硫酸沙丁胺醇定量吸入气雾剂体外一致性评价方法  

Method of In Vitro Correspondence Evaluation of Salbutamol Sulfate Metered Dose Inhalers

作　　者：肖梦琦 李苗 XIAO Mengqi;LI Miao(College of Pharmacy, Hubei University of Chinese Medicine,Wuhan 0430065,China;Wuhan Institute for Drug and Medical Device Control,Wuhan 430075,China)

机构地区：[1]湖北中医药大学药学院,武汉430065 [2]武汉药品医疗器械检验所,武汉430075

出　　处：《医药导报》2019年第7期888-893,共6页Herald of Medicine

基　　金：“重大新药创新”科技重大专项课题(2015ZX09303001);湖北省食品药品监督管理局科研项目(201601019)

摘　　要：目的比较两种硫酸沙丁胺醇定量吸入气雾剂的微细粒子空气动力学特性,建立数学模型,探索该类药品体外一致性评价方法。方法采用安德森撞击器(ACI)和高效液相色谱法测定,分别对两种硫酸沙丁胺醇定量吸入气雾剂进行微细粒子空气动力学特性研究,通过微细粒子分数(FPF)、空气动力学质量中直径(MMAD)、几何标准偏差(GSD)对两种气雾剂的微细粒子进行空气动力学评估,并建立空气动力学微细粒子分布方程。结果A企业样品的FPF小于B企业样品,MMAD与GSD大于B企业样品,A企业样品的微细粒子分布方程拟合程度优于B企业样品。结论两种气雾剂的空气动力学微细粒子分布方程存在差异,可作为吸入制剂体外一致性评价的有效手段。Objective To compare the fine particle characteristics of salbutamol sulfate metered dose inhalers from two manufacturers,a mathematical model was built to explore the method of correspondence evaluation for drug. Methods The fine particle characteristics of salbutamol sulfate metered dose inhalers from two manufacturers were determined by Anderson cascade impactor( ACI) and HPLC,respectively. Aerodynamic assessment of fine particles was determined by means of fine particle fraction( FPF), mass median aerodynamic diameter( MMAD) and geometric standard deviation( GSD). The aerodynamic particle distribution function was also established. Results Inhalers from manufacturer A had less fine particle fraction and higher mass median aerodynamic diameter,geometric standard deviation was basically higher than inhalers from manufacturer B.The fitting degree of the fine particle distribution function of manufacturer A was better than that of manufacturer B. Conclusion The aerodynamic particle distribution functions which two manufacturers are different could be a effective means of consistency evaluation for inhalation preparation.

关 键 词：硫酸沙丁胺醇定量吸入气雾剂 空气动力学特性 空气动力学微细粒子分布方程 体外一致性评价方法 

分 类 号：R917[医药卫生—药物分析学] R562.2[医药卫生—药学]