Preparation method of cefazolin sodium for injection

A technology of cefazolin sodium and cefazolin, which is applied in the field of sterile raw materials, can solve the problems of purity influence and high water content of cefazolin sodium, and achieve the effect of high purity

Inactive Publication Date: 2020-03-20
上海欣峰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In view of the above-mentioned shortcoming of prior art, the purpose of the present invention is to provide a kind of preparation method of ...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A preparation method of cefazolin sodium for injection, comprising the steps of:

[0026] Step 1. Add ethanol, cefazolin and sodium carbonate into the reaction vessel according to the molar ratio of 30:0.5:0.5, heat the reaction until the solution is clear, continue to stir and reflux for at least 20 minutes, control the pH at 5.8, cool down in a water bath to crystallize, filter, and wash with ethanol , to obtain cefazolin sodium;

[0027] Step 2. Add cefazolin sodium and purified water into the reaction vessel according to the molar ratio of 0.5:5, heat until completely dissolved, cool to 24°C (room temperature), put the reaction vessel in a constant magnetic field, and add the eluent dropwise Apply a constant magnetic field to obtain a cefazolin sodium solution; the intensity of the constant magnetic field is 0.5T, and the direction of the magnetic field is a horizontal direction; the eluent is a mixed solvent of methanol and formic acid in a volume ratio of 1:0.5, a...

Embodiment 2

[0031] A preparation method of cefazolin sodium for injection, comprising the steps of:

[0032] Step 1. Add ethanol, cefazolin and sodium acetate into the reaction vessel according to the molar ratio of 30:1.5:1.5, heat the reaction until the solution is clear, continue to stir and reflux for at least 20 minutes, control the pH at 7.0, cool down in a water bath to crystallize, filter, and wash with ethanol , to obtain cefazolin sodium;

[0033] Step 2: Add cefazolin sodium and purified water into the reaction vessel at a molar ratio of 1.5:20, heat until completely dissolved, cool to 25°C (room temperature), put the reaction vessel in a constant magnetic field, and add the eluent dropwise Finally, a constant magnetic field is applied to obtain a cefazolin sodium solution; the intensity of the constant magnetic field is 0.5-0.8T, and the direction of the magnetic field is a horizontal direction; The amount added is 3% of the volume of purified water;

[0034] Step 3, the cef...

Embodiment 3

[0037] A preparation method of cefazolin sodium for injection, comprising the steps of:

[0038] Step 1. Add ethanol, cefazolin and sodium bicarbonate into the reaction vessel according to the molar ratio of 30:1.0:1.0, heat the reaction until the solution is clear, continue to stir and reflux for at least 20 minutes, control the pH at 5.0-9.0, and cool down in a water bath to crystallize. Filter and wash with ethanol to obtain cefazolin sodium;

[0039]Step 2: Add cefazolin sodium and purified water into the reaction vessel at a molar ratio of 1:20, heat until completely dissolved, cool to 24°C (room temperature), put the reaction vessel in a constant magnetic field, and add the eluent dropwise Finally, a constant magnetic field is applied to obtain a cefazolin sodium solution; the intensity of the constant magnetic field is 0.6T, and the direction of the magnetic field is a horizontal direction; the dissolution agent is a mixed solvent in which methanol and formic acid are m...

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PUM

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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...

Claims

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Application Information

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IPC IPC(8): C07D501/36C07D501/04C07D501/12
CPCC07D501/04C07D501/12C07D501/36
Inventor 范海峰李文献吴王平卢平平
Owner 上海欣峰制药有限公司
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