阿西美辛缓释片的制备及其稳定性考察

目的:制备阿西美辛缓释片并考察其释药影响因素及稳定性.方法:采用湿法制粒工艺,以羟丙基甲基纤维素(HPMC)为骨架材料,制备了阿西美辛缓释片.对影响释药的因素,如HPMC规格、用量、润湿剂的用量、制片压力等因素进行了考察,并参照中国药典2000年版附录考察了制剂的稳定性.结果:除了HPMC规格对药物的释放产生一定的影响,而HPMC用量、润湿剂的用量、制片压力对阿西美辛缓释片的释药影响不大.在光、湿、热等因素影响下及长期试验时,本制剂稳定性良好.结论:采用HPMC作为基本骨架材料制备阿西美辛缓释片,具有较强的光稳定性、热稳定性、湿稳定性,长期放置稳定性良好.

Preparation and stability test of acemetacin sustained release tablets

Objective:To investigate the preparation and stability of the acemetacin sustained release tablets(Ac-SRT).Methods: Acemetacin sustained release tablets composed of a matrix material HPMC were prepared by the wet granulation.Several factors that affected the sustained release characteristics,such as the viscosity and amount of HPMC and the adhesive concentrations,were assessed.The stability test was performed according to the guideline in China Pharmacopoeia.Results: The viscosity of HPMC was found to be the sole factor that affected the sustained release.The rest of factors had no significant effects on the sustained release behavior of Ac-SRT.This Ac-SRT showed a good stability in a long-term stability test involved with light,moisture and heat.Conclusion: The stable Ac-SRT was attainable.