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噻托溴铵雾化吸入溶液的制备及体外评价 被引量：5

Preparation and in vitro Evaluation of Tiotropium Bromide Inhalation Solution
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摘要 采用Omron振动网式雾化器进行雾化,以雾化性能及稳定性为指标,研制了噻托溴铵雾化吸入溶液(TIS)。分别采用飞行时间空气动力学粒径谱仪、双层液体碰撞器和新一代撞击器3种仪器测定其空气动力学粒径分布和微细粒子分数(FPF),并考察了制品在60℃、4 500 lx光照(4℃)环境放置10 d和40℃放置3个月的稳定性。结果表明,所制备的TIS稳定性好,经振动网式雾化器雾化后雾粒的空气动力学质量中位径约2μm,与市售干粉吸入剂相近;FPF<5μm为70.8%,是市售干粉吸入剂的2倍以上。提示制品对于治疗慢性阻塞性肺病具有较好的开发应用前景。 A tiotropium bromide inhalation solution （TIS） atomized by an Omron vibrating-mesh nebulizer was prepared with atomizing characteristics and stability as the indexes. The aerodynamic particle size distribution （APSD） and fine particle fraction （FPF） of the product nebulized by this device were evaluated by three kinds of equipments, including time of flight （TOF） aerodynamic particle size analyzer, twin-stage liquid impinger and next generation impactor. The stability of the product stored at 60 ℃ or 4 500 lx （4 ℃） for 10 d or 40 ℃ for 3 months was also evaluated. The results showed that the prepared TIS was stable and could provide a consistent delivered dose with a mass median aerodynamic diameter （MMAD） of 2 μm, whose MMAD was similar to the commercial dry powder inhalation. The FPF〈5 μm （70.8%） was over twice that of a marketed dry powder inhalation. The results indicated that TIS might be a useful candidate vehicle for the treatment of chronic obstructive pulmonary disease （COPD）.
作者 王伟 王健 王浩
机构地区 中国医药工业研究总院药物制剂国家工程研究中心
出处 《中国医药工业杂志》 CAS CSCD 北大核心 2012年第4期268-272,共5页 Chinese Journal of Pharmaceuticals
基金 国家"重大新药创制"科技重大专项(2009ZX09310-003)
关键词 噻托溴铵 雾化吸入溶液 慢性阻塞性肺病 制备 体外评价 tiotropium bromide inhalation solution chronic obstructive pulmonary disease preparation in vitro evaluation
分类号 R944.9 [医药卫生—药剂学]
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参考文献8

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二级参考文献12

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共引文献23

同被引文献53

  • 1向云洁,邓震,沈清.HPLC测定吸入用硫酸沙丁胺醇溶液的含量[J].中国现代应用药学,2011,28(S1):1351-1353. 被引量：5
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引证文献5

二级引证文献9

中国医药工业杂志
2012年 第4期

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