论文部分内容阅读
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 compare the quality of ampicillin sodium in different production processes. Methods: Powder X - ray diffraction, scanning electron microscopy, infrared spectroscopy, related substances and other detection methods, while accelerating test, a comprehensive evaluation of different process products. Residual organic solvents in the product and solvent crystallization of the product 2-ethylhexanoic acid residues were detected. Results: The solvent crystallization process sample is crystalline powder, freeze-drying and spray-drying process sample is amorphous powder. The related substances of the solvent crystallization process sample are obviously lower, and the product stability is good. Conclusion: The research shows that the raw materials produced by the solvent crystallization process are the most stable and should be used to guide the enterprises to actively use the raw materials.