挤出法制备卡巴他赛脂质体的工艺优化  

Optimization of preparation process of cabazitaxel liposomes by extrusion method

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,China;Scientific Research Department of Shandong NewTimes Pharmaceutical Co.,Ltd.,Linyi 273400,China)

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：《药学研究》2023年第4期243-246,284,共5页Journal of Pharmaceutical Research

基　　金：山东省重大科技创新工程项目(No.2019JZZY011116)。

摘　　要：目的对挤出法制备卡巴他赛脂质体的挤出工艺进行优化。方法以产品的平均粒径(MD)和多分散指数(PDI)为评价指标,采用正交设计法和部分正交析因法来筛选最优工艺参数。结果最优挤出工艺参数为:核孔膜组合200 nm+80 nm(单层或双层),挤出次数组合3+3或3+2,挤出温度10~23℃,挤出时间控制在18 h内,挤出压力0.5~1.2 MPa。结论采用最优挤出工艺参数可以成功制得平均粒径值和多分散指数值均符合规定标准且储存稳定性良好的卡巴他赛脂质体产品。Objective To optimize the extrusion process for preparing cabazitaxel liposomes by extrusion method.Methods The mean diameter(MD)and polydispersity index(PDI)of the product were used as evaluation indexes,and the optimal process parameters were screened by orthogonal design method and partial orthogonal factorial method.Results The optimal extrusion process parameters are as follows:nuclear pore membrane combination 200 nm+80 nm(single layer or double layer),extrusion times combination 3+3 or 3+2,extrusion temperature 10~23°C,extrusion time controlled within 18 h,extrusion pressure is 0.5~1.2 MPa.Conclusion The optimal extrusion process parameters can be used to successfully prepare the cabazitaxel liposomes with MD value and PDI value meeting the specified standards and good storage stability.

关 键 词：卡巴他赛脂质体 挤出法 正交设计法 部分正交析因法 平均粒径 多分散指数 

分 类 号：R943[医药卫生—药剂学]