苯溴马隆片溶出度测定方法的研究  

Study on Dissolution Method of Benzbromarone Tablets

作　　者：孟长虹[1] 陆益红[1] 金卫红[1] 

机构地区：[1]江苏省药品检验所,南京210008

出　　处：《中国药品标准》2011年第4期282-284,共3页Drug Standards of China

摘　　要：目的:建立苯溴马隆片的溶出度测定方法。方法:通过对溶出介质、溶出方法、转速和取样时间的选择,确定苯溴马隆片的溶出度方法。并对方法的回收率、线性、稳定性进行考察。结果:采用桨法,以含0.25%十二烷基硫酸钠的磷酸盐缓冲液为溶出介质,转速100 r.min-1,45 min取样,以紫外分光光度法测定。苯溴马隆在2.085～16.678μg.mL-1范围内溶液浓度与吸收值呈良好线性关系(r=0.999 5);平均回收率为98.9%,(RSD为0.84%,n=9)。结论:该方法稳定、简便易行,可用于苯溴马隆片的溶出度检查。Objective： To establish a method to determine the dissolution of Benzbromarone Tablets. Methods： To establish the disso- lution condition by choosing the optimal dissolution medium, dissolution method, rotational speed and taking solutions time. Its recov- ery and linear relationship have been tested. Results： The paddle method was used. Phosphate buffer solution with O. 25 % sodium do- decyl sulfate was used as dissolution medium, and rotational speed was 100 r · min^-1. After 45min the dissolution solution of tablet was taken. Use uhra-violet absorption spectrometry method. Good linearity between absorption value and benzbromarone concentration was achieved in the range of 2.085 ~ 16.678 μg·mL^-1 （r =0.999 5）. The average recoveries （n =9） was 98.9% （RSD = 0. 84% ）. Conclusion ： The method was simple, practical and accurate to determine the dissolution of benzbromarone tablets.

关 键 词：苯溴马隆片 溶出度 

分 类 号：R921.2[医药卫生—药学]