注射用哌拉西林钠质量评价

目的: 对不同生产工艺哌拉西林钠的质量进行对比研究及评价。 方法: 运用水分、水活度、酸度、有关物质等方法测定不同工艺产品,同时进行加速试验,并将测定结果进行多因素相关分析,综合评价不同工艺产品的质量。 结果: 冷冻干燥样品的水分、水活度、有关物质测定结果明显低于喷雾干燥样品,pH高于喷雾干燥样品,且产品的稳定性较喷雾干燥样品好。结果表明,水分与产品质量密切相关。 结论: 控制水分是保证本品质量的关键环节;应对现行标准部分项目控制指标予以修改;研究表明冷冻干燥工艺生产的原料质量较好,且不易受环境因素的影响,应当引导企业主动使用该原料。

Objective: To study and assessment the quality of different process for production of piperacillin sodium. Methods: By using water,water activity,pH,the related substances determination,the samples and accelerated samples were analyzed.Evaluate the quality status of piperacillin sodium for injection by multi-factors correlation analysis of the determination results. Results: Water,water activity and the related substances of freeze drying process products were much lower than spray drying process products,and the pH was higher.The production of freeze drying process was more stable.Water was concerned with the quality of piperacillin sodium. Conclusion: Control the water of piperacillin sodium is very important.The limits of water and the related substances should be adjusted.Studies have shown that the raw materials of freeze drying process of production is better and should guide enterprises to use the raw materials.