酮康唑微囊的体外溶出度研究

The dissolution behavior of Ketoconazole microcapsules in vitro

目的 研究酮康唑微囊的体外溶出特点。方法 按中国药典所载转蓝法进行体外溶出度测定。结果 酮康唑微囊在人工胃液中 90min内可达到最大溶出 ,其最高累积溶出百分率接近 90 %,其溶出行为符合Weibull概率函数分布 ,相关参数为 :药物溶出 5 0 %的t1/2 =2 5min ,特征数td=42min ,形态参数m =0 .6min。结论 酮康唑微囊在人工胃液中溶出较理想。

OBJECTIVE To prepare Ketoconazole microcapsules and to study on its dissolution behavior.METHODS According to Chinese Pharmacopoeia(2000 edition), the rotating basket method was employed.RESULTS The kinetics of Ketoconazole microcapsules in the simulated gastric fluid obeyed the Weibull Distribution.Approximate 90% Ketoconazole was released from microcapsules within 90 min, The parameters were t 1/2=25 min, t d=42 min and m=0.6 min.While the Ketoconazole powder released more than 95% Ketoconazole within 10 min in the same solvent.CONCLUSION The releasing of Ketoconazole from the microcapsules is ideal and showed sustained-release character compared with Ketoconazole powder.