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机构地区:[1]上海恒瑞医药有限公司,上海200245 [2]上海市食品药品监督管理局科技情报研究所,上海200233
出 处:《中国新药与临床杂志》2010年第12期899-903,共5页Chinese Journal of New Drugs and Clinical Remedies
摘 要:目的了解鼻喷雾剂的物理性质,黏度和触发参数对混悬型鼻喷雾剂雾滴粒度分布的影响。方法本实验应用Spraytec誖激光衍射喷雾粒径测定仪测定鼻喷雾剂的喷雾粒径分布。采用Box-Behnken设计考察了黏度、触发力和触发距离对雾滴粒径分布的影响,考察指标包括Dv10、Dv50和Dv90。结果黏度是影响雾滴粒径的最显著因素,随着黏度的增大,雾滴粒径显著增大。触发力和触发距离对喷雾粒径的影响较小,随着触发力、触发距离的增大,喷雾雾滴粒径先减小后增大。结论雾滴粒径分布与黏度、触发力和触发距离确实有一定关系。AIM To understand the physical properties of nasal formulations by the laser diffraction method(Spraytec).METHODS The effects of viscosity,actuation force and actuation distance were investigated using Box-Behnken experimental design and Spraytec with the eNSP actuation station(InnovaSystems,Moorestown,NJ).Parameters for the droplet-size distribution(DSD)included Dv10,Dv50 and Dv90.RESULTS The viscosity of solution was the most significant factor on DSD of suspension nasal spray.DSD increased observably with the increase of viscosity.Actuation force and actuation distance had less effects on DSD with the results that droplet-size decreased first and then increased respectively with the increase of actuation force and actuation distance.CONCLUTION The DSD of suspension nasal spray is dependent on a combination of viscosity,actuation force and actuation distance.The Spraytec with the eNSP actuation station provides an efficient and reliable way of monitoring the effects of parameter variables on DSD from nasal spray.
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