阿哌沙班片溶出度实验方法研究

Experimental Study on Dissolution of Apixaban Tablets

目的:开发和验证阿哌沙班片具有区分力的溶出度方法。方法:从药物溶解性、溶出度研究、药代特性等系统地筛选阿哌沙班片具有区分力的溶出度方法。结果:在0.05%十二烷基硫酸钠pH=6.8磷酸盐缓冲液,900 mL,37℃,75 rpm条件下,阿哌沙班片溶出曲线平滑上升,30 min释放度大于85%。结论:该溶出度方法最具有区分力,可用于评价阿哌沙班片体外溶出的结果。

Objective:Discriminatory dissolution method development and validation of apixaban tablets.Methods:We comprehensively considered the drug solubility,dissolution rate and pharmacokinetics to screen the distinguishing dissolution of apixaban tablets.Results:The dissolution curves of apixaban tablets in 0.05%sodium lauryl sulfate p H6.8 phosphate buffer,900 ml,37°C,75 rpm,increased smoothly,and the dissolution at 30 min was greater than 85%.Conclusion:The dissolution method has appropriate discrimination and can be used to evaluate the dissolution results of apixaban tablets in vitro.