自制氨氯缬沙噻嗪片与Exforge HCT的体外溶出行为比较  

Comparison of Dissolution between Self-made Amlodipine Valsartan and Hydrochlorothiazide Tablets and Exforge HCT

作　　者：何晓燕 谢俊霞[2] 赫玉霞 白敏 陈玉洁 

机构地区：[1]石药集团药物研究院,河北石家庄050035 [2]河北化工医药职业技术学院,河北石家庄050026

出　　处：《中国医药工业杂志》2013年第7期702-705,共4页Chinese Journal of Pharmaceuticals

基　　金：国家"十一五"重大新药创制(2011ZX09401-306)

摘　　要：测定了自制氨氯缬沙噻嗪片与原研制剂(Exforge HCT)在4种溶出介质(pH 6.8磷酸盐缓冲液、pH 4.5磷酸盐缓冲液、0.1 mol/L盐酸和水)中的溶出曲线,并进行相似性评价。结果表明,自制样品与原研制剂在4种溶出介质中溶出曲线相似因子f2大于50,差异因子f1小于15,表明两种制剂体外溶出行为相似。The dissolution profiles of the self-made compound tablets of amlodipine, valsartan and hydrochlorothiazide were compared with the brand-name drug （Exforge HCT） in four kinds of dissolution media including pH 6.8 and pH 4.5 phosphate buffer, 0.1 mol/L HCl and water. The data were analyzed by similarity factor （f2） and difference factor （f1） methods. The results indicated that the f2 values of three components were all more than 50 and the f1 values were less than 15 in four kinds of dissolution media. It revealed that the dissolution behaviors of the selfmade tablets were similar with Exforge HCT.

关 键 词：氨氯地平 缬沙坦 氢氯噻嗪 溶出曲线 相似因子 差异因子 

分 类 号：R944.4[医药卫生—药剂学]