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
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摘要: 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、T50、T30、Td、T80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。Abstract: Objective:To compare the dissolution of loratadine tablets or capsules in vitro from five different pharmaceutical facto- ries and give suggestions for clinical use.Methods:The dissolution tests were carried out with rotating basket and the content of lorata- dine 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 loratadine tablets or capsules in vitro from five factories were all in conformity with Chinese Pharmacopoeia（2005 edition）.But significant differ- ences 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.
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Key words:
- loratadine /
- dissolution /
- UV spectrophotometry
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