更新于：2024-11-15
Bromhexine Hydrochloride
盐酸溴己新
更新于：2024-11-15
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
37
项与 盐酸溴己新 相关的临床试验盐酸溴己新片生物等效性试验
盐酸溴己新片在健康研究参与者中的单剂量、随机、开放、交叉、两周期空腹和餐后人体生物等效性试验
Fasted-state in vivo bioequivalence study of Bromhexine 8 mg tablet manufactured by AaniDarman compared with innovator product
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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513
项与 盐酸溴己新 相关的文献（医药）2024-12-01JOURNAL OF TRACE ELEMENTS IN MEDICINE AND BIOLOGY
Bidentate bromhexine drug coordination modes with various transition metal ions: Synthesis, characterization, and in vitro antibacterial and anti-breast cancer activity tests
Article
作者: Mahmoud, Nessma Fathi ; Omar, Norhan Refaie ; Sayed, Fatma Nabil ; Mohamed, Gehad Genidy
BACKGROUND:
Bromhexine (BHX) is a mucolytic drug used in treatment the respiratory disorders which are associated with excessive or viscid mucus. Transition metal complexes have made tremendous progress in the treatment of a variety of human ailments, according to reported articles. Transition metal complexes are being developed as medications with a lot of effort. Metal complexes can form a variety of coordination geometries, giving them distinct forms. So, binary metal complexes of bromhexine drug have been prepared to enhance the biological activity and stability of the free drug.
METHODS:
A new series of binary complexes with bromhexine drug (BHX) has been prepared with some transition metal ions namely Cr(III), Mn(II), Fe(III), Co(II), Ni(II), Cu(II), Zn(II), and Cd(II). Elemental analyses, FT-IR, mass spectrometry, thermal studies and UV-Vis spectra have been used to characterize and structurally elucidate the produced metal complexes. Antibacterial activity has been tested for the ligand and metal complexes against a variety of pathogenic bacterial species (Bacillus subtilis, Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus). In addition, the ligand has been tested for anticancer efficacy against the MCF-7 breast cancer cell line, as opposed to binary metal complexes. The binding orientation or conformation of the free BHX ligand and Co(II) complex in the active region of the protein of crystal structure of Escherichia coli (PDB ID: 3T88) and Pseudomonas aeruginosa (PDB ID: 6NE0) has been performed using molecular docking studies.
RESULTS:
The BHX ligand coupled in neutral bidentate mode to the metal ions, according to FT-IR and 1H-NMR spectral results. The molar conductivity measurements of the complexes in DMF proved the electrolytic nature of all binary complexes. Co(II) complex showed the highest inhibition zone diameter against S. aureus, E. coli and P. aeruginosa. Zn(II) complex had the greatest inhibitory effect against P. aeruginosa and B. subtilis. Also, Cd(II) chelate appeared high efficacy as antibacterial agent against Pseudomonas aeruginosa and Staphylococcus aureus.
CONCLUSION:
All the output data conjugated to confirm the octahedral geometry of the metal complexes. The biological findings revealed that metal complexes can be more active than the free BHX ligand. Against MCF-7 cell line, Cd(II)-L complex is highly active complex (4.95 µg/mL) but BHX free drug is the most active compound (3.96 µg/mL).
2024-10-01SCIENCE PROGRESS
Development of a rapid method for the simultaneous determination of aminophylline, doxofylline, bromhexine, and ambroxol by HPLC
Article
作者: Feng, Yunxia ; Shi, Ming ; Chen, Fuchao ; Meng, Xia ; Fang, Baoxia
Introduction: Antitussive and expectorant drugs such as aminophylline (APL), doxofylline (DXL), bromhexine hydrochloride (BXH), and ambroxol hydrochloride (AXH), either individually or in combination, are widely used in the prevention and treatment of respiratory diseases. The study aimed to establish a high-performance liquid chromatography (HPLC) method for the simultaneous determination of these four drugs and to investigate their stability in 0.9% sodium chloride injection or 5% glucose injection over 48 hours. Methods: An InertSustain C18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile and 50 mmol·L−1 potassium dihydrogen phosphate solution (pH 4.0) with gradient elution. The flow rate was 0.8 mL·min−1, and the column temperature was maintained at 30°C. The stability of APL, DXL, BXH, and AXH in 0.9% sodium chloride and 5% glucose injections over 48 h was determined using HPLC. Results: APL, DXL, BXH, and AXH showed good linearity within the ranges of 0.01 to 0.20, 0.003–0.06, 0.015–0.30, and 0.016–0.16 mg·mL−1, respectively (r > 0.999). The intraday and interday relative standard deviations were <2%, with recovery rates between 98.4% and 102.2%. The four drugs remained colorless and clear in infusion mixtures. The pH value fluctuated within ±0.3 over 48 hours, and the relative percentage content of the drugs ranged from 95.0% to 105.0%. Conclusion: The established HPLC method is simple, reliable, and stable, allowing for the simultaneous determination of the four antitussive and expectorant drugs. APL, DXL, BXH, and AXH were stable within 48 hours when mixed with 0.9% sodium chloride and 5% glucose injections.
2024-09-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
A drug–excipient interaction impurity of bromhexine hydrochloride injection: Structure and formation mechanism elucidation
Article
作者: Zhou, Min ; Chen, Feng ; Wu, Wei ; Pu, Hong ; Long, Yuande ; Yi, Chaofan
A long-term stability study using high performance liquid chromatography (HPLC) revealed an unidentified impurity in the bromhexine hydrochloride injection, which was employed as a mucolytic agent. Investigations into stress degradation and elemental impurities revealed one of the elemental impurities Fe3+ in this injection as the primary generator of these impurities. This impurity, named N-carboxymethyl bromhexine, was a product formed during drug-excipient interaction between bromhexine and tartaric acid with Fe3+. The structure of the impurity was identified through ultra-high-performance liquid chromatography with diode array detector (UHPLC-DAD), liquid chromatograph mass spectrometer (LC-MS). Further, the formation mechanism of the impurity was discussed. Overall, this study elucidates the cause, origin, and mechanism of an unknown impurity in bromhexine hydrochloride injection, providing a basis for quality control for bromhexine hydrochloride injections and drug products containing both amine and tartaric acid.
100 项与 盐酸溴己新 相关的药物交易
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研发状态
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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) | 顧積願憲齋憲衊鏇築夢(醖艱襯選構繭鹽襯範餘) = 網鑰鹹淵製鬱窪網遞獵 夢遞壓繭憲憲膚積壓繭 (蓋憲製衊繭願鹽積衊鏇, 廠簾願鏇衊膚糧鹹糧淵 ~ 憲觸膚遞範願範艱鏇夢) 更多 | - | 2022-04-13 | ||
(Bromhexine Hydrochloride Group) | 築積範網繭齋膚願網願(願選夢鏇淵願範襯鬱觸) = 積糧淵範鬱願繭簾遞艱 鹽蓋遞積顧鏇網夢憲襯 (夢鏇構壓簾獵範醖顧選, 蓋願襯範鏇範觸壓廠積 ~ 艱衊廠鹽鏇鏇積網選積) 更多 |
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