右旋布洛芬-β-环糊精包合物分散片质量控制  

Quality control of dexibuprofen-β-cyclodextrin inclusion complex dispersible tablets

作　　者：钟继昌 谢金涛[2] Zhong Jichang;Xie Jintao(North Anhui Health Vocational College,Suzhou Anhui 234099;First People′s Hospital of Suzhou City,Suzhou Anhui 234000)

机构地区：[1]皖北卫生职业学院,安徽宿州234099 [2]宿州市第一人民医院,安徽宿州234000

出　　处：《山西中医药大学学报》2022年第4期313-316,共4页Journal of Shanxi University of Chinese Medicine

基　　金：安徽省高校优秀青年人才支持计划重点项目(gxyqZD2020064)。

摘　　要：目的:建立右旋布洛芬-β-环糊精包合物分散片的质量控制方法。方法:采用高效液相色谱(HPLC)测定右旋布洛芬含量与有关物质,确定其溶出度测定方法,建立质量控制方法。结果:回归方程A=45130C+19587(r=0.9998),在10~60μg/mL浓度范围内右旋布洛芬与峰面积线性关系良好,含量测定平均回收率为99.21%(RSD=1.06%);最佳溶出条件为篮法、100 r/min,pH值为7.20的磷酸盐缓冲液作为溶出介质;制剂的重量差异、分散均匀性和有关物质检测合格。结论:该方法简便、结果准确、重现性好,可有效控制右旋布洛芬-β-环糊精包合物分散片的质量。Objective:To establish a method for the quality control of dibuprofen-β-cyclodextrin inclusion complex dispersible tablets.Methods:The content of dexibuprofen and related substances in dexibuprofen-β-cyclodextrin inclusion complex dispersible tablets were determined by HPLC.The determination method of its dissolution was determined,and the quality control method was established.Results:The linear regression formulae was A=45130C+19587(r=0.9998).At the concentration range between 10 and 60μg/mL,it showed a good linear relationship with peak area.The average recovery of content determination was 99.21%(RSD=1.06%).The most suitable dissolution conditions were basket method,100 r/min.And pH7.20 phosphate buffer was the dissolution medium.The weight variation,dispersion uniformity and related substances of the preparation were tested to be qualified.Conclusions:The method has the advantages of convenient operation,accurate results and good reproducibility,and can effectively control the quality of dexibuprofen-β-cyclodextrin inclusion complex dispersible tablets.

关 键 词：右旋布洛芬 分散片 质量控制 高效液相色谱法 

分 类 号：R285[医药卫生—中药学]