吸气流速对载体型粉雾剂分散行为影响的考察  

Investigation on Influence of Airflow Rate on Dispersion Behavior of Carrier-based Dry Powder Inhaler

作　　者：汪选 陈岚[1,2] 陈东浩 WANG Xuan;CHEN Lan;CHEN Donghao(School of Medical Instrument and Food Engineering,University of Shanghai for Science and Technology,Shanghai 200093;Hangzhou Chance Pharmaceuticals Co.,Ltd.,Hangzhou 311121)

机构地区：[1]上海理工大学医疗器械与食品学院,上海200093 [2]杭州畅溪制药有限公司,浙江杭州311121

出　　处：《中国医药工业杂志》2022年第1期77-85,共9页Chinese Journal of Pharmaceuticals

摘　　要：本试验考察了吸入气流大小对以HandiHaler;为药物递送装置的载体型粉雾剂中粉末分散、沉积表现的影响。将载体乳糖Lactohale LH206与微粉化马来酸氯苯那敏混合,制得制剂粉末模型,利用新一代撞击器分析制剂粉末在20、30、40、50、60 L/min流速下的分散表现。同时,运用计算流体力学耦合离散元建模方法,探讨不同流速条件下不同形状(球形和非球形)粉末颗粒的分散行为。试验表明,随着吸气流速的升高,胶囊和装置中的药物残留量均降低,但粉末分散性能变化相对较小。计算机模拟结果与体外试验结果规律一致,可较好地解释分散过程。本试验处方与HandiHaler;的组合对吸气流速不敏感,有效沉积量较稳定。将颗粒碰撞及颗粒与气流的相对运动分别与微细粒子剂量建立拟合关系,相对于球形颗粒模型而言,非球形颗粒模型的计算结果更贴近实际载体乳糖的分散过程,更适用于本制剂粉末分散过程的数值分析。This research investigated the effect of airflow rate on drug powder dispersion and deposition performance of carrier-based dry powder inhaler with HandiHaler;.The formulation model was prepared by mixing the carrier lactose Lactohale 206 and the micronized chlorpheniramine maleate.The next-generation pharmaceutical impactor(NGI) was used to analyze the powder deposition at the airflow rates of 20,30,40,50 and 60 L/min,respectively.Meanwhile,the coupled computational fluid dynamics and discrete element method was adopted to evaluate the dispersion behaviors of the powder particles with two different shapes(spherical and non-spherical) at variant airflow rates.The reults showed that the drug residues in the capsule and the device decreased with the increase of air flow rate.However,the powder dispersion performance rarely changed.Furthermore,the computer simulation results were consistent with the in vitro experimental outcomes,which could help to understand the dispersion process.In this study,the system of inhalation powders and Handihaler;was relatively independent of the air flow rate,and the effective deposition amount was stable.The relationships between particle collision or relative motion(between particles and airflow) and fine particle dose were respectively established.Comparing to the spherical particle model,the non-spherical particle model of the carrier lactose was more reliable in the simulation,thus the non-spherical model should be better for the numerical analysis of the dispersion process.

关 键 词：马来酸氯苯那敏 粉雾剂 吸气流速 颗粒 分散 计算机模拟 

分 类 号：R943[医药卫生—药剂学]