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目的制备酒石酸美托洛尔择时缓释微丸并研究该制剂的体外释药影响因素。方法采用Eudragit?NE30D为缓释层包衣材料制备缓释丸芯,水溶胀性材料交联羧甲基纤维素钠为内包衣溶胀层,乙基纤维素水分散体Surelease为外包衣控释层对缓释丸芯进行包衣,制备择时缓释微丸,并考察处方因素和溶出条件对药物释放的影响。结果缓释层材料类型和包衣增重、溶胀层包衣增重和控释层包衣增重对该择时缓释微丸的释药时滞和释放速率具有显著影响,药物释放情况不受介质pH值和溶出转速的影响。
Objective To prepare metoprolol timed sustained-release pellets and to study the influencing factors of in vitro release of this preparation. Methods Eudragit NE30D was used as sustained-release coating material to prepare sustained-release pellets. The water-swellable material, croscarmellose sodium, was used as inner coating swellable layer and the ethyl cellulose aqueous dispersion Surelease as outer coat control release layer The sustained-release pellets were coated to prepare sustained-release pellets, and the effects of prescription factors and dissolution conditions on drug release were investigated. Results The type and weight gain of the sustained release coating, the weight gain of the swelling layer and the weight gain of the controlled release coating had a significant effect on the release delay and release rate of the sustained release pellets. The drug release did not By the media pH and dissolution speed.