氟尼辛葡甲胺掩味口腔崩解片的质量标准研究

Quality Standard of Flunixin Meglumine Taste-Masked Orally Disintegrating Tablet

为了建立氟尼辛葡甲胺掩味口腔崩解片的质量标准,采用薄层色谱法(TLC)鉴别氟尼辛葡甲胺掩味口腔崩解片中的氟尼辛葡甲胺,采用高效液相色谱法(HPLC)测定该制剂中氟尼辛葡甲胺的含量,并测定了其崩解时限、重量差异、脆碎度和溶出度。结果显示:氟尼辛葡甲胺掩味口腔崩解片能在30 s内崩解完全,重量差异和脆碎度均符合规定;制剂在人工唾液中60 s内溶出低于10%,在pH值4.5的醋酸缓冲液中10 min内溶出超过80%,表明具有掩味效果及速释特性;TLC背景清晰,分离效果好,无干扰;氟尼辛葡甲胺在24.5~245μg/mL范围内线性良好,相关系数为0.9998,平均回收率为99.55%,RSD(n=6)为0.58%。表明本试验建立的鉴别和含量测定方法简便、准确、可靠,为氟尼辛葡甲胺掩味口腔崩解片质量标准的建立提供了参考。

This study aimed to establish the quality standard of flunixin meglumine(FM)taste-masked orally disintegrating tablets(ODTs).FM was identified by thin layer chromatography(TLC),the contents of FM in the taste-masked ODTs were determined by HPLC,and the disintegration,tablet weights,brittleness and dissolution rate were been evaluated.The FM taste-masked ODTs could be disintegrated in 30 s,and the weight difference and friability met the requirements of Chinese Veterinary Pharmacopoeia.The dissolution of FM was less than 10%within 60 s in artificial saliva and more than 80%within 10 min in pH 4.5 acetate buffer,indicating that the FM taste-masked ODTs has a taste-masked effect,as well as immediate release characteristics.The TLC background was clear,separation effect was good and negligible interference was observed.A good linearity of flunixin meglumine was obtained in the range of 24.5~245μg/mL with the correlation coefficient of 0.9998.The recovery was 99.55%,and RSD was 0.58%.The process of TLC and HPLC was simple,accurate and reliable and these methods further provide a reference for the establishment of quality control of flunixin meglumine taste masked orally disintegrating tablets.