李月婷;侯靖宇;胡杰;潘洁;黄勇;郑林;
LI Yueting;HOU Jingyu;HU Jie;PAN Jie;HUANG Yong;ZHENG Lin;Guizhou Provincial Key Laboratory of Pharmaceutics,Guizhou Medical University;School of Pharmacy,Guizhou Medical University;Engineering Research Center of Ministry of Education for the Development and Application of Ethnic Medicine and TCM,Guizhou Medical University;

• 1:贵州医科大学贵州省药物制剂重点实验室
• 2:贵州医科大学药学院
• 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

摘要(Abstract)：

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1.19²1.49 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%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%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 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% 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% 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(KeyWords)： 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
dexketoprofen trometamol;ultraviolet spectrophotometry;quality standard;dilution degree;release degree

Abstract:

Keywords:

基金项目(Foundation): 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]

作者(Authors): 李月婷;侯靖宇;胡杰;潘洁;黄勇;郑林;
LI Yueting;HOU Jingyu;HU Jie;PAN Jie;HUANG Yong;ZHENG Lin;Guizhou Provincial Key Laboratory of Pharmaceutics,Guizhou Medical University;School of Pharmacy,Guizhou Medical University;Engineering Research Center of Ministry of Education for the Development and Application of Ethnic Medicine and TCM,Guizhou Medical University;

DOI: 10.19367/j.cnki.1000-2707.2015.11.010

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