摘要
目的 :以盐酸地尔硫为模型药物研制脉冲片剂并同时考察用压制包衣法制备脉冲给药系统的可行性。方法 :以疏水性物质巴西棕榈蜡、蜂蜡为包衣材料 ,采用压制包衣法 ,制备盐酸地尔硫脉冲片。通过正交设计和体外释放度实验 ,考察释放介质的pH、处方及工艺对盐酸地尔硫脉冲释放的影响。结果 :通过调整包衣处方的组成、压制包衣的压力和包衣层的重量得到滞后时间分别为 2 ,4,6h和 8h的盐酸地尔硫的脉冲释放片剂。介质的pH对盐酸地尔硫的脉冲释放无显著性影响。结论 :通过调整处方和工艺 ,可以得到体外不同时间脉冲释药的盐酸地尔硫片剂。
OBJECTIVE: To investigate the method of press-coated to prepare the pulsatile tablets of diltiazem hydrochloride as a model drug. METHOD: The tablet with a core of 30 mg diltiazem hydrochloride and a outer shell of hydrophobic material was prepared by the method of press-coated. The effect of media pH, the composition of the outer shell and the manipulation on pulsatile release was also studied. RESULT: The pulsatile release tablets of diltiazem hydrochloride with the lag time of 2, 4, 6 h and 8 h were prepared by changing the composition, the thickness of the coating material and the pressure used. The pH media was found to have no significantly effect on the release of diltiazem hydrochloride. CONCLUSION: The pulsatile release of ditiazem hydrochloride could be controlled by adjusting the composition of the outer shell materials and the manipulation condition.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2000年第5期317-320,共4页
Chinese Pharmaceutical Journal
基金
国家自然科学基金!资助项目
第 39770 878号
关键词
盐酸地尔硫ZHUO
脉冲片剂
释放度
压制包衣
diltiazem hydrochloride, pulsatile tablets, release in vitro, pressed coated
