An aerosol formulation of R-salbutamol sulfate for pulmonary inhalation  

作　　者：Xuemei Zhang Qing Liu Junhua Hu Ling Xu Wen Tan 

机构地区：[1]School of Bioscience and Bioengineering,South China University of Technology,Guangzhou 510006,China [2]Key-Pharma Biomedical Inc.,Dongguan 523000,China

出　　处：《Acta Pharmaceutica Sinica B》2014年第1期79-85,共7页药学学报（英文版）

基　　金：We thank Key-Pharma Biomedical Inc.Dongguan,China,for the technical and financial support on this project;The study was supported by grant 10C26214404752 from small and mid-sized enterprise technology innovation fund management center of Science and Technology Department.

摘　　要：An aerosol formulation containing 7.5 mg of R-salbutamol sulfate was developed.The aerosol was nebulized with an air-jet nebulizer,and further assessed according to the new European Medicines Agency(EMA)guidelines.A breath simulator was used for studies of delivery rate and total amount of the active ingredient at volume of 3 mL.A next generation impactor(NGI)with a cooler was used for analysis of the particle size and in vitro lung deposition rate of the active ingredient at 51C.The anti-asthmatic efficacy of the aerosol formulation was assessed in guinea pigs with asthma evoked by intravenous injection of histamine compared with racemic salbutamol.Our results show that this aerosol formulation of R-salbutamol sulfate met all the requirements of the new EMA guidelines for nebulizer.The efficacy of a half-dose of R-salbutamol equaled that of a normal dose of racemic salbutamol.

关 键 词：R-salbutamol NEBULIZER NGI Particle size Dose uniformity Guinea pigs ASTHMA 

分 类 号：O62[理学—有机化学]