奥拉西坦注射液处方工艺及研究

Study on the Formulation and Preparation Technique of Oxiracetam Injection

确定了奥拉西坦注射液的处方及制备工艺。选用适宜的络合剂,对处方进行筛选,并通过加速实验考察奥拉西坦注射液的稳定性。本品在加速条件下6个月的自制样品与0天的自制样品比较、与哈尔滨三联药业有限公司的奥拉西坦注射液比较,p H值、有关物质、含量均无明显变化。奥拉西坦注射液的处方和工艺可行,质量稳定。

To study the formulation and preparation technique of oxiracetam injection, suitable complexing agent was chosen, theformulation of oxiracetam injection was optimized, and the stability of the oxiracetam injection was investigated by accelerated test.The results show that pH valves, related materials and their contents of prepared samples before and six-month accelerated testas well as oxiracetam injection from Harbin Medisan Pharmaceutical Co.,Ltd. are not significantly different. Both the formulationand preparation technique of oxiracetam injection are feasible, and product quality is stable.