盐酸地尔硫胃漂浮延迟缓释片的研制

Preparation of Diltiazem Hydrochloride Intragastric Floating Delayed-onset Sustained-release Tablets

采用干法包衣压片法制备盐酸地尔硫胃漂浮延迟缓释片。考察了溶出介质pH、助漂剂种类、碳酸氢钠及羟丙甲纤维素用量对制剂漂浮性能及释药行为的影响。对释药曲线的拟合结果显示,该制剂4～12h以零级动力学释药,释药机制为药物扩散和骨架溶蚀共同作用。

Diltiazem hydrochloride intragastric floating delayed-onset sustained-release tablets were prepared by dry-compression coating technique. The effects of the pH of dissolution medium, the varieties of floating assistants, and the amount of NaHCO3 and HPMC on the flotation and release behaviors were investigated. After a fitting with the release curve, the drug release from the tablet within 4 - 12h was found to conform to zero-order kinetics and was controlled by the joint action of drug diffusion and bulk erosion mechanism.