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目的制备水飞蓟宾(silybin,SLB)前体脂质体并对其进行质量评价。方法采用冷冻干燥法制备SLB前体脂质体,以包封率和载药量为评价指标,采用单因素考察和正交试验法,优化SLB前体脂质体处方及制备工艺,筛选最优冻干保护剂并考察SLB前体脂质体的形态、粒径分布、包封率及稳定性。结果 SLB前体脂质体的最优处方及制备工艺为药脂比1∶12,磷脂胆固醇比4∶1,水合介质p H值为7.4,制备温度为45℃;最优冻干保护剂为甘露醇;所形成的前体脂质体外观饱满、致密,复水水合后粒径为(251.40±2.14)nm,Zeta电位值为(-30.80±0.89)m V,包封率为(88.92±5.86)%,贮存期间(30 d)稳定性较好。结论制备的SLB前体脂质体工艺简单、包封率高、稳定性好,值得进一步研究。
Objective To prepare silybin (SLB) precursor liposomes and evaluate their quality. Methods The SLB precursor liposomes were prepared by freeze-drying method. The encapsulation efficiency and drug loading were used as the evaluation indexes. Single factor test and orthogonal test were used to optimize the formulation and preparation of SLB precursor liposomes. Lyoprotectant and investigate the morphology, particle size distribution, entrapment efficiency and stability of SLB precursor liposomes. Results The optimum formulation and preparation technology of SLB precursor liposomes were ratio of lipid to lipid 1:12, ratio of phospholipid cholesterol 4:1, pH value of hydration medium 7.4 and temperature 45 ℃. The optimum lyoprotectant was (251.40 ± 2.14) nm, the Zeta potential was (-30.80 ± 0.89) m V, the entrapment efficiency was (88.92 ± 5.86)%, the storage stability (30 d) is better. Conclusion SLB liposomes preparation process is simple, high encapsulation efficiency, good stability, it is worth further study.