Preparation and quality evaluation of entecavir microspheres
Objective To prepare entecavir microspheres and evaluate the quality.Methods The entecavir microspheres were prepared by spray drying method.The morphology and particle size distribution were observed by scanning electron microscope and a Masterzier 3000 Particle Size Analyzer respectively.The entrapment efficiency,drug loading rate and in vitro release rate were determined by HPLC.Results The microspheres were spherical,with an average particle size of 9.58μm,drug loading rate of 11.5%,entrapment efficiency of 92.0%,and it could release for 24 days in vitro.The morphology of microspheres was influenced by the inlet temperature,PLGA concentration,and PLGA viscosity.The in vitro drug release process was affected by the concentration of PLGA and the ratio of LA/GA.Conclusion The entecavir microspheres showed good sustained release effect in vitro,and it is expected to provide reference for the development of anti HBV drugs.
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