微柱离心-HPLC法测定六甲蜜胺脂质体包封率  

Minicolumn centrifugation-HPLC determination of entrapment efficiency for liposomal formulation of altretamine

作　　者：高晓非[1] 邓英杰[1] 曹金娜[1] 王秀敏[2] 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]厦门大学医学院药学系,厦门361005

出　　处：《药物分析杂志》2009年第2期247-249,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：国家自然科学基金(30672555)资助

摘　　要：目的:对六甲蜜胺脂质体进行质量评价,建立六甲蜜胺脂质体包封率的测定方法。方法:采用(凝胶)微柱离心法分离游离药物与脂质体;利用流动相:甲醇-乙腈-水(50∶35∶15);柱温:30℃;流速:0.8 mL·min-1;紫外检测波长:228 nm的HPLC条件测定六甲蜜胺的含量,最终计算得包封率。结果:微柱离心法能够将100%的空白脂质体和小于3.5%的游离药物洗脱下来,游离药物与脂质体可被分离,游离药物基本上被截留于微柱中。在本法选择的色谱条件下,六甲蜜胺得到良好的分离,辅料不干扰测定,六甲蜜胺在2.0～40.0 mg·L-1内线性关系良好(r=0.9996),日内和日间RSD均<2.0%(n=5),加样回收率在97.9%～98.5%之间(RSD<2.0%,n=5)。用该方法测得3份六甲蜜胺脂质体的包封率在82.49%～86.56%之间(RSD均<2.0%,n=3)。结论:本方法可用于测定六甲蜜胺脂质体包封率。Objective：To establish a method for determining the entrapment efficiency and estimating the quality control of ahretamine liposomes. Methods：The minieolumn was employed to separate the free drug from the lipo- somes. The content of altretamine was quantified by HPLC. The mobile phase consisted of methanol - acetonitrile - water（50： 35： 15） was pumped through the system at a rate of 0. 8 mL · min^-1 at 30 ℃. The UV - detector was set at 228 nm. Results：The liposomes were well separated using minicolumn centrifugation by which free altretamine could be absorbed. A calibrated linear curve of altretamine concentration was within 2.0 - 40. 0 mg· L^-1 （ r = 0. 9996）, and within - day and between - days RSD were all less than 2.0% （ n = 5 ）, the recovery rate of altret- amine with blank liposomes was in a range of 97.9% -98.5% with RSD of 1.4% or below （n = 5 ）. The entrap- ment efficiency of three batches of altretamine liposomes was in a range of 82.49% -86. 56% ,with RSD 〈2.0% （n = 3 ） by minicolumn centrifugation -HPLC. Conclusion ：The minicolumn centrifugation -HPLC may be used for the determination of entrapment efficiency of ahretamine liposomes

关 键 词：微柱离心 高效液相色谱法 六甲蜜胺 脂质体 包封率 

分 类 号：R917[医药卫生—药物分析学]