氨苯蝶啶片溶出度测定方法的研究  

Study on Determination Method of Dissolution of Triamterene Tablets

作　　者：郭小洁[1] 余倩[1] 周立春[1] 

机构地区：[1]北京市药品检验所

出　　处：《药物分析杂志》2005年第4期473-475,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立氨苯蝶啶片溶出度测定方法。方法:采用转篮法,以盐酸溶液(9→1000)为溶剂,转速为100r.min^(-1),45min时取样,以紫外分光光度法测定,检测波长为357nm。结果:氨苯蝶啶在1.0-10.0μg·mL^(-1)的浓度范围内,线性关系良好。线性方程为:A=8.39×10^(-2)C+2.1×10^(-3)(r=1.000);3个厂家8批样品测定结果显示,仅有2批样品在45min 的溶出量不低于标示量的75%。结论:氨苯蝶啶在水中不溶,增加其片剂溶出度检查项极为必要。本方法操作简便,结果准确,为完善氨苯蝶啶片的质量标准提供有效手段。Objective:The UV method was described for determination of the dissolution of triamterene tablets. Method:The apparatus was used with hydrochloric acid(9→1000)as dissolution medium at a rotate speed of at 100 r·min^(-1).According to the UV method,the absorbance of triamterene which was dissolved from its tablets in 45 mi- nutes was determined at the wavelength of maximum absorbanee at about 357 nm.Results:The linear range of tri- amterene was 1.0-10.0μg·mL^(-1),A=8.39×10^(-2)C+2.1×10^(-3)(r=1.000).The dissolutions of eight sam- ples produced by three different factories were tested,only two samples meeted the tolerances(not less than 75% of the labeled amount of triamterene dissolved in 45 minutes).Conclusion:Because triamterene is not dissolved in wa- ter.It is necessary to set up the method of dissolution of triamterene tablets.The method is rapid,convenient,accu- rate and reliable.It can be used as a reliable method of quality control for triamterene tablets.

关 键 词：氨苯蝶啶 测定方法 溶出度 紫外分光光度法 盐酸溶液 检测波长 浓度范围 线性关系 线性方程 测定结果 质量标准 转篮法 标示量 溶出量 检查项 样品 

分 类 号：R983.1[医药卫生—药品] R927.11[医药卫生—药学]