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PubMed1975

A controlled trial of bromhexine ('Bisolvon') in out-patients with chronic bronchitis.

Bromhexine, 16 mg. 3-times daily, was compared with placebo in a double-blind crossover trial in 41 out-patients with chronic bronchitis and irreversible airways obstruction, and who were considered to be in a steady state. Each treatment was given for 3 weeks with a week of placebo in between; in addition, all patients took oxytetracycline, 500 mg. twice daily, starting 1 week before the trial and continuing throughout the duration of it. All patients completed the trial but the results from 5 were excluded because during the first 3 weeks they developed an influenza-like illness accompanied by a decrease in FEV1,and peak expiratory flow rate. Results from the remaining 36 patients showed a statistically significant reduction in phlegm stickiness (p smaller than 0.05) as judged by the patient, and a significant improvement in overall clinical state (p smaller than 0.05) as judged by the physician during bromhexine treatment, but no significant change in symptoms like cough, chest tightness, ease of breathing or sputum volume, peak expiratory flow rate and FEV1 etc. Five patients reported 6 side-effects, 3 with bromhexine, 1 with placebo and 1 with both treatments.

Adult↗
PubMedDate not supplied

The effect of bromhexine on albumin excretion in insulin dependent diabetes.

The effect of the mucolytic agent bromhexine, 72 mg daily for one month, on albumin excretion in insulin dependent diabetes was investigated in a double-blind, randomised, cross-over, placebo-controlled study. Nine patients with normal albumin excretion [overnight albumin excretion rate 3.2 (2.1-8.8) micrograms/min.; mean (range)], six with microalbuminuria [36 (22-95) micrograms/min.] and six with macroalbuminuria [321 (201-1215) micrograms/min.] participated. Albumin excretion was similar after treatment with bromhexine and placebo in all 3 groups [normoalbuminurics 3.6 (1.7-13.5) versus 3.3 (1.9-13.2) micrograms/min.; microalbuminurics 40 (20-128) versus 37 (20-103); macroalbuminurics 396 (247-2160) versus 443 (292-2592)]. Excretion of beta 2-microglobulin and creatinine clearance were identical at the end of each treatment. Blood glucose control and blood pressure remained constant throughout the study in the 3 groups. We conclude that bromhexine 72 mg daily for 1 month had no effect on albumin excretion in IDDM patients with normal and pathological albuminuria.

Adult↗
PubMed1987

Deposition and clearance of monodisperse aerosols in the calf lung: effects of particle size and a mucolytic agent (bromhexine)

Mucociliary clearance and retention of monodisperse aerosols of radiolabelled polystyrene particles of both 3.3 microns and 5 microns diameter were investigated in four healthy calves and two sick calves. The effect of the mucolytic agent bromhexine was also assessed at two dosage levels. There were significant differences (P less than 0.05) in clearance rate constant between calves, but similar patterns of clearance for each calf. These characteristics of mechanical lung clearance did not vary over a two month period. Values of clearance rate constant and percentage retention varied significantly (P less than 0.001) between the two different particle sizes, 5 microns particles giving faster clearance and lower retention of particles than 3.3 microns particles. Bromhexine at the recommended dose of 1.6 mg/kg 0.75 caused a significant (P less than 0.05) increase in clearance rate in both healthy and sick calves, but affected percentage retention only in sick calves. This study illustrates the variation in mucociliary clearance rates shown by individuals and also underlines the importance of particle size in aerosols used for studies of pulmonary deposition and clearance. The work also indicates that bromhexine may be of use in the therapy of respiratory disease in calves.

Aerosols↗
PubMed1987

In-vitro and in-vivo formation of N-nitrosomethylcyclohexylamine from bromhexin and sodium nitrite, and DNA methylation in rats.

After oral administration of a commercial bromhexin (N-methyl-N-cyclohexyl(2-amino-3,5-dibrombenzyl)ammonium chloride) solution (1-90 mg/kg) together with sodium nitrite (1-90 mg/kg) to female Wistar rats, ring-hydroxylated metabolites of N-nitrosomethyl-cyclohexylamine (NMCA) were excreted in urine as glucuronide/sulfate conjugates. When [14C-methyl]-bromhexin (30 mg/kg) was given intragastrically together with sodium nitrite (30 mg/kg), alkylated DNA adducts were detected in liver and oesophagus. Gastric juice of 75 healthy human volunteers (fasted, then ingesting up to 200 mg nitrate) was incubated in vitro with bromhexin (16 mg/100 ml). In only one sample, 50 ng NMCA/100 ml were formed.

Administration, Oral↗
PubMed1985

[Effect of bromhexine on microthrombosis in animal experiments].

The secretolytic agent bromhexine and its active metabolite ambroxol prevent the collagen- and ADP-induced decrease in circulating blood platelets in rabbits, while they do not inhibit the aggregation induced by ADP, collagen or arachidonic acid of human and rabbit blood platelets in vitro. Bromhexine was found to exert beneficial effects on the disturbances of pulmonary function that might be caused by a reduced surfactant production observed during thrombin-induced disseminated intravascular coagulation in rats. The results suggest that bromhexine has a protective effect on the acute impairment of pulmonary function due to microthrombosis.

Adenosine Diphosphate↗
PubMed1983

The effect of bromhexine on experimentally induced diabetic nephropathy.

Diabetes was induced in male Wistar rats by a single i.v. injection of streptozotocin (40 mg/kg). Animals were treated with bromhexine at 2 dose levels (2.5 mg/kg/day and 25 mg/kg/day) for 13 months thereafter and compared to non-diabetic controls and untreated diabetic animals. Renal pathology showed a significant increase in glomerular volume and basement membrane thickening in untreated diabetic animals. The higher dose bromhexine treated diabetic animals showed a significant decrease in glomerular volume as compared with diabetic animals not given bromhexine.

Animals↗
PubMed1982

[Effect of a secretolytic agent (bromhexine) on the penetration of erythromycin into bronchial secretions].

The authors report the results of a double blind study in 22 patients on the penetration of erythromycin into bronchial secretion. The antibiotic erythromycin was administered in combination with bromhexine, which is known to disrupt mucopolysaccharide fibers in respiratory secretions. The objective of the study was to demonstrate the possible increase of the rate of penetration of erythromycin when combined with bromhexine. The study was carried out in a double blind experiment; bronchial secretions were obtained from patients with bronchial hypersecretion by means of fiberoptic bronchoscopy. The assessment of erythromycin concentrations in all samples was performed by means of microbiological agar diffusion method. The results of the investigation show a significant increase of the ratios between bronchial levels and simultaneous serum concentrations of erythromycin when administered in combination with bromhexine. The results of this preliminary study suggest the continuation of similar investigations with other antibiotics usually administered for the treatment of respiratory infections.

Bromhexine↗
PubMed1994

[Skin reactions attributed to the use of bromhexine].

Since 1972, the Netherlands Centre for Monitoring of Adverse Reactions to Drugs has received 22 reports of skin reactions attributed to use of bromhexine. The reports concerned II men and II women. The ages ranged between 5 months and 88 years. The skin reactions occurred within one to 30 days after starting the use of bromhexine. Most skin reactions consisted of generalised urticaria. Other reports concerned once an angioedema and once an anaphylactic reaction. Most patients recovered completely after cessation of bromhexine without further treatment.

Adolescent↗
PubMed1980

Electron-capture GLC determination of bromhexine in human plasma.

A specific and sensitive GLC analysis of bromhexine in human plasma is described. After addition of the internal standard and an aqueous triethanolamine solution, bromhexine is extracted at alkaline pH into n-hexane, transferred to an acidic aqueous solution, and back-extracted into n-hexane after alkalinization. Both compounds are derivatized with trifluoroacetic anhydride and quantified by GLC using , 63Ni-electron-capture detector. The method has a sensitivity of approximately 1.0 ng/ml of plasma. Linearity of plasma working curves was good. The extraction recovery from spiked plasma was 90.1 +/- 5.68% (SD). The within-run and within-day precisions (CV) were 6.0% (4.3 ng/ml, n = 8) and 8.6% (11.0 ng/ml, n = 13), respectively. The procedure was applied successfully to measurement of the plasma concentration-time profile in a human volunteer after oral drug administration.

Bromhexine↗
PubMedDate not supplied

Automatic determination of amylocaine and bromhexine by atomic absorption spectrometry.

An automatic method for the determination of amylocaine and bromhexine hydrochloride by atomic absorption spectrometry (AAS) is proposed. The drugs were determined indirectly by formation of reineckates, extraction into 1,2-dichloroethane and measurement of chromium in the organic phase. The chemical conditions and experimental variables influencing the performance of the flow system of the liquid-liquid extractor were established. The proposed method allows the determination of amylocaine and bromhexine at concentrations between 3 and 120 micrograms ml-1 with a relative standard deviation of 1 and 3%, respectively, even in the presence of other synthetic drugs.

Autoanalysis↗
PubMed2006

Kinetics of bromhexine-mediated down-regulation of focal adhesive molecules of uterus and trophectoderm affecting conception in the rat.

PURPOSE: Quantitative evaluation of properties of bromhexine (B) for expression of uterine proteins in ovariectomized (OVX) and pregnant rats. MATERIALS AND METHODS: Expression of proteins through SDS-PAGE, along with incorporation of glycosidic moieties, was conducted in pregnant and OVX rats under B influence. These findings were corroborated with other tests such as implantation sites, fetal and litter sizes in pregnant rats. RESULTS: In OVX animals, even under the influence of estradiol dipropionate and progesterone, the B recreated a condition akin to OVX animals. It also induced 50-80% inhibition in the incorporation of glycosidic moieties to polypeptide chain. Distinct reduction in implantation sites, fetal sizes and interference in the conception (16/46) in pregnant rats substantiated the results of the action of B as an antiimplantation agent. CONCLUSION: Bromhexine has shown interference in blastocyst attachment, conception, reduction in number of implantation sites and dwarfing of fetuses; hence, it is a potential candidate for antiimplantation.

Animals↗
PubMed1982

Assay of bromhexine in human plasma by capillary gas--liquid chromatography with nitrogen-selective detection and selected ion monitoring.

A specific, sensitive method for the determination of bromhexine in human plasma is described. It comprises a selective extraction procedure and a specific determination with capillary gas--liquid chromatography and nitrogen-selective flame ionization detection. The detection limit of the assay is about 0.5 ng/ml. The specificity of the assay was checked by gas chromatography--mass spectrometry. The method is applied to the pharmacokinetics of bromhexine in humans.

Adult↗
PubMed1988

Determination of bromhexine in plasma by reversed-phase liquid chromatography. Interference of lipoproteins on extraction.

Extraction of the hydrophobic tertiary amine bromhexine from plasma using cyclohexane-heptafluorobutanol (99.5:0.5, v/v) was studied at different pH values. The extraction yield from buffer solutions was quantitative at pH greater than 4.1, but from plasma the extraction yield decreased with increasing pH. Furthermore, at pH 8.4 the extraction yield varied greatly (56-99%) in different human plasma. The addition of lipoproteins to phosphate buffer, at pH 8.1, decreased the extraction yields considerably. Quantitative extraction from plasma was obtained by using a very long extraction time at pH 8.4 or by decreasing the pH to 5.4. The chromatographic system consisted of a reversed-phase column (Nucleosil C18, 5 microns) with an acidic mobile phase (methanol-phosphate buffer, pH 2) containing an aliphatic tertiary amine. UV detection at 308 or 254 nm was used. The limit of quantitation was 5 ng/ml using 3.00 ml of plasma and detection at 254 nm. The intra-assay precision for bromhexine was better than 3.6% at 5 ng/ml.

Bromhexine↗
PubMed1997

Determination of bromhexine and ambroxol in pharmaceutical dosage forms, urine and blood serum.

Data presented in this paper show that bromhexine and its pharmacologically active metabolite can easily be determined by capillary zone electrophoresis. The composition of the running buffer had a significant effect on the reproducibility of the migration time for which a carrier solution containing 30 mM phosphate buffer (pH 3.0), 5 M urea and 10% (v/v) acetonitrile was used. The method was validated with respect to its response linearity and reproducibility. The method is suitable for the determination of bromhexine and ambroxol in several samples such as pharmaceuticals, urine and serum. Photodiode-array detection permitted the rapid identification of both drugs in the sample analyzed.

Ambroxol↗
PubMed2003

Simultaneous high-throughput determination of clenbuterol, ambroxol and bromhexine in pharmaceutical formulations by HPLC with potentiometric detection.

Potentiometric detection of clenbuterol, ambroxol and bromhexine in marketed pharmaceuticals was described in six isocratic HPLC systems. The podant- and macrocyclic-type neutral ionophores, N,N,N',N'-tetracyclohexyl-oxybis(o-phenyleneoxy)diacetamide (TOPA) and hexakis(2,3,6-tri-O-octyl)-alpha-cyclodextrin (OCD), were applied in poly(vinyl)chloride (PVC)-based liquid membrane electrodes. Both types of neutral ionophores improve the sensitivity for all mentioned drugs when compared with a tetrakis(p-chlorophenyl)borate (BOR)-based electrode as well as with single wavelength UV detection. Detection limits (S/N=3) of 2.6 x 10(-10) mol l(-1) (injected concentration) for the highly hydrophobic bromhexine were achieved with the TOPA-based electrode and a cyano reversed-phase (RP)-HPLC with Uptisphere UP5CN-25QS silica column (250 x 4.6 mm i.d.) eluted with acetonitrile (AcN)-ethanol-perchloric acid (1.66 mM) (60:2:38, v/v/v) (pH* 2.45). Comparable result was obtained with OCD-based electrodes and an XTerra RP18 hybrid silica-polymer column eluted with AcN-phosphoric acid (20 mM) (25:75, v/v) (pH* 2.60). In the mobile phases containing 60-75% v/v AcN or methanol, stable and reproducible response of both types of neutral ionophore-based electrodes was observed for at least 3 days. The results of the validated procedure for reliable simultaneous determination of the drugs in fortified representative samples of pharmaceuticals were also presented.

Ambroxol↗
PubMed1998

Simultaneous determination of dextromethorphan HBr and bromhexine HCl in tablets by first-derivative spectrophotometry.

A rapid, simple and direct assay procedure based on first-derivative spectrophotometry, using a zero-crossing and peak-to-base measurement at 234 and 324 nm, respectively, has been developed for the specific determination of dextromethorphan HBr and bromhexine HCl in tablets. Calibration graphs were linear with the correlation coefficients of 0.9999 for both analytes. The limit of detections were 0.033 and 0.103 microgram ml-1 for dextromethorphan HBr and bromhexine HCl, respectively. A HPLC method has been developed as the reference method. The results obtained by the first-derivative spectrophotometry were in good agreement with those found by the HPLC method.

Antitussive Agents↗
PubMed1995

Use of ambroxol and bromhexine as mucolytics for enhanced diffusion of furaltadone into tracheobronchial secretions in broilers.

1. Ambroxol and bromhexine were evaluated as mucolytics and to enhance the passage of furaltadone into tracheobronchial secretions (TBS) in chronic complicated respiratory disease-affected broilers. 2. Viscosity of TBS was noticeably increased in the ambroxol-treated birds and only slightly increased in the bromhexine groups; however, the physical (nature) of TBS was superior in the ambroxol-treated broilers. 3. There was a clear increase in the passage of furaltadone into tracheobronchial secretions only in the ambroxol-treated birds. 4. Everyday use of ambroxol in broilers is discussed.

Ambroxol↗
PubMed2004

Metabolism of bromhexine in pig hepatocyte cultures.

The metabolism of bromhexine [N-cyclohexyl-N-methyl-2-(2-amino-3,5-di-bromo-benzyl)-amine] was studied using pig hepatocyte cultures and LC/MS/MS techniques. Phase I 'single-step' reactions, i.e. hydroxylation and demethylation occurred the fastest whereas the formation of hydroxylated/demethylated and aminal hydroxylated metabolites, which can be considered as multiple-step reactions, occurred more slowly. Phase II conjugates were detected for all hydroxylated metabolites. The glucuronides of the hydroxylated/demethylated components tended to accumulate. In addition to metabolites known to be formed in vivo, three unknown components related to bromhexine were detected. Two of these metabolites accumulated during incubation. Based on the fragmentation patterns, a possible molecular structure is proposed for these components.

Animals↗