Administration, Inhalation ; Ambroxol ; administration & dosage ; Female ; Humans ; Infant, Newborn ; Male ; Pneumonia ; drug therapy ; physiopathology

AIMTo develop a near-infrared diffuse reflectance analysis (NIRDRA) method for rapid noninvasive quantitative determination of ambroxol hydrochloride in half-finished product particles and non-blister-packed, blistered tablets.

METHODSAll spectra were measured with a Fourier transform spectrometer equipped with a PbS and a InGaAs detector, an external integrating sphere, a rotating sample cup, and a fibre-optic probe for reflectance measurements. All samples were scanned from 12,000 cm-1 to 4,000 cm-1, and each sample spectrum was obtained as an automatic mean of 64 scans. No spectrum pre-processing method was used, and spectral regions, 4,602-4,247, 12,000-7,498 and 6,102-5,446, 12,000-5,446 cm-1 were selected to develope mathematical models by partial least square method for half-finished product particles and non-blister-packed, blistered tablets samples, respectively.

RESULTSThe optimal rank and mean square error determined for half-finished product particles and non-blister-packed, blistered tablets samples by cross validation method all was 6 and 0.306, 0.972 and 1.492, respectively, the average recovery was 100%, 100% and 102% respectively; and the RSD was 1.17%, 1.70% and 1.78% respectively.

CONCLUSIONResults showed that the NIRDRA method was rapid, simple, noninvasive and sensitive, and it can be applied to assay the content of ambroxol hydrochloride in half-finished product particles non-blister-packed and blistered tablets.

Ambroxol ; administration & dosage ; analysis ; Expectorants ; administration & dosage ; analysis ; Quality Control ; Spectroscopy, Near-Infrared ; methods ; Tablets

Ambroxol ; administration & dosage ; therapeutic use ; Bronchitis, Chronic ; etiology ; therapy ; Bronchoalveolar Lavage ; Humans ; Male ; Middle Aged ; Pneumoconiosis ; complications ; therapy ; Treatment Outcome

OBJECTIVE: To study the clinical effect of the oxygen drive aerosol in halation with budesonide and ambroxol in the prevention of adult post-thoracotomy pneumonia. METHODS: This was a randomized, open and parallel controlled trial. We chose 80 cases of patients in the department of thoracic surgery in the First Affiliated Hospital of Xi'an Jiaotong University which fitted our criteria as the research object. The selected patients were randomly divided into the active group and the control group, and the active group underwent oxygen drive aerosol inhalation (2 mg budesonide combined 60 mg ambroxol) for 3 days before operation, and the control group without preoperative aerosol inhalation, and their postoperative therapy was the same. RESULTS: The baseline data showed that the differences in sex, age, disease and smoking were not statistically significant between the two groups, P>0.05. The results of blood gas analysis before 12 hours of operation suggested that, the PaO₂and PaCO₂values of the active group were (88.40±9.40) mmHg and (38.30±6.10) mmHg; The PaO₂and PaCO₂ values of the control group were (85.09±7.18) mmHg and (41.21±3.15) mmHg. And the two groups' P values were 0.029 and 0.011, with statistical differences. There were 3 patients who developed postoperative pneumonia out of 40 patients in the active group, the incidence was 7.50%, but the incidence of control group was 25.00%. The P value was 0.034, with statistical differences. We also analyzed the influence of different diseases and surgical methods on postoperative pneumonia, and the results showed that in the active group and the control group, the incidence of postoperative pneumonia in the patients with esophageal cancer was lower than that in lung cancer patients, and there was a statistically significant difference (P<0.05). In the active group, the numbers of pulmonary deed resection, lobectomy and pulmonary sleeve resection were 2, 21 and 1 cases respectively, and the corresponding numbers in the control group were 2, 21 and 2. Among the two groups, the incidence of postoperative pneumonia in the patients with different surgical methods of lung cancer was statistically significant (P<0.05). CONCLUSION If we implement respiratory preparation with budesonide plus ambroxol inhalation for 3 days before operation, we can greatly reduce the incidence of postoperative pneumonia?
Adult ; Aerosols ; Ambroxol/administration & dosage* ; Bronchodilator Agents/administration & dosage* ; Budesonide/administration & dosage* ; Drug Therapy, Combination ; Humans ; Oxygen ; Pneumonia/prevention & control* ; Thoracotomy/adverse effects*

OBJECTIVEAmbroxol induces the synthesis of surfactant in lung alveolar type II cells. Some studies have shown its effectiveness for the prevention of respiratory distress syndrome (RDS) in preterm infants. This study aimed to compare the efficacy of two different ways of ambroxol administration, ie, intravenous injection and atomizing inhalation, for the prevention of RDS in preterm infants.

METHODSA total of 125 preterm infants born between 28-37 weeks of gestation were randomly assigned into three groups: Intravenous and Atomizing ambroxol treatment groups (n=40 each) or Control group (n=45). The Intravenous group was injected with 15 mg/kg of ambroxol through the umbilical vein immediately after birth and then received 30 mg/kg of ambroxol daily for 2 days by intravenous drip. The Atomizing group was administered with 30 mg/kg of ambroxol daily for 2 days by atomizing inhalation immediately after birth. The Control group received no ambroxol treatment. The incidences of RDS and complications as well as the blood gas results 6 hrs after birth were compared among the three groups.

RESULTSThe incidence of RDS was 7.5%, 5.0% and 24.4% in the Intravenous, Atomizing and Control groups respectively. There were no significant differences in the incidence of RDS between the two ambroxol treatment groups. However, the incidence of RDS in the two treatment groups were noticeably lower than in the Control group (P < 0.05). The blood gas results did not show significant differences between the two ambroxol treatment groups but both groups demonstrated improved blood gas results compared with the Control group at 6 hrs after birth (P < 0.05). The incidence of complications, such as pulmonary hemorrhage, respiratory failure, intraranial hemorrhage, in the two ambroxol treatment groups was reduced compared with the Control group (P < 0.05), but there were no differences between the two ambroxol groups.

CONCLUSIONSEarly administration of either intravenous or atomizing ambroxol can produce a positive efficacy for the prevention of RDS in preterm infants. The two different ways of administration seem to result in a similar efficacy in the prevention of RDS.

Administration, Inhalation ; Ambroxol ; administration & dosage ; adverse effects ; pharmacology ; Female ; Humans ; Infant, Newborn ; Infant, Premature ; Injections, Intravenous ; Male ; Pulmonary Surfactants ; metabolism ; Respiratory Distress Syndrome, Newborn ; prevention & control

Adult ; Ambroxol ; administration & dosage ; therapeutic use ; Expectorants ; administration & dosage ; therapeutic use ; Female ; Glycoproteins ; therapeutic use ; Humans ; Lung ; pathology ; Lung Injury ; drug therapy ; pathology ; Male ; Paraquat ; poisoning ; Respiratory Distress Syndrome, Adult ; drug therapy ; etiology ; Retrospective Studies ; Young Adult

This paper reported that a new type of floating osmotic pump of ambroxol hydrochloride was designed. Third method apparatus (Chinese Pharmacopeia 2010, appendix XD) was employed to simultaneously evaluate the release and floating behavior in vitro. The system was optimized using central composite design-response surface methodology. Similar factor (f2) between the release profile of self-made formulation and the target release profile was chosen as dependent factor. The amount of glucose (A, mg), pore former (B, %) and weight of coating (C, %) were employed as independent factors. Optimized formulation was: A (100.99 mg), B (1.70%), C (4.21%). The value of f2 (89.14) was higher than that of market capsules (69.02) and self-made tablets (72.15). It was showed that self-made capsules possessed character of zero-order release (r = 0.994 4) and drug release completely (>90%). It was showed in result of in vivo study that tmax and Cmax of self-made capsules were significantly lower than that of market capsules and self-made tablets. The correlation coefficient between the fraction of absorption in vivo and the release rate in vitro was 0.985 1, and relative bioequivalence of self-made capsules was 110.77%. Accordingly, self-made capsules displayed obviously characteristics of controlled release both in vivo and in vitro.
Absorption ; Administration, Oral ; Ambroxol ; administration & dosage ; chemistry ; pharmacokinetics ; Animals ; Area Under Curve ; Capsules ; Delayed-Action Preparations ; Dogs ; Drug Compounding ; methods ; Drug Delivery Systems ; Excipients ; Female ; Glucose ; chemistry ; Male ; Osmosis ; Osmotic Pressure ; Porosity ; Random Allocation ; Solubility ; Therapeutic Equivalency

OBJECTIVETo observe the effect of three Chinese medical formulae (Zhifei Mixture I , Zhfei Mixture II, and Zhifei Mixture II) on main and secondary symptoms and signs of children with Totally 70 mycoplasma pneumonia in treating three types of children mycoplasma pneumonia.

METHODSchildren with mycoplasma pneumonia were assigned to the control group (38 cases) and the treatment group (32 case). All patients were intravenously injected with Azithromycin and took Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution. Those in the treatment group additionally took Zhifei Mixture I , Zhfei Mixture II, and Zhifei Mixture Ill by syndrome typing. Their main and secondary symptoms and signs were observed before and after treatment (main symptoms and signs covered fever, cough, abundant sputum, short breath, and anoxia; secondary symptoms and signs covered aversion to cold, heart rate, facial complexion, spirit, appetite, and sweating).

RESULTSSeven patients were lost in this study. Compared with before treatment in the same group, scores for main and secondary symptoms and signs decreased in the treatment group (P <0.01). The therapeutic effect on fever and cough was obviously better in the control group (P <0.01). The main and secondary symptoms and signs were more obviously improved in the treatment group than in the control group (P <0.01). Commpared with the control group, scores for main and secondary symptoms and signs decreased more in the treatment group (P <0.01). Patients' main and secondary symptoms and signs were more obviously improved (P <0.05).

CONCLUSIONSZhifei Mixture combined Western drugs could significantly improve main and secondary symptoms and signs of mycoplasma pneumonia children patients. Its efficacy was superior to that of using Western medicine alone.

Ambroxol ; administration & dosage ; therapeutic use ; Anti-Bacterial Agents ; administration & dosage ; therapeutic use ; Azithromycin ; administration & dosage ; therapeutic use ; Bronchodilator Agents ; administration & dosage ; therapeutic use ; Child ; Clenbuterol ; administration & dosage ; therapeutic use ; Drugs, Chinese Herbal ; therapeutic use ; Expectorants ; administration & dosage ; therapeutic use ; Fever ; Humans ; Pneumonia, Mycoplasma ; drug therapy ; Syndrome

OBJECTIVETo investigate the intervention and mechanism of ambroxol combined with low-dose heparin on oxidative stress, TNF-alpha and IL-1beta in rabbits with acute lung injury (ALI).

METHODSTwenty-four healthy Japanese rabbits were randomly divided into three groups: (1) Normal saline control group (NC), (2) Oleic acid injury group (OA), (3) Ambroxol + low-dose heparin therapy group (AH). After the success of ALI model, AH group was injected ambroxol + low-dose heparin, while the NC group and OA group were injected the same dose of normal saline by the same method. Arterial oxygen tension (PaO2), tumor necrosis factor-alpha (TNF-alpha) and interleukin-1beta (IL-1beta) at different time points were determined. The pathological manifestation of both side lungs was observed at the end of expeiment. The activity of glutathione peroxidase (GSH-Px), superoxide dismutase (SOD), xanthine oxidase (XO) and the content of malondialdehyde (MDA) in bronchoalveolar lavage fluid (BALF) and lung tissue homogenate were tested. The apoptosis index was detected. The lung wet/dry (W/D) ratio was calculated. The pathological changes in lung tissue were observed by light microscopy, and the ultrastructural changes of lung tissue were observed by electron microscopy.

RESULTS(1) The instructive injury induced by ALI observed under electron microscope and light microscope and W/D was decreased significantly in AH group. (2) PaO2 was improved significantly in AH group, compared with that in OA group (P < 0.01). (3) The activity of GSH-Px and SOD in AH group increased significantly (P < 0.01 or P < 0.05) but the activity of XO and the content of MDA decreased significantly (P < 0.01), compared with those in OA group. (4) Except the content of IL-1beta in serum before treatment, the content of IL-1beta and TNF-alpha in serum, BALF, lung tissue homogenate of OA group increased significantly (P < 0.01), and those were obviously improved in AH group. (5) Apoptosis index (AI) in AH group decreased significantly (P < 0.01) compared with that in OA group.

CONCLUSIONIn ALI induced by OA, IL-1beta and TNF-alpha increases significantly and involved in the occurrence and development of ALI. Ambroxol combined with low-dose heparin can reduce lung cells oxidative stress to inhibit the release of IL-1beta and TNF-alpha, which play a role in the treatment of ALI.

Acute Lung Injury ; chemically induced ; drug therapy ; metabolism ; Ambroxol ; therapeutic use ; Animals ; Drug Therapy, Combination ; Female ; Heparin ; administration & dosage ; Interleukin-1beta ; metabolism ; Male ; Oleic Acids ; Oxidative Stress ; drug effects ; Rabbits ; Tumor Necrosis Factor-alpha ; metabolism

Ambroxol and clenbuterol were extracted from human plasma samples by liquid-liquid extraction, ambroxol was separated on a Zorbax XDB-C18 column and detected by tandem mass spectrometry with an atmospheric pressure chemical ionization interface after oral administration of a compound preparation. Clenbuterol was separated on a Zorbax XDB-C8 column and detected by tandem mass spectrometry with an electrospray ionization interface. Diphenhydramine is used as the internal standard. The linear concentration ranges of the calibration curves for ambroxol and clenbuterol were 0.080 - 400 microg x L(-1) and 5.0 - 5 000 ng x L(-1), respectively. The lower limits of quantification were 0.080 microg x L(-1) for ambroxol and 5.0 ng x L(-1) for clenbuterol, individually. The inter-day and intra-day precision (RSD) across three validation run over the entire concentration range was below 7.5%, and the accuracy (RE) was within +/- 2.5% for both ambroxol and clenbuterol. The methods were used to determine the pharmacokinetic parameters of ambroxol and clenbuterol in human plasma after oral administration of a compound preparation containing 60 mg ambroxol hydrochloride and 40 microg clenbuterol hydrochloride. The method was proved to be highly sensitive, selective and suitable for the pharmacokinetic study of different compound preparations containing ambroxol and clenbuterol.
Administration, Oral ; Adrenergic beta-Agonists ; administration & dosage ; blood ; pharmacokinetics ; Adult ; Ambroxol ; administration & dosage ; blood ; pharmacokinetics ; Area Under Curve ; Chromatography, Liquid ; methods ; Clenbuterol ; administration & dosage ; blood ; pharmacokinetics ; Diphenhydramine ; standards ; Expectorants ; administration & dosage ; analysis ; pharmacokinetics ; Humans ; Male ; Reference Standards ; Reproducibility of Results ; Tandem Mass Spectrometry ; methods