Cefpiramide sodium powder injection and preparation method thereof

A technology of cefpiramide sodium powder and cefpiramide sodium, which is applied in the field of pharmaceutical preparations, can solve the problems of high content of related substances in powder injections and damage to the structure of cefpiramide sodium, so as to avoid high content of related substances, plump appearance and high quality. controllable effect

Active Publication Date: 2011-10-19
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method uses a strong alkali solution to adjust the pH value, which will destroy the structure of cefpiramide sodium, decompose cefpiramide sodium, and cause the content of related substances in the prepared powder injection to be generally high

Method used

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  • Cefpiramide sodium powder injection and preparation method thereof
  • Cefpiramide sodium powder injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] 1. Prescription composition

[0044] Cefpiramide sodium 518g (equivalent to cefpiramide 500g)

[0045] Sodium Benzoate 37.5g

[0046] Add water for injection to 2600g

[0047] 5% sodium bicarbonate aqueous solution appropriate amount

[0048] Packed into 1000 bottles

[0049] 2. Preparation method (specification: 0.5g)

[0050] Dissolve the cefpiramide sodium and sodium benzoate of the prescribed amount in water for injection accounting for 80% of the total mass of water for injection, stir until completely dissolved, add water for injection to 2600g to form a medicinal liquid, and then dropwise add a mass of 100% to the above medicinal liquid. Divide concentration into 5% sodium bicarbonate aqueous solution, adjust the pH value of the medicinal solution to be 6.6, obtain a medicinal solution with a pH value of 6.6; add 7.8g gac and stir for 30 minutes in the medicinal solution with a pH value of 6.6, and coarsely filter with filter paper Afterwards, use a 0.22 μm ...

Embodiment 2

[0052] 1. Prescription composition

[0053] Cefpiramide sodium 1036g (equivalent to cefpiramide 1000g)

[0054] Sodium Benzoate 75g

[0055] Add water for injection to 5200g

[0056] 5% sodium bicarbonate aqueous solution appropriate amount

[0057] Packed into 1000 bottles

[0058] 2 Preparation method (specification: 1.0g)

[0059] Dissolve the prescribed amount of cefpiramide sodium and sodium benzoate in water for injection accounting for 80% of the total mass of water for injection, stir until completely dissolved, add water for injection to 5200g to form a medicinal liquid, and then dropwise add a mass of 100% to the above medicinal liquid. Concentration is 5% sodium bicarbonate aqueous solution, the pH value of adjusting medicinal liquid is 6.7 and obtains the medicinal liquid that pH value is 6.7; In the medicinal liquid that pH value is 6.7, add 15.6g gac and stir for 30 minutes, after coarse filtration with filter paper Use a 0.22 μm microporous membrane to ster...

Embodiment 3

[0061] 1. Prescription composition

[0062] Cefpiramide sodium 2072g (equivalent to cefpiramide 2000g)

[0063] Sodium Benzoate 150g

[0064] Add water for injection to 10400g

[0065] 5% hydrochloric acid aqueous solution appropriate amount

[0066] Packed into 1000 bottles

[0067] 2. Preparation method (specification: 2.0g)

[0068] Dissolve the prescribed amount of cefpiramide sodium and sodium benzoate in water for injection accounting for 80% of the total mass of water for injection, stir until completely dissolved, add water for injection to 10400g to form a medicinal liquid, and then dropwise add a mass of 100% to the above medicinal liquid. Concentration is 5% hydrochloric acid aqueous solution, and the pH value of adjusting medicinal liquid is 6.5 and obtains the medicinal liquid that pH is 6.5; In the medicinal liquid that pH value is 6.5, add 31.2g gac and stir for 30 minutes, filter with filter paper and use 0.22 μm microporous membrane sterilizing filtration...

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Abstract

The invention discloses a cefpiramide sodium powder injection and a preparation method thereof. The preparation method comprises the following steps: dissolving cefpiramide sodium powder and sodium benzoate in water for injection; dropwisely adding sodium bicarbonate water solution or hydrochloric acid water solution to regulate the pH value to 6.2-7.2; filtering; and freeze-drying the filtrate to obtain the cefpiramide sodium powder injection. In the invention, cefpiramide sodium powder and sodium benzoate are directly dissolved in water for injection to prepare the powder injection in a slightly acid or neutral environment. Thus, the invention has the advantages of controllable related substances, cost saving, simple technical process and energy saving, and is applicable to industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a cefpiramide sodium powder injection and a preparation method thereof. Background technique [0002] The chemical name of cefpiramide sodium is (6R,7R)-7-[(R)-2-(4-hydroxy-6-methyl-3-pyridinecarbonylamino)-2-(p-hydroxyphenyl)acetamido ]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4,2,0]octane -2-ene-2-carboxylic acid sodium salt, molecular weight 634.62, molecular formula C 25 h 23 N 8 NaO 7 S 2 , the chemical structural formula is: [0003] [0004] Cefpiramide sodium is a semi-synthetic third-generation cephalosporin antibiotic with broad antibacterial spectrum and bactericidal activity. Cefpiramide sodium has strong antibacterial activity against Gram-positive bacteria and broad-spectrum antibacterial activity against bacteria including Gram-negative bacteria; , anaerobic bacteria and aeruginosa have strong antibacterial activity...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/546A61K47/12A61P31/04
Inventor 刘全国
Owner HAINAN HULUWA PHARMA GRP CO LTD
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