国产盐酸普萘洛尔片溶出评价  

Evaluation of dissolution of propranolol hydrochloride tablets

作　　者：刘海涛[1] 王俊秋[1] 余立[1] 周立春[1] 

机构地区：[1]北京市药品检验所,北京100032

出　　处：《中国医院药学杂志》2011年第23期1947-1950,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:考察国内21个厂家生产的盐酸普萘洛尔片的体外溶出度,为提高药品内在质量和临床用药提供参考。方法:采用桨法进行体外溶出度试验,以紫外分光光度法测定盐酸普萘洛尔的含量,计算累积溶出百分率;使用相似因子法和威布尔方程法对结果进行分析和评价。结果:21个厂家盐酸普萘洛尔片的体外溶出度均符合中国药典2010年版中的相关规定,但各厂家产品溶出行为差别较大,产品质量存在差异。结论:不同厂家盐酸普萘洛尔片的溶出参数存在差异,临床用药时应加以注意。OBJECTIVE To compare the in vitro dissolution of propranolol hydrochloride tablets from different pharmaceuti- cal factories for giving references of clinical application of propranolol hydrochloride tablets. METHODS The dissolution test was Carried out with paddle-rotating method. The content of propranolol hydrochloride was determined by UV spectrophotometry. The accumulative dissolution percentage was calculated. The similarity factor and the Weibull equation were used to evaluate the dissolution results. RESULTS The dissolution of propranolol hydrochloride tablets from 21 manufactories conformed to the requirements of Chinese Pharmacopoeia（2010 edition）. But significant differences were found among propranolol hydrochloride tablets dissolution behaviour. CONCLUSION There was significant difference in dissolution parameters among the propranolol hydrochloride tablets preparations from different manufactories,which should be given attention in clinical application

关 键 词：盐酸普萘洛尔片 相似因子 威布尔方程 溶出度 紫外分光光度法 

分 类 号：R942[医药卫生—药剂学]