不同厂家盐酸昂丹司琼片的溶出度考察

Study on the dissolution of ondansetron hydrochloride tablets of different manufacturers

目的对3个不同厂家所生产的盐酸昂丹司琼片体外溶出度进行了考察,为临床用药提供参考。方法根据《中华人民共和国药典》(2010版)中盐酸昂丹司琼片的溶出度实验项下要求,采用浆法测定溶出度,紫外-可见分光光度法测定吸光度,对照品法计算溶液中盐酸昂丹司琼浓度。利用Excel软件计算累积溶出百分率及溶出参数,并进行比较分析。结果 3个厂家盐酸昂丹司琼片的体外溶出度均符合药典规定,但各自间存在一定差异。结论不同厂家盐酸昂丹司琼片的溶出情况存在一定差异。

Objective To investigate the dissolution of ondansetron hydrochloride tablets of 3 different manufacturers.Methods The dissolution test was carried out by paddle method inChinese Pharmacopoeia 2010 edition,and the absorbance of ondansetron hydrochloride solution was measured by UV spectrometry,then the concentration of ondansetron hydrochloride was calculated according to the absorbance of standard reference.Cumulative dissolution percentage as well as dissolution parameters was calculated using Excel software.Results The dissolution performance of ondansetron hydrochloride tablets in 3 different manufacturers all reached the Chinese Pharmacopoeia requirements,but there are some differences between each brand.Conclusion Attentions should be paid in the clinical use of ondansetron hydrochloride tablets because of the differences dissolution patterns between different manufacturers.