聚(2-乙基-2-噁唑啉)修饰超氧化物歧化酶模拟物脂质体冻干制剂的制备

Preparation of the Freeze-dried Preparation of PEOZ Modified SOD Mimics Liposomes

目的:制备聚(2-乙基-2-噁唑啉)(PEOZ)修饰超氧化物歧化酶(SOD)模拟物脂质体的冻干制剂。方法:通过考察预冻方式、预冻时间、真空干燥时间及联合冻干保护剂的种类及比例等优化冻干工艺,并测定所制制剂的水化复溶时间、粒径和包封率。结果:以10%乳糖+1%甘露醇+10%海藻糖作为联合冻干保护剂,并以外加方式加入PEOZ修饰SOD模拟物脂质体中,快速冷冻5h,真空干燥30h,可得到外观光洁、平整的目标冻干制剂;其水化复溶时间为(10±1)s,粒径为(159.3±10.2)nm,包封率为86.25%(RSD=3.26%,n=6)。结论:该优化冻干工艺质量可控,重复性好。

OBJECTIVE：To prepare freeze-dried preparation of poly（2-ethyl-2-oxazoline）（PEOZ）modified Superoxide dismutase（SOD）mimics liposomes.METHODS：The freeze-dried process of liposomes was investigated by investigating pre-freezing pattern,pre-freezing time,vacuum drying time,types and proportion of cryoprotectants.Re-dissolved time,particle size and entrapment efficiency of preparation were determined.RESULTS：The optimal technology：10% lactose＋1% mannitol＋10% trehalose as cryoprotectants were added into PEOZ modified SOD mimics liposomes,with rapid freezing for 5 h and vacuum drying for 30 h.The lyophilized preparation was prepared with smooth and complete appearance.Re-dissolved time was（10±1）s,particle size was（159.3±10.2）nm and entrapment efficiency was 86.25%（RSD=3.26%,n=6）.CONCLUSION：The lyophilized technology is controllable in quality and reproducible.