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At least 19 recordsLinked to original sources
PubMed1992

Interaction between polyethylene films and bromhexine HCl in solid dosage form. V. Effect of packaging materials on the sorption of bromhexine HCl.

A prevention method of the sorption of bromhexine HCl to plastic materials used in packaging was investigated. Four kinds of plastic packaging materials were used: Polyethylene (PE), polyethylene terephthalate (PET), polypropylene (PP) and polyacrylonitrile (PAN). Three polyethylenes having different densities were used. No effect of PE density on the sorption of bromhexine HCl from granules was observed. The effects of different kinds of plastics on the sorption of bromhexine HCl from solution and granules were studied. The sorption of bromhexine HCl to PAN, which had a high relative dielectric constant, was the most depressed among the four plastics. The sorption of meclizine HCl to PAN from the solution was also lowest, the same as bromhexine HCl.

Acrylic Resins↗
PubMed1977

[Prevention and therapy of respiratory distress syndrome in premature infants by means of bromhexine metabolite VIII. Animal experimental studies on the therapeutic efficacy of bromhexine metabolite VIII in premature respiratory distress syndrome].

In preparing a clinical study 14C-labelled bromhexine metabolite VIII was applied intraamnially in animal experiments. The distribution was measured in different maternal and fetal organs by thinlayer chromatography and autoradiography. A complete placental passage was found in both directions. An organspecific accumulation in the fetal lungs could not be demonstrated.

Ambroxol↗
PubMed1992

Interaction between polyethylene films and bromhexine HCl in solid dosage form. IV. Prevention of the sorption by addition of magnesium aluminum silicate.

The effects of magnesium aluminum silicate (MAS) addition on the sorption of bromhexine HCl to polyethylene film in tablets were studied. The addition of MAS prevented the sorption of bromhexine HCl to polyethylene film. In order to investigate the mechanism, the interaction between bromhexine HCl and MAS was studied by the powder X-ray diffraction method. It was observed that bromhexine HCl was preferentially adsorbed to the surface of MAS rather than to polyethylene film. The adsorption was accelerated at high temperature and reduced pressure conditions. The sorption of bromhexine base and bromhexine HCl to packaging material were compared using tablet dosage forms. The sorption of bromhexine base to polyethylene film was greater than that of bromhexine HCl.

Aluminum Compounds↗
PubMed1978

Sjörgren's syndrome treated with bromhexine: a randomised clinical study.

Existing treatment for Sjögren's syndrome is unsatisfactory, and uncontrolled observations have suggested that bromhexine may be effective. Twenty-nine patients with Sjögren's syndrome were therefore assigned to two randomised double-blind crossover trials with bromhexine and placebo, each comprising two two-week periods. In the first trial bromhexine 24 mg/day was given by mouth; in the second the dose was increased to 48 mg/day. After each treatment period the Schirmer test response, break-up time, Bijsterveld score, and the time taken for the patient to eat a dry biscuit were recorded, as well as the patient's estimate of moistness in the eyes and mouth. In the second (higher-dose) trial values on the Schirmer test were significantly higher after bromhexine than after placebo and the break-up time was also increased after bromhexine, which suggested that the drug has a dose-dependent effect on lacrimal gland secretion in Sjögren's syndrome. It had no effect on salivary gland function. Bromhexine is therefore valuable in the treatment of Sjögren's syndrome.

Bromhexine↗
PubMed1975

Effect of bromhexine on the incidence of postoperative bronchopneumonia after upper abdominal surgery.

The incidence of postoperative bronchopneumonia in 70 patients undergoing upper abdominal surgery who received intramuscular and oral bromhexine after operation for 5 days was 25% (8 of 32), compared with 34% (13 of 38) in a control group, but this difference in favour of bromhexine does not reach statistical significance. All patients had postoperative physiotherapy. However, in a high-risk group (patients who smoked more than 10 cigarettes a day, who admitted to a productive cough before the operation and in whom the forced expiratory volume as a percentage of the forced vital capacity was less than 70) the incidence of postoperative bronchopneumonia in those who had bromhexine was 6 of 17 compared with 9 of 15 in the controls. Thus bromhexine for the prevention and treatment of postoperative bronchopneumonia in high-risk patients after upper abdominal surgery deserves further study.

Adult↗
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↗
PubMed1978

Bromhexine in severe asthma.

Fourteen patients with acute severe asthma necessitating hospital admission were all treated with a standard therapeutic regimen, and in addition received either bromhexine or placebo (initially intravenously and subsequently orally) double-blind. We were unable to show any significant improvement in the rate of recovery of the bromhexine-treated group, in terms of either arterial blood gases or change in peak expiratory flow rates.

Acute Disease↗
PubMed1978

[Clinical results in the treatment of chronic obstructive bronchitis with ambroxol in comparison with bromhexine (author's transl)].

Preclinical studies of trans-4-[(2-amino-3,5-dibromobenzyl)-amino]-cyclohexanol hydrochloride (ambroxol, NA 872), the metabolite VIII of bromhexine, show that it is superior to the basic substance with respect to its bronchosecretolytic properties. In a double blind study 30 patients suffering from chronic obstructive bronchitis received in randomized order 36 mg bromhexine/d or 45 mg ambroxol/d, each over a period of 4 weeks. The following parameters were studied: mean bronchial flow resistance, forced expiratory volume, static lung volumes, arterial blood gases as well as clinical and laboratory results. Bromhexine was not associated with a change in lung function parameters. Ambroxol was associated with a 25% reduction of the average bronchial flow resistance. The forced expiratory volume improved over the period on the average by 14%. Patients with slight arterial hypoxemia had an increase in the partial pressure of arterial oxygen. The patients found both substances facilitated expectoration. Further studies appear necessary to confirm the improved respiratory performance under the influence of ambroxol.

Adult↗
PubMed1975

[Experimental studies on the question of an adjuvant function of bromhexine].

On a possible adjuvant function of a bronchosecretolytic preparation commercially available, N-cyclohexyl-N-methyl-(2-amino-3,5-dibromobenzyl)-amine-hydrochloride (bromhexine, Bisolvon-R), sensibilization tests on 30 rabbits were undertaken. 5 animals received Bisolvon and human albumin as antigen, 5 rabbits human albumin only, 5 rabbits Bisolvon and human lymphocytes, 5 rabbits human lymphocytes only, 5 rabbits Bisolvon alone, and 5 received neither Bisolvon nor any antigen. The techniques in these studies, such as two-dimensional double immunodiffusion in agar gel, lymphocytotoxicity test, mixed lymphocyte culture test, electrophoresis on cellulose-acetate foil were used as well as histologic preparations. It could be ascertained that sensitizing with human albumin and simultaneous application of Bisolvon led to a higher concentration of antibodies against albumin than did sensitizing with human albumin alone. Rabbits sensitized with human lymphocytes showed no obvious difference in their antibody rates whether they had received Bisolvon or not. This applied to cell mediated antibodies as well as to the rate of cytotoxic antibodies against human lymphocytes. Among the histologic findings of spleen, bone marrow showed the morphologic equivalences expected from xenosensitization. Comparing the results of sensitized rabbits with and without Bisolvon there were no positive differences as to intensity and/or type of reactivity to be seen. Liver and kidney showed no considerable pathologic phenomena with the exception of some cases with coccidiosis in the bile ductuli. Concerning the bronchial mucosa, in all rabbits treated with Bisolvon an increase of mucine enriched goblet cells as well as a hypergranulation of different epithelial cell types could be observed. Moreover in all animals, including the controls, an intense lymphatic infilitration in the subepithelial and submucous area was identified. The increased antibody concentration in the sera of animals from group I compared with that of rabbits from group II is interpreted as an enhancement of cell membrane's permeability effected by bromhexine. By this mechanism, on one hand antigen molecules could be absorbed better, while on the other elimination of molecular antibodies, that means immunoglobulins, from plasma cells could be favoured.

Adjuvants, Immunologic↗
PubMed1977

Increased incorporation of fatty acids into phospholipids of lungs and livers of rabbits under the influence of bromhexine and ambroxol.

The incorporation of lauric acid, palmitic acid and oleic acid into phospholipids of lung and liver has been studied in tissue slices of control rabbits and of rabbits treated with bromhexine or ambroxol in doses of 10 mg/kg. A marked increase (up to 200% of the controls) of palmitic acid incorporation into phosphatidylcholine (lecithin) and phosphatidylethanolamine of the lung was found whereas the incorporation rate of palmitic acid into lecithin and phosphatidylethanolamine of the liver displayed no significant change. The incorporation of lauric acid and oleic acid into lung phospholipids was not accelerated. The observed effects were more marked in short time experiments (analysis 2 h after drug injection) than after treatements for 7 days. It is concluded that the phospholipid synthesis is stimulated by the drugs especially in the lungs. This seems to be of particular interest with respect to the surfactant system of the lung and might have some therapeutic relevance.

Ambroxol↗
PubMed1976

Studies on the formation of cyclohexylamine and N-methylcyclohexylamine from bromhexine in animals and man, and simultaneous determination of cyclohexylamine and N-methylcyclohexylamine by gas chromatography.

In order to detect cyclohexylamine and N-methylcyclohexylamine simultaneously in urine, a gas chromatographic method was developed in which Chromosorb 103 (porous polymer) was found to be suitable as the column packing. The detection limits were 0.1 mug/ml of cyclohexylamine and 0.4 mug/ml of N-methylcyclohexylamine in urine. In tests on animals administered bromhexine, which contains N-methylcyclohexylamine as part of its side-chain, neither cyclohexylamine nor N-methylcyclohexylamine was detected in the urine.

Animals↗
PubMed1978

Surfactant in the amniotic fluid and bromhexine metabolite VIII.

The effect of metabolite VIII of bromhexine on surfactant content in the amniotic fluid was investigated in a double blind study. Administration of 100 and 200 mg NA-872 daily for 5 days to pregnant women ranging in gestational age from 196 to 243 days was not followed by a significant rise in the L/S ratio.

Ambroxol↗
PubMed1979

Determination of bromhexine as its trifluoroacetyl derivative by gas-liquid chromatography with electron-capture detection.

A specific gas-liquid chromatographic method with electron-capture detection is described for the determination of bromhexine at the nanogram level. Structurally analogous internal standards were synthesized and their suitability was investigated, based on their chromatographic properties on different stationary liquid phases. The electron-capture activity of the compounds is increased by trifluoroacetylation. Reaction conditions for this derivatization were studied. Calibration graphs in the range 0-57 ng (in a total of 100 microliters of reaction mixture) showed good linearity.

Bromhexine↗
PubMed1979

Biochemical modifications of pulmonary surfactant after bromhexine derivate injection.

The authors study the influence of bromhexine metabolite VIII on phospholipid and fatty acid composition comparatively to controls. The subcutaneous injection of NA 872 produces on pulmonary surfactant an increase of 43% of total phospholipids. This change in the distribution of phospholipids is shown by the increase of 53% of phosphatidylcholines. A rise of 61.9--74.4% of palmitic acid appears in the phosphatidylcholines of the pulmonary surfactant. It can be noticed that the specific activity of the phosphatidylcholines rises by 31%.

Animals↗
PubMed1975

[Bromhexine residues in calves, pigs, and in the milk of cows].

After several oral applications of N-cyclohexyl-N-methyl-(2-amino-3,5-dibromobenzyl)-aminehydrochloride (bromhexine, Bisolvon-R) to various calves and pigs the residue behaviour was examined. In animals slaughtered immediately after the final application significant amounts of Bisolvon were found. The substance showed a greater affinity to liver and fat tissue whilst, in general, in the muscle tissue, the lungs and kidneys only very small amounts were traceable. In the liver and lungs 3 different metabolites appeared in small quantities. They were partly in conjugated and partly in free form. Within 2 days the amounts greatly decreased and after 7 days at the latest, no residues were traceable; only in the fat of both animal species and in the kidneys of the calves were small quantities of Bisolvon still to be found. Excretion by the milk following oral and parenteral application was also studied. Only traces of Bisolvon were found, which rapidly decreased. Results of the studies show that, neither at a later date of slaughtering nor immediately after the final application, the residues in the animal tissues and in the milk examined present a danger to the health of the human consumer.

Adipose Tissue↗
PubMed1975

The absorption, excretion and metabolic pattern of bromhexine in man after oral and i.v. administration.

The fate of 14C-labelled bromhexine (Bisolvon¿) in man following intravenous and oral administration was studied by investigation of the blood and plasma levels and the excretion profiles. Slight variations observed between the two administration routes are explained by the somewhat different distribution patterns resulting from the different "first path" after oral application (liver) and intravenous injection (tissues).

Administration, Oral↗