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目的制备酮洛芬肠溶微球,并对其制备工艺进行考察。方法采用紫外分光光度法建立了微球的载药量及体外释放度测定方法。采用乳化溶剂扩散法制备酮洛芬肠溶微球,以载药量、包封率及微球外观为指标进行单因素考察优化处方,并以优化处方制备的微球进行体外溶出实验。结果最优处方下制得微球外观圆整,粒径较均匀,载药量与包封率分别为25.86%和45.09%,酮洛芬肠溶微球在人工胃液中2h释药百分率低于10%,在人工肠液中70min释放可达90%。结论该法制备工艺简单,可得到球形度好、粒径分布均匀的酮洛芬肠溶微球,并且微球在人工胃液中释放较少,在人工肠液中释放较快。
Objective To prepare ketoprofen enteric-coated microspheres and study its preparation process. Methods The method of determination of drug loading and in vitro release of microspheres was established by ultraviolet spectrophotometry. The ketoliprofen enteric-coated microspheres were prepared by emulsion solvent diffusion method. The single-factor study was carried out to optimize the formulation with drug loading, entrapment efficiency and microsphere appearance as indicators. The microspheres prepared by optimized formulation were used for in vitro dissolution experiments. Results The microspheres prepared by optimal prescription were round and uniform in size with drug loading and entrapment efficiency of 25.86% and 45.09%, respectively. The percentage release of ketoprofen enteric-coated microspheres in artificial gastric juice for 2 hours was lower than 10%, 70min release in artificial intestinal fluid up to 90%. Conclusion The preparation method of the method is simple, and the ketoprofen enteric-coated microspheres with good sphericity and uniform particle size distribution can be obtained. The microspheres release less in artificial gastric juice and release faster in the artificial intestinal juice.