门冬氨酸洛美沙星葡萄糖注射液处方工艺优化

Formulation Process Optimization of Lomefloxacin Aspartate Glucose Injection

为优化制备工艺,提高注射液的稳定性,采用正交设计法筛选门冬氨酸洛美沙星葡萄糖注射液制剂处方工艺。以门冬氨酸洛美沙星的含量和有关物质为考察指标,针对可能影响产品稳定性的因素开展实验研究。研究发现,最佳处方工艺是后加0.1%活性炭,以0.01%亚硫酸氢钠为稳定剂,采用115℃、灭菌30 min,并且灭菌后快速冷却至70℃以下。结果表明,优化后的处方工艺可明显提高制剂的稳定性。

To optimize the preparation process and improve the stability of lomefloxacin aspartate glucose injection,orthogonal design was used to screen the formulation process.The content and related substances of lomefloxacin aspartate were used as indexes to study the factors that might affect the stability of the products.The optimal formulation was 0.1%activated carbon followed added,0.01%sodium bisulfite as stabilizer,and sterilization at 115℃for 30 minutes,then rapid-cooling to below 70℃.The results indicated that optimized formulation process can obviously improve the stability of the preparation.