对布洛芬颗粒溶出度一致性评价的探索

目的建立布洛芬颗粒的溶出度测定法，并通过多条溶出曲线考察其与参比制剂的一致性。方法分别以水、pH=1．2盐酸溶液、pH=5．5磷酸氢二钠-柠檬酸缓冲液、pH=6．8磷酸盐缓冲液及pH=7．2磷酸盐缓冲液各900mL为溶出介质，转速为50r·min^-1，采用高效液相色谱法于263nm测定。结果布洛芬在40．15～280．99μg·mL^-1与峰面积呈良好的线性关系（r=0．9999）；平均回收率为99．4％，RSD为0．40％；在4种溶出介质中，15min累积溶出基本达到平衡，样品与参比制剂溶出行为基本一致。结论该方法准确、可靠，可用于布洛芬颗粒溶出度评价。

Dissolution consistency of ibuprofen granules by different manufacturers

Objective To establish a method for the determination of dissolution of ibuprofen granules and to investigate the consistency of stripping curves. Methods Water, pH = 1.2 hydrochloride solution, pH = 5.5 disodium hydrogen phosphate -citrate buffer, pH = 6.8 phosphate buffer, and pH = 7.2 phosphate buffer 900 mL were used respectively as stripping media. The rotation speed was 50 r·min^-1, and HPLC determination at 263 nm. Results The method showed a good linear relationship between the peak area and the concentration range of 40.15 - 280.99 μg·mL^-1 （r = 0.999 9）. The average recovery was 99.4%, and the RSD was 0.40%. The cumulative leaching reached the balance at 15 min and stripping curves were similar in the 4 media. Conclusion The method is accurate, reliable, and can be used to study the dissolution consistency of ibuprofen granules.