阿哌沙班片溶出度测定方法研究  

Study on Dissolution Determination Method of Apixaban

作　　者：郭兆元[1] 聂忠莉[2] 胡一冰[2] 曾吉[2] 王晓玲 叶丁 张勇 萧茂玲 郭瑞 GUO Zhaoyuan NIE Zhongli HU Yibing ZENG Ji WANG Xiaoling YE Ding ZHANG Yong XIAO Maoling GUO Rui(Sichuan Industrial Institute of Antibiotics, Chengdu University, Chengdu 610052, China School of Pharmacy and Bioengineering, Chengdu University, Chengdu 610106, China Chengdu Climb Phamaceutical Technology Co., Ltd., Chengdu 610041, China)

机构地区：[1]成都大学四川抗生素工业研究所,四川成都610052 [2]成都大学药学与生物工程学院,四川成都610106 [3]成都克莱蒙医药科技有限公司,四川成都610041

出　　处：《成都大学学报（自然科学版）》2016年第4期317-320,334,共5页Journal of Chengdu University（Natural Science Edition）

摘　　要：建立了以高效液相色填充谱法测定阿哌沙班片溶出度的测定方法,采用0.1%CTAB-pH 6.8的磷酸盐缓冲溶液900mL为溶出介质,温度为37℃±0.5℃,转速为75r/min,溶出介质经脱气处理,取样时间为30min.结果显示,6批供试品及对照药品30min的溶出度均在80%以上,均符合规定.方法专属性强,灵敏度高,结果准确,可用于测定阿哌沙班片的溶出度.The paper is going to establish a method of dissolution determination of Apixaban. The establishment of the determination method for dissolution of Apixaban tablets is based on High Performance Liquid Chromatography. Phosphate buffer solution of 0.1% CTAB-pH 6.8 is used as dissolution medium which is degassed at 37 - 0.5 ℃, with the rotate speed of 75 r/min and the sampling time of 30 min. The results show that the dissolution of six batches of test samples and reference drug is over 80% in 30 min. It is in compliance with the regulations. The method can be used to determine the dissolution of Apixaban tablets with its selective, sensitive and accurate traits.

关 键 词：阿哌沙班片 溶出度 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]