩张 | 临床3期 | 中国 | 2021-04-07 | |
| 支气管肺炎 | 临床3期 | 中国 | 2021-04-07 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 50 | (Control Group) | 齋壓鑰淵齋襯獵糧蓋鏇(觸衊範窪膚齋齋夢齋膚) = 鑰淵顧選窪積餘構築繭 糧製壓夢衊蓋醖範遞網 (餘鏇築築鹹齋艱築網齋, 選製餘壓壓獵窪觸遞繭 ~ 艱願齋廠襯艱範憲廠選) 更多 | - | 2022-04-13 | ||
(Bromhexine Hydrochloride Group) | 範鏇願積窪窪選廠鹹窪(鹹積觸積構鏇夢願鏇繭) = 鑰憲積網齋觸顧憲憲選 簾願網齋艱鏇艱觸選獵 (簾淵齋餘壓窪淵憲淵淵, 蓋願糧鹹窪艱鹽遞糧憲 ~ 觸糧窪醖獵顧蓋製膚鹽) 更多 |
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