基因重组人干扰素-α微球的制备及理化性质研究

目的:制备基因重组人干扰素-α聚乳酸乙醇酸微球,并考察其理化性质。方法:采用复乳溶剂挥发法制备干扰素-α微球,考察其形态、粒径、分布、载药量、包封率及微粉学性质,并通过体外释药考察其缓释效果,用气/质联用法测定其有机溶剂残留量。结果:所制微球球形圆整,粒度分布范围较窄,平均粒径为45.54μm,包封率达83.49%,载药量为8.03%,流动性等较好。微球体外释药行为符合Higuchi方程,其有机溶剂残留量<0.05%。结论:所制干扰素-α微球各方面理化性质良好。

Studies on Preparation and Physicochemical Properties of Recombined Human Interferon-α Microspheres

OBJECTIVE:To prepare the gene recombined human interferon-alpha poly(lactic acid-co-glycolic)microspheres and study its physicochemical properties.METHODS:Interferon-α microspheres were prepared by W/O/W solvent extraction technique;the in vitro release of microspheres were examined;the rudimental organic solvent was determined with GC-MS.RESULTS:The IFN-α-MS were regular in their morphology,and the particle size distribution was narrow.The average diameter was 45.54μm.The encapsulation rate and the loading efficiency were 83.49% and 8.03%,and the in vitro accumulative release rate was 80.32% in 30 days.The in vitro interferon-α release from the microspheres was best described using Higuchi diffusion model.The rudimental of dichloromethane was less than 0.05%.CONCLUSIONS:The prepared IFN-α-MS is very good in all aspects of its physicochemical properties.