阿替洛尔缓释微囊的稳定性研究

Studies on the Stability of the Atenolol Sustained Release Microcapsules

目的考察高温、高湿、强光照射条件对阿替洛尔缓释微囊稳定性的影响。方法以阿替洛尔缓释微囊的外观、载药量、累积释放度为测定指标,分别对缓释微囊样品进行了影响因素(高温、高湿、强光照射)试验,并采用f2相似因子法判断本品释放度曲线的相似性。结果影响因素试验中,高温试验0d与5d比较的f2=61.54,0d与10d比较的f2=50.37;高湿试验0d与5d比较的f2=75.05,0d与10d比较的f2=65.46;强光照射试验0d与5d比较的f2=66.15,0d与10d比较的f2=56.17。结论高温和强光照射条件下会增加阿替洛尔缓释微囊的释放速度,在高湿条件释放速度未发生明显变化,微囊的其它各项指标无明显变化。

OBJECTIVE To investigate the influence of high temperature ,high humidity ,strong light irradiation on stability of Atenolol sustained release microcapsules .METHODS With the appearance、drug loading capacity and accumulative releasing of capsules as index ,influence factors （ high temperature ,high humidity and strong light ir-radiation） on sustained release microcapsules were tested respectively and the similarity of Release curve was esti -mated by f2 similarity factor method.RESULTS f2 was 61.54（0d vs 5d） and 50.37（0d vs 10d） in the high tem-perature test;f2 was 75.05（0d vs 5d） and 65.46（0d vs 10d） in the high humidity test;in the strong light irradiation test,f2 was 66.15（0d vs 5d） and 56.17（0d vs 10d）.CONCLUSION The release rate of Atenolol sustained re-lease microcapsules increase under the condition of the high temperature and the strong light irradiation ,and do not change significantly under the condition of the high humidity .The other index has no obvious change .