右旋酮洛芬氨丁三醇速释缓释双层片的质量标准研究  

Study on Quality Standard of Dexketoprofen Trometamol Immediate-Release and Sustained-Release Tablets

作　　者：李月婷[1,2] 侯靖宇[1] 胡杰[1] 潘洁[3] 黄勇[1,2] 郑林[1,2] 

机构地区：[1]贵州医科大学贵州省药物制剂重点实验室,贵州贵阳550004 [2]贵州医科大学药学院,贵州贵阳550004 [3]贵州医科大学民族药与中药开发应用教育部工程研究中心,贵州贵阳550004

出　　处：《贵阳医学院学报》2015年第11期1172-1175,共4页Journal of Guiyang Medical College

基　　金：贵州省中药现代化科技产业专项基金项目[黔科合中药字(2012)5023号;黔科合重G字(2013)4001];贵阳市科技计划项目[筑科合同(2012)2042号]

摘　　要：目的：建立右旋酮洛芬氨丁三醇（DKPF）速释缓释双层片的质量标准。方法：以DKPF原料药为对照品,采用紫外分光光度法测定3批DKPF速释缓释双层片中DKPF的含量,并对双层片的溶出度、释放度及在不同介质中的稳定性等进行评价。结果：建立的紫外分光光度（UV）法测定DKPF速释缓释双层片中右旋酮洛芬的浓度在1.19-21.49 mg/L范围内与吸光度线性关系良好,A=0.042 3 C＋0.002,r=0.999 9,回收率在99.8%-100.6%,RSD在0.34%-1.02%;释放度测定结果表明双层片的释药行为符合一级动力学方程;溶出度的测定结果表明,3批样品均能在30 min内迅速释放药物,之后缓慢释放,达到速释缓释的要求;DKPF速释缓释双层片对光、热稳定,在湿度75%条件下吸湿严重。结论：UV法能有效监测DKPF速释缓释双层片的质量,该方法简便、可靠。Objective： To establish the quality standard of dexketoprofen trometamol（ DKPF） immediate-release and sustained-release tablets. Methods： Using DKPF as control subject,adopting UV spectrophotometry to determine contents,solubility,dissolution and the accumulated release rates of DKPF tablets. Evaluating stability of DKPF tablets in different mediators. Results： It showed a good linearity between the absorbance and the concentration of DKPF in DKPF immediate-release and sustained-release tablets detected by UV spectrophotometry among the ranges of 1. 19 ~ 21. 49 mg / L（ A =0. 042 3 C ＋ 0. 002,r = 0. 999 9）. The recoveries were 99. 8% ~ 100. 6%,RSD were 0. 34% ~1. 02%. The drug release behavior of DKPF double layers tablet followed the fist-order dynamics equation and can quickly dissolve within 30 minutes,then slow dissolution later to reach the requirement of immediate-release and sustained-release. The DKPF double layers tablet was stable in light and high temperatures but badly hygroscopic in 75% humidity. Conclusion： The method is practical,accurate and reliable,can be capable to effectively control the quality of dexketoprofen trometamol immediaterelease and sustained-release tablets.

关 键 词：右旋酮洛芬氨丁三醇 紫外分光光度法 质量标准 溶出度 释放度 

分 类 号：R943.3[医药卫生—药剂学]