摘要
制备了渗透泵控释的盐酸维拉帕米片芯,依次包时滞衣层和控释衣层制得脉冲控释片。考察了时滞衣层增重和控释衣膜处方及增重对药物释放时滞和释放速率的影响,同时比较了制品在不同释放介质中的释药行为。结果显示,时滞衣层增重与脉冲控释片的释放时滞呈正相关(r=0.9959),但对药物的释放速率影响较小;控释衣膜中的致孔剂种类和用量及控释衣层增重对体外释药均有不同程度的影响;释药孔的数量对药物释放影响较小,但释药孔的减少可能会导致衣膜膨胀变形。脉冲控释片的体外释放不受介质pH的影响。
The osmotic pump controlled-release verapamil hydrochloride tablets were coated with the inner coating layer (lag time) and outer coating layer (controlled-release) to prepare the pulsatile release tablets. The effects of coating thickness of the two layers and the formulation of the outer layer on lag time and release rate were investigated. The in vitro release behaviors of the products in different pH value media were also investigated. The results indicated that there was a linear correlation between the inner layer weight and lag time (r=0.9959). The thickness of the inner layer did not significantly affect drug release rate. The kinds and amount of pore-making agent and the thickness of the outer layer also affected drug release. Although the number of delivery orifice had rarely influence on drug release, less orifice would result in the expansion of tablets. Furthermore, the lag time and release rate were pH-independent.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2008年第6期423-427,共5页
Chinese Journal of Pharmaceuticals
关键词
盐酸维拉帕米
渗透泵
脉冲控释
时滞
非pH依赖性
verapamil hydrochloride
osmotic pump
pulsatile release
lag time
pH-independent