不同厂家布洛芬缓释胶囊体外释放度比较

Comparison of release rates of ibuprofen sustained-release capsules from different manufacturers

目的:考察9个不同厂家的布洛芬缓释胶囊的体外释放度并与芬必得缓释胶囊进行对比,为临床合理用药提供参考。方法:按照《中华人民共和国药典》2010年版有关布洛芬缓释胶囊释放度测定的规定,采用转篮法的装置进行体外溶出实验,用高效液相色谱法进行含量测定,计算累积释放百分率,进行释药曲线拟合,比较溶出参数,并通过计算相似因子的方法与芬必得进行比较。结果:9个厂家中仅F厂的产品释放不符合要求,其余厂家产品释放度均符合要求,且与芬必得缓释胶囊相似因子大于50。除F厂家外,其余厂家产品的释药曲线均符合威布尔方程。结论:不同厂家产品存在内在差异,可为临床用药提供参考。

Objective： To investigate the release rates of different ibuprofen sustained-release capsules in vitro by comparing with fenbid, thus provide a reference for its rational use in clinical. Methods： The release rate tests of ibuprofen sustained-release capsules were performed accordance to China Pharmacopeia （2010 edition, basket-rotating method of drug release rate）, and the release amount was determined by HPLC. Release curve was used to fit different equation, and the parameters of m, T50 and Td were caculated and compared with fenbid. f2 factor was calculated to compare their similarity with fenbid. Results： The f2 factors of nine manufacturers＇ products with fenbid were greater than 50, except for F capsule. And their release curves are fit with Weibull equation. Conclusion： There are differences in dissolution parameters among the ibuprofen sustained-release capsules from different manufacturers.