乙酰谷酰胺葡萄糖注射液工艺研究

Study on Preparation Technology of Aceglutamide and Glucose Injection

目的研究乙酰谷酰胺葡萄糖注射液的生产工艺,为大容量注射剂的生产提供依据。方法采用正交试验方法优化生产工艺,并用室温留样方法进行初步稳定性考察,选择最佳工艺参数。结果确定乙酰谷酰胺葡萄糖注射液的最佳生产工艺参数为A2B2C2,即pH值为5.0,灭菌条件以115℃、30m in为佳。乙酰谷酰胺葡萄糖注射液质量稳定。结论该工艺生产出的乙酰谷酰胺葡萄糖注射液质量稳定,可以用于大容量注射剂的生产。

Objective To study the preparation technology of Aceglutamide and Glucose Injection, and to provide a basis for the production of large volume parenteral solutions. Methods The production technology of Aceglutamide and Glucose Injection was optimized by orthogonal experiment, and its stabilization was proved by remaining sample at room temperature, Results The optimal technologic parameters of Aeeglutamide and Glucose Injection was A2B2C2, i. xt, pH 5.0, the best sterilizing condition was 30 min at 115℃. The quality of Aceglutamide and Glucose Injection was stable. Conclusion The quality of Aceglutamide and Glucose Injection produced with that method is stable. It can be used for the production of the large volume parenteral solutions.