【摘要】 目的对洛莫司汀脂质体进行质量评价,建立洛莫司汀脂质体包封率的测定方法。方法采用微柱离心法分离洛莫司汀脂质体与游离药物,采用HPLC法测定洛莫司汀含量。结果微柱离心法对洛莫司汀游离药的吸附率在97.25%~98.36%内,空白脂质体回收率在98.60%~100.5%内,洛莫司汀脂质体和游离洛莫司汀得到良好的分离;在选定色谱条件下,洛莫司汀与脂质体分离良好,辅料不干扰测定,洛莫司汀质量浓度在0.5~50.0 mg.L-1内与峰面积呈良好的线性关系(r=0.999 9),日内和日间RSD均小于2%(n=5),加样回收率在97.96%~98.79%内。结论微柱离心-HPLC法可用于洛莫司汀脂质体包封率的测定。更多还原

【Abstract】 Objective To evaluate the quality and determine the entrapment efficiency of lomustine liposomes.Methods The microcolumn centrifuge method was adopted to separate the free lomustine from liposome and HPLC method was used for analyzing the amount of lomustine.Results The interception to free lomustine by microcolumn centrifuge method was 97.25%98.36%,the recovery rate of liposomes was 98.60%-100.5%,lomustine liposomes and lomustine could be well separated;A calibrated linear curve of lomustine was within 5.0-50.0 mg · L-1(r=0.999 9),and RSDs within day and between days were all less than 2%(n=5),the recovery rate of lomustine with blank liposomes was in a range of 97.96%-98.79%.Conclusions The microcolumn centrifuge-HPLC method can be used for the determination of entrapment efficiency of lomustine liposomes.更多还原