普卢利沙星片的质量标准研究  

Quality Research of Prulifloxacin Tablets

作　　者：孙金娥 陈红燕 朱建军[3] 贾红圣[4] 

机构地区：[1]南京苏中药物研究有限公司,江苏南京210016 [2]太仓市农业技术推广中心,江苏太仓215411 [3]太仓市沙溪人民医院,江苏太仓215421 [4]健雄职业技术学院,江苏太仓215411

出　　处：《盐城工学院学报（自然科学版）》2013年第1期52-55,74,共5页Journal of Yancheng Institute of Technology:Natural Science Edition

摘　　要：采用高效液相色谱法(HPLC)测定普卢利沙星片中普卢利沙星的含量及有关物质。使用紫外-可见分光光度法测量片剂溶出度,作为普卢利沙星片的质量控制标准的一种新方法。在片剂的含量测定中,3种浓度下回收率均良好,RSD=0.015%,空白辅料对主药测定无干扰。本品3批有关物质均小于1.0%;溶液浓度在(1～10)g/mL范围内,与吸光度值线性关系良好,A=0.097 8C+0.002,相关系数r=1。本品在45 min内溶出量达85%以上。建立的普卢利沙星片的含量、有关物质和溶出度测定方法简便、快速、准确。To establish the quality standard for Prulifloxacin tablets. Methods： Utilizing high performance liquid chromatography （HPLC） to determine the content of Prulifloxacin and the relevant components in tablets. The measurement method of dissolu- tion rate is UV - Vis spectrophotometry method. Results： In the content measurement, tablets of three concentrations all have good recovery rates, RSD = 0.015%, blank materials have no impact on the determination of medicine. The relevant materials in 3 batches of the tablets were less than 1.0%. The concentration of the solution is in good linear with the absorbance value. In the range of 1 - 10 g/ml, the linear equation is A = 0. 097 8C ＋ 0.002, the correlation coeiticient r = 1. In 45 rain, this product dis- solves more than 85% of the initial amount. Conclusion： The essay method and dissolution determination method are simple, quick and accurate. It could be applicable in quality control.

关 键 词：普卢利沙星片 质量控制 有关物质 溶出度 含量 

分 类 号：TQ472.3[化学工程]