Preparation process of cefotaxime sodium for injection

A preparation technology of cefotaxime sodium, which is applied in the field of medicine and chemical industry, can solve the problems of low product purity, impurities, and poor stability, and achieve uniform crystal particle size, reduce degradation or side reactions, and improve stability.

Pending Publication Date: 2022-01-04
HAINAN HAILING CHEMIPHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the production and preparation process of cefotaxime sodium for injection, due to the high acid-base and stability sensitivity of cefotaxime sodium itself, it is easy to occur in the preparation process of cefotaxime sodium for injection to different degrees of degradation or side reactions , leading to the generation of impurities, low purity and poor stability of the product, etc.

Method used

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  • Preparation process of cefotaxime sodium for injection
  • Preparation process of cefotaxime sodium for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0029] A preparation process of cefotaxime sodium for injection, comprising the following steps:

[0030] S1. Preparation of mixed solvent: take ethanol and n-propanol and mix them at a volume ratio of 7:1 to obtain a composite organic solvent, and add water to make a mixed solvent with an organic solvent volume fraction of 50% for later use;

[0031] S2. Under the condition of controlling the temperature at 25° C., according to the solid-liquid ratio of 50 mg / mL, sodium acetate is added to the mixed solvent prepared in step 1 to mix and dissolve to obtain a sodium acetate solution;

[0032] S3, under the stirring state of 110r / min, add cefotaxime acid step by step to the sodium acetate solution in a mass ratio of 0.3:1, the first addition of cefotaxime acid is 1 / 5 of the prescription amount of cefotaxime acid, Then add 1 / 10 of the prescription amount of cefotaxime acid in equal increments each time, with an interval of 100 seconds, keep stirring at a constant temperature of 4...

Embodiment 2

[0037] A preparation process of cefotaxime sodium for injection, comprising the following steps:

[0038] S1. Preparation of mixed solvent: take ethanol and n-propanol and mix them in a volume ratio of 7:2 to obtain a composite organic solvent, and add water to make a mixed solvent with an organic solvent volume fraction of 70% for later use;

[0039] S2. Under the condition of controlling the temperature at 35° C., according to the solid-liquid ratio of 80 mg / mL, sodium acetate is added to the mixed solvent prepared in step 1 to mix and dissolve to obtain a sodium acetate solution;

[0040] S3, under the stirring state of 130r / min, add cefotaxime acid step by step to the sodium acetate solution in a mass ratio of 0.4:1, the first addition of cefotaxime acid is 1 / 5 of the prescription amount of cefotaxime acid, Then add 1 / 15 of the prescription amount of cefotaxime acid in equal increments each time, with an interval of 120 seconds, keep stirring at a constant temperature of 5...

Embodiment 3

[0045]A preparation process of cefotaxime sodium for injection, comprising the following steps:

[0046] S1. Preparation of mixed solvent: take ethanol and n-propanol and mix them in a volume ratio of 7:2 to obtain a composite organic solvent, and add water to make a mixed solvent with an organic solvent volume fraction of 55% for later use;

[0047] S2. Under the condition of controlling the temperature at 30° C., according to the solid-liquid ratio of 65 mg / mL, sodium acetate is added to the mixed solvent prepared in step 1 to mix and dissolve to obtain a sodium acetate solution;

[0048] S3, under the stirring state of 120r / min, add cefotaxime acid step by step to the sodium acetate solution in a mass ratio of 0.35:1, the first addition of cefotaxime acid is 1 / 5 of the prescription amount of cefotaxime acid, Then add 1 / 10 of the prescription amount of cefotaxime acid each time in an equal increment manner, with an interval of 120 seconds, and keep stirring at a constant tem...

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Abstract

The invention relates to a preparation process of cefotaxime sodium for injection, which comprises the following steps of: S1, mixing ethanol and n-propanol according to a volume ratio of 7:2, and adding water to prepare a mixed solvent; S2, at 25-35 DEG C, adding sodium acetate into the mixed solvent according to a solid-liquid ratio of 50-80 mg / mL to obtain a sodium acetate solution; S3, adding cefotaxime acid into the sodium acetate solution according to the mass ratio of 1:(0.3-0.4), and performing stirring for reaction at constant temperature to obtain a solution containing cefotaxime sodium; S4, performing filtering and purifying; and S5, adding a sterile cefotaxime sodium seed crystal, dropwise adding ethyl alcohol while stirring, after dropwise adding is completed, stopping stirring, growing crystal, performing suction filtration and freeze drying to obtain freeze-dried powder of cefotaxime sodium, and performing bottling and sealing to obtain the cefotaxime sodium for injection. The cefotaxime sodium for injection prepared through the method in the invention has the advantages that: the agglomeration phenomenon of precipitation is fully reduced; the precipitation rate of cefotaxime sodium is controlled; the degradation or side reaction of the cefotaxime sodium in the precipitation process is reduced; and the yield and the purity are improved.

Description

technical field [0001] The invention relates to the technical field of medicine and chemical industry, in particular to a preparation process of cefotaxime sodium for injection. Background technique [0002] Fotaxime is a third-generation semi-synthetic cephalosporin with a broad antibacterial spectrum and is effective against Gram-negative bacteria such as Escherichia coli, Klebsiella, Citrobacter, and Salmonella. Strong activity. Because cefotaxime is a derivative of cephalosporanic acid, its free acid is insoluble in water, therefore, it is often clinically used in the form of injection of cefotaxime sodium salt for pneumonia, respiratory tract infection, urinary tract infection, Meningitis, skin and soft tissue infections, bone and joint infections, etc. [0003] In order to improve the efficacy and safety of drugs, it is usually necessary to strictly control the drug safety of the prescription design and the drug quality and safety of the production process. In the p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/546A61P31/04C07D501/04C07D501/12C07D501/34
CPCA61K31/546A61K9/19A61K9/0019A61P31/04C07D501/04C07D501/12C07D501/34
Inventor 陈兴禹
Owner HAINAN HAILING CHEMIPHARMA CORP
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