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异亚丙基莽草酸脂质体的包封率测定方法比较
引用本文:曲昌海,尹兴斌,张慧,林龙飞,闫磊,杨培,田晶辰,付京,倪健.异亚丙基莽草酸脂质体的包封率测定方法比较[J].中国实验方剂学杂志,2013,19(1):21-24.
作者姓名:曲昌海  尹兴斌  张慧  林龙飞  闫磊  杨培  田晶辰  付京  倪健
作者单位:北京中医药大学中药学院,北京,100029
基金项目:北京中医药大学复方中药制药创新团队基金项目(2011-CX70-13);北京中医药大学自主选题项目(2011-JYBZZ-XS037)
摘    要:目的:研究异亚丙基莽草酸脂质体含量和包封率的测定方法,建立一套准确度好、简便可行的质控方案。方法:采用Agilent Eclipse Plus C18色谱柱(4.6 mm×100 mm,3.5μm),流动相乙腈-0.05%磷酸溶液(10∶90),检测波长220 nm,流速1.0 mL·min-1,柱温30℃,进样量20μL。采用HPLC测定脂质体中异亚丙基莽草酸的含量;比较超滤法、凝胶色谱法和透析法用于包封率的测定。结果:异亚丙基莽草酸脂质体采用4倍量甲醇破乳并高速离心沉淀后,取上清液进行测定,药物专属性良好,线性范围1.004~150.6 mg·L-1(r=0.999 9),加样回收率(102.01±1.18)%,准确度和精密度良好,异亚丙基莽草酸对照品溶液于6 h内稳定;超滤法、葡聚糖凝胶法及透析法测得的包封率分别为(92.96±1.91)%,(91.23±2.23)%,(73.66±7.10)%。结论:所建立的HPLC稳定可靠、准确度良好,可用于异亚丙基莽草酸脂质体的质量控制和体外分析;超滤法测定包封率简便快捷、测定结果与凝胶色谱法相当,可作为本品包封率测定的常规方法;透析法由于测定条件的限制,其测定结果受脂质体溶液稳定性、药物在脂质体中存在状态的影响较大,可能会造成测定结果偏低。

关 键 词:异亚丙基莽草酸  包封率  超滤法  透析法  凝胶柱色谱  甲醇沉淀
收稿时间:2012/8/16 0:00:00
修稿时间:9/8/2012 12:00:00 AM

Comparative Study of Entrapment Efficiency Determination for Isopropylidene Shikimic Acid Liposome
QU Chang-hai,YIN Xing-bin,ZHANG Hui,LIN Long-fei,YAN Lei,YANG Pei,TIAN Jing-chen,FU Jing and NI Jian.Comparative Study of Entrapment Efficiency Determination for Isopropylidene Shikimic Acid Liposome[J].China Journal of Experimental Traditional Medical Formulae,2013,19(1):21-24.
Authors:QU Chang-hai  YIN Xing-bin  ZHANG Hui  LIN Long-fei  YAN Lei  YANG Pei  TIAN Jing-chen  FU Jing and NI Jian
Institution:School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China;School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China;School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China;School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China;School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China;School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China;School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China;School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China;School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China
Abstract:
Keywords:isopropylidene shikimic acid  entrapment efficiency  ultrafiltration method  dialysis method  gel column chromatography  precipitation with methanol
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