Preparation of Lyophilized Epirubicin Long Circulation Liposome Powder / 医药导报

ABSTRACT

Objective To improve the stability of epirubicin long circulation liposomes via lyophilizing technology and preliminarily evaluate their quality. Methods The effect of the various cryoprotectant,different pre-freezing and total drying time on the preparation was analyzed. The stability of the lyophilized powder was tested at (25±2) ℃ and (60±10)% relative humidity for 3 months. Results The protective agent trehalose to liposomes was 31. The freeze-drying was conducted with pre-freezing temperature at -70 ℃,precooling for 8 h and total drying for 24 h. There were no significant differences in particle size,encapsulation efficiency and drug content of lyophilized long-circulating liposomes compared with those un-lyophilized. After 3 months under the accelerated condition,it had good redispersibility, entrapment rate (>94%) and drug content (>99%) . Conclusion Lyophilizing the long-circulation epirubicin liposomes can effectively improve the stability of the preparation.