卡巴他赛脂质体包封率的测定  

Determination of Encapsulation Efficiency of Cabazitaxel Liposomes

作　　者：柳宇红 姜宇 郝贵周 刘善奎 LIU Yuhong;JIANG Yu;HAO Guizhou;LIU Shankui(School of Biological Science and Technology,University of Jinan,Jinan 250022;Scientific Research Dept.of Shandong New Times Pharmaceutical Co.,Ltd.,Linyi 273400)

机构地区：[1]济南大学生物科学与技术学院,山东济南250022 [2]山东新时代药业有限公司科研部,山东临沂273400

出　　处：《中国医药工业杂志》2022年第3期373-377,共5页Chinese Journal of Pharmaceuticals

基　　金：山东省重大科技创新工程项目(2019JZZY011116)。

摘　　要：采用乙醇注入法制备卡巴他赛(1)脂质体,并建立离心-微孔滤膜过滤法分离脂质体和游离结晶药物,采用HPLC法测定脂质体中1的包封率。结果显示,在建立的色谱条件下,1的专属性良好,且在1~20 μg/ml内线性关系良好;日内和日间精密度也均符合要求,重复性好。样品测定结果显示,3批1脂质体的平均包封率为99.24%,RSD为1.00%,可用于准确测定1脂质体的包封率。Cabazitaxel(1) liposomes were prepared by ethanol injection method,and a centrifugal-microporous membrane filtration method was established to separate liposomes and free crystalline drug,and an HPLC method was used to determine the encapsulation efficiency of 1 in liposomes.The results showed that under the established chromatographic conditions,the specificity of 1 was good,and it was linear for 1 in the range of 1-20 μg/ml.The intra-and inter-day precisions both met the requirements,and the repeatability was good.The measuring results showed that the average encapsulation efficiency of 1 liposomes in three batches was 99.24%,with the RSD of 1.00%,which could be used to accurately determine the encapsulation efficiency of 1 liposomes.

关 键 词：卡巴他赛 脂质体 包封率 微孔滤膜过滤法 

分 类 号：R917[医药卫生—药物分析学]