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A kind of preparation technology of cefuroxime sodium for injection

A technique for preparing cefuroxime sodium and its preparation process, which is applied in the field of preparation process of cefuroxime sodium for injection, can solve problems such as easy residual solvent, improper operation, and influence on drug quality and safety, and achieve reduction of residual water and promotion of precipitation , Improve the crystallization effect

Active Publication Date: 2022-07-19
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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  • A kind of preparation technology of cefuroxime sodium for injection
  • A kind of preparation technology of cefuroxime sodium for injection
  • A kind of preparation technology 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. Preparation of phosphate buffered saline solution: mix disodium hydrogen phosphate solution and sodium dihydrogen phosphate solution, adjust the pH to 6.8, aseptically process, and prepare a phosphate buffer solution with a concentration of 0.2 mol / L;

[0028] S2. Preparation of resin: pulverize the starch to 350 mesh, dissolve the starch with water, then add poly-N-isopropylacrylphthalamide and 0.75 times the weight of starch by adding poly-N-isopropylacrylphthalamide and 0.75 times the weight of the starch. The temperature is controlled at 190°C, the pressure is controlled at 0.55MPa, and after 40min of treatment, it is returned to the normal pressure level, filtered, and the filter cake is granulated. ;

[0029] S3. Decolorization: add cefuroxime sodium to the phosphate buffered saline solution of step S1, stir until completely dissolved, add activated carbon 10 ti...

Embodiment 2

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

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

[0034] S2. Preparation of resin: pulverize the starch to 200 mesh, dissolve the starch with water, then add poly-N-isopropylacrylphthalamide and 0.83 times the weight of starch by adding poly-N-isopropylacrylphthalamide and 0.83 times the weight of the starch. The temperature is controlled at 195°C, and the pressure is controlled at 0.5MPa. After treatment for 1 hour, it is restored to the normal pressure level, filtered, and the filter cake is granulated. After soaking the granules in a phosphate buffer solution for 10 minutes, drying is performed to obtain the resin;

[0035] S3. Decolorization: add cefuroxime sodium ...

Embodiment 3

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

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

[0040] S2. Preparation of resin: pulverize the starch to 400 mesh, dissolve the starch with water, then add poly-N-isopropylacrylphthalamide and 0.7 times the weight of the starch by adding poly-N-isopropylacrylphthalamide and 0.7 times the weight of the starch. The temperature is controlled at 185°C, and the pressure is controlled at 0.65MPa. After treatment for 0.5h, return to the normal pressure level, filter, take the filter cake and granulate, soak the particles in phosphate buffer solution for 30min, and then dry to obtain the resin;

[0041] S3. Decolorization: add cefuroxime sodium to the phosphate buffered sali...

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Abstract

The invention provides a preparation process of cefuroxime sodium for injection. The cefuroxime sodium is dissolved in a phosphate buffer solution, activated carbon is used for decolorization, and the filter cake is washed with water to remove impurities in the cefuroxime sodium and prevent cefuroxime During the decolorization process, the sodium fluorescein degrades, and then the crystal seed, resin and acetone are added to the cefuroxime sodium solution for crystal growth, and the water absorption property of the resin is used to absorb the water in the solution during the crystallization process, increasing the proportion of acetone, and then Improve the crystallization effect of cefuroxime sodium, reduce the residual water in the crystal form, improve the stability of cefuroxime sodium for injection, and carry out pressure treatment at regular intervals, which can change the water absorption and absorption of the resin when the crystallization reaches the bottleneck. The solubility of cefuroxime sodium promotes the precipitation of cefuroxime sodium crystals.

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, binds to penicillin-binding proteins (PBPs) on bacterial cell membranes, inhibits cell division and growth, and finally dissolves and kills bacteria. Cefuroxime has a broad-spectrum antibacterial effect and is suitable for a wide range of applications. It can be used for respiratory tract infections, ear, nose and throat infections, urinary tract infections, skin and soft tissue infections, bone and joint infections, gonorrhea, including sepsis and Meninges and other infections. [0003] Injection refers to sterile solutions (including emulsions and suspensions) prepared from drugs for injection into the body, as well as sterile powders or concentrated solutions for preparation of solutions or suspensions before use. [0004] Cefuroxim...

Claims

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Application Information

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