阿司匹林与双嘧达莫双层片的研制及体外释药

 目的研制了阿司匹林、双嘧达莫双层片并考察了体外释药特性。方法湿法制粒压制双层片，ＨPLC检测释放度，并对释放介质进行筛选，建立了释药方程，采用相似因子法与国外制剂进行比较。结果释药曲线可用一级方程及Peppas方程拟合，相似因子法得到的f₂为60.84，双嘧达莫可维持12h缓释释放，阿司匹林溶出符合中国药典标准，与国外制剂释药行为相似。结论研制的复方缓释双层片剂达到设计要求。

Studies on aspirin and dipyridamole double-layer tablet and evaluation of its release characteristics

OBJECTIVE To study the aspirin and dipyridamole double layer tablets and evaluate its in vitro release characteristics.METHODS The double layer tablets were prepared by grenulation and the dissolution was determined by HPLC.Also the media were selected,then the release equations were established,which were compared to an imported preparation with similarity factor method.RESULTS The curve of cumulative drug release was accorded with the first grade equation and Peppas equation.The values of similarity factor(f 2) was 60.84,which was similar to the release behavior of the imported preparation.Dipyridamole was sustained for 12 hours and the dissolution of aspirin was consistent with the standard of Chinese Pharmacopeia.CONCLUSION The compound sustained release double layer tablet was prepared and the drug release equation and release pattern was established.