右兰索拉唑缓释胶囊溶出度测定方法的研究  

Research of dissolution determination method of dexlansoprazole sustained-release capsules

作　　者：陈娟[1,2] 张坤[2] 杨志强[2] 王杏林[2] 潘凤[1] 

机构地区：[1]天津医科大学研究生院,天津300070 [2]天津药物研究院有限公司,释药技术与药代动力学国家重点试验室,天津300193

出　　处：《中国新药杂志》2016年第23期2659-2663,共5页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2014ZX09507005-001)

摘　　要：目的:探索不同介质中右兰索拉唑缓释胶囊的溶出行为,确定适合的溶出介质与质控标准。方法:采用中国药典2015年版通则0931溶出度测定第一法,测定右兰索拉唑缓释胶囊在不同pH、表面活性剂浓度、缓冲液盐浓度介质下的溶出曲线。结果:在不同溶出介质中,右兰索拉唑质量浓度在0.583 3~100.4μg·mL^(-1)范围内与吸光度值呈良好的线性关系(r≥0.999 4),精密度试验RSD分别为0.58%,0.04%,0.08%,0.11%,0.46%,每种浓度下的平均回收率均在95%~105%内。pH、表面活性剂浓度、缓冲液盐浓度对右兰索拉唑的溶出均有影响,其中以pH影响较为显著。结论:pH 7.0(含5 mmol·L^(-1)SLS)0.48mol·L^(-1)磷酸盐缓冲液介质可较好地表现右兰索拉唑缓释胶囊的释放特性,10,50,105 min时的累积释放量是质量控制的关键点。Objective： To investigate the dissolution behavior of dexlansoprazole sustained-release capsule（ Dexilant） in different media and establish appropriate dissolution media and quality control standards. Methods：The dissolution profiles of Dexilant in media of different pHs,surfactant concentrations and buffer salt concentrations were tested by the first method of Chinese Pharmacopoeia 2015 Part Ⅳ General 0931. Results： In different media,dexlansoprazole had good linearity between 0. 583 3 ~ 100. 4 μg·m L-1（ r≥0. 999 4）; the RSDs of precision test were 0. 58%,0. 04%,0. 08%,0. 11% and 0. 46%; the average recoveries of each concentration were within95% to 105%. pH,surfactant concentration and buffer concentration all could influence the dissolution behavior,especially pH. Conclusion： 0. 48 mol·L^（-1）phosphate buffer containing 5 mmol·L^（-1）SLS（ pH 7. 0） can reflect the release characteristics of Dexilant,and the release at 10,50 and 105 min is the key point of quality control.

关 键 词：非糜烂性胃食管反流病 右兰索拉唑缓释胶囊 溶出曲线 紫外-可见分光光度法 质控标准 

分 类 号：R914.1[医药卫生—药物化学]