不同厂家阿奇霉素片溶出度评价

Evaluation of Dissolution of Azithromycin Tablets from 5 Pharmaceutical Factories

目的:建立阿奇霉素片的溶出度测定方法,并对不同生产厂家的阿奇霉素片溶出度进行考察及比较,为临床用药提供参考。方法:参考2005年版《中国药典》相关标准对5厂家5个批次的阿奇霉素片的含量和累积溶出百分率进行检测,再按威布尔分布模型原理计算溶出参数。结果:所有片剂在45min内溶出量均在75%以上,符合要求,但各样品溶出参数的方差分析结果具有显著性差异(P<0.01)。结论:建立的溶出度测定方法简便、可靠;不同厂家阿奇霉素片溶出度有差异,临床用药时应加强监控。

OBJECTIVE： To establish a method for the determination of the dissolution rates of azithromycin tablets and to compare the dissolution rates among azithromycin tablets that from different manufacturers so as to provide references for clinical medication. METHODS： The concentrations and drug cumulative dissolution rates of a total of 5 batch numbers＇ azithromycin tablets that from 5 pharmaceutical factories were determined based on the related standard procedure indexed in China Pharmacopoeia （2005 edition）, then the dissolution parameters were calculated with Weibull formula. RESULTS： The dissolution rates at 45 min were above 75%, which was up to the standard. The analysis of variance showed that there were significant differences among samples in dissolution parameters （P〈 0.01） . CONCLUSION： The established method for the determination of the dissolution rates of azithromycin tablets was simple and reliable, but significant differences were noted in dissolution of azithromycin tablets from different manufacturers, therefore, monitoring of drug quality should be strengthened in the clinic.