HPLC法测定阿那曲唑片溶出度及与原研产品的一致性评价  

Evaluation of the dissolution consistency between generic and original anastrozole tablets by HPLC

作　　者：孙晓阳[1] 王彬杰[1] 张瑜[1] 毕开顺[1] 陈晓辉[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2016年第8期643-646,658,共5页Journal of Shenyang Pharmaceutical University

摘　　要：目的考察国内阿那曲唑片仿制药(受试制剂)与原研阿那曲唑片(参化制剂)在4种溶出介质中的溶出度,对二者溶出行为的一致性进行评价。方法按照2015年版《中华人民共和国药典》第四部溶出度与释放度测定方法第二法,采用HPLC法测定2个厂家阿那曲唑片在水、p H值1.2盐酸溶液、p H值4.5磷酸盐缓冲溶液、p H值6.8磷酸盐缓冲溶液4种溶出介质中的溶出曲线,并采用f_2相似因子法对溶出曲线的相似性进行比较分析。结果在考察的4种溶出介质中,受试制剂和参比制剂的溶出曲线均相似。结论受试制剂和参比制剂的体外溶出行为一致。Objective To compare the dissolution of generic anastrozole tablets（ tested tablets） ith that of original anastrozole tablets（ reference tablets） to provide reference for the consistency evaluation of dissolution process of anastrozole tablets. Methods The dissolution process of tw o kinds of anastrozole tablets as monitored in the follow ing respective medium ： p H 1. 2 HCl solution,p H 4. 5 phosphate buffered saline（ PBS）,p H 6. 8 PBS buffer,and distilledater. The concentration of anastrozole in mediumas determined by HPLC and analyzed using f_2 factor. Results In the 4 types of medium,the dissolution curves of tested anastrozole ere all similar ith that of reference product. Conclusions The dissolution process of tw o kinds of anastrozole tablets is similar.

关 键 词：阿那曲唑片 受试制剂 参比制剂 浆法 高效液相色谱法 溶出曲线 f2相似因子 一致性评价 

分 类 号：R917[医药卫生—药物分析学]