盐酸文拉法辛微孔型渗透泵片的制备工艺研究

Technology Study of Venlafaxine Hydrochloride Micro-porous Osmotic Pump Tablet

目的制备具有零级释药特征的盐酸文拉法辛微孔型渗透泵片。方法以累积释药百分率为指标,采用单因素法考察片芯组成和衣膜处方对制剂释药行为的影响。结果优化后的盐酸文拉法辛微孔型渗透泵片遵从以渗透压作为主要释药动力的零级模型,体外释药方程为:Q=7.454 3t+2.877 1,r=0.998 3。结论基于渗透压释药机制的盐酸文拉法辛微孔型渗透泵片理论可行,结果可控,有利于渗透泵控释制剂的产业化推广。

Objective To prepare the venlafaxine hydrochloride （Ven） micro-porous osmotic pump tablet exhibiting zero-order release. Methods Single factor tests for cumulative percentage of drug release were used to investigate effects of the core and coating material on it. Results It was proved that optimized Ven micro-porous osmotic pump fitted with the zero-order model in which osmotic pressure was the main driving force for controling drug delivery. The in vitro dissolution equation was as follows ： Q = 7. 454 3t ＋ 2. 877 1 ,r = 0. 998 3. Conclusion The osmotic pressure control based VEN micro- porous osmotic pump tablet is theoretically possible and controllable. It will profit the industrialized manufacture of osmotic pump controlled preparation.