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Cefuroxime lysine medicinal composition

A cefuroxime lysine and composition technology, applied in the field of cefuroxime lysine, can solve the problem of less than 99% purity, and achieve the effects of no solvent residue, improved stability, and improved curative effect

Active Publication Date: 2013-06-12
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After adding sodium bicarbonate to form a salt, use dichloromethane, ethyl acetate and tetrahydrofuran ternary compound extractant to remove the by-reaction product lactone and other unsaponifiable impurities in the reaction solution. After layering, add hydrochloric acid to the aqueous phase to acidify , plus a ternary compound extractant to extract and separate cefuroxime acid, remove water-soluble impurities, and the organic phase is crystallized after distillation, filtered, and dried to obtain cefuroxime acid, but its purity is still less than 99%.

Method used

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  • Cefuroxime lysine medicinal composition
  • Cefuroxime lysine medicinal composition
  • Cefuroxime lysine medicinal composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] (1) Add cefuroxime lysine solid to 100ml of distilled water at 25°C to prepare a saturated solution of cefuroxime lysine solid;

[0043] (2) In a sound field with a frequency of 25KHz and an output power of 30W, add a mixed solution of absolute ethanol and ethyl acetate at 0°C and stir while adding at a stirring speed of 600 rpm; absolute ethanol and ethyl acetate The volume ratio of the ester is 1:0.2, the volume of absolute ethanol and ethyl acetate is 200ml, and the adding speed is v=3.33ml / min;

[0044] (3) Remove the sound field after adding the mixed solvent, and let the crystal grow at 5°C for 5 hours;

[0045] (4) Filtrate, wash the filter cake with ethanol, and dry in vacuum for 3 hours to obtain cefuroxime lysine crystals.

[0046] The prepared cefuroxime lysine crystal obtained by Cu-Kα ray measurement X-ray powder diffraction pattern is as follows figure 1 Shown; The main particle size is 350-600 μm and the distribution width is 250-800 μm through scanning...

Embodiment 2

[0048] (1) Add cefuroxime lysine solid to 600ml of distilled water at 30°C to prepare a saturated solution of cefuroxime lysine solid;

[0049] (2) In a sound field with a frequency of 30KHz and an output power of 40W, add a mixed solution of absolute ethanol and ethyl acetate at 1°C, stir while adding, and the stirring speed is 150 rpm; absolute ethanol and ethyl acetate The volume ratio of the ester is 1:0.1, the volume of absolute ethanol and ethyl acetate is 2400ml, and the adding speed is 5ml / min;

[0050] (3) Remove the sound field after adding the mixed solvent, and let the crystal grow at 15°C for 5 hours;

[0051] (4) Filtrate, wash the filter cake with ethanol, and dry in vacuum for 6 hours to obtain cefuroxime lysine crystals.

[0052] The prepared cefuroxime lysine crystal obtained by Cu-Kα ray measurement X-ray powder diffraction pattern is as follows figure 1 Shown; The main particle size is 350-600 μm and the distribution width is 250-800 μm through scanning e...

Embodiment 3

[0054] (1) Add cefuroxime lysine solid to 300ml of distilled water at 45°C to prepare a saturated solution of cefuroxime lysine solid;

[0055] (2) In a sound field with a frequency of 30KHz and an output power of 30W, add a mixed solution of absolute ethanol and ethyl acetate at 1°C, stir while adding, and the stirring speed is 120 rpm; absolute ethanol and ethyl acetate The volume ratio of the ester is 1:0.2, the volume of absolute ethanol and ethyl acetate is 900ml, and the adding speed is 2ml / min;

[0056] (5) Remove the sound field after adding the mixed solvent, and let the crystal grow at 8°C for 5 hours;

[0057] (6) Filtrate, wash the filter cake with ethanol, and dry in vacuum for 6 hours to obtain cefuroxime lysine crystals.

[0058] The prepared cefuroxime lysine crystal obtained by Cu-Kα ray measurement X-ray powder diffraction pattern is as follows figure 1 Shown; The main particle size is 350-600 μm and the distribution width is 250-800 μm through scanning ele...

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Abstract

The invention relates to cefuroxime lysine, and particularly relates to a cefuroxime lysine medicinal composition. The cefuroxime lysine medicinal composition comprises cefuroxime lysine and sodium chloride serving as active ingredients in a weight ratio of 10: (0.1-2), and at least one of mannitol, sorbitol, sodium bisulfite and sodium metabisulfite can be added to the active ingredients. The cefuroxime lysine medicinal composition has the advantages of low impurity content, good stability and high flowability and is very suitable for clinical application.

Description

technical field [0001] The invention relates to cefuroxime lysine, in particular to a pharmaceutical composition of cefuroxime lysine. Background technique [0002] There is cefuroxime lysine, molecular formula: C 16 h 16 N 4 o 8 S·C 6 h 14 N 2 o 2 ; Chemical name: L-2,6-diaminocaproic acid (6R, 7R)-7-[2-furyl (methoxyimino) acetamido]-3-carbamoyloxymethyl-8-oxo The chemical structural formula of -5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate is shown in formula (I): [0003] [0004] Cefuroxime lysine is a salt formed by the combination of cefuroxime acid and lysine, which is ionized in water to form cefuroxime. Cefuroxime is a bactericidal cephalosporin antibiotic that is resistant to most β-lactamases and is effective against a variety of Gram-positive and Gram-negative bacteria. Cefuroxime sodium is a semi-synthetic second-generation cephalosporin, which has a good broad-spectrum antibacterial effect. Its mechanism of action is to inhibit cell division a...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61P31/04C07D501/34C07D501/12
Inventor 王平张泽众廉同陈磊
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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