不同厂家盐酸西替利嗪片的体外溶出度比较  

Comparison of Dissolubility in Vitro of Cetirizine Hydrochloride Tablets from Five Different Factories

作　　者：潘柏良[1] 李鹏[2] 

机构地区：[1]重庆市第一人民医院,重庆400011 [2]重庆市中山医院,重庆400013

出　　处：《中国药业》2010年第7期24-25,共2页China Pharmaceuticals

摘　　要：目的测定5厂家盐酸西替利嗪片的体外溶出度,为临床用药提供参考。方法采用转篮法测定溶出度,用威布尔分布模型拟合溶出曲线,并对提取形状参数(m),溶出药物50%所需时间(T50),溶出药物63.2%所需时间(Td)进行方差分析。结果5厂家盐酸西替利嗪片的含量、含量均匀度及体外溶出度均符合2005年版《中国药典(二部)》的相关规定,不同厂家产品间的溶出参数T50,Td,m有显著性差异(P<0.01)。结论5厂家盐酸西替利嗪片的溶出度存在差异,临床应用时应加以注意,药监部门应加强生产质量的动态监测和药品生产工艺管理,以保证产品质量的均衡性。Objective To compare the dissolving ability in vitro of Cetirizine Hydrochloride Tablets from 5 factories for clinical reference in drug choice. Methods To detect the dissolving ability in vitro of Cetirizine Hydrochloride Tablets by the basket- rotating method. The Weibull＇s equation was used to fit the dissolution parameters including T50, Td and shape parameter（m） by the method of variance analysis. Results The content, content uniformity and dissolution in vitro for the products of 5 factories were conformable with the standard of the China Pharmacopoeia（2005 edition）, the dissolution parameters had significant differences among 5 factories（ P〈0. 01）. Conclusion There are significant differences in the dissolution parameters of T50 and Td among 5 factories, which should be given attention in clinical application. Drug supervision and administration department should strengthen the dynamic monitoring on production quality and technology of drug production for ensuring the quality uniformity.

关 键 词：盐酸西替利嗪片 溶出度 转篮法 威布尔分布模型 

分 类 号：R927.11[医药卫生—药学] R976