盐酸曲马多包衣缓释片的制备及体外释药行为

目的制备盐酸曲马多缓释片,考察盐酸曲马多缓释片体外释放度,探讨其体外释放机制。方法片芯以亲水凝胶和疏水阻滞剂组成,运用正交试验确定片芯处方,以醋酸纤维素(CA)、聚乙二醇1500为包衣液包衣,药片打孔,得到盐酸曲马多包衣缓释片。结果经拟合,释放过程符合一级动力学过程。结论该缓释片处方合理,工艺简单,产品稳定。

Preparation and in vitro characterization of tramadol hydrochloride sustained-release tablets

Objective To prepare tramadol hydrochloride sustained-release tablets and study the in vitro release characteristics of the tramadol hydrochloride sustained-release tablets. Method The tablet core composed of hydrophilic gum and hydrophobic blocker. The optimal formulation of the tablet core was obtained by employing orthogonal design. Tablets were coated with the solution which was prepared by cellulose acetate (CA) and polyethylene glycol 1500. The pore was made on either side of tablet. Results The release pattern met the need required in Chinese Pharmacopoeia (2005). The profile of accumulative release accorded with first order kinetics. Conclusion The formulation of the sustained-release tablets is rational and simple, and the releases of different batches are uniform and stable.