两性霉素B脂质体的研制及其质量评价

 目的 对两性霉素B脂质体的处方和制备工艺进行研究，并评价其质量。方法 采用薄膜－超声法制备了两性霉素B脂质体，并对制剂的形态学、载药量、包封率以及粒径分布等性质进行了研究。结果 本研究制备的脂质体包封率大于70%；平均粒径为79 nm，粒径范围为23～122 nm，小于96 nm的占86%，透射显微镜下观察脂质体为粒径均匀的球状或近球状小囊泡。结论 两性霉素B脂质体包封率高，质量稳定，重现性好。

Preparation of amphotericin B liposomes and its quality evaluation

OBJECTIVE To study the formulation and preparation of amphotericin B liposomes(LAMB),and evaluate its quality.METHOD The liposomes were prepared by an film-ultrasonic technique.The morphology of LAMB,the drug loading,the entrapment efficiency and the particle size distribution were studied.RESULTS More than 70% of initial amphotericin B content were entrapped into LAMB.The result of electron micrography and the size distribution showed that the LAMB were small spherical or similar to spherical vesicles,the mean diameter of LAMB was 79 nm with the range of 23～122 nm,with 86% of liposomes smaller than 96 nm.CONCLUSION Amphotericin B was highly entrapped into liposomes with good reproduction and stability.