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目的:对硝酸布康唑阴道软胶囊的释放度进行检查。方法:考察缓冲介质、转速等不同条件对释放度的影响。采用桨法,以pH 5.0的磷酸盐缓冲液(内含0.5%十二烷基硫酸钠)900 ml为释放介质,转速120 r·min~(-1),测定硝酸布康唑阴道软胶囊释放度。结果:根据药物释放曲线及均一性试验可知,硝酸布康唑阴道软胶囊30 min内即释放70%以上,60 min时不同取样胶囊的释放度RSD在2.0%以内,表明该样品释放均一性好。结论:该方法可用于硝酸布康唑阴道软胶囊的释放度检查。硝酸布康唑阴道软胶囊具有良好的释药性。
OBJECTIVE: To examine the release of buconazole nitrate vaginal soft capsules. Methods: The impact of buffer medium, rotation speed and other conditions on the release rate was investigated. The paddle method was used to determine the release of buconazole nitrate vaginal soft capsules with 900 ml of phosphate buffer (containing 0.5% sodium dodecyl sulfate) at pH 5.0 as the release medium and the rotational speed of 120 r · min ~ (-1) degree. Results: According to the drug release curve and homogeneity test, buprenone nitrate vaginal soft capsule released more than 70% in 30 min, and the RSD of different sample capsules was less than 2.0% at 60 min, indicating that the sample released homogeneity . Conclusion: This method can be used for the release of buconazole nitrate vaginal soft capsules. Butoconazole nitrate vaginal soft capsules have good release properties.