五个厂家氯雷他定片或胶囊体外溶出度比较

Comparison of dissolution of loratadine tablets or capsules in vitro from five manufacturers

目的:比较5个厂家的氯雷他定片剂或胶囊剂的溶出度,为临床用药提供参考。方法:采用转篮法进行体外溶出度实验,以紫外分光光度法进行含量测定,计算其累积溶出百分率,并以威布尔方程拟合溶出参数,用方差分析对组间溶出参数进行统计学处理,采用Q检验进行两两检验。结果:5个厂家的氯雷他定片或胶囊的体外溶出度均符合2005年版国家药典标准的规定,但各厂家氯雷他定片或胶囊的溶出度参数m、Kr、T_(50)、T_(30)、T_d、T_(80)间存在显著性差异(P<0.05)。结论:不同厂家氯雷他定片或胶囊的溶出参数存在差异,临床用药时应加以注意。

Objective：To compare the dissolution of loratadine tablets or capsules in vitro from five different pharmaceutical factories and give suggestions for clinical use. Methods ： The dissolution tests were carried out with rotating basket and the content of loratadine was determined by UV spectrophotometry. The accumulation dissolution percent was calculated and Weibull formula was used to fit the deta. The dissolution parameters was statistically analyzed by variance analysis and Q test. Results ： The dissolution of loratadinc tablets or capsules in vitro from five factories were all in conformity with Chinese Pharmacopoeia （2005 edition）. But significant differences of dissolution parameters m ,Kr, T30,T50, Td and T80 were found among the loratadine tablets or capsules from five factories （P 〈 0.05 ）. Conclusion： There is a significant difference in dissolution parameters of the loratadine tablets or capsules from five factories, indicating that attention should be paid to their difference in clinical use.