光纤药物溶出度实时测定布洛芬缓释胶囊的释放度

Fiber-optic in situ dissolution testing method and conditions for ibuprofen sustained-release capsules

目的:采用光纤药物溶出度实时测定仪监测布洛芬缓释胶囊释放度。方法:用FODT仪和2005年版中国药典规定的溶出度及HPLC仪,分别检测4批布洛芬缓释胶囊的释放度,比较它们不同时段的平均累积释放百分率和总平均累积释放百分率。结果:两种方法相比,总平均累积释放百分率无明显差异(P>0.05)。结论:FODT仪监测布洛芬缓释胶囊释放度简便易行。

OBJECTIVE To monitor the release rate of ibuprofen sustained-release capsules with the instrument of fiber-optic in situ dissolution testing（FODT）. METHODS By means of the instruments of FODT and traditional dissolution apparatus and HPLC specified by Ch. P, the release rate of four batch ibuprofen sustained-release capsules were detected respectively, so as to compare the mean dissolution accumulative percentage and the total mean dissolution accumulative percentage in the different time between the two methods. RESULTS Between the two methods, the total mean dissolution accumulative percentage of ibuprofen sustained-release capsules in the different time had no significant difference（P〉0. 05）. CONCLUSION To monitor the release rate of Ibuprofen Sustained-Release Capsules with FODT is simple and convenient.