群体生物等效(PBE)统计方法用于微流控制备的脂质体产品粒径分布一致性的评价  

Population Bioequivalence(PBE)Statistical Method for Evaluation of Particle Size Distribution Consistency of Liposomes Prepared by Microfluidic Control Chip

作　　者：唐海玲 李嘉昕 李逢昌 史俊豪 张新峰 伍世恒 

机构地区：[1]广西中医药大学药学院,广西南宁530200 [2]广西高校中药制剂共性技术研发重点实验室,广西南宁530200 [3]广州中医药大学第二附属医院,广东广州510120

出　　处：《大众科技》2020年第12期37-40,51,共5页Popular Science & Technology

基　　金：广西中医药大学校级博士课题科研启动基金项目(2019BS010);广西高校中青年教师科研基础能力提升项目名单(2020KY0747)。

摘　　要：由于脂质体产品的高变异性特点以及粒径对脂质体的体内分布、组织靶向行为、生物利用度的显著影响,本研究利用群体生物等效(PBE)统计方法评价微流控芯片技术连续制备的脂质体产品粒径分布的一致性。对比分析相同制备工艺参数下,不同分散介质的不同批次的脂质体产品粒径分布特点,以及不同储存温度下脂质体样品粒径随时间的变化规律。通过对脂质体样品粒径分布参数(D10,D50,D90,PDI)的细致对比研究,考察微流控芯片技术连续制备脂质体产品的批间差异和不同分散介质中(生理盐水,5%葡萄糖,水)脂质体粒径的稳定性。利用PBE统计方法可以更好的指导微流控芯片技术制备脂质体样品的处方工艺的优化筛选和稳定性研究。Due to the high variability characteristics of liposome products and the influence of particle size on the distribution,tissue targeting behavior and clinical efficacy of liposomes,population bioequivalence(PBE)statistical method was selected to evaluate the consistency of particle size distribution of liposomes continuously prepared by microfluidic chip technology.The particle size distribution characteristics of different batches of liposome products under the same preparation process parameters in different dispersion medium were compared and analyzed,as well as the variation of the particle size of liposome samples with time under different storage temperature.Through the detailed comparative study of the size distribution parameters(D10,D50,D90,PDI)of liposome samples,the batch differences of continuous preparation of liposomes by microfluidic chip technology and the stability of liposome particle size in different dispersion media(normal saline,5%glucose,water)were investigated.PBE statistical method can be used to guide the optimization of preparation process and stability research of liposome samples by microfluidic chip technology.

关 键 词：群体生物等效统计分析方法 脂质体 粒径分布 微流控技术 

分 类 号：O652[理学—分析化学]