氨氯地平阿托伐他汀钙片的处方和工艺研究

Investigation of formulation and in-process of Amlodipine and Atorvastatin calcium tablets

目的研制与进口制剂具有相似体外溶出行为且质量稳定的氨氯地平阿托伐他汀钙片。方法通过正交试验优化处方,采用湿法制粒;考察不同烘干温度及颗粒水分对主要杂质的影响;比较4种溶出介质中自制制剂与参比制剂的体外溶出行为。结果主要杂质受水分和温度影响较大;自制片与进口制剂的体外溶出行为相似;加速试验中,自制片的稳定性良好。结论所用制备工艺重复性良好,片剂质量稳定。

OBJECTIVE To prepare Amlodipine and Atorvastatin calcium tablets with similar dissolution profile in vitro to reference preparation and a stable quality. METHODS The formula was optimized by orthogonal design with wet granulation, the effect of different drying temperature and moisture on the main impurities was investigated and compare the dissolution curves of reference preparation and self - prepared preparation in 4 dissolution mediums. RESULTS The main impurities were greatly influenced by the moisture and temperature, the dissolution behaviors were similar with that of reference preparation,the accelerated stability tests suggested that self-prepared preparation had a good and stable quality. CONCLUSION Amlodipine and Atorvastatin calcium tablets are stable and the established processes are simple and reproducible.