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Preparation process of cefuroxime sodium for injection

A cefuroxime sodium and preparation process technology, which is applied in the field of preparation process of cefuroxime sodium for injection, can solve problems such as improper operation, influence on drug quality and safety, easy residual solvent, etc., to promote precipitation and improve crystallization effect , the effect of reducing residual water

Active Publication Date: 2021-12-14
HAINAN HAILING CHEMIPHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are many kinds of solvents used in the preparation process of this method, and improper operation is likely to leave solvents, which affects the quality and safety of drugs.

Method used

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  • Preparation process of cefuroxime sodium for injection
  • Preparation process of cefuroxime sodium for injection
  • Preparation process of cefuroxime sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A preparation process of cefuroxime sodium for injection, comprising the following steps:

[0027] S1. Prepare phosphate buffered saline solution: mix disodium hydrogen phosphate solution and sodium dihydrogen phosphate solution, adjust the pH to 6.8, perform aseptic treatment, and prepare a phosphate buffer solution with a concentration of 0.2mol / L;

[0028] S2. Preparation of resin: crush starch to 350 mesh, dissolve starch with water, then add poly-N-isopropylacrylamide 1.5 times the weight of starch and 0.75 times N,N-methylenebisacrylamide, Control the temperature at 190°C and control the pressure at 0.55 MPa. After treatment for 40 minutes, return to the normal pressure level, filter, take the filter cake to granulate, soak the granules in the phosphate buffer solution of step S1 for 20 minutes, and dry to obtain the resin ;

[0029] S3. Decolorization: Add cefuroxime sodium to the phosphate buffered saline solution in step S1, stir until completely dissolved, ad...

Embodiment 2

[0032] A preparation process of cefuroxime sodium for injection, comprising the following steps:

[0033] S1. Prepare phosphate buffered saline solution: mix disodium hydrogen phosphate solution and sodium dihydrogen phosphate solution, adjust the pH to 7.0, perform aseptic treatment, and prepare a phosphate buffer solution with a concentration of 0.2mol / L;

[0034] S2. Preparation of resin: crush the starch to 200 mesh, dissolve the starch with water, then add poly-N-isopropylacrylamide 1.6 times the weight of the starch and 0.83 times the N, N-methylene bisacrylamide. Control the temperature at 195°C and control the pressure at 0.5 MPa. After treatment for 1 hour, return to the normal pressure level, filter, take the filter cake to granulate, soak the granules in phosphate buffer solution for 10 minutes, and dry to obtain the resin;

[0035] S3. Decolorization: Add cefuroxime sodium to the phosphate buffered saline solution in step S1, stir until completely dissolved, add ac...

Embodiment 3

[0038] A preparation process of cefuroxime sodium for injection, comprising the following steps:

[0039] S1. Prepare phosphate buffered saline solution: mix disodium hydrogen phosphate solution and sodium dihydrogen phosphate solution, adjust the pH to 6.5, perform aseptic treatment, and prepare a phosphate buffer solution with a concentration of 0.2mol / L;

[0040] S2. Preparation of resin: crush the starch to 400 mesh, dissolve the starch with water, then add 1.5 times the weight of starch poly-N-isopropylacrylamide and 0.7 times the weight of N,N-methylenebisacrylamide, Control the temperature at 185°C and control the pressure at 0.65MPa. After 0.5h of treatment, return to the normal pressure level, filter, take the filter cake to granulate, soak the granules in phosphate buffer solution for 30min, and dry to obtain the resin;

[0041] S3. Decolorization: Add cefuroxime sodium to the phosphate buffered saline solution in step S1, stir until completely dissolved, add activat...

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Abstract

The invention provides a preparation process of cefuroxime sodium for injection. The preparation process comprises the following steps: dissolving cefuroxime sodium in a phosphate buffer solution, conducting decolorizing with activated carbon, washing a filter cake with water to remove impurities in the cefuroxime sodium and prevent the cefuroxime sodium from being degraded in a decolorizing process, then adding seed crystals, resin and acetone into the cefuroxime sodium solution for crystal growing, and increasing the proportion of the acetone by utilizing the water absorption performance of the resin to absorb water in the solution in a crystallization process so as to improve the crystallization effect of the cefuroxime sodium, reduce residual water in the crystal form and improving the stability of the cefuroxime sodium for injection. According to the invention, pressurizing treatment is carried out once at set intervals, so when crystallization reaches a bottleneck, the water absorption of the resin and the solubility of the cefuroxime sodium can be changed, and the separation of cefuroxime sodium crystals is promoted.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation process of cefuroxime sodium for injection. Background technique [0002] Cefuroxime, a second-generation cephalosporin, inhibits cell division and growth by binding to penicillin-binding proteins (PBPs) on the bacterial cell membrane, and finally lyses and kills the bacteria. Cefuroxime has a broad-spectrum antibacterial effect and a wide range of applications. It can be used for respiratory infections caused by sensitive bacteria, ear, nose, throat infections, urinary tract infections, skin and soft tissue infections, bone and joint infections, gonorrhea, including sepsis and Meningeal and other infections. [0003] Injection (injection) refers to sterile solutions (including emulsions and suspensions) made of drugs for injection into the body, as well as sterile powders or concentrated solutions for making solutions or suspensions before use. [0004]...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/12C07D501/34
CPCC07D501/12C07D501/34
Inventor 路国荣
Owner HAINAN HAILING CHEMIPHARMA CORP
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