Bisgaard H, Klug B, Sumby B S, Burnell P K
Dept of Paediatrics, Pulmonary Service, National University Hospital, Rigshospitalet, Copenhagen, Denmark.
Eur Respir J. 1998 May;11(5):1111-5. doi: 10.1183/09031936.98.11051111.
The study aimed to investigate dose consistency and particle distribution from the dry powder inhalers Diskus and Turbuhaler. Full profiles of inhalation pressure versus time were recorded in 18 4 yr old and 18 8 yr old asthmatic children through Diskus and Turbuhaler inhalers. These data were used in an inhalation profile simulator to assess drug delivery from both a Diskus inhaler and a Turbuhaler inhaler, and in particular to assess the proportion of drug emitted in the coarse (>4.7 microm) and fine (<4.7 microm) particle size range from each type of inhaler. The inhalation profile more accurately represents the changes in flow rate over time through the device than the constant flow rate usually applied with an impactor alone. The aerosol cloud was released before the peak inspiratory effort had been achieved and accordingly the early part and not the peak of the inspiratory performance is a determinant of the quality of the aerosol. The mean (SD) amount of drug in large particles (>4.7 microm), fine particles (<4.7 microm) and very fine particles (<2.1 microm) in percentage of label claim from the Fluticasone Diskus was 72 (5), 15 (2) and 2 (1) from the 4 yr old children and 71 (3), 18 (2) and 2 (1) from the 8 yr old children, respectively. Similar particle fractions from the Budesonide Turbuhaler were 35 (9), 21 (10) and 7 (5) from 4 yr old children and 30 (7), 32 (9) and 12 (6) from 8 yr old children. In conclusion, the Diskus inhaler provides an improved dose consistency through the varying age groups and inspiratory flow performances when compared to the Turbuhaler in terms of the proportion of the dose emitted at each particle size. This improvement is at the expense of a low fine particle mass and a high proportion of coarse particles from the Diskus as compared with the Turbuhaler.
该研究旨在调查都保（Diskus）和准纳器（Turbuhaler）这两种干粉吸入器的剂量一致性和颗粒分布情况。通过都保和准纳器吸入器，记录了18名4岁哮喘儿童和18名8岁哮喘儿童的完整吸入压力随时间变化曲线。这些数据被用于吸入曲线模拟器，以评估都保吸入器和准纳器吸入器的药物递送情况，特别是评估每种类型吸入器在粗颗粒（>4.7微米）和细颗粒（<4.7微米）粒径范围内释放的药物比例。与单独使用撞击器时通常采用的恒定流速相比，吸入曲线能更准确地反映随时间通过该装置的流速变化。气雾剂云在达到吸气努力峰值之前就已释放，因此吸气性能的早期部分而非峰值是气雾剂质量的决定因素。4岁儿童使用氟替卡松都保吸入器时，大颗粒（>4.7微米）、细颗粒（<4.7微米）和极细颗粒（<2.1微米）中的药物平均（标准差）含量占标示量的百分比分别为72（5）、15（2）和2（1），8岁儿童分别为71（3）、18（2）和2（1）。4岁儿童使用布地奈德准纳器时，类似的颗粒比例分别为35（9）、21（10）和7（5），8岁儿童分别为30（7）、32（9）和12（6）。总之，就每种粒径释放剂量的比例而言，与准纳器相比，都保吸入器在不同年龄组和吸气流量性能方面提供了更好的剂量一致性。与准纳器相比，这种改进是以都保吸入器细颗粒质量较低和粗颗粒比例较高为代价的。
