不同厂家盐酸左西替利嗪片溶出度比较

Comparison of dissolution of levocetirizine dihydrochloride tablets from 4 different manufacturers

目的建立盐酸左西替利嗪片溶出度的液相测定方法,并对不同生产厂家的盐酸左西替利嗪片溶出度进行考察及比较,为临床用药提供依据。方法参考相关标准及文献,对4厂家的盐酸左西替利嗪片的含量和累积溶出百分率进行检测分析,以威布尔方程拟合溶出参数。结果 4个厂家的产品在相同的溶出条件下的体外溶出度均符合药典规定,但其溶出参数间差异较大。结论不同厂家盐酸左西替利嗪片的溶出参数存在差异,临床用药时应加以注意。

Objective To establish a method for the determination of the dissolution of levocetirizine dihydrochloride tablets in vitro and to evaluate the dissolution rates of levocetirizine dihydrochloride tablets from 4 different manufacturers so as to provide basis for its rational use.Methods Based on the related standard and other references,the determination and accumulative dissolution of the tablets from 4 different pharmaceutical factories were detected.The Weibull＇s equation was used to model the dissolution parameters.Results The in vitro dissolution of levocetirizine dihydrochloride tablets from 4 different manufacturers were all conformed to standards of Chinese Pharmacopoeia（2010）.But the dissolution parameter had difference.Conclusion There was difference in dissolution parameters among the levocetirizine dihydrochloride tablets from different manufacturers,indicating that attention should be given in clinical application.