尼莫地平纳米脂质体冻干粉的质量评价方法

 目的 研究尼莫地平纳米脂质体冻干粉的性质，建立其质量评价方法。方法 考察处方的粒径分布、Zeta电位、溶血性、沉降稳定性，用反透析法测其包封率、脂质体的血浆稳定性，观察其基本形态。结果 尼莫地平纳米脂质体的平均粒径为24.8 nm,多分散系数为0.326，包封率为86.1%，体外稳定性好,人血浆稳定期约为1 h。结论 上述方法适用于尼莫地平纳米脂质体冻干粉的质量评价,可有效地反映其各方面的性质。

Quality evaluation of nimodipine nanoliposomes freeze-dried powder

OBJECTIVE To study the properties of nimodipine nanoliposomes and to establish the quality evaluation methods. METHODS The particles size, Zeta potential, haemolyticus, and sedimentation stability were evaluated. Entrapment efficiency and the stability of liposomes in human plasma were determined by reverse dialysis method, and the shape of these nanoliposomes was observed by transmission electron microscopy. RESULTS The mean particle size of these nanoliposomes was 24.8 nm with the polydispersity index of 0.326. The entrapment efficiency reached 86.1% . The liposomes were stable for 1 hour in human plasma. CONCLUSION The methods above were suitable for the quality evaluation of nimodipine nanoliposomes freeze-dried powder, and can effectively demonstrate its properties.