注射用前列地尔脂质体的研制及质量评价  

Preparation and quality control of alprostadil liposome for injection

作　　者：时念秋[1] 王东凯[1] 李海刚[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中国新药杂志》2006年第20期1762-1765,共4页Chinese Journal of New Drugs

摘　　要：目的:制备注射用前列地尔脂质体并建立其包封率的测定方法,对其进行质量评价。方法:采用薄膜分散法制备前列地尔脂质体,采用超滤法分离脂质体和游离药物,并用高效液相色谱法测定前列地尔脂质体的包封率,并考察了冻干品的稳定性和冻干前后的变化。结果:前列地尔脂质体的包封率为(95±1．2)％。前列地尔脂质体冻干前后包封率在94％～96％范围内,长期放置稳定性好。结论:采用薄膜分散法制备的前列地尔脂质体冻干前后剂型稳定性好。超滤法测定前列地尔脂质体包封率,方法简单、准确、易行。Objective：To optimize preparation and quality jection. Methods：Alprostadil liposome was prepared by a film-disp control of alprostadil liposome for iners mal alprostadil were separated by uhrafihration. The inclusion rate of ing technique. The free and liposoalprostadil liposome was measured by HPLC. The stability of the liposome was analyzed before and after lyophilization. Results：The inclusion rate accounted for （95 ± 1.2）% before and after lyophilization. The alprostadil liposome was stable for long-term storage. Conclusion：The stable and higher inclusive alprostadil liposomes were achievable.

关 键 词：前列地尔 脂质体 包封率 稳定性 薄膜分散法 

分 类 号：R943.41[医药卫生—药剂学] R973[医药卫生—药学]