【摘要】：采用沉淀法制備布地奈德納米晶體,以藥物晶體平均粒徑為指標,進行了工藝參數(shù)研究,以粒徑1μm的藥物晶體累積百分數(shù)、穩(wěn)定性和霧化性能為指標進行了霧化吸入用布地奈德納米混懸液的處方篩選,最終制得平均粒徑500~600 nm,粒徑1μm的藥物粒子質(zhì)量累積百分數(shù)為95%~100%的布地奈德納米混懸液,40℃條件下的穩(wěn)定性良好。采用新一代撞擊器(NGI),考察了布地奈德納米混懸液經(jīng)Pari霧化器(噴射式霧化器)和自制振動網(wǎng)式霧化器霧化的霧化性能。結(jié)果顯示Pari霧化器的藥物遞送劑量百分數(shù)為(39.50±4.27)%,空氣動力學(xué)粒徑小于5μm的粒子中累積藥量占輸出藥量的百分比(FPF_(5 μm))為(68.25±0.26)%;自制振動網(wǎng)式霧化器藥物遞送劑量百分數(shù)為(90.67±2.94)%,FPF_(5μm)為(85.94±0.32)%。表明自制振動網(wǎng)式霧化器可顯著提高藥物的遞送劑量,且微細粒子分數(shù)更高,提示布地奈德納米混懸液經(jīng)振動網(wǎng)式霧化器給藥具有較好的開發(fā)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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