Clinical study of the oxygen drive aerosol inhalation with budesonide and ambroxol in the prevention of adult post-thoracotomy pneumonia / 北京大学学报(医学版)

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?

Immunomodulatory Effects of Ambroxol on Airway Hyperresponsiveness and Inflammation

Ambroxol is used in COPD and asthma to increase mucociliary clearance and regulate surfactant levels, perhaps through anti-oxidant and anti-inflammatory activities. To determine the role and effect of ambroxol in an experimental model of asthma, BALB/c mice were sensitized to ovalbumin (OVA) followed by 3 days of challenge. Airway hyperresponsiveness (AHR), lung cell composition and histology, and cytokine and protein carbonyl levels in bronchoalveolar lavage (BAL) fluid were determined. Ambroxol was administered either before the first OVA challenge or was begun after the last allergen challenge. Cytokine production levels from lung mononuclear cells (Lung MNCs) or alveolar macrophages (AM) were also determined. Administration of ambroxol prior to challenge suppressed AHR, airway eosinophilia, goblet cell metaplasia, and reduced inflammation in subepithelial regions. When given after challenge, AHR was suppressed but without effects on eosinophil numbers. Levels of IL-5 and IL-13 in BAL fluid were decreased when the drug was given prior to challenge; when given after challenge, increased levels of IL-10 and IL-12 were detected. Decreased levels of protein carbonyls were detected in BAL fluid following ambroxol treatment after challenge. In vitro, ambroxol increased levels of IL-10, IFN-γ, and IL-12 from Lung MNCs and AM, whereas IL-4, IL-5, and IL-13 production was not altered. Taken together, ambroxol was effective in preventing AHR and airway inflammation through upregulation of Th1 cytokines and protection from oxidative stress in the airways.

Effect of perioperative treatment with ambroxol on lung cancer patients after video-assisted thoracic surgery lobectomy / 中南大学学报(医学版)

OBJECTIVE@#To evaluate the influence of perioperative intravenous administration of ambroxol on pulmonary function, postoperative complications, postoperative hospital stay, and cost after video-assisted thoracic surgery lobectomy for lung cancer.@*METHODS@#Sixty patients who underwent video-assisted thoracic surgery lobectomy for lung cancer in Xiangya Hospital, Central South University between May 2011 and May 2012 were randomly assigned into 2 groups: An ambroxol group (n=30) and a control group (n=30). In the ambroxol group, patients were given ambroxol (1 000 mg/d) on the day of operation and on the first 3 postoperative days. In control group, placebo was given. The pulmonary function tests, arterial blood gases, incidence of perioperative morbidity, postoperative mechanical ventilation time, duration of ICU stay, length and costs of postoperative hospital stay were compared between the 2 groups.@*RESULTS@#The 2 groups were well matched for demographics and operative variables. The ambroxol group showed better the percent predicted forced expiratory volume in 1 second (FEV1%), the ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC%), the percent predicted diffusing capacity of the lung for carbon monoxide (DLCO%) and arterial oxygen pressure than the control group. The postoperative pulmonary complications was significantly reduced, the duration of mechanical ventilation and the length of ICU stay were shortened, and the length and costs of postoperative hospital stay were significantly decreased in the ambroxol group compared with the control group (all P<0.05).@*CONCLUSION@#Perioperative intravenous administration of ambroxol can improve the postoperative lung function, reduce the incidence of pulmonary complications, shorten the length of postoperative hospital stay, and lower the total cost of hospitalization after video-assisted thoracic surgery lobectomy for lung cancer.

Effect of Zhifei mixture combined western drugs on symptoms and signs of children with mycoplasma pneumonia / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To 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.</p><p><b>METHODS</b>children 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).</p><p><b>RESULTS</b>Seven 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).</p><p><b>CONCLUSIONS</b>Zhifei 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.</p>

Effect of ambroxol on biofilm of Haemophilus influenzae and bactericidal action / 临床耳鼻咽喉头颈外科杂志

OBJECTIVE@#To establish a biofilm model of Haemophilus influenzae and observe the effect of ambroxol on biofilm of Haemophilus influenzae and bactericidal action.@*METHOD@#Thirty strains of Haemophilus influenzae were isolated from adenoids of children with adenoidal hypertrophy. Two strains which could build stronger biofilms was selected in a 96-well plate. The effect of ambroxol on biofilms were determined by crystal violet, and the structure of biofilms were observed by scanning electron microscope (SEM). The numbers of viable bacterial in biofilm after ambroxol treatmented determined by plate culture count.@*RESULT@#Through crystal violet assay, significant difference (P < 0.01) between the two group after treatment was found when ambroxol concentration reached at 0.25 mg/ml and 0.49 mg/ml. The biofilms was destroyed by SEM. Ambroxol had the positive effect on bacterial killing by plate culture count,and the effect was in a dose dependent.@*CONCLUSION@#Ambroxol could destroy the biofilm of Haemophilus influenzae, and had bactericidal function in vitro.

Comparación de la eficacia de la asociación de cefalexina y ambroxol versus cefalexina en la cura clínica de la faringoamigdalitis estreptocócica aguda que cursa con producción de secreciones / Comparison of the efficacy of the association of ambroxol versus cephalexin and cephalexin in clinical cure of acute strep throat that causes mucus production

Objetivo. Determinar la eficacia de la asociación de cefalexina y ambroxol en el tratamiento de la faringitis bacteriana asociada a producción de de secreciones. Material y Métodos. Se realizó un ensayo clínico aleatorizado y doble ciego. Se evaluó una población de 72 pacientes de 18 a 65 años que acudieron a la consulta en siete consultorios privados, durante el periodo de mayo 2012 a julio 2013. Los casos fueron pacientes con diagnóstico de faringoamigdalitis por estreptococo β-hemolítico del grupo A establecido con base en criterios clínicos y una prueba rápida para estreptococo del grupo A positiva. El criterio clínico de diagnóstico fue dolor de garganta asociado a dos o más de los siguientes: fiebre mayor de 38 ºC; eritema de la uvula y faringe o amígdalas; edema de la úvula, faringe o amígdalas; exudado en la faringe o amígdalas; linfadenopatías cervicales. Adicionalmente, los pacientes debían presentar producción de secreciones (tos productiva). Resultados. Se encontró mayor mejoría de los síntomas en el segundo control (día 11) en el grupo tratado con ceflexina y ambroxol que en el grupo cefalexina sola (p < 0,05). Conclusion. La asociación cefalexina-ambroxol es más efectiva que el de la cefalexina sola en los pacientes con faringoamigdalitis aguda estreptocócica que cursa con producción de secreciones.

Objective. To determine the efficacy of the association of cephalexin and ambroxol in the treatment of bacterial pharyngitis associated with production of secretions. Material and MethOds. It was a controlled, double blind, prospective clinical trial. We evaluated a population of 72 patients from 18 to 65 year-old who attended to five private clinics, during the period of May 2012 and July 2013. The cases were patients with diagnosis of sore throat by β-hemolytic Streptococcus Group A based on clinical criteria and a positive rapid test for Streptococcus Group A. The clinical diagnosis was sore throat associated with two or more of the following signs: fever > 38 °C; erythema of the uvula and pharynx, or tonsils; edema of the uvula, pharynx, or tonsils; exudate in the pharynx, or tonsils; and, cervical lymphadenopathy. In addition, patients had to have production of secretions (productive cough). Results. Further improvement of symptoms in the second control (day 11) was found in the group treated with cephalexin and ambroxol than in the group with cephalexin alone (p < 0,05). Conclusion. The association cephalexin-ambroxol is more effective than the single cephalexin in patients with streptococcal acute sore throat with production of secretions.

Optimization of a floating osmotic pump system of ambroxol hydrochloride using central composite design-response surface methodology and its pharmacokinetics in Beagle dogs / 药学学报

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.

Clinical observation of mucoregulatory agents' application after chronic rhinosinusitis surgery / 临床耳鼻咽喉头颈外科杂志

OBJECTIVE@#To explore the effect of mucoregulatory agents during endoscopic sinus surgery.@*METHOD@#Ninety-seven cases with chronic rhinosinusitis were randomly divided into three groups, with 31 cases in B group treated by ambroxol, 33 cases in C group treated by eucalyptol-limonene-pinene enteric soft capsule and 33 cases in control group (A group). The follow-up visit lasted for 6 months for three groups. Then, the therapeutic effects were evaluated and compared among these three groups.@*RESULT@#By the end of 6 months after treatment,the effective rate was 90.3% and 97.0% for cases in the B and C groups respectively, and only 75.8% in A group. The difference between A and C was statistically significant (P < 0.05).@*CONCLUSION@#Eucalyptol-limonene-pinene enteric soft capsule,as a multicomponent mucoregulatory agent, can obviously improve the secretion of mucosa and epithelial recovery, thus accelerate healing of the disease. It can also improve the success rate of functional endoscope sinus surgery, and may play a promising role in clinical application.

Effects of ambroxol combined with low-dose heparin on TNF-alpha and IL-1beta in rabbits with acute lung injury / 中国应用生理学杂志

<p><b>OBJECTIVE</b>To 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).</p><p><b>METHODS</b>Twenty-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.</p><p><b>RESULTS</b>(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.</p><p><b>CONCLUSION</b>In 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.</p>

Ambroxol for the prevention of respiratory distress syndrome in preterm infants: a meta analysis / 中国当代儿科杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of ambroxol in the prevention of respiratory distress syndrome (RDS) in preterm infants.</p><p><b>METHODS</b>Electronic searches were performed in the Cochrane Library, PubMED, EMBASE, Chinese CBM, Chinese VIP Database, Chinese Wanfang Database and Chinese CNKI Database up to the year of 2009 for randomized controlled trials (RCT) on ambroxol for the prevention of RDS in preterm infants. The meeting articles related to the RCT were manually searched in Pediatrics and Pediatric Research. Meta analysis was performed for the results of homogeneous studies by the Cochrane Collaboration's software RevMan 5.0.17.</p><p><b>RESULTS</b>Six RCTs involving 823 preterm infants were included, and the quality assessment for the trials demonstrated 1 article as A class, 1 article as B class and 4 articles as C class. The Meta analysis showed that ambroxol administration significantly reduced the incidence of RDS (OR=0.24, 95%CI: 0.15 - 0.64, P<0.01), bronchopulmonary dysplasis (BPD, OR=0.41, 95%CI: 0.23 - 0.75, P<0.01), intraventricular hemorrhage (IVH, OR=0.39, 95%CI:0.24 - 0.64, P<0.01), patent ductus arteriosus (PDA, OR=0.33, 95%CI: 0.17 - 0.67, P<0.01) and pulmonary infection (OR=0.24, 95%CI:0.14 - 0.38, P<0.01). No adverse events related to the ambroxol treatment were reported.</p><p><b>CONCLUSIONS</b>The current evidence shows that early use of ambroxol can reduce the risk of RDS, BPD, IVH, PDA and pulmonary infection in preterm infants.</p>

Stability study of ambroxol hydrochloride sustained release pellets coated with acrylic polymer

The aim of the present study is to perform stability study of Ambroxol Hydrochloride sustained release pellets stored in different storage conditions. The drug loaded beads were prepared by Extrusion-Spheronization technology then coated with ammonio methacrylate copolymer Type A [Eudragit RL 30 D] and ammonio methacrylate copolymer Type B [Eudragit RS 30 D] at a ratio of 2:3 [8% polymer by weight on dry basis] in Fluid Bed Coater [Wurster column]. Stability study of pellets was performed as capsule dosage form in Aluminium-PVDC packaging mode at room temperature, 40°C, 40°C/75%RH and 30°C/70%RH for three months. After one month the shape and size of the pellets was changed in all conditions. The color of the pellets remains unchanged up to the 2nd month in all conditions except at 40°C/75%RH and in this case some pellets become brown. But after 3[rd] month, pellets become brownish in all conditions except at room temperature. At RT the color of pellets remains unchanged during the stability study. The mean drug content decreased gradually in all conditions. In acid media the initial drug release was 23% but after 1[st] month it was decreased to 13-15% in all conditions. In the buffer media [pH 6.8] the drug release was increased a little bit in all conditions except at 30°C/70%RH with the passes of storage time. Stability studies at 30°C/70%RH revealed consistent drug release [f2 > 50] throughout the stability period. The physical properties of pellets as well as the in vitro release profile of the drug was found to be a function of the different storage conditions as well as the physico-chemical nature of the polymers

Effects of ambroxol on renal function in children undergoing cardiopulmonary bypass / 中国当代儿科杂志

<p><b>OBJECTIVE</b>Some research has shown that ambroxol can alleviate lung injury induced by cardiopulmonary bypass (CPB). However, whether ambroxol has protective effects against CPB-induced renal injury remains unknown. This study investigated the effect of ambroxol on renal function in children undergoing CPB.</p><p><b>METHODS</b>Forty children at ages of 3-8 years with cardiac function class I or II and weighing 12-25 kg, underwent repair of ventricular septal defect (VSD) under CPB. They were randomly divided into two groups (n=20 each):control and ambroxol-treated. The children in the ambroxol-treated group received ambroxol of 4.5 mg/kg in 10 mL normal saline by intravenous injection after skin incision. The control group received 10 mL of normal saline instead. Serum concentrations of urea nitrogen (BUN), beta(2)-microglobulin (beta(2)-MG) and creatinine (Cr) and urinary beta(2)-MG, retinol-binding-protein (RBP) and N-acetyl-beta-D-glucosaminidase (NAG) were measured before operation, and 2, 12, 24 and 48 hrs after operation.</p><p><b>RESULTS</b>Serum Cr and urinary beta(2)-MG concentrations 2 hrs after operation, serum beta(2)-MG concentration 2 and 12 hrs after operation, urinary RBP concentration 2, 12, 24 and 48 hrs after operation, and urinary NAG concentration 2, 12 and 24 hrs after operation in the control and the ambroxol-treated groups increased significantly as compared with their baseline values (before operation) (P<0.05). Serum Cr concentration 2 hrs after operation, serum beta(2)-MG and urinary beta(2)-MG concentrations 2 and 12 hrs after operation, urinary RBP concentration 2, 12, 24 and 48 hrs after operation, and urinary NAG concentration 12 and 24 hrs after operation in the ambroxol-treated group were significantly lower than those in the control group (P<0.05).</p><p><b>CONCLUSIONS</b>Ambroxol administration before CPB is effective in reducing CPB-induced renal injury in children undergoing repair of VSD. Further research is required to understand the mechanism.</p>

Simultaneous determination of multi drug components theophylline, etofylline, guaiphenesine and ambroxol hydrochloride by validated RP-HPLC method in liquid dosage form

The RP-HPLC [reverse phase high performance liquid chromatography] method was developed and validated for simultaneous determination of Multi drug components i.e., Theophylline, Etofylline, Guaiphenesine and Ambroxol Hydrochloride in a liquid dosage form. Chromatographic separation of the four drugs was performed on a Hypersil Phenyl BDS [25cmX4.6mm, 5um]. The mobile phase constituted of triethylamine pH 3.0 buffer: methanol [85:15] v/v was delivered at the flow rate 1.5 mL/min. Detection was performed at 235 nm. The peak purity of Theophylline, Etofylline, Guaiphenesine and Ambroxol Hydrochloride were 0.99970, 0.99979, 0.99986 and 0.99949 respectively. Calibration curves were linear with correlation coefficient between 0.99995 to 0.99997 over a concentration range of 5 to 37 micro g/mL for Theophylline, 19 to 140 micro g/mL for Etofylline, 20 to 149 micro g/mL for Guaiphenesine and 6 to 45 micro g/mL for Ambroxol hydrochloride. The relative standard deviation [RSD] was found < 2.0%. The percentage recovery was found between th e range of 98.6% and 100.5% at three different levels. Robustness and ruggedness were performed and result found within the RSD of 2%. All the parameters of validation were found in the acceptance range of ICH guideline

Determination of ambroxol and clenbuterol in human plasma by LC-MS/MS method / 药学学报

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.

Effects of high dose ambroxol on lung injury induced by paraquat in rats / 中华劳动卫生职业病杂志

<p><b>OBJECTIVE</b>To evaluate the protective effect of high dose ambroxol, a mucoactive drug, on acute lung injury caused by paraquat in rats.</p><p><b>METHODS</b>One hundred and thirty-six healthy male Sprague-Dawley rats were randomly divided into three groups: control group (n = 24) injected with normal saline intraperitoneally, PQ group (n = 56) [(2% paraquat (25 mg/kg) injected into peritoneal cavity on the first day)] and AT group (n = 56) ambroxol 35 mg/kg was injected into peritoneum daily after paraquat intoxication once daily for 7 consecutive days. The arterial gas was determined and the extent of lung injury was assessed by measuring the ratio of wet to dry weight (W/D) and protein content in BALF, the WBC count, the percentage of PMN, the content of malondialdehyde (MDA) and the levels of superoxide dismutase (SOD) in the blood and BALF respectively. Left lung tissue was observed through both light microscope and electron microscope (TEM).</p><p><b>RESULTS</b>The white cell count and the content of protein in the blood and the BALF of PQ group were significantly higher than those of the control group (P < 0.05 or P < 0.01). On the 7th day, the content of MDA 9 [(8.12 +/- 1.12) nmol/ml] in the serum of PQ group was significantly higher than the control group and the GSH-Px activity [(1256.8 +/- 133.2) U/ml] was significantly lower than the control group (P < 0.01). The white cell count and the content of protein in the blood and the BALF of AT group were significantly lower than the PQ group (P < 0.05 or P < 0.01). On the 7th day, the content of MDA in the serum of the AT group [(4.86 +/- 0.75) nmol/ml] was significantly lower than the PQ group and the GSH-Px activity [(1509.5 +/- 183.0) U/ml] and the SOD activity [(3903.2 +/- 374.7) U/ml] were significantly higher than the PQ group (P < 0.01). Under optical and electronic microscopes, the injury of lung tissue was reduced after large dose of ambroxol was administered.</p><p><b>CONCLUSION</b>Treatment with ambroxol (35 mg/kg) could influence the status of oxidative stress in lung and alleviate lung injury induced by paraquat. Ambroxol has obviously therapeutic effect on paraquat poisoning.</p>

Evaluation of the role of postnatal ambroxol in the prevention and treatment of Respiratory Distress Syndrome [RDS] in preterm neonates

To study the effect of the postnatal administration of Ambroxol in the prevention of respiratory distress syndrome in preterm neonates at risk and on the severity of the disease in those neonates already suffering from it. The study was a randomized clinical trial performed on 120 preterm neonates admitted to the neonatal unit of the Suez Canal University Hospital, Egypt, with gestational age of 28 to 34 weeks. It was performed in the period from September 2001 through March 2003. Half of the enrolled neonates received intravenous Ambroxol [20 mg/kg/d], while the control group received the routine management of prematurity and a placebo. Ambroxol decreased the incidence of RDS, improved the gas exchange, and decreased CPAP pressure, the length of mechanical ventilation and also the mortality rate. The study concluded that Ambroxol reduced the incidence of this disease in preterm neonates at risk of developing it, and improved the clinical course of RDS

Influence of ambroxol on paraquat-induced lung tissue injury and change of pulmonary surfactant-associated protein A in the experimental rats / 中华劳动卫生职业病杂志

<p><b>OBJECTIVE</b>To investigate the influence of ambroxol on paraquat poisoning induced acute lung tissue injury and the change of pulmonary surfactant associated protein A in the experimental rats.</p><p><b>METHODS</b>One hundred and twenty healthy adult male Sprague-Dawley rats were randomizedly assigned into normal saline (NS) group (n = 24), paraquat poisoning induced lung tissue injury model (PQ) group (n = 48) and ambroxol treatment (AT) group (n = 48). The indexes were observed among the three groups comprising the mortality rate, the change of arterial blood PaCO(2) and PaO(2), the ratio of wet to dry lung tissue (W/D), the change of the lung tissue under light and electric microscope respectively, and the expression of pulmonary surfactant associated protein A.</p><p><b>RESULTS</b>The mortality rate of rats in the PQ group was 50.0% on the seventh day while the mortality rate in the AT group was 25.0%. The level of arterial blood PaCO(2) in the PQ group (6.94 +/- 0.8) kPa was significantly higher than that in the AT group (6.12 +/- 0.5) kPa and the NS group (4.6 +/- 0.4) kPa. The level of arterial blood PaO(2) in the PQ group (6.98 +/- 1.1) kPa was significantly lower than that in the AT group (8.25 +/- 0.7) kPa and the NS group (12.7 +/- 0.8) kPa. There were significant differences among the groups (P < 0.05). The degree of lung tissue injury was severe in PQ group and relieved in AT group. The expression of pulmonary surfactant associated protein A was significantly decreased in PQ group 13.22% +/- 2.21% on the seventh day, compared with that in the AT group (21.82% +/- 3.67%) (P < 0.05). The expression of pulmonary surfactant associated protein A in AT group was significantly higher in the AT group (18.97% +/- 0.91%) than that in the PQ group on the seventh day (P < 0.05).</p><p><b>CONCLUSION</b>Ambroxol plays a role in facilitating synthesis and secretion of pulmonary surfactant protein A and relieves the lung tissue injury induced by paraquat poisoning.</p>

Efficacy of intravenous or atomizing ambroxol for prevention of respiratory distress syndrome in preterm infants / 中国当代儿科杂志

<p><b>OBJECTIVE</b>Ambroxol 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.</p><p><b>METHODS</b>A 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.</p><p><b>RESULTS</b>The 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.</p><p><b>CONCLUSIONS</b>Early 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.</p>

Effect of ambroxol, spirulina and vitamin-E in naphthalene induced cataract in female rats.

Anticataract activity of Ambroxol, Spirulina and Vitamin E was examined using the naphthalene cataract model. Adult female albino rats of Wistar strain weighing between 180 and 220 grams were taken and divided into eight groups. Group I received light liquid paraffin 5 ml/kg/ day p.o. for 6 weeks. Group II received naphthalene solution 0.5 gm/kg/ day p.o. for first three days and 1 gm/kg/day p.o. thereafter for six weeks. Group III received Ambroxol suspension in 0.5% carboxy methyl cellulose (CMC) at the dose of 100 mg/kg/day p.o. alongwith naphthalene. Group IV received Spirulina in distilled water at the dose of 1500 mg/kg/ day p.o. alongwith naphthalene. Group V received Vitamin E emulsion at the dose of 50 mg/kg/day p.o. alongwith naphthalene. Group VI received Ambroxol alone at the dose of 100 mg/kg/day p.o. Group VII received Spirulina alone at the dose of 1500 mg/kg/day p.o. Group VIII received vitamin E alone at the dose of 50 mg/kg/day p.o. Lens glutathione, soluble protein and water content profiles revealed the preventive role of Ambroxol, Spirulina and Vitamin E in naphthalene-induced cataract in female rats.