Technology for preparing cefuroxime sodium for injection

A technology for the preparation of cefuroxime sodium and its preparation technology, which is applied in the field of preparation technology of cefuroxime sodium for injection, can solve the problems of degradation products, inclusions, unclearness, etc., and achieve the effect of good stability and less impurities

Inactive Publication Date: 2017-01-04
南昌立健药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The stability of cefuroxime sodium is relatively poor, and it is unstable to heat, acidic environment, and alkaline environment. It is manifested in problems such as easy discoloration of appearance, lower content, and occurrence of degradation products. The reason for the occurrence may be that some impurities, Residual solvents in the crystal form, etc., due to t

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A preparation process of cefuroxime sodium for injection, the steps are as follows:

[0028] 1) Use ethanol to dissolve sodium acetate into a sodium acetate solution for later use, wherein the mass ratio of ethanol to sodium acetate is 10:1;

[0029] 2) Add ethanol and water into the reaction tank, add cefuroxime acid under nitrogen protection, and stir until completely dissolved to obtain a cefuroxime acid solution, wherein the mass ratio of ethanol to water is 7:1, and the cefuroxime acid solution The concentration is 0.5g / mL;

[0030] 3) Add activated carbon to the cefuroxime acid solution for decolorization, stir and mix for 40 minutes, filter, add the filtrate to the crystallization tank, wash the filter residue and filter bottle with ethanol and water to obtain the washing liquid, and add the washing filtrate obtained by filtering the washing liquid into into the crystallization tank;

[0031] 4) Control the temperature of the crystallization tank at 14°C, the s...

Embodiment 2

[0038] A preparation process of cefuroxime sodium for injection, the steps are as follows:

[0039] 1) Use ethanol to dissolve sodium acetate into a sodium acetate solution for later use, wherein the mass ratio of ethanol to sodium acetate is 11:1;

[0040] 2) Add ethanol and water into the reaction tank, add cefuroxime acid under nitrogen protection, and stir until completely dissolved to obtain a cefuroxime acid solution, wherein the mass ratio of ethanol to water is 8:1, and the cefuroxime acid solution The concentration is 0.4g / mL;

[0041] 3) Add activated carbon to the cefuroxime acid solution for decolorization, stir and mix for 42 minutes, filter, add the filtrate to the crystallization tank, wash the filter residue and filter bottle with ethanol and water to obtain the washing liquid, and add the washing filtrate obtained by filtering the washing liquid into into the crystallization tank;

[0042] 4) Control the temperature of the crystallization tank at 15°C, the s...

Embodiment 3

[0049] A preparation process of cefuroxime sodium for injection, the steps are as follows:

[0050] 1) Use ethanol to dissolve sodium acetate into a sodium acetate solution for later use, wherein the mass ratio of ethanol to sodium acetate is 11:1;

[0051] 2) Add ethanol and water into the reaction tank, add cefuroxime acid under nitrogen protection, and stir until completely dissolved to obtain a cefuroxime acid solution, wherein the mass ratio of ethanol to water is 8:1, and the cefuroxime acid solution The concentration is 0.5g / mL;

[0052] 3) Add activated carbon to the cefuroxime acid solution for decolorization, stir and mix for 45 minutes, filter, add the filtrate to the crystallization tank, wash the filter residue and filter bottle with ethanol and water to obtain the washing liquid, and add the washing filtrate obtained by filtering the washing liquid into into the crystallization tank;

[0053] 4) Control the temperature of the crystallization tank at 15°C, the s...

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PUM

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Abstract

The invention discloses a technology for preparing cefuroxime sodium for injection. The technology includes the steps that a sodium acetate solution is dropwise added into a cefuroxime acid solution, and a cefuroxime sodium crude product is prepared with the crystallization technology; then the cefuroxime sodium crude product is extracted with the supercritical fluid extraction technology, recrystallization is carried out with the crystallization technology, and the cefuroxime sodium for injection is finally obtained. The cefuroxime sodium prepared with the technology is small in impurity number and good in stability, the problems that existing cefuroxime sodium is large in impurity number, deep in color, poor in stability and the like are solved, and the requirements for an injection can be completely met.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a preparation process of cefuroxime sodium for injection. Background technique [0002] Cefuroxime sodium is white, off-white or light yellow powder or crystalline powder; odorless, bitter taste; hygroscopic. This product is easily soluble in water, slightly soluble in methanol, insoluble in ethanol or chloroform, in the solution containing 10mg per 1ml, the specific rotation is +55° to +65°; it is determined by spectrophotometry at 274nm The absorbance is measured at the wavelength of , and the absorption coefficient (Elcml%) is 390-425. [0003] Cefuroxime sodium is a second-generation cephalosporin with broad antibacterial spectrum and strong antibacterial activity. It has good antibacterial activity against Gram-positive microorganisms and Gram-negative microorganisms, and is highly stable against β-lactamase. And the side effect is small, and its mechanism of action is to combine w...

Claims

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Application Information

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IPC IPC(8): C07D501/34C07D501/12C07D501/04
CPCC07B2200/13C07D501/04C07D501/12C07D501/34Y02P20/54
Inventor 郑玲英
Owner 南昌立健药业有限公司
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