硫酸沙丁胺醇定量吸入气雾剂体外一致性评价方法
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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.
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.
引文
[1]陈桂良,侯惠民.大鼠肺部给药后血浆中沙丁胺醇浓度的LC-MS/MS测定[J].中国医药工业杂志,2006,37(6):411-414.
[2]罗柱,刘春涛,吴松泽,等.国产与进口含HFA-134A抛射剂的硫酸沙丁胺醇气雾剂对哮喘肺功能影响的比较[J].中国新药杂志,2014,23(6):682-685.
[3]刘进芳,马艳,刘苇.反相高效液相色谱法测定硫酸沙丁胺醇片和气雾剂中沙丁胺醇的含量[J].天津化工,2016,30(6):33-36.
[4]魏宁漪,周颖,高蕾,等.双级撞击器法与安德森撞击器法的比较[J].中国新药杂志,2017,26(19):2324-2327.
[5]马锦芳,郑劲平,曹照龙,等.沙丁胺醇吸入粉雾剂与气雾剂治疗支气管哮喘的随机对照多中心研究[J].中国新药与临床杂志,2015,34(2):115-119.
[6] RAHIMKHANI S,GHANBARZADEH S,NOKHODCHI A,et al. An in vitro aerosolization efficiency comparison of generic and branded salbutamol metered dose inhalers[J].Pharm Sci,2017,23(3):77-81.
[7]国家药典委员会.中华人民共和国药典(二部)[M].北京:中国医药科技出版社,2015:1332-1333.
[8]国家药典委员会.中华人民共和国药典(四部)[M].北京:中国医药科技出版社,2015:125-130.
[9] MOMENI S,NOKHODCHI A,GHANBARZADEH S,et al.The effect of spacer morphology on the aerosolization performance of metered-dose inhalers:spacer shape effect on aerosolization performance[J]. Adv Pharm Bull,2016,6(2):257-260.
[10] HAMISHEHKAR H,EMAMI J,NAJAFABADI A R,et al.Influence of carrier particle size,carrier ratio and addition of fine ternary particles on the dry powder inhalation performance of insulin-loaded plga microcapsules[J].Powder Technol,2010,201(3):289-295.
[2]罗柱,刘春涛,吴松泽,等.国产与进口含HFA-134A抛射剂的硫酸沙丁胺醇气雾剂对哮喘肺功能影响的比较[J].中国新药杂志,2014,23(6):682-685.
[3]刘进芳,马艳,刘苇.反相高效液相色谱法测定硫酸沙丁胺醇片和气雾剂中沙丁胺醇的含量[J].天津化工,2016,30(6):33-36.
[4]魏宁漪,周颖,高蕾,等.双级撞击器法与安德森撞击器法的比较[J].中国新药杂志,2017,26(19):2324-2327.
[5]马锦芳,郑劲平,曹照龙,等.沙丁胺醇吸入粉雾剂与气雾剂治疗支气管哮喘的随机对照多中心研究[J].中国新药与临床杂志,2015,34(2):115-119.
[6] RAHIMKHANI S,GHANBARZADEH S,NOKHODCHI A,et al. An in vitro aerosolization efficiency comparison of generic and branded salbutamol metered dose inhalers[J].Pharm Sci,2017,23(3):77-81.
[7]国家药典委员会.中华人民共和国药典(二部)[M].北京:中国医药科技出版社,2015:1332-1333.
[8]国家药典委员会.中华人民共和国药典(四部)[M].北京:中国医药科技出版社,2015:125-130.
[9] MOMENI S,NOKHODCHI A,GHANBARZADEH S,et al.The effect of spacer morphology on the aerosolization performance of metered-dose inhalers:spacer shape effect on aerosolization performance[J]. Adv Pharm Bull,2016,6(2):257-260.
[10] HAMISHEHKAR H,EMAMI J,NAJAFABADI A R,et al.Influence of carrier particle size,carrier ratio and addition of fine ternary particles on the dry powder inhalation performance of insulin-loaded plga microcapsules[J].Powder Technol,2010,201(3):289-295.