摘要
目的对阿莫西林舒巴坦匹酯分散片的制备工艺进行研究。方法采用均匀设计试验法,以分散片剂崩解时限、分散均匀度为指标。结果筛选的制剂最优处方为微晶纤维素20%、淀粉12%、交联羧甲基纤维素钠6%,以药用乙醇为黏合剂制粒压片。试制的3批样品的加速试验表明工艺稳定,在(40±2)℃、相对湿度(75±5)%条件下放置6个月,主要质量指标无明显变化。结论设计的处方工艺稳定,可用于工业生产。
Objective To study the preparation technology of Amoxicillin Sulbactam Pivoxil Dispersible Tablets. Methods The uniform design method was used, and the disintegration time and the dispersing uniformity were selected as the indexes. Results The optimal formulation contained 20% microcrystalline cellulose, 12% starch, 6% sodium carboxymethyl starch. Ethyl alcohol （medicinal） was chosen as the adhesives to granulate and press. The acceleration testing in 3batches of trial products showed that the technology was stable and the main quality indexes had no obvious change when placed in the condition of （40±2）℃ and the relative humidity （75 ±5）% for 6 months. Conclusion The designed prescription is reasonable. The preparation technology is stable and suitable for industrial production.
出处
《中国药业》
CAS
2009年第3期23-25,共3页
China Pharmaceuticals
关键词
阿莫西林舒巴坦匹酯分散片
均匀设计试验
稳定性
Amoxicillin Sulbactam Pivoxil Dispersible Tablets
uniform design method
stability
