To study the pharmacokinetics of the test preparation bambuterol hydrochloride tablets and the reference preparation bambuterol hydrochloride tablets (Bangbei®) in healthy adult subjects after a single oral dose in the fasting/postprandial state, and to evaluate the bioequivalence and safety of the two preparations when taken orally in the fasting/postprandial state.

Start Date11 Apr 2023

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20222261 / CompletedNot Applicable

评估受试制剂盐酸班布特罗片与参比制剂盐酸班布特罗片（帮备®）在健康成年受试者中的单中心、开放、随机、单剂量、双交叉空腹/餐后生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, double-crossover fasting/fed bioequivalence study to evaluate the test formulation of bambuterol hydrochloride tablets and the reference formulation of bambuterol hydrochloride tablets (Bangbei®) in healthy adult subjects

[Translation]

Start Date09 Oct 2022

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

NCT01796730 / CompletedPhase 4IIT

A 12-week, Double-blind, Multicenter, 3-crossover, Placebo Controlled and Randomized Trial to Investigate the Efficacy and Safety of 10mg and 5mg Bambuterol Tablets Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This is a randomized, double-blind, 3-crossover trial with a 7-days washout baseline period followed by three treatment periods of 21-days each performed in patients with COPD. Patients will be randomized to receive three treatments (bambuterol 10mg, bambuterol 5 mg and placebo).

Start Date01 Feb 2013

Sponsor / Collaborator

The First Affiliated Hospital of Guangzhou Medical University

[+2]

100 Clinical Results associated with Bambuterol Hydrochloride

100 Translational Medicine associated with Bambuterol Hydrochloride

100 Patents (Medical) associated with Bambuterol Hydrochloride

168

Literatures (Medical) associated with Bambuterol Hydrochloride

01 Dec 2023·Chinese Journal of Chromatography

Determination of 14 <italic>β</italic>-agonists in animal meat by ultra high performance liquid chromatography-tandem mass spectrometry

Article

Author: Wang, Xuesong ; Li, Ning ; Xiao, Jin ; Zhou, Xin ; Kang, Junjie ; Dong, Jieqiong

The addition of β-agonists to animal feed can significantly improve the lean-meat rate of pigs, cattle, sheep, and other animals. However, the food residues of β-agonists are harmful to human health. When meat with β-agonist residues is consumed, poisoning symptoms such as palpitation, dizziness, and muscle tremors may develop, and damage to the cardiovascular system, liver, and kidney may occur. In this study, a method based on ultra high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) was established for the rapid detection of 14 β-agonists (clenbuterol, salbutamol, ractopamine, clorprenaline, terbutaline, tulobuterol, bromobuterol, bambuterol, zilpaterol, mabuterol, fenoterol, arformoterol, cimaterol, and cimbuterol) in animal food sources. The sample pretreatment method and chromatographic conditions were optimized. The samples were hydrolyzed with β-glucuronidase hydrochloride/aryl sulfate esterase in ammonium acetate buffer (pH 5.2). Enzymatic hydrolysis was performed in a constant-temperature water bath ((36±2) ℃) oscillator for 16 h. The samples were cooled to room temperature and extracted with 0.5% formic acid acetonitrile. NaCl was added to separate the organic and aqueous phases, and 5 mL of the upper organic layer was purified using a one-step purification solid-phase extraction column. After drying with nitrogen at 50 ℃, the residue was dissolved in 0.4 mL of 0.2% formic acid aqueous solution. The samples were passed through a 0.22 μm filter and detected by UHPLC-MS/MS with gradient elution using acetonitrile and 0.1% formic acid aqueous solution as the mobile phases. The analytes were separated on a Phenomenex Kinetex F5 column and detected by positive-ion scanning in multiple-reaction monitoring (MRM) mode. Internal and external standard methods were used for quantitative analysis. The effects of the extract pH, solid-phase extraction column, purification method, and dissolved solution on the extraction efficiency were optimized during pretreatment. UHPLC-quadrupole time-of-flight MS was used to verify the purification effect of the one-step purification solid-phase extraction column, and the results indicated that this type of column could remove most of the phospholipids, sphingolipids, and glycerides in the sample extract. The factors influencing the different chromatographic columns and mobile phases were investigated. MS scanning was conducted in positive-ion mode with needle pump injection in mass-only mode, and the two daughter ions with the highest responses for each target were selected as the quantitative and qualitative ions. The declustering potential (DP) and collision energy (CE) of each ion were separately optimized in MRM mode. The switching mode of the mass spectrum and waste liquid was used, and the mobile phase was switched to waste liquid after all the target peaks were removed. These steps ensured that impurities in the sample flowed out of the column in a timely manner and that the effects of excessive impurities on the mass spectra were avoided. The 14 β-agonists showed good linear relationships in the range of 1.0-50 μg/L, with correlation coefficients of >0.99. The limits of detection (LODs) and quantification (LOQs) were in the range of 0.1-0.2 and 0.3-0.6 μg/kg, respectively. The average recoveries of the 14 β-agonists ranged from 70.25% to 117.48%, with relative standard deviations (RSDs) in the range of 0.63%-14.29% at low, medium, and high spiked levels. Pork, beef, and mutton samples were selected and analyzed using the developed method. The results were close to those of the national standard method, indicating that the method is accurate and reliable. Moreover, the proposed method has good stability and high accuracy; thus, it is suitable for the qualitative and quantitative determination of β-agonists in animal meat.

01 Sep 2023·Journal of Fluorescence

Investigating the Effect of Silver Nanoparticles on the Fluorescence Intensity of Bambuterol and its Active Metabolite Terbutaline Using FRET

Article

Author: Shalan, Sh ; Belal, F ; Abd Elhaleem, Shymaa M ; Elsebaei, F

AbstractSilver nanoparticles (AgNPs) were found to significantly quench the fluorescence of bambuterol hydrochloride (BAM) and its active metabolite terbutaline sulfate (TER). The intrinsic fluorescence intensity of each of BAM (at 264/292 nm) and TER (at 276/306 nm) decreased by the gradual addition of AgNPs. Quenching of the steady state fluorescence of BAM and TER probably resulted from the energy transfer to the photo-excited state of AgNPs. The estimated Stern–Volmer quenching constant at several temperature settings proved that the quenching mechanism of the two drugs was dynamic quenching in case of BAM while it was static quenching in case of TER. The number of binding sites, binding constants, and corresponding thermodynamic parameters depending on the interaction system were estimated at 293, 313, and 333 °K and the results obtained were interpreted.

25 Mar 2023·BMC nephrology

Idiopathic systemic capillary leak syndrome: a case report.

Article

Author: Hwang, Jin Ho ; Lee, Hyang-Yun ; Shin, Jungho ; Kim, Su-Hyun

BACKGROUNDIdiopathic systemic capillary leak syndrome (ISCLS) is a rare disease characterized by recurrent episodes of acute life-threatening attacks of shock, hemoconcentration, and hypoalbuminemia. Increase in capillary permeability results in reversible plasma movement into the interstitial spaces followed by appearance of related symptoms or complications, including renal failure. This condition can be potentially life-threatening; however, it is easily misdiagnosed.CASE PRESENTATIONA 47-year-old man with no previous medical history presented to the emergency department after experiencing general weakness and abdominal pain. He developed hypovolemic shock within 3 h of presentation and initial laboratory tests showed hemoconcentration, hypoalbuminemia and acute kidney injury. Following vigorous fluid therapy and supportive care, the patient recovered, but a similar episode recurred after 4 months without any specific trigger. Based on the combined clinical manifestations and laboratory findings of both the attacks, he was diagnosed with ISCLS. Symptomatic relief was achieved via oxygen supplementation and massive volume replacement using normal saline and the patient was prescribed bambuterol 10 mg and theophylline 400 mg once-a-day. He was discharged from the hospital on day 5 of hospitalization. Thereafter, the patient has been followed for 5 years without any symptoms or recurrence of ISCLS even in the situation of COVID-19 infection.CONCLUSIONSISCLS is an extremely infrequent and commonly misdiagnosed disease. However, early diagnosis, treatment and prophylaxis through accumulated clinical data can prevent ISCLS recurrence and the development of related fatal complications. Therefore, clinicians need to be well aware of the variety of clinical characteristics and treatment options of this disease.

100 Deals associated with Bambuterol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D07489	Bambuterol Hydrochloride	R03CC12	DB01408

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Asthma	CN	AstraZeneca Pharmaceuticals Co. Ltd.	01 Jan 1999
Pulmonary Disease, Chronic Obstructive	CN	AstraZeneca Pharmaceuticals Co. Ltd.	01 Jan 1999

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Inflammatory Bowel Diseases	IND Approval	CN	Suzhou Kaifa Biotechnology Co. Ltd.	28 Jun 2022
Inflammatory Bowel Diseases	IND Approval	CN	Hainan Zhongyu Medicine Co. Ltd.	28 Jun 2022

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