西那普肽脂質(zhì)體氣溶膠體外評價
發(fā)布時間：2018-10-15 10:06
【摘要】：制備并評價了西那普肽脂質(zhì)體。凍干前后脂質(zhì)體的平均粒徑、ζ電位和包封率分別為556.5和651.2 nm、-56.8和-41.6mV、83.8%和70.4%。凍干脂質(zhì)體中殘余水分含量為1.48%,氯仿和甲醇的殘留量低于中國藥典2015年版的限度要求。利用Pari霧化器將用生理鹽水復(fù)溶后的西那普肽脂質(zhì)體霧化,形成氣溶膠,再分別采用雙級撞擊器、新一代撞擊器(next generation impactor,NGI)、飛行時間(time-of-flight,TOF)空氣動力學(xué)粒徑譜儀對氣溶膠的體外沉積性質(zhì)進(jìn)行考察。結(jié)果表明,雙級撞擊器、NGI和TOF測得的體外沉積性質(zhì)相似;雙級撞擊器和NGI測得空氣動力學(xué)粒徑小于6.4 um的脂質(zhì)體氣溶膠中的西那普肽含量占總藥量的比例為50.86%和43.87%,NGI和TOF測得的空氣動力學(xué)質(zhì)量中位徑(mass median aerodynamic diameter,MMAD)值為3.09和2.81 um。這些結(jié)果提示西那普肽脂質(zhì)體氣溶膠能夠在肺部沉積,具有較好的開發(fā)應(yīng)用前景。
[Abstract]:Sinapeptide liposomes were prepared and evaluated. The average particle size, 味 potential and entrapment efficiency of liposomes before and after freeze-drying were 556.5 and 651.2 nm,-56.8 and -41.6 MV respectively, and 70.448% and 70.4%, respectively. The residual moisture content in freeze-dried liposomes was 1.48 and the residues of chloroform and methanol were lower than the limit of Chinese Pharmacopoeia 2015. Pari atomizer was used to atomize sinapeptide liposome after redissolution with normal saline to form aerosol, and two stage impactor was used respectively. The in vitro deposition properties of aerosols were investigated by a new generation of impactor (next generation impactor,NGI) and time of flight (time-of-flight,TOF) aerodynamics particle size spectrometer. The results show that the in vitro deposition properties measured by two-stage impactor, NGI and TOF are similar. The ratio of Sinapeptide content in liposome aerosols with aerodynamic diameter less than 6.4 um measured by two-stage impactor and NGI was 50.86% and 43.87g / TOF, respectively, and the (mass median aerodynamic diameter,MMAD values of aerodynamic mass were 3.09 and 2.81 um. respectively. These results suggest that Sinapeptide liposome aerosols can be deposited in the lungs and have a good prospect of development and application.
【作者單位】： 中國醫(yī)藥工業(yè)研究總院藥物制劑國家工程研究中心;
【分類號】：R943
本文編號：2272198
[Abstract]:Sinapeptide liposomes were prepared and evaluated. The average particle size, 味 potential and entrapment efficiency of liposomes before and after freeze-drying were 556.5 and 651.2 nm,-56.8 and -41.6 MV respectively, and 70.448% and 70.4%, respectively. The residual moisture content in freeze-dried liposomes was 1.48 and the residues of chloroform and methanol were lower than the limit of Chinese Pharmacopoeia 2015. Pari atomizer was used to atomize sinapeptide liposome after redissolution with normal saline to form aerosol, and two stage impactor was used respectively. The in vitro deposition properties of aerosols were investigated by a new generation of impactor (next generation impactor,NGI) and time of flight (time-of-flight,TOF) aerodynamics particle size spectrometer. The results show that the in vitro deposition properties measured by two-stage impactor, NGI and TOF are similar. The ratio of Sinapeptide content in liposome aerosols with aerodynamic diameter less than 6.4 um measured by two-stage impactor and NGI was 50.86% and 43.87g / TOF, respectively, and the (mass median aerodynamic diameter,MMAD values of aerodynamic mass were 3.09 and 2.81 um. respectively. These results suggest that Sinapeptide liposome aerosols can be deposited in the lungs and have a good prospect of development and application.
【作者單位】： 中國醫(yī)藥工業(yè)研究總院藥物制劑國家工程研究中心;
【分類號】：R943
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