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Medicine composite containing cefamandole nafate compound

A cefamandole sodium and compound technology, which is applied in the directions of medical preparations containing active ingredients, organic chemistry, antibacterial drugs, etc., can solve the problems of high equipment requirements, inconvenient use and long time, and achieves good stability, It is not easy to stick to the bottle, and the effect of high fluidity

Inactive Publication Date: 2013-06-12
四川省惠达药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, most of the cefamandole sodium mainly sold in the market are injection powder preparations. Due to the influence of the synthesis process and the chemical stability of the prodrug, cefamandole sodium usually contains a small amount of cefamandole. Sodium carbonate is commonly used as a solubilizer. It is recorded in 1g of cefamandole sodium that about 63mg of sodium carbonate needs to be added. When the powder is prepared as an injection, more carbon dioxide will be produced. Inconvenient to use
There are also some powder injections that use cefamandole sodium freeze-dried powder injections. The freeze-drying process requires high equipment, high energy consumption, and a long time

Method used

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  • Medicine composite containing cefamandole nafate compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Preparation of cefamandole sodium crystals:

[0026] At a temperature of 35°C, dissolve 3.0g of cefamandole sodium solid in 9.2mL of ethanol and distilled water, wherein the volume ratio of ethanol to distilled water is 1:10, and apply it in the horizontal direction of the liquid surface of the mixed solution A constant magnetic field with a magnetic field strength of 0.6T was left standing at 5°C for 6 hours to obtain white crystals, which were filtered, the filter cake was washed twice with ethanol, and vacuum-dried for 2 hours to obtain cefamandole sodium crystals. The powder XRD diffraction pattern of this cefamandole sodium crystal (as figure 1 shown), at 5.9°, 6.02°, 11.3°, 16.9°, 17.9°, 18.0°, 21.1°, 22.0°, 22.1° and 23.5° diffraction angles (2θ ± 0.01) are shown.

Embodiment 2

[0028] Preparation of cefamandole sodium crystals:

[0029] At a temperature of 40°C, dissolve 3.0g of cefamandole sodium solid in 11.5mL of ethanol and distilled water, wherein the volume ratio of ethanol to distilled water is 1:9, and apply in the horizontal direction of the liquid surface of the mixed solution A constant magnetic field with a magnetic field strength of 1.0 T was left standing at 2° C. for 9 hours to obtain white crystals, which were filtered, the filter cake was washed twice with ethanol, and vacuum-dried for 2 hours to obtain cefamandole sodium crystals. Show through powder XRD detector analysis, accord with the result shown in accompanying drawing.

Embodiment 3

[0031] Preparation of cefamandole sodium crystals:

[0032] At a temperature of 30°C, dissolve 3.0g of cefamandole sodium solid in 14.8mL of ethanol and distilled water, wherein the volume ratio of ethanol to distilled water is 1:10, and apply it in the horizontal direction of the liquid surface of the mixed solution A constant magnetic field with a magnetic field strength of 0.5 T was left standing at 0° C. for 7 hours to obtain white crystals, which were filtered, the filter cake was washed twice with ethanol, and vacuum-dried for 2 hours to obtain cefamandole sodium crystals. Show through powder XRD detector analysis, accord with the result shown in accompanying drawing.

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Abstract

The invention discloses a cefamandole nafate compound for injection. The cefamandole nafate compound is a crystal compound; and in X-ray powder diffraction, main peaks are shown at diffraction angles of 5.9+ / -0.01 degrees, 6.02+ / -0.01 degrees, 11.3+ / -0.01 degrees, 16.9+ / -0.01 degrees, 17.9+ / -0.01 degrees, 18.0+ / -0.01 degrees, 21.1+ / -0.01 degrees, 22.0+ / -0.01 degrees, 22.1+ / -0.01 degrees, and 23.5+ / -0.01 degrees. The invention also discloses a medicine composite containing the cefamandole nafate compound. The cefamandole nafate crystal is good in stability and high in fluidity; when a cefamandole nafate sterile powder injection is prepared, the sub-package amount of active medicine components is accurate and the operation is facilitated; and besides, the sterile powder injection is not easily adhered to bottles, and is very convenient regardless of being used independently or mixed with other medicine powder. The cefamandole nafate compound does not degrade fundamentally and can be placed for a long time, thereby having a great advantage in medicine preparation.

Description

technical field [0001] The invention relates to a cefamandole sodium compound, and also relates to a composition containing the cefamandole sodium and cefamandole sodium sterile powder for injection. Background technique [0002] The chemical name of Cefamandole Nafate is: 7-D-(2-formyloxyphenylacetamide)-3-[(1-methyl-1H-tetrazol-5-yl)thiomethyl ]-3-cephem-4-carboxylic acid sodium salt, chemical structural formula: [0003] [0004] Cefamandole sodium is a second-generation cephalosporin created by E.Lilly Company of the United States in 1972. It was used clinically abroad in 1978 and successfully developed in China in 1979. Cefamandole sodium is a cephalosporin with strong bactericidal effect, which has some advantages of the first-generation and third-generation cephalosporins. It has strong antibacterial activity against most Gram-positive bacteria, some negative bacteria and Clostridium dentifrice, relatively stable to β-lactamase, low toxicity, high blood concentra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12A61K31/546A61K9/14A61P31/04
Inventor 闫晓晔梁宏平
Owner 四川省惠达药业有限公司
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