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Cefodizime sodium composition and powder injection

A technology of cefidiazine and composition, which is applied in the field of medicine and can solve problems such as the difference in dissolution rate and bioavailability of preparations

Active Publication Date: 2010-09-15
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, among the polymorphic forms of cimetidine, type A has the best curative effect, because the dissolution difference of different crystal forms causes differences in the dissolution rate and bioavailability of the preparation.

Method used

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  • Cefodizime sodium composition and powder injection
  • Cefodizime sodium composition and powder injection
  • Cefodizime sodium composition and powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: the preparation of cefodizime sodium crystal

[0029] Dissolve the solid cefodizime sodium in distilled water, control the pH value of the solution to 6.6-7.2, and add a mixed solvent of anhydrous isopropanol, anhydrous ethanol and anhydrous diethyl ether at 15°C at a rate of 6ml / minute; the volume ratio of anhydrous isopropanol, absolute ethanol and anhydrous ether is 1:1.25:0.5, and the stirring speed is 100 rpm; after the mixed solvent is added, the temperature is lowered to 4°C; after crystals are obtained, continue to stir for 2 hours , stirring at a speed of 65 rpm; filtering, washing the filter cake with ethanol for 2 to 3 times, and vacuum drying for 2 hours to obtain cefodizime sodium crystals.

[0030] The X-ray powder diffraction pattern obtained by measuring Cu-Kα rays of the crystal is as follows: figure 1 shown.

Embodiment 2

[0031] Embodiment 2: the preparation of cefodizime sodium crystal

[0032] Dissolve the solid cefodizime sodium in distilled water, control the pH value of the solution to 6.6-7.2, and add a mixed solvent of water isopropanol, absolute ethanol and anhydrous ether under the condition of 20°C, and the dropping rate is 8ml / min; anhydrous The volume ratio of isopropanol, absolute ethanol and anhydrous ether is 1: 1.75: 0.75, and the stirring speed is 120 rpm; after the mixed solvent is added, the temperature is lowered to 10°C, and stirring is continued for 4 hours after the crystal is obtained, and the stirring speed is 75 RPM; filter, wash the filter cake with ethanol, and vacuum-dry for 4 hours to obtain cefodizime sodium crystals. Show through powder XRD detector analysis, with attached figure 1 The results shown match.

Embodiment 3

[0033] Embodiment 3: the preparation of cefodizime sodium crystal

[0034] Dissolve the solid cefodizime sodium in distilled water, control the pH value of the solution to 6.6-7.2, add dropwise a mixed solvent of water isopropanol, absolute ethanol and anhydrous ether at 15°C, and the dropping speed is 7ml / min The volume ratio of anhydrous isopropanol, absolute ethanol and anhydrous ether is 1: 1.5: 0.7, and the stirring speed is 110 rpm; after the mixed solvent is added, the temperature is lowered to 10 ° C, and the crystal is obtained and then stirred for 3 hours. The stirring speed was 70 rpm; filtered, the filter cake was washed with ethanol, and vacuum-dried for 3 hours to obtain cefodizime sodium crystals. Show through powder XRD detector analysis, with attached figure 1 The results shown match.

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PUM

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Abstract

The invention relates to a cefodizime sodium composition, which comprises the following components in percentage by mass: 99.00 to 99.99 percent of cefodizime sodium crystals and 0.01 to 1.00 percent of sodium benzoate. The invention also relates to a preparation containing the cefodizime sodium crystals and the sodium benzoate and a method for preparing the cefodizime sodium crystals. The cefodizime sodium crystals have the advantages of high stability and good liquidity.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a cephalosporin drug, more specifically a cefodizime sodium composition powder injection. Background technique [0002] Cefodizime sodium, its chemical name is: (6R, 7R)-7-[(2-amino-4-thiazolyl)-(methoxyimino)acetamido]-3-[[(5-carboxymethyl yl-4-methyl-2-thiazolyl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid disodium salt , molecular formula: C 20 h 18 N 6 Na 2 o 7 S 14 Molecular weight: 628.64, structural formula: [0003] [0004] Cefodizime sodium is a semi-synthetic third-generation cephalosporin, which has antibacterial activity against Gram-positive and negative bacteria, is stable against β-lactamase, and is extremely stable against cephalosporinase and penicillinase. Cefodizime sodium was invented by Hoechst, Germany. It has dual properties of antibacterial and immune regulation, and is widely used clinically. Clinically, it is mainly...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K9/14A61K47/12A61P31/04
Inventor 李明华孙松李华
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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