Ambroxol Hydrochloride Research Articles

Development of a rapid method for the simultaneous determination of aminophylline, doxofylline, bromhexine, and ambroxol by HPLC.

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.

The efficacy of nebulized budesonide and ambroxol hydrochloride in treating pediatric community-acquired pneumonia and their impact on clinical characteristics and inflammatory markers

PurposeTo evaluate the therapeutic efficacy of intravenous amoxicillin clavulanate potassium combined with nebulized budesonide and ambroxol hydrochloride in pediatric community-acquired pneumonia (CAP) and its impact across various microbial strains and clinical symptoms. The primary objective of this study is to evaluate the efficacy of intravenous amoxicillin-clavulanate combined with nebulized budesonide and ambroxol hydrochloride in the treatment of pediatric community-acquired pneumonia (CAP), and to analyze their impact on different microbial strains and clinical symptoms. Secondary objectives include assessing the treatment's effect on the improvement of clinical symptoms, hospital stay duration, and the levels of inflammatory markers.DesignProspective, single-center study.MethodsFifty-six children with CAP, aged under 6 years, from Affiliated Maternity and Child Health Care Hospital of Nantong University were included. Patients were treated with conventional therapy and the study medication. Clinical characteristics, microbiological data, symptom improvement, and hospitalization times were analyzed.FindingsYoung children, particularly under 1 year, exhibited a higher incidence of multiple microbial infections and severe clinical manifestations. Treatment with budesonide and ambroxol hydrochloride led to significant clinical improvement across all age groups, with notable efficacy against various pathogens.ConclusionsNebulized budesonide and ambroxol hydrochloride are effective in treating pediatric CAP, offering a promising therapeutic option, particularly for young children with severe presentations.

Comparative Study on the Effect of Different Modes of Administration of Ambroxol Hydrochloride in the Treatment of Pediatric Respiratory Diseases

Objective: To investigate the comparison of the effects of intravenous infusion of Ambroxol Hydrochloride and nebulized inhalation in the treatment of pediatric respiratory diseases. Methods: 188 children with respiratory diseases admitted to the pediatrics department of the hospital from September 2022 to March 2024 were selected as the study subjects, and were randomly divided into the control group (n = 41) and the observation group (n = 41) according to the random number table method. Both groups of patients were first treated with conventional treatment, and based on conventional treatment, the control group was treated with intravenous infusion of Ambroxol Hydrochloride, and the observation group was treated with nebulized inhalation of Ambroxol Hydrochloride. The general information, clinical symptom improvement time, oxygen therapy time, sputum aspiration frequency, hospitalization time, and the occurrence of adverse reactions were observed in the two groups. Results: The baseline data of the two groups of patients were not statistically significant (P &gt; 0.05); the disappearance time of clinical symptoms such as cough, lung rales, and shortness of breath in the observation group was shorter than that in the control group (t = 8.739, t = 10.108, t = 19.448, P &lt; 0.001); the time of oxygen therapy, number of sputum aspirations, and hospital stay of the patients in the observation group were significantly shorter than that of the control group (t = 10.593, t = 10.665, t = 14.673, all P &lt; 0.001); the total incidence of adverse reactions in patients in the observation group (3/3.18%) was significantly lower than that in the control group (14/14.89%) (x2 = 7.825, P = 0.005 &lt; 0.01). Conclusion: In the treatment of pediatric respiratory diseases with Ambroxol Hydrochloride, nebulized inhalation has better efficacy than intravenous drip, and can better improve the clinical symptoms and reduce the side effects in children.

Tissue Dissolution Ability of Sodium Hypochlorite, EDTA, Ambroxol Hydrochloride and Triphala Evaluated and Compared when used as an Irrigant on Bovine Pulp Tissue

Aim: The aim of the study is to evaluate pulp tissue dissolution ability of Sodium hypochlorite (NaOCl), Ethylenediaminetetraacetate (EDTA), Ambroxol hydrochloride and Triphala.  Methods: Pulp tissue of BOS Taurus primigenius was extracted from 20 mandibular incisors of 4 bovine jaws .Decoronation was done at the cementum–enamel junction and roots were resected at a length of 3 mm from the apex with a diamond disc connected to a electric micromotor. Pulp tissue was then taken out of the pulp chamber of the bovine tooth with a periodontal probe and cotton pliers. Specimens were weighed using a hermetic precision electronic balance (AND Company LTD) before the test to analyze the initial weight (T0) of the samples. Extracted bovine pulp tissue specimens were weighed and randomly distributed in to 4 experimental groups of 3% sodium hypochlorite, 17% EDTA, Ambroxol hydrochloride(35mg/ml), Triphala(100mg/ml) that were taken in 4 centrifugation tubes. Contents are filtered and undissolved tissue remnants collected and reweighed.  Results: Results obtained indicate that highest pulp dissolution is for NaOCl, followed by EDTA, Ambroxol Hydrochloride and least for Triphala.  Conclusion: Highest pulp dissolution is for NaOCl, followed by EDTA, Ambroxol Hydrochloride and least for Triphala.

Prospective,multi-center,and large-scale hospital centralized monitoring of clinical safety of Reduning Injection in 100249 children cases

This study utilized a prospective, large-sample, multi-center, and registered key specialty approach of hospitals to monitor the application of Reduning Injection. A total of 100 249 adolescent patients aged 14 years and below who received Reduning Injection were monitored, resulting in 83 cases of adverse events, with 76 of them being classified as adverse drug reaction(ADR). The calculated incidence rate of ADR for Reduning Injection was 0.076%, indicating a very rare ADR. The main symptoms of ADR were pruritus, diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsion, and chills. All ADR cases were reported for the first time, including three new ADR cases and 73 known ADR cases. The categories of ADR was general ADR. All ADR was mild in severity. There were more males than females in ADR patients. One patient had a history of ADR, and the drug causing ADR was buprofen. The largest number of ADR cases occurred when the dosage of Reduning injection was 5-10 mL. The dropping speed was 30 drops or less per min, and the solvent type was 5% glucose injection. The most common manifestation of ADR patients was pruritus, followed by diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsions, and chills. 72 patients(94.74% of ADR patients) discontinued the drug, and three patients(3.95% of ADR patients) were given oxygen inhalation. 47 cases(61.84% of ADR patients) were treated with medication, of which dexamethasone was the most used(24 cases, 46.15% of ADR patients). 76 ADR patients were cured or improved. ADRs are more likely to occur when diagnosed with acute bronchitis by western medicine and cough by traditional Chinese medicine(TCM), TCM syndrome type is wind heat syndrome, and the combination medicine is ambroxol hydrochloride and bromhexine hydrochloride injection, ascorbic acid/vitamin C injection. This result provides an evidence-based safety basis for active pharmacovigilance of Reduning Injection in adolescents aged 14 years and below.

Smart green versatile spectrophotometric and HPTLC techniques for the investigation of ambroxol, doxycycline, in presence of ambroxol precursor and impurity: Appraisal and comparison with various green metrics

Recently, Countless people have become affected as a result of the Covid-19 crisis. Even after recovery, COVID-19 can lead to respiratory difficulties and lung impairment consequently; bacterial infections have a good possibility of infiltrating our respiratory system due to reduction in respiratory immunity. Therefore, the importance of the chosen mixture of doxycycline and ambroxol becomes clear here curing bacterial illnesses invade respiratory tract. The ternary blend of (DOX) doxycycline hyclate, (AMB) ambroxol hydrochloride, (IMP) chemical ambroxol precursor, and pharmacopeial impurity was quantified using four contemporary, selective, and straightforward methods. Method (I) was area under the curve spectrophotometric method (AUC), where zero order absorption spectra were used for calculating the area under the curve of AMB, IMP, and DOX in ranges of 205–219, 222–245, and 264–290 nm, respectively. Each component's absorptivity values (a) at the chosen area were computed. Method (II) was differential dual wavelength (DDW), where upon collecting the first derivative spectra of AMB, IMP, and DOX, amplitudes at 252–263.4, 236–246.6, and 388.8–420 nm were subtracted, consecutively. Method (III) the mean centering of ratio spectra spectrophotometric method (MCR), peak to peak amplitudes on these resulted spectra were measured at (258.2 and 258.4 nm) for AMB, (264.4 and 264.6 nm) for IMP, and at (230.4 and 230.6 nm) for DOX. In addition, method (IV) HPTLC using a stationary phase made of silica gel HPTLC plates that had been pre-treated with 0.27 M di-sodium-EDTA (pH 9 with 21 % sodium hydroxide). The platform is developed using the eluent of ethyl acetate, acetone, distilled water, and acetic acid (9:2:0.7:0.55, by volume) and scanning by employing ultraviolet light regarding AMB and IMP at 254 nm while DOX at 380 nm. For validating the developed procedures, ICH principles were adhered to. The proposed methods were successful in studying dosage form containing investigated substances. The developed techniques' greenness features were assessed using a variety of greenness parameters, and an environmental evaluation comparison between the current methods and the reported one was done. Obtained methods' statistical analyses were also performed.

The results of an experimental toxicological assessment of the pharmaceutical substance ambroxol hydrochloride, justification of the maximum permissible content in the air of the working area

Introduction. Ambroxol hydrochloride is a biologically active substance used as a pharmaceutical substance in the manufacture of medicines for secretolytic therapy in the case of acute and chronic bronchopulmonary diseases. To date, there is no hygienic standard for the safe content of substances in the air of the working area in the republic.&#x0D; The study aims to substantiate and develop the maximum permissible concentrations and hazard class of the pharmaceutical substance ambroxol hydrochloride in the air of the working area.&#x0D; Materials and methods. The authors have conducted experimental toxicological studies of the pharmaceutical substance on animals (rats, mice, rabbits) in accordance with the requirements of technical regulatory legal acts and recommendations of methodological documents regulating the justification of hygienic standards.&#x0D; Results. Scientists have found that the pharmaceutical substance ambroxol hydrochloride, when injected into the stomach and inhaled, is classified as a low-hazard substance at an average lethal dose/concentration (according to GOST 12.1.007-76), has a mild irritant effect on the skin and moderate on the mucous membranes of the eyes, does not exhibit a skin-resorptive effect, is characterized by a weak cumulative effect and does not it has sensitizing activity. Under the conditions of inhalation of the substance into the body of laboratory animals (rats), the threshold values of acute and chronic harmful effects of this pharmaceutical substance were at the level of 90 mg/m3 (in terms of the effect on the functional state of the nervous activity of rats) and 30 mg/m3, respectively (in terms of changes in behavioral indicators, weight and mass coefficient spleen, blood glucose, alanine aminotransferases and urea) accordingly.&#x0D; Conclusion. Based on the experimental results of the toxicological assessment, the authors have justified the standard of permissible content of the pharmaceutical substance ambroxol hydrochloride in the air of the working area at the level of 4.0 mg/m3, they also have established the hazard class of the substance according to GOST 12.1.007-76 (class 3, medium-hazard substances).&#x0D; Ethics. The Bioethics Commission of the State Enterprise "SPCH” has approved the use of laboratory animals for experimental purposes (Protocol No. 1 dated 03/04/2020). The treatment of animals was in accordance with the provisions of Directive 2010/63/EU of the European Parliament and of the Council of the European Union of September 22, 2010 on the protection of animals used for scientific purposes.

Two green and sensitive spectrofluorimetric approaches for determination of Ambroxol and guaifenesin in their single and combined pharmaceutical formulations.

Ambroxol hydrochloride (AMX) and guaifenesin (GFN) are approved drugs utilized to treat coughs through their potent mucolytic and expectorant properties. Due to their massive, combined administration in many illnesses, there is a persistent need for their concurrent estimation in different pharmaceutical formulations. Two sensitive, environmentally friendly spectrofluorimetric methods were developed. AMX was determined using the first method (I) without interference from GFN. This method depends on the quenching of Erythrosine B (EB) native fluorescence at 552 nm after excitation at 527 nm due to the formation of a non-fluorescent AMX-EB ion-pair complex in Britton-Robinson buffer (BRB) solution pH (3.5). The concentration plot is linear over the 0.25-5.0μg/mL range, with a mean percent found value of 99.74%. Method (II) depends on measuring the native fluorescence of aqueous GFN solution at two analytical wavelengths, either 300 or 600 nm, after excitation at 274 nm. Relative fluorescence intensity (RFI)-concentration plots are linear over the ranges of 0.02-0.5 and 0.1-2.0μg/ml, with mean percent found at 99.96% and 99.91% at dual wavelengths, respectively. The proposed methods were successfully applied to assay both drugs in raw materials and different single and combined pharmaceutical formulations. These methods have been thoroughly validated following International Committee on Harmonisation (ICH) guidelines. National Environmental Methods Index, Analytical Eco-Scale, and Green Analytical Procedure Index were used to prove greenness, thereby enhancing their applicability. The proposed techniques provide straightforward, precise, and cost-effective solutions for routine formulation analysis in quality control laboratories.

The Peculiarities of Studies on the Stability of Ambronat

In this article, the quality indicators for determining the persistence of a cough–stimulating and secretomotor type of drug commonly used in the treatment of inflammatory diseases of the upper respiratory tract were investigated. “Ambronate” qiyami did not change its color, taste and smell during the years of its stability in terms of its appearance. The indicator of рN environment is normally in the range of 5.0–7.5 and during the study it was in the range of 6.3–7.8. The results for the 3 years of the study were presented. In the 2.5–3rd year of storage, the amount of fungi and bacteria in the kiyama increased, and the results of the study in 2.5 years of storage were presented. In the quantitative analysis, the amount of ambroxol hydrochloride was determined by the spectrophotometric method, the obtained results were reflected in the regulatory documents.

Drug compatibility with various closed intravenous infusion containers.

Objective: The aim was to systematically compare the drug compatibility with various closed intravenous (i.v.) infusion containers, to provide a reference for selecting a relatively superior infusion container and improve the medication safety for patients in clinical practice. Methods: The compatibility of four commonly used clinical injections (ceftazidime, pantoprazole sodium, ambroxol hydrochloride, edaravone) with three representative closed i. v. infusion containers (non-PVC infusion bags, upright polypropylene infusion bags, inner sealed polypropylene infusion bags) prefilled with infusion fluids (0.9% sodium chloride or 5% dextrose) in the Chinese market were investigated in this study. The particle counts of both infusion fluids and diluted chemical injections by infusion fluids in various infusion containers were determined by the light obscuration method. At 0, 2 and 6h after four injections following dilution with infusion fluids in each container, the pH of the solutions was detected, and the physical properties were examined by visual inspection. Meanwhile, the drug concentrations were assessed by high performance liquid chromatography (HPLC). Results: As for either infusion fluids or diluted injections by infusion fluids, the particle counts in non-PVC infusion bags were significantly greater than those in the other two bags under some circumstances. The particle counts in diluted injections by infusion fluids increased dramatically compared with those in infusion fluids in all infusion containers, especially for the small-size particles. But pH, physical properties and drug concentrations of diluted infusion solutions in all infusion containers remained nearly unchanged over the test period. Conclusion: Closed i. v. infusion containers included in this study are all well-compatible with four injections. Moreover, the closed infusion containers produced by Chinese manufacturers have met the international quality standard. Particularly, the intravenous admixture preparation process needs to be optimized to reduce the overall particulate contaminants.

Effects of N-Acetylcysteine combined with Ambroxol Hydrochloride on clinical symptoms, CRP, and PCT in children with pneumonia

ObjectiveThis study investigated the effects of N-Acetylcysteine (NAC) combined with Ambroxol Hydrochloride (AH) on clinical symptoms, C-Reactive Protein (CRP), and Procalcitonin (PCT) levels in children with pneumonia. MethodsA total of 98 children with pneumonia were assigned to the control group and observation group by random number table method. NAC was administered to the observation group and AH was given to the control group. The therapeutic effect was observed, the disappearance time of clinical symptoms and levels of inflammatory factors, lung function parameters, blood gas analysis parameters, and immunoglobulin were measured. The incidence of adverse reactions was statistically analyzed. ResultsA higher effective rate was observed in the observation group than in the control group (p < 0.05). Antipyretic time, cough disappearance time, and lung rale disappearance time in the observation group were shorter than those in the control group (p < 0.05). After treatment, CRP and PCT were lower (p < 0.05), FVC, FEV1, and FEV1/FVC were higher, PaCO2 was lower, PaO2 and SaO2 were higher, and IgA, IgG, IgM, and C3 were higher in the observation group than those in the control group (p < 0.05). The incidence of adverse reactions between the two groups was not significantly different (p > 0.05). ConclusionNAC combined with AH is effective in the treatment of pediatric pneumonia by effectively alleviating clinical symptoms, reducing inflammatory factors, and improving lung function and immune function.

A magnetic mucus-penetrating nanoagent boosting phlegm elimination for inhalation injury treatment.

Inhalation injuries arising from exposure to toxic gases or smoke in fires or industrial accidents pose grave risks and significant respiratory complications. The limited efficacy of current treatment strategies stems from challenges in delivering therapeutic agents across the mucus barrier to the damaged trachea and bronchus. This research explores the reparative potential and underlying mechanisms of sputum-penetrable magnetic nanoparticles (MNPs) coated with poly(N-isopropylacrylamide) (PNIPAM), combined with polyethylene glycol (PEG), and loaded with ambroxol hydrochloride (AH) (MNPs@PNIPAM-AH@PEG) as an innovative therapeutic approach for inhalation injuries. The PNIPAM coating, a thermo-responsive polymer, aims to enhance targeted drug release under an external stimulus. The PEG component is designed to mitigate hydrophobic repulsion and electrostatic forces, facilitating nanoagent penetration of the mucus barrier-an obstacle in inhalation injury treatment. PEG's hydrophilicity, combined with the magnetically attracted NPs, enables deep penetration through the mucus layer adhering to the mucus epithelium. Thermal effects break the outer thermal shell of MNPs, accelerating drug release, resolving sputum, and reducing inflammation. The results showed improved therapeutic impact by significantly reducing inflammation, enhancing mucociliary clearance, and promoting tissue repair. Moreover, the MNPs@PNIPAM-AH@PEG NPs showed good biocompatibility and biosafety both in vitro and in vivo. This research underscores the potential of MNPs@PNIPAM-AH@PEG NPs as a novel therapeutic strategy for inhalation injuries, paving the way for innovative treatments in emergency medicine and respiratory care.

Therapeutic Effect of Ambroxol Hydrochloride in Conjunction with Azithromycin in Treating Mycoplasma pneumoniae Pneumonia in Children

Therapeutic Effect of Ambroxol Hydrochloride in Conjunction with Azithromycin in Treating Mycoplasma pneumoniae Pneumonia in Children

The combination of astragalus injection and ambroxol hydrochloride in the adjuvant treatment of COPD: a systematic review and meta-analysis

Chronic obstructive pulmonary disease (COPD) is a severe condition that leads to premature mortality and places a significant financial burden on healthcare systems. An adjunctive therapy in COPD includes the simultaneous administration of astragalus injection and ambroxol hydrochloride. Despite its widespread use, the effectiveness of this combined approach in COPD treatment has not been systematically evaluated. Thus, we conducted a systematic review and meta-analysis to assess the efficacy of combining astragalus injection with ambroxol hydrochloride as an adjuvant treatment for COPD. Six electronic databases were used to search for relevant randomized controlled trials, and data analysis was conducted using Review Manager 5.4. A total of 14 randomized controlled trials were included, involving 1070 patients who met the criteria. The results of the meta-analysis indicated that the combination of astragalus injection with ambroxol hydrochloride as an adjuvant treatment can improve various clinical parameters in patients with COPD compared to conventional treatment alone. These parameters include the clinical effective rate (OR = 5.44, 95% CI 3.51–8.43, I2 = 0%), partial pressure of oxygen in artery (MD = 1.12, 95% CI 0.87–1.36, I2 = 5%), partial pressure of carbon dioxide in artery (MD = − 1.43, 95% CI − 1.65 to − 1.21, I2 = 0%), forced expiratory volume in one second (MD = 0.30, 95% CI 0.18–0.42, I2 = 0%), percentage of forced expiratory volume in one second (MD = 16.18, 95% CI 12.60–19.76, I2 = 82%), forced vital capacity (MD = 0.33, 95% CI 0.21–0.45, I2 = 36%), hemoglobin (MD = − 16.17, 95% CI − 20.84 to − 11.51, I2 = 29%), and the ratio of forced expiratory volume in one second to forced vital capacity (MD = 2.51, 95% CI − 0.05 to 5.06, I2 = 0%). The combination of astragalus injection and ambroxol hydrochloride could be a selection of COPD patients as an adjuvant treatment. However, further validation is required to evaluate the effectiveness of combining astragalus injection and ambroxol hydrochloride as an adjunctive treatment for patients with COPD.

Analytical insights: Reviewing established methods for ambroxol hydrochloride, levosalbutamol sulphate, and guaiphenesin

Analytical insights: Reviewing established methods for ambroxol hydrochloride, levosalbutamol sulphate, and guaiphenesin

Development and characterization of a spray-dried inhalable ternary combination for the treatment of Pseudomonas aeruginosa biofilm infection in cystic fibrosis

Cystic fibrosis (CF) is an inherited lung disease characterised by the accumulation of thick layers of dried mucus in the lungs which serve as a nidus for chronic infection. Pseudomonas aeruginosa is the predominant cause of chronic lung infection in cystic fibrosis. The dense mucus coupled with biofilm formation hinder antibiotic penetration and prevent them from reaching their target. Mucoactive agents are recommended in the treatment of CF in combination with antibiotics. In spite of the extensive research in developing novel drug combinations for the treatment of lung infection in CF, to our knowledge, there is no study that combines antibiotic, antibiofilm and mucoactive agent in a single inhaled dry powder formulation. In the present study, we investigate the possibility of adding a mucoactive agent to our previously developed ciprofloxacinquercetin (antibiotic-antibiofilm) dry powder for inhalation. Three mucoactive agents, namely mannitol (MAN), N-acetyl-L-cysteine (NAC) and ambroxol hydrochloride (AMB), were investigated for this purpose. The ternary combinations were prepared via spray drying without the addition of excipients. All ternary combinations conserved or improved the antibacterial and biofilm inhibition activities of ciprofloxacin against P. aeruginosa (ATCC 10145). The addition of AMB resulted in an amorphous ternary combination (SD-CQA) with superior physical stability as indicated by DSC and nonambient XRPD. Furthermore, SD-CQA displayed better in vitro aerosolization performance (ED ∼ 71 %; FPF ∼ 49 %) compared to formulations containing MAN and NAC (ED ∼ 64 % and 44 %; FPF ∼ 44 % and 29 %, respectively). In conclusion, a ternary drug combination powder with suitable aerosolization, physical stability and antibacterial/antibiofilm properties was prepared by a single spray drying step.

A modern chromatographic energy-saving approach for the analysis of doxycycline, ambroxol, and its precursor and impurity: Green metric assessment and comparison

The ternary mixture of doxycycline hyclate (DOX), ambroxol hydrochloride (AMB), and ambroxol synthetic precursor and process impurity (IMP) as chemically identified in the British Pharmacopeia as 2-amino-3, 5-dibromobenzaldehyde was examined for the first time using an ultra-performance liquid chromatographic technique. The presented work aimed to develop and validate a green accurate sensitive modern method for determination of this mixture. The obtained UPLC was accomplished by using an UPLC C18 column with mobile phase combination of acetonitrile: water (60:40, v/v) which was flowed at the rate of 0.22 mL per minute. Elution was in an isocratic manner and temperature control set at room temperature. UV was used to identify the effluent, which was injected at a volume of 5.00 µL; 370 nm for DOX and 240 nm for AMB and IMP. In concentration ranges; of (5–150) µg mL−1, linearity of both DOX and AMB was attained and of (0.5–40) µg mL−1, linearity of IMP was attained. Accuracy of this UPLC method was found to be 100.28, 99.66, and 100.36 for DOX, AMB, and IMP, respectively. ICH standards were followed while making the method validation. The existing combined pharmaceutical dosage form was analyzed by the obtained UPLC method for determination of the evaluated drugs successfully and the obtained results expressed as (Recovery % ± SD) were 101.02 ± 1.37 for DOX and 102.22 ± 1.56 for AMB. Also, the statistically significant correlation of our created approach to the reported HPLC method revealed no appreciable differences in terms of accuracy and precision. The developed method’s greenness profile was appraised using many greenness metrics, green assessment comparison between the established columnar method and the published ones was made.

Meta-analysis of the efficacy of budesonide and ambroxol hydrochloride inhalation in children with pneumonia and their effects on inflammatory response

Childhood pneumonia, often caused by acute upper respiratory tract infections or bronchitis, is one of the leading causes of mortality in children. Nebulized inhalation, as a low-risk treatment method, has garnered significant attention. However, its effectiveness and safety remain controversial. In this study, a systematic review of relevant literature on the use of budesonide (BUD) and ambroxol hydrochloride (AMB) inhalation in the treatment of childhood pneumonia was conducted, and a total of 10 articles were included. The meta-analysis revealed an odds ratio (OR) of 1.61 and an I2 value of 0.00 % for the effectiveness of combined BUD and AMB inhalation therapy in children with pneumonia, indicating no heterogeneity among the studies in terms of effectiveness. The OR values for BUD or AMB inhalation in alleviating cough, lung auscultation abnormalities, respiratory distress, body temperature, and cyanosis of the lips in children with pneumonia all favored the combined BUD therapy, showing significant relief of the aforementioned symptoms. However, due to variations in drug dosage and administration methods, high heterogeneity was observed. This study suggested that combined BUD and AMB inhalation therapy has better efficacy in treating childhood pneumonia, and BUD combined with AMB inhalation is more effective in alleviating symptoms such as cough, lung auscultation abnormalities, respiratory distress, normalizing body temperature, and reducing cyanosis of the lips. Nevertheless, further validation is required due to the limited sample size and substantial heterogeneity in the included studies. To sum up, this study provides the first analysis of the efficacy and inflammatory response of BUD and AMB inhalation in children with pneumonia. Future research should aim to verify and clarify these findings, considering the limitations of the existing studies in terms of sample size and heterogeneity.

Low Energy Vibrations and Crystalline Structure of Ambroxol Hydrochloride by THz Spectroscopy and DFT Calculations

AbstractThe widely used drug ambroxol hydrochloride (A‐HCl), was subjected to analysis by terahertz time domain (THz‐TDS) spectroscopy and quantum chemistry calculations. The performed X‐ray measurement confirmed the C2/c crystallographic group for A‐HCl. On the contrary, the presented theoretical calculations, achieved by solid‐state density functional theory (ss‐DFT), determined the structure in the global minima on potential energy surface which belong to the Cc crystallographic group. In the frame of this symmetric group, the ss‐DFT calculations resulted in 40 vibrational normal modes up to wavenumber 110 cm−1. The three different functionals (B3LYP, PBE, and PW1PW) were applied and all of them provided similar results. In the same range of wavenumbers (10–110 cm−1) the THz spectrum was measured at two different temperatures (room and cryogenic). Thanks to the very good correspondence of the experiment and calculations in both position and intensities of the peaks, we were able to analyze each peak from percentage contributions of inter‐ and intra‐molecular movements point of view and trivial nomenclature for such complex normal modes was suggested as well.

Characterization of Ambroxol and Its Hydrochloride Salt Crystals by Bromine K-Edge X-Ray Absorption Near-Edge Structure Spectroscopy and X-Ray Crystal Structure Analysis.

Polymorphic crystals of ambroxol, forms I and II, and form A ambroxol hydrochloride crystals were characterized with bromine K-edge X-ray absorption near-edge structure (XANES) spectroscopy and single-crystal X-ray structure analysis. The XANES spectra had unique shapes depending on the crystal forms. Refined single-crystal structures revealed different interatomic interactions around bromine atoms, such as C-H…Br and N-H…Br hydrogen bonds, Br…O halogen bonds, and N-H…π interactions. Differences in these weak interactions could affect the electronic states of the bromines, resulting in differences in the XANES spectra. The results demonstrated that weak non-conventional interatomic interactions could alter the shape of XANES spectra. Hence, the spectra could be used for evaluating polymorphs of active pharmaceutical ingredients.