桂利嗪片的溶出行为研究及溶出曲线绘制  

Study on dissolution behavior and drawing of dissolution curve of Guirizi ne tablets

作　　者：敦康 付莉 王若琳 DUN Kang;FU Li;WANG Ruolin(Hebei Drug Evaluation Center,Shijiazhuang 050091,China;College of Materials Science and Engineering,Hebei University of Science and Technology,Shijiazhuang 050018,China)

机构地区：[1]河北省药品审评中心,河北石家庄050091 [2]河北科技大学材料科学与工程学院,河北石家庄050018

出　　处：《当代医药论丛》2023年第8期113-115,共3页

基　　金：2021年度河北省市场监督管理局科技计划项目;题目:桂利嗪原料和片剂的质量标准完善和工艺路线优化研究;编码:2021YJ12。

摘　　要：目的:考察桂利嗪片在四种典型溶出介质中的溶出情况,探索不同条件下溶出行为的差异,并绘制溶出曲线。方法:篮法,转速100 r/min,温度37.0℃,分别以pH=1.0的盐酸溶液、pH=4.0的醋酸盐缓冲液、pH=6.8的磷酸盐缓冲液以及水作为溶出介质,采用紫外-可见分光光度法(检测波长为253 nm)分别测定桂利嗪片在不同溶出介质中的溶出度,并绘制溶出曲线。结果:试样在水和磷酸盐缓冲液中无溶出,在盐酸溶液和醋酸盐缓冲液中溶出良好,且在盐酸溶液中溶出更快、更完全。结论:桂利嗪片在强酸溶液中溶出更完全,溶出曲线更趋近于水平,在碱性和水介质中无溶出。Objective:To investigate the dissolution of Guirizine tablets in four typical dissolution media,to explore the difference of dissolution behavior under different conditions,and to draw the dissolution curve.Method:Basket method,the rotation speed is 100 r/min,the temperature is 37.0℃,respectively with pH=1.0 hydrochloric acid solution,pH=4.0 acetate buffer,pH=6.8 phosphate buffer and water as dissolution media.The dissolution of Guirizine tablets in different dissolution media was determined by UV-VIS spectrophotometry(detection wavelength was 253 nm),and the dissolution curves were drawn.Results:The sample was not dissolved in water and phosphate buffer,but dissolved well in hydrochloric acid solution and acetate buffer,and dissolved faster and more completely in hydrochloric acid solution.Conclusion:The dissolution curve of guillizine tablets is more horizontal in strong acid solution,and there is no dissolution in alkaline and water medium.

关 键 词：桂利嗪片 溶出行为 溶出曲线 紫外-可见分光光度法 

分 类 号：R917[医药卫生—药物分析学]