中性磷霉素钠生产工艺探讨

Discussion on the production process for neutral fosfomycin sodium

研究一种新的、高效价的中性磷霉素钠生产方法。方法:磷霉素钠在生产过程中,左盐游离分层后加入柠檬酸或乙酸等有机酸,生成中性磷霉素钠的水溶液,再用无水乙醇结晶,过滤、干燥,得磷霉素一钠与二钠混合的中性磷霉素钠。结果:加入乙酸后生成的中性磷霉素钠效价每1 mg超过740磷霉素单位。结论:本次研究的中性磷霉素钠的生产方法,工艺简单,操作方便,减小了质量控制的难度,降低了生产成本,提高效价,使产品质量得到了进一步提高,增强了企业的竞争力。

This paper introduce a new, high effective preparation method of neutral fosfomycin sodium. Methods：The free fosfomycin phenythylamine layered in the production process, adding organic acids such as citric acid or acetic acid, to generate aqueous solution of neutral fosfomycin sodium, and then crystallized with the ethanol, filtrated, dried, generated neutral mono-and di-sodium salts of fostomycin mixed. Results： The titer of neutral fosfomycin produced by adding acetic acid is 740 unit/mg above. Conclusion： The production process of neutral fosfomycin sodium is simple, easy to operate, reduces the difficulty of quality control, reduce production costs, improve titcr, so that product quality has been further improved and enhanced competitiveness of enterprises.