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Cefamandole nafate powder injection, production method of powder injection and raw machine thereof

A technology of cefamandole sodium and sterile powder injection, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of unsatisfactory product yield and purity and reaction conditions Harsh and other problems, to achieve good clarity, low cost of raw materials, and good stability

Active Publication Date: 2008-07-16
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The reaction temperature of this synthesis method is between -15--10°C, that is, the reaction conditions of this synthesis method are relatively harsh, and the yield and purity of the obtained product are not ideal

Method used

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  • Cefamandole nafate powder injection, production method of powder injection and raw machine thereof
  • Cefamandole nafate powder injection, production method of powder injection and raw machine thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Preparation of Cefamandole Sodium Sterile Powder for Injection (Specification: 1.0 / bottle)

[0046] prescription:

[0047] Cefamandole Sodium 1000g

[0048] Anhydrous sodium carbonate 30g

[0049]

[0050] Total 1000 bottles

[0051] Preparation process: under sterile conditions, accurately weigh 1000g of cefamandole sodium and pulverize it, with a particle size of 90-120 μm, sieve, then weigh 30g of sterile sodium carbonate powder and place the sieved cefamandole sodium in the solid powder Mix evenly in the mixer, transfer the obtained raw materials to the aseptic preparation workshop, accurately measure and subpackage according to 1g of active ingredients per bottle, and press the cap to obtain the aseptic powder injection of cefamandole sodium.

Embodiment 2

[0053] Preparation of Cefamandole Sodium Sterile Powder for Injection (Specification: 1.0 / bottle)

[0054] prescription:

[0055] Cefamandole Sodium 1000g

[0056] Anhydrous sodium carbonate 25g

[0057]

[0058] Total 1000 bottles

[0059] Preparation process: under aseptic conditions, accurately weigh 1000g of cefamandole sodium and pulverize it, with a particle size of 75-90 μm, sieve, then weigh 25g of sterile sodium carbonate powder and place the sieved cefamandole sodium into the solid powder Mix evenly in the mixer, transfer the obtained raw materials to the aseptic preparation workshop, accurately measure and subpackage according to 1g of active ingredients per bottle, and press the cap to obtain the aseptic powder injection of cefamandole sodium.

Embodiment 3

[0061] Preparation of Cefamandole Sodium Sterile Powder for Injection (Specification: 1.0 / bottle)

[0062] prescription:

[0063] Cefamandole Sodium 1000g

[0064] Anhydrous sodium carbonate 30g

[0065]

[0066] Total 1000 bottles

[0067] Preparation process: under aseptic conditions, accurately weigh 1000g of cefamandole sodium and pulverize to a particle size of 75-90 μm, sieve, then weigh 30g of sterile sodium carbonate powder and place the sieved cefamandole sodium into the solid powder Mix evenly in the mixer, transfer the obtained raw materials to the aseptic preparation workshop, accurately measure and subpackage according to 1g of active ingredients per bottle, and press the cap to obtain the aseptic powder injection of cefamandole sodium.

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Abstract

The invention relates to an aseptic powder injection of cefamandole nafate and a preparation method thereof; the aseptic powder injection of cefamandole nafate comprises cefamandole nafate and anhydrous sodium carbonate; after the improvement of the preparation technology, the dosages of auxiliary material are small, and therefore the aseptic powder injection of cefamandole nafate obtained is good in stability and low in cost. The synthetic process of the drug material of cefamandole nafate adopted by the invention has simple operation process, low material cost and moderate reaction conditions; the cefamandole nafate produced has high purity and high productive rate.

Description

technical field [0001] The invention relates to a cefamandole sodium powder injection and a preparation method thereof, and also relates to a preparation method of a crude drug. Background technique [0002] Cefamandole sodium (Cefamandole Nafate) is a second-generation cephalosporin created by E. Lilly Company of the United States in 1972. It was used clinically abroad in 1978 and was 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 concentration, wide tissue distribution, in the kidney parenchyma and bile concentration is particularly high. [0003] The chemical name of cefamandole sodium is: 7-D-(2-formyloxyphenylacetamide)-3-[(1-methyl-1H-te...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546A61K47/04A61P31/04
Inventor 刘保起李明华张亮
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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