流速对激光衍射法测试2种市售雾化吸入剂粒径大小及分布结果的影响

目的 探究流速对激光衍射法测试经3种喷雾器雾化的吸入溶液的气溶胶粒径分布的影响.方法 分别在6 L/min和15 L/min的测量流速条件下,用Spraytec STP2000激光粒度仪测试硫酸沙丁胺醇雾化吸入溶液(溶液型)和吸入用布地奈德混悬液(混悬型)2种吸入溶液经LC sprint 1、LC sprint 2、LC Family3种喷雾器雾化的气溶胶的粒径分布情况.结果 吸入用布地奈德混悬液经LC sprint 1雾化的气溶胶,在6 L/min和15 L/min条件下测试的DV(50)(累积分布为50%时对应的粒径)分别为(2.963±0.067)μm和(3.068±0.255)μm,差异无统计学意义;经LC sprint 2雾化的气溶胶,6 L/min和15 L/min测试的DV(50)分别为(3.247±0.146)μm和(3.693±0.116)μm,差异具有统计学意义(P<0.05);经LC Family雾化的气溶胶,6 L/min和15 L/min测试的DV(50)分别为(3.532±0.131)μm和(3.701±0.122)μm,差异具有统计学意义(P<0.01).在体积累积分布图和体积频数分布图中,LC sprint 1 (2.2 μm)雾化的气溶胶在15 L/min和6 L/min的条件下的结果无明显的差异,而LC sprint 2 (2.9 μm)、LC Family (3.5 μm)雾化的气溶胶在这两个流速条件下的分布图均有差别.硫酸沙丁胺醇雾化吸入溶液的测试结果与吸入用布地奈德混悬液结果相似.结论 测量流速对激光衍射法测试吸入溶液的气溶胶粒径分布存在影响,影响的程度与所选用的喷雾器有关.

Influence of flow rate on laser diffraction measurement of particle size and distribution with two commercial nebulizers

Objective To investigate the effect of flow rate on measuring the aerosol's particle size and distribution atomized by three types of nebulizer.Methods The particle size distribution of salbutamol sulfate nebules inhalation solution and budesonide suspension for inhalation atomized by three types of nebulizer (LC sprint 1,LC sprint 2,LC Family) with the flow rate of 6 L/min and 15 L/min were evaluated with Spraytec STP2000.Results There was no difference of DV (50) between 6 L/min and 15 L/min when the aerosol was atomized by LC sprint 1,which was (2.963±0.067) μm and (3.068±0.255) μm,respectively.However,the difference was significant between 6 L/min and 15 L/min when the aerosol was atomized by LC sprint 2 (P<0.05),which was (3.247±0.146) μm and (3.693±0.116) μm,respectively.More significant difference was observed between 6 L/min and 15 L/min when the aerosol was atomized by LC Family (P<0.01),which was (3.532±0.131) μm and (3.701±0.122) μm,respectively.As for cumulative volume frequency and volume frequency,the particle size distribution of aerosol atomized by LC sprint 1 (2.2 μm) at 15 L/min and 6 L/min were similar,but they showed difference when atomized by LC sprint 2 (2.9 μm) and LC Family (3.5 μm).The particle size distribution of two drugs were similar.Conclusion The flow rate may have influence on the particle size distribution of aerosol,and the extent is relevant with nebulizers.