注射用氨苄西林钠质量研究

目的: 对不同生产工艺氨苄西林钠的质量进行对比研究。 方法: 采用粉末X-射线衍射、电镜扫描、红外光谱、有关物质等检测方法, 同时进行加速试验, 综合评价不同工艺产品。对产品中有机溶剂残留量和溶媒结晶工艺产品的2-乙基己酸残留进行检测。 结果: 溶媒结晶工艺样品为结晶型粉末, 冷冻干燥和喷雾干燥工艺样品为无定型粉末。溶媒结晶工艺样品的有关物质明显较低, 且产品稳定性好。 结论: 研究表明溶媒结晶工艺生产的原料最为稳定, 应当引导企业主动使用该原料。

Objective: To study the quality of different process for production of ampicillin sodium. Methods: By using powder X-ray diffraction,scanning electron microscope,infrared spectroscopy,related substances determination,accelerated samples were analyzed.The residual solvents of ampicillin sodium and 2-ethylhexanoic acid of crystalline samples were determined. Results: Solvent crystallinzation process samples are crystalline powder,freeze drying and spray drying process products were amorphous powder.Related substances of solvent crystallinzation process samples were much lower and the production was more stable. Conclusion: Studies have shown that the raw materials of solvent crystallinzation process of production is the most stable and should be used by guiding the enterprises.