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Flucloxacillin sodium freeze-dried powder injection composition and preparation method thereof

A technology of flucloxacillin sodium and freeze-dried powder injection, which is applied in the field of flucloxacillin sodium freeze-dried powder injection composition and its preparation, can solve problems such as instability and increased impurities, achieve good stability, and be beneficial to industrial production , The effect of simple preparation process

Inactive Publication Date: 2014-04-30
GUILIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Flucloxacillin sodium has been included in the 2000 edition of the British Pharmacopoeia and the 2010 Supplement of the Chinese Pharmacopoeia. Currently, there are injections and oral preparations on the market. large, causing instability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1) Weigh 20g of L-lysine and 500g of flucloxacillin sodium, add 2500ml of water for injection below 30°C, stir until dissolved, and obtain solution 1;

[0019] 2) Weigh 10g of lecithin, add 2500ml of medicinal ethanol, stir until dissolved, and obtain solution 2;

[0020] 3) Slowly pour solution 1 into solution 2, stir evenly, filter through a φ0.22μm microporous membrane, add medicinal ethanol to the filtrate to 5000ml, and then adjust the pH to 5.0 with 0.1mol / L NaOH solution, Fill into vials, fill each vial with 0.5g of flucloxacillin sodium, and fill 1,000 vials in total, each vial of 5ml, half-tightened, put the half-tightened medicine in a freeze-drying box, and pre-freeze to -20 Keep the temperature below ℃ for 2 hours, continue to cool down to below -30℃ and evacuate to below 10Pa, keep the temperature for 1h, then raise the temperature to -15℃ and keep it for 8 hours, then raise the temperature to -5℃ within 3h, continue to heat up within 5h to 35°C, finally e...

Embodiment 2

[0022] 1) Weigh 40g of L-lysine and 500g of flucloxacillin sodium, add 2500ml of water for injection below 30°C, stir until dissolved, and obtain solution 1;

[0023] 2) Weigh 20g of lecithin, add 2500ml of medicinal ethanol, stir until dissolved, and obtain solution 2; 3) Slowly pour solution 1 into solution 2, stir evenly, filter through a φ0.22μm microporous membrane, and add the filtrate to Set the volume to 5000ml with medicinal ethanol, then adjust the pH to 5.0 with 0.1mol / L NaOH solution, fill it into vials, fill 0.5g flucloxacillin sodium per bottle, and fill a total of 1000 bottles, each 5ml, For half-tamponing, put the half-tamponed medicine in a freeze-drying box, pre-freeze to below -20°C and keep warm for 2 hours, continue to cool down to below -30°C and evacuate to below 10Pa, keep warm for 1h, and then heat up to - Keep warm at 15°C for 8 hours, then raise the temperature to -5°C within 3 hours, continue to heat up to 35°C within 5 hours, finally evacuate to 4 ...

Embodiment 3

[0025] 1) Weigh 30g of L-lysine and 500g of flucloxacillin sodium, add 2500ml of water for injection below 30°C, stir until dissolved, and obtain solution 1;

[0026] 2) Weigh 15g of lecithin, add 2500ml of medicinal ethanol, stir until dissolved, and obtain solution 2;

[0027] 3) Slowly pour solution 1 into solution 2, stir evenly, filter through a φ0.22μm microporous membrane, add medicinal ethanol to the filtrate to 5000ml, and then adjust the pH to 5.0 with 0.1mol / L NaOH solution, Fill into vials, fill each vial with 0.5g of flucloxacillin sodium, and fill 1,000 vials in total, each vial of 5ml, half-tightened, put the half-tightened medicine in a freeze-drying box, and pre-freeze to -20 Keep the temperature below ℃ for 2 hours, continue to cool down to below -30℃ and evacuate to below 10Pa, keep the temperature for 1h, then raise the temperature to -15℃ and keep it for 8 hours, then raise the temperature to -5℃ within 3h, continue to heat up within 5h to 35°C, finally e...

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Abstract

The invention discloses a flucloxacillin sodium freeze-dried powder injection composition and a preparation method thereof. The composition comprises the following components in parts by weight: 500 parts of flucloxacillin sodium, 10-20 parts of lecithin and 20-40 parts of L-lysine. The preparation method comprises the following steps: (1) dissolving L-lysine and flucloxacillin sodium into water for injection; (2) dissolving lecithin into medicinal ethanol; (3) uniformly mixing the two solutions, filtering the solutions by virtue of a microporous film with the aperture of 0.22 microns, adding the medicinal ethanol into filtrate for volume fixing, adjusting the pH to 5.0 by virtue of a NaOH solution, and performing filling, half tamponade, freeze-drying and tamponade to obtain the flucloxacillin sodium freeze-dried powder injection composition. The flucloxacillin sodium freeze-dried powder injection composition disclosed by the invention is high in stability and easy for realization of industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a flucloxacillin sodium freeze-dried powder injection composition and a preparation method thereof. Background technique [0002] Flucloxacillin sodium is a semi-synthetic isoxazole penicillin. It is an acid-resistant penicillin. By changing the side chain to have a protected central D-lactam ring, it has anti-penicillinase effect and has a wider antibacterial spectrum. , including staphylococci that produce penicillinase. Flucloxacillin sodium is resistant to or sensitive to penicillin Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Bacillus, Bacillus anthracis, Listeria monocytogenes, Corynebacterium diphtheriae, Gonorrhea Serella and Neisseria meningitidis effective. It is clinically used to treat severe infections of penicillin-resistant Staphylococcus aureus, respiratory tract infections (such as acute pharyngitis, suppurativ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/431A61K47/24A61P31/04
Inventor 胡伟松潘梅黄军
Owner GUILIN PHARMA
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