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目的:制备阿苯达唑纳米脂质体冻干粉并对其性质进行考察。方法:利用冷冻干燥法制备阿苯达唑纳米脂质体冻干粉,以粒径、包封率联合外观、再分散性为指标,采用单因素试验联合正交试验筛选冻干处方工艺。考察冻干前、后脂质体的形态学变化、粒径、Zeta电位、水分含量、4 ℃下12个月的稳定性。结果:采用外加冻干保护剂的总量为10%,其中葡萄糖-海藻糖-甘露醇配比为1.0 ∶ 1.0 ∶ 3.0,以速冻的方式,于-35 ℃冰箱预冻18 h,冷冻干燥48 h获得冻干粉。与冻干前比较,冻干后脂质体形态未发生明显变化,可见清晰的磷脂双分子层膜结构;冻干前、后脂质体的粒径分别为(208.63±1.04)、(223.04±2.02) nm,Zeta电位分别为 (-15.6±0.04)、(-19.4±0.06) mV,包封率分别为(94.62±0.49)%、(91.10±0.46)%(n=3);与脂质体比较,脂质体冻干粉在4 ℃下12个月较稳定。结论:成功制得阿苯达唑纳米脂质体冻干粉,其稳定性优于阿苯达唑纳米脂质体,冻干工艺可行。
OBJECTIVE: To prepare the Albendazole nanoliposomes freeze-dried power and study its properties. METHODS: Freeze-drying method was conducted to prepare Albendazole nanoliposomes freeze-dried power, using the particle size, encapsulation efficiency, appearance, redispersibility as indexes, single factor test was combined with orthogonal test to screen freeze-drying preparation technology. The morphological changes, particle size, Zeta potential, moisture content, 12 months stability at 4 ℃ before and after freeze-drying were detected. RESULTS: Plus a total content of freeze-dried protective agent was 10%, the ratio of glucose-trehalose-mannitol was 1.0 ∶ 1.0 ∶ 3.0, using quick-freeze, pre-freezing 18 h in -35 ℃ refrigerator, dry-freezing 48 h to obtain freeze-dried powder. Compared with before freeze-drying, the freeze-dried liposomal morphology had no obvious changes, showing clear phospholipid bilayer membrane structure; the particle sizes before and after freeze-drying were (208.63±1.04) nm and (223.04±2.02) nm, Zeta potentials were (-15.6±0.04) mV and (-19.4±0.06) mV, encapsulation efficiencies were (94.62±0.49)% and (91.10±0.46)% (n=3), respectively. Compared with liposomes, liposomes freeze-dried power had good stability in 12 months at 4 ℃. CONCLUSIONS: Albendazole nanoliposomes freeze-dried power is prepared successfully, its stability is superior to albendazole nanoliposomes, and the freeze-drying technology is feasible.
阿苯达唑纳米脂质体冻干粉粒径包封率稳定性正交试验
AlbendazoleNanoliposomesFreeze-dried powderParticle sizeEncapsulation efficiencyStabilityOrthogonal test
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