摘要
目的:选用不同类型雾化器比较两家企业生产的吸入用异丙托溴铵溶液空气动力学粒径分布(APSD)的一致性。方法:选用两种类型的雾化器,采用新一代撞击器(NGI)和HPLC法分别对两家企业生产的吸入用异丙托溴铵溶液进行APSD测定,通过微细粒子剂量(FPD)、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)对两家企业的样品进行了比较,并建立了APSD曲线。结果:使用雾化器A时,甲企业与乙企业样品的APSD曲线基本重合,一致性较好;使用雾化器B时,乙企业的3批样品APSD曲线与甲企业样品的APSD曲线存在差异。结论:使用不同类型的雾化器和APSD曲线可评价不同企业生产的吸入用异丙托溴铵溶液空气动力学粒径分布的一致性。
Objective: To compare the aerodynamic particle size distribution( APSD) of ipratropium bromide solution for inhalation by using different types of nebulizers. Methods: The APSD of ipratropium bromide solution for inhalation from two manufacturers were determined using two different types of nebulizers by next generation impactor( NGI) and HPLC method,respectively. Aerodynamic assessment of fine particles was determined by means of fine particle dose( FPD),fine particle fraction( FPF),mass median aerodynamic diameter( MMAD) and geometric standard deviation( GSD). The aerodynamic particle distribution function was also established. Results: When the atomizer A was used,the APSD curves of the samples from enterprise 1 and enterprise 2 were basically the same,and the consistency was promising. When the nebulizer B was used,the APSD curves of 3 batches of samples from enterprise2 were different from those from enterprise 1. Conclusion: The APSD results from two types of nebulizers have statistically significant differences. The uniformity of aerodynamic particle size distribution of ipratropium bromide solution for inhalation from different manufacturers can be evaluated by using different types of nebulizers and APSD curves.
作者
李苗
冯光
黄慧芬
Li Miao;Feng Guang;Huang Huifen(Wuhan Institute for Drug and Medical Device Control,Wuhan 430075,China)
出处
《中国药师》
CAS
2020年第4期655-658,670,共5页
China Pharmacist
关键词
吸入用异丙托溴铵溶液
空气动力学粒径分布
雾化器
Ipratropium bromide solution for inhalation
Aerodynamic particle size distribution
Nebulizer
