Study On The Crystallization Process Of Cefmetazole Sodium

Cefmetazole sodium,with broad spectrum,high efficiency,low toxicity and other effects,is the second generation semi-synthetic cefiboxin antibacterial drug and have a good antibacterial effect on gram-positive,negative bacteria and anaerobic bacteria,staphylococcus aureus,klebsiella pneumoniae and hemolytic streptococcus.At present,compared with foreign similar products,domestic cefmetazole sodium products have some quality issues such as low purity,small size,uneven distribution of particle size.In addition,the current production and refining process of cefmetazole sodium in the current situation,cefmetazole sodium in the crystallization process is likely to appear into the oil,coalescence and other phenomena,the crystallization process is very unstable.These problems are mainly due to the crystallization process.In this context,in order to improve the quality of cefmetazole sodium products,the crystallization of cefmetazole sodium in this paper systematically was studied.The solubility of cefmetazole sodium and cefmetazole in pure solvent and mixed solvent was determined by gravimetric method and UV ultraviolet method respectively.The solubility data were fitted using the modified Apelblat equation,the CNIBS / R-K model and the Jouyban-Acree model thermodynamic equation.With the surface electrostatic potential theory(MSEP),the dissolution phenomenon is given a reasonable explanation.In this paper,we determined the phase diagram of cefmetazole sodium in ethanol and water mixed solvent,and carried out a series of on-line studies on the thermodynamic properties of cefmetazole sodium during the oil crystallization process,and gave a reasonable explanation of the oil analysis mechanism.By examining the effect of the reaction crystallization and the antivolvent crystallization of the product on crystallinity and yield of the product,it was determined that the antivolvent crystallization was used as the process to be optimized.Through the comprehensive study of the concentration of the solution,temperature,stirring and other operating parameters on the product performance and process indicators,the antivolvent crystallization was determined.The above systematic study on the crystallization process of cefmetazole sodium has not been reported in domestic and foreign patents and other related literatures.