超滤-HPLC法测定注射用多西他赛脂质体的含量和包封率  

Determination and entrapment efficiency of docetaxel liposomes for injection by ultrafiltration-HPLC

作　　者：胡波[1] 周郁斌[1] 杨艳[1] 叶小玲[1] 袁中文[1] 李海刚[1] 关世侠[1] 

机构地区：[1]广州中医药大学中药学院,广东广州510006

出　　处：《广东药学院学报》2012年第2期132-134,共3页Academic Journal of Guangdong College of Pharmacy

摘　　要：目的测定注射用多西他赛脂质体的含量和包封率。方法:用乳化挥散法制备多西他赛脂质体;采用超滤法分离脂质体中的游离药物;用HPLC法测定脂质体的含量及包封率:采用Agilent Tc-C18柱(4.6mm×250 mm,5μm)为色谱柱,流动相为甲醇-乙腈-水(体积比35∶40∶25),流速为1.0 mL.min-1,检测波长为233 nm,柱温为室温。结果:超滤法能很好地把脂质体和游离药物分离,超滤膜空白回收率为96.5%,加样回收率为98.3%;在所选色谱条件下,辅料不干扰多西他赛的含量测定,多西他赛在3～300μg.mL-1范围内线性关系良好,加样回收率在97.06%～102.19%之间,多西他赛脂质体含量为3.87 mg.mL-1,包封率为99.26%。结论:该方法方便、快捷,可以用于多西他赛脂质体含量和包封率的测定。Objective To study on the determination and entrapment efficiency of docetaxel liposomes for injection.Methods Docetaxel liposomes were prepared with emulsify-volatilizing method,and the free drug were separated from liposomes with ultrafiltration.The content and entrapment efficiency of docetaxel liposomes were determined by HPLC.HPLC conditions were as follows： Agilent Tc-C18（4.6 mm×250 mm,5 μm）;eluting with methanol-acetonitrile-water（35：40：25）at a flow rate of 1.0 mL·min-1,detecting at 233 nm wavelength,20 μL injection volume.Results The free docetaxel was separated from the liposomes with ultrafiltration,in which the blank recovery rate was 96.5%,and the sample recovery rate was 98.3%.Accessories don＇t affect the determination of docetaxel in these chromatographic conditions;It has a good linearity in a range of 3～300 μg·mL-1of docetaxel,and the recovery ratio was 97.06%～102.19%.The content of docetaxel liposomes was 3.87 mg·mL-1,and the entrapment efficiency of docetaxel liposomes was 99.26%.Conclusion The content and entrapment efficiency of docetaxel liposomes can be determined conveniently and quickly with ultrafiltration-HPLC.

关 键 词：多西他赛 脂质体 超滤法 高效液相色谱法 包封率 

分 类 号：R927.2[医药卫生—药学]