Nikander K, Turpeinen M, Wollmer P
Astra Draco AB, Lund, Sweden.
J Aerosol Med. 1999 Summer;12(2):47-53. doi: 10.1089/jam.1999.12.47.
A study was undertaken to compare the amount of nebulized budesonide suspension and nebulized terbutaline sulphate solution inhaled by healthy adult subjects when conventional jet and ultrasonic nebulizers were used. Ten healthy subjects (5 male; age range, 16-52 years) used two conventional nebulizers: the Spira Elektro 4 jet nebulizer (Respiratory Care Center, Hämeenlinna, Finland) and the Spira Ultra ultrasonic nebulizer (Respiratory Care Center) in a breath-synchronized mode with each drug. The amount of drug inhaled, the inhaled mass, was defined as the amount of drug deposited on a filter between the inspiratory port of the nebulizer and the mouthpiece. The amount of budesonide and terbutaline sulphate was determined by reversed-phase high-performance liquid chromatography. Single-dose respules were used (0.5 mg of budesonide and 5.0 mg of terbutaline sulphate), and nebulization time up to the defined gravimetric output was recorded. The inhaled mass of budesonide varied depending on the nebulizer used, whereas the inhaled mass of terbutaline was unaffected by the choice of nebulizer. The median inhaled mass of budesonide was 31.4% of the nominal dose (i.e., dose of drug in the respule per label claim) with the Spira Elektro 4 and 9.9% with the Spira Ultra, whereas the median inhaled mass of terbutaline was 50% with the Spira Elektro 4 and 52% with the Spira Ultra. It appears that a suspension is generally more difficult to nebulize than a solution and that the budesonide suspension should not be used in conventional ultrasonic nebulizers.
开展了一项研究，比较健康成年受试者使用传统喷射式雾化器和超声雾化器时吸入的布地奈德雾化混悬液和硫酸特布他林雾化溶液的量。十名健康受试者（5名男性；年龄范围为16 - 52岁）使用了两种传统雾化器：Spira Elektro 4喷射式雾化器（芬兰海梅恩林纳呼吸护理中心）和Spira Ultra超声雾化器（呼吸护理中心），每种药物均采用呼吸同步模式。吸入药物的量，即吸入质量，定义为沉积在雾化器吸气口与吸嘴之间过滤器上的药物量。布地奈德和硫酸特布他林的量通过反相高效液相色谱法测定。使用单剂量吸入用溶液剂（0.5mg布地奈德和5.0mg硫酸特布他林），记录达到规定重量输出的雾化时间。布地奈德的吸入质量因所使用的雾化器而异，而硫酸特布他林的吸入质量不受雾化器选择的影响。使用Spira Elektro 4时，布地奈德的中位吸入质量为标称剂量（即标签声明中吸入用溶液剂中的药物剂量）的31.4%，使用Spira Ultra时为9.9%，而使用Spira Elektro 4时硫酸特布他林的中位吸入质量为50%，使用Spira Ultra时为52%。似乎混悬液通常比溶液更难雾化，并且布地奈德混悬液不应在传统超声雾化器中使用。
