尼美舒利颗粒溶出度测定方法研究

Dissolution test of Nimesulide granules

目的研究尼美舒利颗粒溶出度。方法以磷酸盐缓冲液(pH=8.8)为溶出介质,采用篮法进行溶出度测定,转速:100 r.min-1,用紫外分光光度法在393 nm波长处测定。结果绘制的溶出曲线表明20 min内尼美舒利颗粒可溶出80%以上,确定的溶出时间30 min,限度为80%。结论测定6批样品的溶出量均符合规定。

Aim To study the dissolution of nimesulide granules.Methods Phosphate buffer was used（pH=8.8）as the dissolution medium and rotational speed of the basket was adjusted to 100 r·min-1.The absorbance was measured at 393 nm.Results The curve showed that nimesulide granules could dissolve 80% and upwards within 20 minutes.It was confirmed that the time of dissolution was 30 minutes and the limit was 80%.Conclusion 6 batches of samples were tested and the results met the qualification.