4厂家卡维地洛片溶出度考察

目的:考察不同厂家生产的卡维地洛片的体外溶出度,为临床用药提供参考。方法:采用转篮法进行体外溶出度试验,以紫外分光光度法测定卡维地洛的含量,计算累积溶出百分率;以威布尔方程拟合溶出参数T50、Td、T80、m,再对参数进行方差分析。结果:4厂家卡维地洛片的体外溶出度均符合2005年版《中国药典》中的相关规定,但各厂家产品T50、Td、T80、m间均有显著性差异(P<0.01)。结论:不同厂家卡维地洛片的溶出参数存在差异,临床用药时应加以注意。

Comparison of Dissolution of Carvedilol Tablets from Four Pharmaceutical Factories

OBJECTIVE： To compare the in vitro dissolution of carvedilol tablets from four different pharmaceutical factories for references of clinical application of carvedilol tablets. METHODS： The dissolution test was carried out with basket- rotating method. The content of carvedilol was determined by UV spectrophotometry. The accumulative dissolution percentage was calculated. The Weibull＇ s equation was used to fit the dissolution parameters including T50, Td, T80, and m. Then an ANOVA was performed on these parameters. RESULTS： The dissolution of carvedilol from four manufactories conformed to the requirements of Chinese Pharmacopoeia （2005 edition） . But significant differences were found among carvedilol preparations from different factories in dissolution parameters including m, T50, Td and T80（P〈0.01） . CONCLUSION： There was significant difference in dissolution parameters among the carvedilol preparations from different manufactories, which should be given attention in clinical application.