过程分析阿莫西林分散片的溶出度

Compare dissolution rate of amoxicillin dispersible tables with process analysis

目的建立阿莫西林分散片溶出度的光纤传感实时检测方法。方法参照新药转正标准中阿莫西林分散片的溶出度测定方法,采用桨法,转速75r/min,以水为溶出介质,用光纤化学传感药物溶出度实时分析系统在272nm处检测紫外吸收,同时用紫外分光光度法检测溶出浓度,以相互对照。结果在44.44～333.33μg/ml范围内,吸收度与阿莫西林分散片的浓度成线形关系,日内、日间精密度及回收率的RSD均小于5%,2种测定方法差异无统计学意义(P>0.05)。结论光纤传感药物溶出度实时分析系统在位、在线并且连续定量地反映了分散片体外速释的特性,更有效、准确地反映分散片释放的过程,过程监控准确,结果可信。

Objective To develop a fiber optic chemical sensor dissolution test system for determining the dissolution of amoxicillin dispersible tablets.Methods The dissolution test of amoxicillin dispersible tablets which were carried out in water using the paddle method at a rate of 100 r/min.The drug dissolution concentration was detected using the optic fiber chemical sensor dissolution test system and UV spectrophotometry,the detection wavelength was at 272 nm.Results A good linearity was obtained over the range of 44.44～333.33 μg/ml.The precision（RSD）of within-day,day-to-day and the rangs of recovery was less than 5%.There was no distinctly difference when compared to the two methods（P0.05）.Conclusion The fiber-optic sensor dissolution test system is capable of the literal dissolution process of dispersible tablets and supplying more complete and accurate details of the dissolution process.