This invention discloses a highly stable
amphotericin B liposome and its preparation method, belonging to the field of
pharmaceutical formulation technology. This invention utilizes a
methanol-water-
chloroform ternary mixed
solvent system to achieve complete molecular-level
dissolution of the raw materials, eliminating the conventional
drying process and directly hydrating and homogenizing. It also provides optimal formulation ratios and process parameters. The preparation method includes steps such as
oil phase preparation, aqueous phase preparation, homogenization, incubation, cooling,
filtration, volumetric filling, and lyophilization. This invention creatively proposes optimal formulation composition and
process conditions, resulting in a product with high encapsulation efficiency, uniform particle size, and strong stability. Furthermore, the preparation process is simple and easily industrialized, solving the problems of complex preparation processes and poor stability of existing injectable
amphotericin B liposomes, and possesses good clinical application value.