Preparation method of cefazolin sodium for injection

Abstract

The invention relates to the technical field of aseptic bulk drugs, particularly to a preparation method of cefazolin sodium for injection. The preparation method comprises the following steps: mixingethanol, cefazolin and a sodium salt according to a molar ratio of 30:(0.1-2.0):(0.1-2.0), adding into a reaction container, heating, carrying out stirring reflux, controlling the pH value at 5.0-9.0, carrying out cooling crystallizing in a water bath, adding cefazolin sodium and purified water into the reaction container according to a molar ratio of 1:(10-20), carrying out heating dissolving, adding a solventing-out agent in a dropwise manner, applying a constant magnetic field, performing microporous sterile filtration on the cefazolin sodium solution in a sterile area, and performing freeze drying, crushing and sterile packaging in the sterile area so as to obtain the cefazolin sodium for injection. According to the invention, the method can solve the problems of high water content and easy influence on the purity of cefazolin sodium in the prior art; and through cefazolin sodium water bath crystallization and magnetic field directional arrangement, the prepared cefazolin sodium for injection is low in moisture content and has the significantly improved hygroscopicity.

Description

technical field

[0001] The invention relates to the technical field of sterile raw materials, in particular to a preparation method of cefazolin sodium for injection. Background technique

[0002] The chemical name of cefazolin sodium is (6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-7-[(1H- Tetrazol-1-yl)acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.o]oct-2-ene-2-carboxylic acid sodium salt.

[0003] Cefazolin Sodium for Injection is white or off-white powder or crystalline powder, odorless. Before use, add an appropriate amount of sterile water for injection to dissolve. Intramuscular or intravenous injection. Allergic to penicillin, liver, renal insufficiency patients with caution. It is suitable for the treatment of otitis media, bronchitis, pneumonia and other respiratory infections caused by sensitive bacteria, urinary tract infections, skin and soft tissue infections, bone and joint infections, sepsis, infective endocarditis, hepatobiliary system infections a...