曲普瑞林微球的制备及质量控制  

Preparation and Quality Control of Triptorelin Acetate Microsphere

作　　者：龙镭 王仁友 唐样明 周长华[2] 陈健文[2] 

机构地区：[1]深圳翰宇药业股份有限公司,广东深圳518057 [2]中山大学药学院,广东广州510006

出　　处：《湖北民族学院学报（医学版）》2011年第2期11-13,共3页Journal of Hubei Minzu University(Medical Edition)

摘　　要：目的制备曲普瑞林微球并建立其质量控制标准。方法以聚乳酸-羟基乙酸为载体,采用改良的W/O/W复乳-液中蒸发法制备曲普瑞林微球;以包封率为指标,优化微球的制备工艺,建立微球的质量标准。结果优化后的曲普瑞林微球载药量大于6%,粒径小于100μm,28 d累积释放度超过90%。结论成功制备了曲普瑞林微球并建立了其质量控制标准。Objective To prepare triptorelin acetate microsphere and set up the standard of quality control.Methods Triptorelin microsphere was prepared by modified W/O/W double emulsion in liquid evaporation process,using the poly lactic-co-glycolic acid as carrier.The encapsulation efficiency was used as the main index to optimize the preparation of microspheres and evaluate the quality criteria.Results The optimized method of microspheres was established.The amount of drug loading was over 6%,the particle diameter was less than 100 μm,and the release rate of accumulation was more than 90% in the period of 28 days.Conclusion Triptorelin microsphere was prepared,and its standard of quality control was established accordingly.

关 键 词：曲普瑞林 微球 制备 质量控制 

分 类 号：R977.1[医药卫生—药品]