雾化吸入用布地奈德纳米混悬液的制备及体外评价

发布时间：2018-10-18 07:52

【摘要】：采用沉淀法制备布地奈德纳米晶体,以药物晶体平均粒径为指标,进行了工艺参数研究,以粒径1μm的药物晶体累积百分数、稳定性和雾化性能为指标进行了雾化吸入用布地奈德纳米混悬液的处方筛选,最终制得平均粒径500~600 nm,粒径1μm的药物粒子质量累积百分数为95%~100%的布地奈德纳米混悬液,40℃条件下的稳定性良好。采用新一代撞击器(NGI),考察了布地奈德纳米混悬液经Pari雾化器(喷射式雾化器)和自制振动网式雾化器雾化的雾化性能。结果显示Pari雾化器的药物递送剂量百分数为(39.50±4.27)%,空气动力学粒径小于5μm的粒子中累积药量占输出药量的百分比(FPF_(5 μm))为(68.25±0.26)%;自制振动网式雾化器药物递送剂量百分数为(90.67±2.94)%,FPF_(5μm)为(85.94±0.32)%。表明自制振动网式雾化器可显著提高药物的递送剂量,且微细粒子分数更高,提示布地奈德纳米混悬液经振动网式雾化器给药具有较好的开发前景。
[Abstract]:Budesonide nanocrystals were prepared by precipitation method. The average particle size of drug crystals was taken as the index, and the technological parameters were studied. The cumulative percentage of drug crystals with the diameter of 1 渭 m was calculated. The stability and atomization performance of budesonide nano-suspension for aerosol inhalation were selected. Finally, the cumulative percentage of drug particles with an average diameter of 500,600 nm, and 1 渭 m was 95% and 100%. The stability of budesonide nanoparticles was good at 40 鈩，

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