【摘要】 目的确定乙酰谷酰胺冻干粉针合理的处方及制备工艺。方法选用适宜赋型剂,对处方进行筛选,并通过影响因素实验考察乙酰谷酰胺的稳定性。结果本品在光照及高温条件下,5d及10d的样品与0d的样品比较,酸度、有关物质及含量均无明显变化。结论乙酰谷酰胺冻干粉针处方和工艺可行,质量稳定。更多还原

【Abstract】 OBJECTIVE To study the reasonal formulation and preparation technique of aceglutamide powder for injection.METHODS The formulation of aceglutamide powder for injection was optimized by choice of suitable vehicle,the stability of aceglutamide powder for injection was observed by stress testing.RESULTS Under light,high temperature,comparsion between the samples of the 5th day and the 10th day with the primary sample found its pH value,related materials and the content were not significally different.CONCLUSION Both the formulation and preparation technique of aceglutamide powder for injection were feasible and its quality was stable.更多还原