3种撞击器测定异丙托溴铵气雾剂体外沉积性质的比较

发布时间：2018-07-04 20:18

本文选题：异丙托溴铵 + 空气动力学粒径分布　；参考：《中国新药杂志》2017年19期

【摘要】：目的:通过测定异丙托溴铵气雾剂的动态粒径分布,评估其体外沉积性质,并评价不同测定方法的优缺点。方法:分别采用二级撞击器(TI)、安德森撞击器(ACI)和新一代撞击器(NGI)测定异丙托溴铵气雾剂的动态粒径分布。结果:采用TI方法研究气雾剂的肺部沉积,该方法简单易行,但仅能预估肺部沉积量和喉部沉积量,很难进行进一步分析;尽管级联撞击器(CI)方法操作步骤繁杂、耗时,但该方法不仅能得到药物的微细粒子剂量,还能得到气雾剂的空气动力学粒径分布信息。此外,实验结果亦表明ACI与NGI在测定气雾剂的空气动力学粒径分布方面无显著性差异,但NGI的层级间损失更少,并且操作更简便,因此,相比于ACI,NGI方法更具优越性。结论:与二级撞击器相比,级联撞击器方法在评价气雾剂的质量时更为完善。
[Abstract]:Aim: to determine the dynamic particle size distribution of ipratropium bromide aerosol, to evaluate its deposition in vitro and to evaluate the advantages and disadvantages of different methods. Methods: two stage impactor (TI), Anderson impactor (ACI) and new generation impactor (NGI) were used to determine the dynamic particle size distribution of ipratropium bromide aerosol. Results: using TI method to study pulmonary deposition of aerosol is simple and feasible, but it can only predict the amount of deposition in lung and larynx, so it is difficult to analyze further, although the cascade impactor (CI) method is complicated and time-consuming. But this method can not only get the dose of fine particles, but also get the information of aerodynamics particle size distribution of aerosol. In addition, the experimental results show that there is no significant difference between ACI and NGI in the determination of aerodynamics particle size distribution of aerosol, but the loss between levels of NGI is less, and the operation is easier. Therefore, compared with the ACINGI method, it is superior to the ACINGI method. Conclusion: compared with two stage impactor, cascade impactor method is more perfect in evaluating aerosol quality.
【作者单位】：中国食品药品检定研究院;
【基金】：国家“重大新药创制”科技重大专项资助项目(2015ZX093001002009)
【分类号】：R927

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