光纤药物溶出度测定仪实时监测罗红霉素胶囊的溶出度

目的:建立实时监测罗红胶囊溶出过程的方法,并考察5批罗红霉素胶囊溶出过程的差异。方法:运用标准品法,采用光纤药物溶出度测定(FODT)仪对不同批次罗红霉素胶囊溶出进行实时监测,并与《中国药典》法测定结果比较。结果:不同批次罗红霉素胶囊溶出过程存在差异,药物溶出100%的时间从10min到32min不等;FODT仪法与《中国药典》法测定溶出45min时总溶出率平均值分别为(96.64±2.95)%、(91.76±3.12)%。结论:光纤药物溶出度实时测定法能够有效、快速地测定罗红霉素胶囊体外溶出度,可以作为罗红霉素胶囊半成品溶出度检验手段,促进成品合格率提高。

Real-time Monitoring of the Dissolution of Roxithromycin Capsules by FODT

OBJECTIVE： To establish a method for the real-time monitoring of the dissolution process of Roxithromycin cap- sules, and to investigate the difference of dissolution process of Roxithromycin capsules. METHODS： The dissolution of different batches of Roxithromycin capsules was monitored by FODT, compared with result by method stated in Chinese Pharmacopeia. RE- SULTS： There were differences in the dissolution process of Roxithromycin capsules, and they dissolved completely from 10 min to 32 min. Average dissolution rates of roxithromycin in 45 min by 2 methods were （96.64 ± 2.95）% and （91.76 ± 3.12）%. CON- CLUSION： FODT can detect the real-time in vitro dissolution rate of Roxithromycin capsules rapidly. The method can be used for the dissolution determination of semi-manufactures of Roxithromycin capsules to improve the passing rate of finished product.