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

作　　者：龙宪军 仇萍 刘艳[2] 陈迪钊[2] 彭祖仁 杨雪纯 庞思远 LONG Xian-jun;QIU Ping;LIU Yan;CHEN Di-zhao;PENG Zu-ren;YANG Xue-chun;PANG Si-yuan(Hunan Zhenqin Pharmaceutical Group Co.,Ltd.,Hunan Huaihua 418005;College of Chemistry and Material Engineering,Huaihua University,Hunan Huaihua 418000,China)

机构地区：[1]湖南正清制药集团股份有限公司,湖南怀化418005 [2]怀化学院,湖南怀化418000

出　　处：《广州化工》2020年第16期72-73,90,共3页GuangZhou Chemical Industry

摘　　要：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.

关 键 词：门冬氨酸洛美沙星 正交设计 优化处方工艺 

分 类 号：R944.11[医药卫生—药剂学]