Waldrep J C, Berlinski A, Dhand R
Division of Pulmonary, Critical Care, and Environmental Medicine, University of Missouri-Columbia, Columbia, MO 65212, USA.
J Aerosol Med. 2007 Fall;20(3):310-9. doi: 10.1089/jam.2007.0538.
Different approaches have been employed for in vitro assessment of the aerosol particle size generated by inhalation devices. In this study, aerosols from the Omron MicroAir vibrating mesh (VM) nebulizer were measured by cascade impaction (CI) using the MSP Next Generation Pharmaceutical Impactor (NGI), the ThermoAndersen Cascade Impactor (ACI), and by time-of-flight (TOF) analysis with the TSI 3321 Aerodynamic Particle Sizer Spectrometer (APS). The VM nebulizer was evaluated with sodium fluoride (NaF; 2.5%) and with generic albuterol (0.083%). Aerosol particle size (MMAD), respirable fractions (RF < 5 microm), and fine particle fractions (FPF < 3.3 microm) were determined with each method at room temperature (RT) and 4 degrees C using 50% average relative humidity. By NGI at either RT or 4 degrees C, aerosol particle sizes were similar for both NaF and albuterol (4.3-4.5 microm MMAD) with 55-61% RF and 27-43% FPF. With ACI, the distribution of particles at RT was similar except at the extremes of the dispersion and the MMAD was smaller (3.3 microm MMAD; p = 0.03). At 4 degrees C, particle sizes determined by ACI results were similar to the NGI (MMAD 4.1 microm; p > 0.05). TOF analysis by APS with albuterol gave significantly larger calculated MMAD (cMMAD) than either CI method (7.2 microm; p < 0.001). TOF measurements of nebulized albuterol at RT and 4 degrees C were equivalent. In summary, the results of VM nebulized NaF and albuterol were more consistent and generally equivalent when determined by NGI (at RT and 4 degrees C) and ACI analysis (at 4 degrees C). In contrast, aerosol particle sizes measured by TOF in the APS at both RT and 4 degrees C were larger than results obtained by CI. Differences in aerosol particle distribution obtained by different analysis methods should be considered while evaluating the in vitro performance of VM nebulizers.
已采用不同方法对吸入装置产生的气溶胶粒径进行体外评估。在本研究中，使用MSP下一代药物撞击器（NGI）、热电安德森撞击器（ACI）通过级联撞击（CI）对欧姆龙微空气振动网（VM）雾化器产生的气溶胶进行测量，并使用TSI 3321气动粒径分析仪（APS）通过飞行时间（TOF）分析进行测量。使用氟化钠（NaF；2.5%）和通用沙丁胺醇（0.083%）对VM雾化器进行评估。在室温（RT）和4℃、平均相对湿度50%的条件下，用每种方法测定气溶胶粒径（MMAD）、可吸入分数（RF<5微米）和细颗粒分数（FPF<3.3微米）。在RT或4℃下，通过NGI测定，NaF和沙丁胺醇的气溶胶粒径相似（MMAD为4.3 - 4.5微米），RF为55 - 61%，FPF为27 - 43%。使用ACI时，RT下的颗粒分布相似，但在分散的极端情况下除外，且MMAD较小（MMAD为3.3微米；p = 0.03）。在4℃时，ACI测定的粒径结果与NGI相似（MMAD为4.1微米；p>0.05）。使用APS通过TOF分析沙丁胺醇得到的计算MMAD（cMMAD）明显大于任何一种CI方法（7.2微米；p<0.001）。在RT和4℃下对雾化沙丁胺醇的TOF测量结果相当。总之，当通过NGI（在RT和4℃）和ACI分析（在4℃）测定时，VM雾化NaF和沙丁胺醇的结果更一致且总体相当。相比之下，在RT和4℃下通过APS中的TOF测量的气溶胶粒径大于CI获得的结果。在评估VM雾化器的体外性能时，应考虑不同分析方法获得的气溶胶颗粒分布差异。
