Preparation method and product of ceftriaxone sodium sterile powder

Abstract

The invention discloses a preparation method of ceftriaxone sodium sterile powder, and belongs to the technical field of medicine. The method comprises the following steps of mixing methylene dichloride and alcohol; lowering the temperature; sequentially adding antioxidizers, 7-ACT and AE-active esters; dissolving the materials to obtain a mixed solution; dripping triethylamine into the mixed solution within 1h for reaction; performing extraction after the reaction is completed; after the pressure reduction suction filtration on a water phase, adding a salt forming agent for reaction and salt forming; after a decoloring agent is added into a salt forming reaction solution, performing sterile filtration; adding a solvating agent into filter liquid for crystallization; performing post-treatment to obtain the ceftriaxone sodium sterile powder. The preparation method has the advantages that the operation is simple; the reaction conditions are mild; the control is easy; the ceftriaxone sodium sterile powder is prepared in one step; the refining process is omitted; the production period is shortened; the cost is greatly reduced; the quality yield reaches 165 percent or higher; the product purity can reach 99.5 percent or higher.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method and product of ceftriaxone sodium sterile powder. Background technique [0002] Ceftriaxone sodium (Ceftriaxone sodium), the chemical name is {6R[6α,7β(2)]}-3-{[1,2,5,6-tetrahydro-2-methyl-5,6-dioxide -1,2,4-Triazin-3-yl)thio]methyl}-7-{[(2-amino-4-thioxime)(methylimino)acetyl]amino}-β- Oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid disodium salt triple hemihydrate is the third-generation cephalosporin widely used in clinical practice Compared with other cephalosporins, ceftriaxone sodium has the following significant advantages: 1) The bactericidal effect mainly inhibits the synthesis of bacterial cell walls, and human cells do not have cell walls, so they are less affected, so the relative toxicity is relatively low; 2) Long half-life, one-time administration The drug can play an antibacterial effect within 24 hours; 3) It has a br...

AI Technical Summary

Problems solved by technology

And mostly use dichloromethane as solvent in production, sodium acetate is salt-forming agent, crystallizes with acetone, but the crystal form of ceftriaxone sodium product produced under this condition is relatively poor, is unfavorable for washing and separating, and quality is relatively poor, also needs further refined

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