西那普肽脂质体气溶胶体外评价
发布时间：2018-10-15 10:06
【摘要】：制备并评价了西那普肽脂质体。冻干前后脂质体的平均粒径、ζ电位和包封率分别为556.5和651.2 nm、-56.8和-41.6mV、83.8%和70.4%。冻干脂质体中残余水分含量为1.48%,氯仿和甲醇的残留量低于中国药典2015年版的限度要求。利用Pari雾化器将用生理盐水复溶后的西那普肽脂质体雾化,形成气溶胶,再分别采用双级撞击器、新一代撞击器(next generation impactor,NGI)、飞行时间(time-of-flight,TOF)空气动力学粒径谱仪对气溶胶的体外沉积性质进行考察。结果表明,双级撞击器、NGI和TOF测得的体外沉积性质相似;双级撞击器和NGI测得空气动力学粒径小于6.4 um的脂质体气溶胶中的西那普肽含量占总药量的比例为50.86%和43.87%,NGI和TOF测得的空气动力学质量中位径(mass median aerodynamic diameter,MMAD)值为3.09和2.81 um。这些结果提示西那普肽脂质体气溶胶能够在肺部沉积,具有较好的开发应用前景。
[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.
【作者单位】： 中国医药工业研究总院药物制剂国家工程研究中心;
【分类号】：R943
本文编号：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.
【作者单位】： 中国医药工业研究总院药物制剂国家工程研究中心;
【分类号】：R943
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