门冬氨酸洛美沙星葡萄糖注射液制备处方与工艺优化研究

Study on optimization of preparation and formulation of Lomefloxacin Aspartate and Glucose Injection

目的:探讨优化制备工艺,提高门冬氨酸洛美沙星葡萄糖注射液的稳定性。方法:考察影响因素,筛选制剂处方工艺。结果:最佳处方工艺是不加亚硫酸氢钠,配制时主药加入前使用活性炭0.1%吸附,105℃湿热灭菌30分钟,灭菌后快速冷却至50℃以下。结论:优化后的处方工艺可明显提高制剂的稳定性。

Objective：To study the optimization of preparation process for improving the stability of Lomefloxacin Aspartate and Glucose Injection.Methods：To study the impact factors,and to screen the formulation process.Results：The optimal technology was without adding sodium bisulfate,before adding the main drug,0.1% activated carbon was used for adsorption,105 ℃ moist heat sterilization for 30 min,rapid cooling to below 50 ℃ after sterilization.Conclusion：Optimized prescription process can significantly improve the stability of formulation.