布洛芬颗粒的溶出度测定及评价

目的：创建一种测定布洛芬颗粒溶出度的方法。方法：采用桨法，pH值7.2磷酸盐缓冲液500ml为溶出介质，转速50r/min，采用高效液相法测定含量及溶出曲线，并用f2相似因子法进行比较分析。结果：布洛芬颗粒的进样量在0.04～0.6（mg/ml）（r=0.9999）的范围内线性关系良好，平均回收率99.7%，RSD=0.52%。结论：本法准确、可行性强，可作为布洛芬颗粒的质量标准中控制项目之一。

Determination and Evaluation of the Dissolution of Ibuprofen Granules

Objective To establish a method for the determination of ibuprofen granules dissolution. Methods The paddle method was used, with the dissolution medium of 500ml phosphate buffer pH 7.2 and the rotating speed of 50r/min. The ibuprofen contents and dissolution curve were determined with HPLC method and were then compared and analyzed with f 2 factor. Results The standard curve of ibuprofen granules’ sample size was good in the range of 0.04~0.6mg/ml (r=0.9999),the recovery was 99.7% and RSD was 0.52%. Conclusion The method is simple, accurate and feasible, which can be used as one of the control items in the quality standards of ibuprofen granules.