枸橼酸西地那非片溶出曲线对比研究  

Comparative Studies on Dissolution Profiles of Sildenafil Citrate Tablet

作　　者：王琳琳 张淑锋 李凤英 廖梓岑 袁多红 WANG Linlin;ZHANG Shufeng;LI Fengying;LIAO Zicen;YUAN Duohong(Nanchang Lijian Pharmaceutical Co.,Ltd.,Nanchang 330032,China)

机构地区：[1]南昌立健药业有限公司,江西南昌330032

出　　处：《山东化工》2025年第6期154-156,159,共4页Shandong Chemical Industry

摘　　要：建立枸橼酸西地那非片溶出曲线检验方法,在3种不同介质中对自制制剂与参比制剂进行溶出曲线对比研究。自制制剂采用3批,参比制剂采用国家药监局公布参比目录中的美国上市1批和原研地产化3批。自制制剂与参比制剂在0.01 mol·L^(-1)盐酸溶液、pH值4.0醋酸盐缓冲液、含0.1%SLS pH值6.8磷酸盐缓冲液三种溶出介质中的溶出曲线15 min平均溶出量均大于85%,溶出曲线相似。The dissolution method was established.To compare the dissolution profiles in three different mediums between self-made preparation and reference preparation.Three batches self-made preparation,one batch reference preparation sold in USA and three batches reference preparation made in China were used.The dissolution profiles of the self-made preparations and reference preparations in 0.01 mol·L^(-1) HCl,pH 4.0 acetate buffer solution and 0.1%SLS pH 6.8 phosphate buffer solution are all greater than 50.The dissolution profiles were similar.

关 键 词：枸橼酸西地那非 溶出曲线 多种介质 相似性 

分 类 号：TQ460[化学工程—制药化工]