Response surface methodology to optimize the green synthesis process of cefotaxime sodium: Collaborative improvement...

Based on the response surface method combined with the concept of green chemistry, the synthesis process of cefotaxime sodium (CTX) was optimized, taking into account product yield, quality and environmental benefits, and providing a scientific basis for its industrial production.

Taking the yield of CTX as the response value, based on single-factor experiments, the Box-Behnken response surface method was used, and the reaction temperature, eluent dosage and salt-forming agent ratio were selected as influencing factors to construct a process optimization model and screen the optimal conditions. The related substances of the optimized product were determined by high-performance liquid chromatography (HPLC), and the crystal form and morphological characteristics of the product were characterized using X-ray powder diffraction (XRD) and scanning electron microscopy (SEM). At the same time, green chemistry evaluation software was used to evaluate the environmental performance of the process.

The response surface regression analysis showed that the optimal process conditions were: reaction temperature 14.8°C, eluent dosage 104.4 mL, and salt-forming agent ratio 1:1. Under these conditions, the yield of CTX was stably achieved at 93.66%; HPLC analysis results showed that the total impurity content of the product was only 3.93%, and the active ingredient content reached 96.07%; XRD and SEM characterization confirmed that the optimized product had a regular crystal form and good crystalline integrity; the green chemistry evaluation score was 94.44, indicating that the process has excellent environmental performance.

The synthesis process of CTX optimized by response surface methodology can not only achieve stable and high product yield, but also ensure product quality that meets stringent control criteria. It also has excellent environmental performance and safety, integrating production efficiency, quality control and green development needs, and has significant industrial application value and promotion prospects.