门冬氨酸洛美沙星葡萄糖注射液处方工艺优化

Guangzhou Chemical Industry(2020)

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Abstract
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.
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