盐酸噻吩诺啡缓释微球的体外释放度及其体内外相关性研究
Study on in vitro release and correlation between in vivo and in vivo of thienorphine hydrochloride microspheres
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摘要: 目的: 建立体内外相关性良好的盐酸噻吩诺啡缓释微球的体外释放度测定方法。 方法: 采用直接释药法和透析释药法测定盐酸噻吩诺啡缓释微球的体外释放度;采用高效液相色谱法测定盐酸噻吩诺啡缓释微球在大鼠注射部位的残留量,计算微球在体内的释药速度。通过相关性评价确定最佳的体外释放度测定方法。 结果: 透析释药法和直接释药法均可获得良好的体内外相关性。 结论: 直接释药法和透析释药法均可用于测定盐酸噻吩诺啡微球的体外释放度。Abstract: Objective To establish a method for the determination of in vitro release of thienorphine hydrochloride micro-spheres with a good correlation between in vivo and in vitro. Methods Immediate release and dialysis release Methods were used to determine the in vitro release rate of thienorphine hydrochloride microspheres.The residue thienorphine hydrochloride microspheres in the injection site was determined by HPLC,and in vivo release rate of thienorphine hydrochloride microspheres was caculated.The optimal release solution was chosen based on the correlation evaluation between the in vivo and in vitro Results . Results Immediate release and dialysis release Methods had a good in vitro and in vivo correlation. Conclusion Immediate release and dialysis release method could be used to determine the in vitro release of thienorphine hydrochloride microspheres.
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