Freeze-dried powder injection of cefamandole nafate and preparation method thereof

A technology of cefamandole sodium and freeze-dried powder injection, which is applied in the field of preparation of freeze-dried powder injection, can solve the problems of blocked blood vessel embolism, achieve good stability, good solubility, and do not affect the effect of solubility

Inactive Publication Date: 2012-02-22
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, a large amount of air quickly enters the blood circulation or the gas dissolved in the blood quickly dissociates to form bubbles, which block the blood vessels and cause embolism.

Method used

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  • Freeze-dried powder injection of cefamandole nafate and preparation method thereof
  • Freeze-dried powder injection of cefamandole nafate and preparation method thereof
  • Freeze-dried powder injection of cefamandole nafate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Take by weighing 200g of cefamandole sodium raw material, place in a 100ml beaker, add 50ml of water to dissolve. Filter with a 0.45 μm membrane, and freeze-dry the filtrate to obtain cefamandole sodium freeze-dried powder. Dissolve completely in water for injection within 25s.

Embodiment 2

[0035] Take by weighing 2000g of cefamandole sodium raw material, place in a 1000ml beaker, add 500ml of water to dissolve. Filter with a 0.22 μm membrane, and freeze-dry the filtrate to obtain cefamandole sodium freeze-dried powder. Dissolve completely in water for injection within 20s.

Embodiment 3

[0037] Take by weighing 2000g of cefamandole sodium raw material, place in a 1000ml beaker, add 500ml of water to dissolve. Filter with a 1.0 μm membrane, and freeze-dry the filtrate to obtain cefamandole sodium freeze-dried powder. Dissolve completely in water for injection within 30s.

[0038] Example 3

[0039] Take by weighing some cefamandole sodium freeze-dried powder injections, pass through a 60-mesh sieve after being pulverized, and carry out aseptic subpackaging according to the loading volume requirements under the condition of grade 100 in a sterile room to obtain cefamandole sodium for injection. Dry powder injection. The loading can be but not only 0.5g, 1g, 2g per bottle.

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Abstract

The invention relates to a freeze-dried powder injection of cefamandole nafate, which is obtained by packaging bulk pharmaceutical of the freeze-dried powder injection of cefamandole nafate according to dosage. The bulk pharmaceutical of the freeze-dried powder injection of cefamandole nafate are obtained by the following steps: dissolving the bulk pharmaceutical of cefamandole nafate with water,filtering with a film of 0.22mu m-1.0mu m, and putting the filtered solution into a freeze dryer for freeze drying. The invention adopts the filtration method to reduce the content of cefamandole in the bulk pharmaceutical, and causes the content of cefamandole nafate to be more than 95%; the process of freeze drying is carried out to obtain new bulk pharmaceutical chemicals; and the new bulk pharmaceutical are directly packaged respectively in accordance with the dosage so as to obtain the freeze-dried powder injection of cefamandole nafate. The obtained injection has good solubility, meets the requirements on all indexes in pharmacopeia, does not contain sodium carbonate and can not generate carbon dioxide, thereby solving the problems in the using process. The freeze-dried powder injection of cefamandole nafate obtained by the invention has good stability and high dissolving speed, merely contains a minute amount of cefamandole, can not influence the dissolvability, is not in need of adding sodium carbonate, and is directly packaged.

Description

technical field [0001] The invention relates to a cefamandole sodium freeze-dried powder preparation, and also relates to a preparation method of the freeze-dried powder preparation. Background technique [0002] The chemical formula of cefamandole sodium is 7-D-(2-formyloxyphenylacetamide)-3[(1-methyl-1H-tetrazol-5yl)mercaptomethyl]-3 cephem-4-carboxylate Acid sodium salt, the molecular formula is C 19 h 17 N 6 NaO 6 S 2 , is a second-generation cephalosporin, which is used in infections of the respiratory tract, genitourinary system, skin and soft tissues, bones and joints, pharynx, ear, nose and throat, peritonitis and sepsis caused by sensitive Gram-negative bacteria. It has good curative effect on biliary tract and intestinal infection. [0003] At present, cefamandole sodium is mostly a powder preparation for injection, which contains a small amount of cefamandole, so it is necessary to add sodium carbonate in the preparation as a cosolvent, and a large amount of...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/546A61P31/04A61P11/00A61P13/00A61P15/00A61P17/00A61P19/00A61P19/08A61P19/02A61P11/04A61P27/16A61P11/02A61P1/00A61P1/16
Inventor 曾艺林刚
Owner 湖北美林药业有限公司
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