复方蒿甲醚苯芴醇片体外溶出曲线一致性评价  

Conformance Assessment of the Dissolution Curve of Compound Artemether Lumefantrine Tablets

作　　者：王荣昌 周健 蒋锋 

机构地区：[1]江苏鹏鹞药业有限公司,江苏宜兴214200

出　　处：《淮海工学院学报（自然科学版）》2016年第2期46-48,共3页Journal of Huaihai Institute of Technology:Natural Sciences Edition

摘　　要：考察复方蒿甲醚苯芴醇片中蒿甲醚在4种不同介质中的溶出行为.参考美国药典中蒿甲醚的溶出度试验条件,分别考察蒿甲醚在水、pH 6.8的磷酸盐缓冲液、pH 1.2的盐酸缓冲液(含1%苯扎氯铵溶液)和pH 4.0的醋酸盐缓冲溶液中的体外溶出曲线.采用高效液相色谱法测定蒿甲醚的溶出度,并通过相似因子(f_2)比较法对原研药和自制产品进行相似性比较.结果表明,自制品和原研品在4种介质中蒿甲醚的溶出曲线相似.This paper studied the dissolution behavior of the artemether in compound artemether lumefantrine tablets in four different dissolution media.According to the dissolution test conditions in USP,it investigated the dissolution curve of artemether in water,phosphate buffer of pH6.8,chlorhydric acid of pH 1.2（with 1% benzalkonium chloride）and acetate buffer solution of pH 4.0.High performance liquid chromatography（HPLC）method was developed for the determination of artemether dissolution.Through the method of similarity factor（f_2）,the similarity of original drugs and homemade product were compared,and the results show that the dissolution curves of artemether of homemade product and the original product in four media are similar.

关 键 词：复方蒿甲醚苯芴醇片 蒿甲醚 高效液相色谱法 相似因子 

分 类 号：R917[医药卫生—药物分析学]