目的:制备纳豆激酶免疫脂质体及其冻干品,并对其药剂学性质进行评价。方法:用薄膜分散法制备纳豆激酶脂质体,在此基础上采用碳二亚胺法偶联抗人纤维蛋白D二聚体单克隆抗体SZ-63制备纳豆激酶免疫脂质体,将其冻干保存,并进行药剂学性质评价。结果:所制免疫脂质体为多层脂质体,平均粒径为251.6nm,Zeta电位为-34.6mv,其冻干品外观优良,再分散性良好,干燥失重为14.30%,临界相对湿度为45.66%。结论:成功制备了纳豆激酶免疫脂质体及其冻千品。
OBJECTIVE: To prepare nattokinase immunoliposomes and its lyophilized product and tO evaluate its pharmaceutical quality. METHODS: Nattokinse liposomes were prepared by film dispersion method, then the immunoliposomes were prepared by carbodiimide method coupled anti human fibrin D - dimer monoelone antibody SZ - 63 and lyophilized and evaluated about its pharmaceutical quality. RESULTS: Lyophilized immunoliposomes were multilamellar vesicles with its mean diameter, Zeta potentials at 251.6 nm, -34.6 mV, respectively. The lyophilized product of nattokinase immunoliposomes exhibited good appearance and satisfactory redispersibility, with its loss on drying at 14.30% and critical relative humidity at 45.66%. CONCLUSION: Nattokinase immunoliposomes and its Iyophilized product have been prepared successfully.