盐酸吉西他滨脂质体包封率的测定

目的:建立盐酸吉西他滨脂质体包封率的测定方法。方法:采用超滤法分离脂质体与游离药物,高效液相色谱法测定游离药物含量,并计算包封率。结果:超滤方法中空白回收率为97.8%~100.1%,加样回收率为99.0%~100.1%;盐酸吉西他滨检测浓度的线性范围为1.0~80.0mg.L-1(r=0.999 3),平均回收率为98.7~101.2%,日内和日间RSD均小于3%,平均包封率为81.21%。结论:本方法简便、准确,可用于盐酸吉西他滨脂质体包封率的测定。

Determination of Entrapment Efficiency of Gemcitabine Hydrochloride Liposome

OBJECTIVE： To establish a method for determining the entrapment efficiency of gemcitabine hydrochloride li- posomes（GHL） . METHODS： The liposome and the free gemcitahine hydrochloride were separated by ultrafiltration, and the content of free gemcitabine hydrochloride was determined by HPLC. The entrapment efficiency of gemcitabine hydrochloride liposomes was computed as well. RESULTS： The recovery rate in ultrafiltration methods was 97.8%- 100.1% for blank substance versus 99.0% --100.1% for sample. The linear range of gemcitabine hydrochloride was 1.0--80.0 mg ·L^ -1 （r = 0.999 3） and its average recovery rate was 98.7--101.2%, and its inter - day and intra- day RSD were all less than 3% and its average entrapment efficiency was 81.21%. CONCLUSION： The method is simple, accurate and applicable for the determination of the entrapment efficiency of gemcitabine hydrochloride liposomes.