3種撞擊器測(cè)定異丙托溴銨氣霧劑體外沉積性質(zhì)的比較
發(fā)布時(shí)間:2018-07-04 20:18
本文選題:異丙托溴銨 + 空氣動(dòng)力學(xué)粒徑分布; 參考:《中國(guó)新藥雜志》2017年19期
【摘要】:目的:通過測(cè)定異丙托溴銨氣霧劑的動(dòng)態(tài)粒徑分布,評(píng)估其體外沉積性質(zhì),并評(píng)價(jià)不同測(cè)定方法的優(yōu)缺點(diǎn)。方法:分別采用二級(jí)撞擊器(TI)、安德森撞擊器(ACI)和新一代撞擊器(NGI)測(cè)定異丙托溴銨氣霧劑的動(dòng)態(tài)粒徑分布。結(jié)果:采用TI方法研究氣霧劑的肺部沉積,該方法簡(jiǎn)單易行,但僅能預(yù)估肺部沉積量和喉部沉積量,很難進(jìn)行進(jìn)一步分析;盡管級(jí)聯(lián)撞擊器(CI)方法操作步驟繁雜、耗時(shí),但該方法不僅能得到藥物的微細(xì)粒子劑量,還能得到氣霧劑的空氣動(dòng)力學(xué)粒徑分布信息。此外,實(shí)驗(yàn)結(jié)果亦表明ACI與NGI在測(cè)定氣霧劑的空氣動(dòng)力學(xué)粒徑分布方面無顯著性差異,但NGI的層級(jí)間損失更少,并且操作更簡(jiǎn)便,因此,相比于ACI,NGI方法更具優(yōu)越性。結(jié)論:與二級(jí)撞擊器相比,級(jí)聯(lián)撞擊器方法在評(píng)價(jià)氣霧劑的質(zhì)量時(shí)更為完善。
[Abstract]:Aim: to determine the dynamic particle size distribution of ipratropium bromide aerosol, to evaluate its deposition in vitro and to evaluate the advantages and disadvantages of different methods. Methods: two stage impactor (TI), Anderson impactor (ACI) and new generation impactor (NGI) were used to determine the dynamic particle size distribution of ipratropium bromide aerosol. Results: using TI method to study pulmonary deposition of aerosol is simple and feasible, but it can only predict the amount of deposition in lung and larynx, so it is difficult to analyze further, although the cascade impactor (CI) method is complicated and time-consuming. But this method can not only get the dose of fine particles, but also get the information of aerodynamics particle size distribution of aerosol. In addition, the experimental results show that there is no significant difference between ACI and NGI in the determination of aerodynamics particle size distribution of aerosol, but the loss between levels of NGI is less, and the operation is easier. Therefore, compared with the ACINGI method, it is superior to the ACINGI method. Conclusion: compared with two stage impactor, cascade impactor method is more perfect in evaluating aerosol quality.
【作者單位】: 中國(guó)食品藥品檢定研究院;
【基金】:國(guó)家“重大新藥創(chuàng)制”科技重大專項(xiàng)資助項(xiàng)目(2015ZX093001002009)
【分類號(hào)】:R927
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,本文編號(hào):2097295
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