替米沙坦钠盐制备工艺的优化

Optimization of the preparation process of sodium salt of telmisartan tablets

目的优化替米沙坦片中替米沙坦钠盐制备工艺。方法采用不同的干燥工艺制备替米沙坦钠盐,研究其不同生产工艺对制剂溶出曲线的影响。结果采用真空干燥与喷雾干燥所制备的替米沙坦钠盐生产的制剂溶出曲线存在差异,不同的替米沙坦钠盐干燥工艺对制剂的溶出速度存在影响。结论采用喷雾干燥法制备的替米沙坦钠盐制备的替米沙坦片与参比制剂较为类似。

Objective To optimize the preparation process of telmisartan sodium salt in telmisartan tablets.Methods The effect of different production processes on the dissolution profile of telmisartan sodium salt prepared by different drying processes was studied.Results The dissolution profiles of telmisartan sodium salt prepared by vacuum drying and spray drying were different.Different telmisartan sodium salt drying processes had an effect on the dissolution rate of the formulation.Conclusion The telmisartan tablets prepared by spray-dried telmisartan sodium salt are similar to the reference preparations.The capsule has a feasible process,good repeatability and stable and reliable quality.