摘要
目的:建立阿奇霉素干混悬剂的溶出度测定方法。对10个厂家生产的阿奇霉素干混悬剂的体外溶出过程进行考察,为药品质量控制及临床用药提供参考。方法:采用桨法,以磷酸盐缓冲液(p H 6.0)500 m L为溶出介质,转速为50 r·min-1,采用HPLC法测定10个厂家的阿奇霉素干混悬剂不同时间内的累积溶出度,绘制溶出曲线。结果:10个厂家样品的溶出曲线具有明显差异,可真实的反映药品的溶出过程。结论:本方法简便、准确,可用于阿奇霉素干混悬剂的溶出度测定。不同药品生产企业的制剂处方和生产工艺不同而导致药物的溶出度存在较大差异。
Objective：To establish a dissolution method of Azithromycin for Suspension. To investigate the in vitro dissolution of Az- ithromycin for Suspension from ten manufacturers to provide information for drug quality control and clinical medication. Methods： 500 mL phosphate buffer （ pH 6. 0） was adopted as dissolution medium with paddle method setting at 50 r · min - 1. HPLC method was used to test the cumulative dissolution at different times and draw dissolution profiles. Results： The dissolution profiles of Azithromycin for Sus- pension from ten manufacturers were significantly different, which more really reflect the dissolution processes. Conclusion： The method is simple and accurate which can be used in the determination of dissolution of Azithromycin for Suspension. There was a significant differ- ence in dissolution rate of different manufacturers because of preparation prescription and production engineering.
出处
《中国药物评价》
2017年第4期258-260,共3页
Chinese Journal of Drug Evaluation
