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Fosfomycin sodium composition lyophilized powder for injection

A technology of fosfomycin sodium and freeze-dried powder injection, which is applied in the field of pharmaceuticals and pharmaceutical manufacturing, can solve the problems of β-lactamase instability and reduced sensitivity of Klebsiella pneumoniae, and achieve the elimination of activity and distribution in the body Good, the effect of increased stability

Inactive Publication Date: 2014-02-05
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In recent years, there have been problems such as instability of β-lactamase produced by Gram-negative bacteria and reduced sensitivity to Klebsiella pneumoniae in clinical application.

Method used

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  • Fosfomycin sodium composition lyophilized powder for injection
  • Fosfomycin sodium composition lyophilized powder for injection
  • Fosfomycin sodium composition lyophilized powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1, preparation of fosfomycin sodium composition freeze-dried powder for injection, in 1000 pieces.

[0030] prescription:

[0031] Fosfomycin Sodium 80g

[0032] Chitosan Nanoparticles 72g

[0033] Water for injection 2000ml

[0034] 2. Preparation process:

[0035] The chitosan nanoparticle that takes by weighing 72g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0036] Add 80 g of fosfomycin sodium and stir to dissolve until clear.

[0037] Adjust the pH to 5.1 with buffer salts of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to fosfomycin sodium 80mg per bottle to calculate the filling volume.

[0038] Fill according to the test requirements, put it into a freeze dryer after half-tamping, co...

Embodiment 2

[0039] Embodiment 2, preparation of fosfomycin sodium composition freeze-dried powder for injection, in 1000 pieces.

[0040] 1. Prescription:

[0041] Fosfomycin Sodium 80g

[0042] Chitosan Nanoparticles 81g

[0043] Water for injection 2000ml

[0044] 2. Preparation process:

[0045] The chitosan nanoparticle that takes by weighing 81g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0046] Add 80 g of fosfomycin sodium and stir to dissolve until clear.

[0047] Adjust the pH to 5.1 with buffer salts of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to fosfomycin sodium 80mg per bottle to calculate the filling volume.

[0048] Fill according to the test requirements, put it into a freeze dryer after half-tamping,...

Embodiment 3

[0049] Embodiment 3, the preparation of fosfomycin sodium composition freeze-dried powder for injection, in 1000 pieces.

[0050] prescription:

[0051] Fosfomycin Sodium 80g

[0052] Chitosan Nanoparticles 64g

[0053] Water for injection 2000ml

[0054] 2. Preparation process:

[0055] The chitosan nanoparticle that takes by weighing 64g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0056] Add 80 g of fosfomycin sodium and stir to dissolve until clear.

[0057] Adjust the pH to 5.1 with buffer salts of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to fosfomycin sodium 80mg per bottle to calculate the filling volume.

[0058] Fill according to the test requirements, put it into a freeze dryer after half-tamping...

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Abstract

The invention provides a fosfomycin sodium composition lyophilized powder for injection, and relates to the technical field of medicines and medicine preparation. The fosfomycin sodium composition lyophilized powder for injection comprises the following raw materials in parts by weight: 7.26-9.17 parts of fosfomycin sodium, 7.02-8.97 parts of chitosan nanoparticle, and 81.38-87.10 parts of injection water. The fosfomycin sodium composition lyophilized powder for injection has the following advantages that (1) the antibacterial effect on klebsiella pneumoniae is good, the antibiotic sensitive rate is 89.9%, and the advantage in klebsiella pneumoniae producing ESBLs (Extended Spectyum beta Lactamase) is obvious; (2) the stability on beta-lactamase produced by gram-negative bacterium is increased, and the in-vivo distribution is good; (3) as the activity is improved, the medication period of a patient is shortened, and the possibility of untoward effect caused by the accumulation of fosfomycin sodium is reduced; and (4) the chitosan nanoparticle can replace mannitol to function as the lyophilization skeleton agent of the lyophilized powder, and the activation effect on a human body by the mannitol is eliminated.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a freeze-dried powder injection of fosfomycin sodium composition for injection. Background technique: [0002] Fosfomycin has an antibacterial effect on Gram-positive cocci such as Staphylococcus aureus and Staphylococcus epidermidis. It also has strong antibacterial activity against Gram-negative bacteria such as Escherichia coli, Serratia, Shigella, Yersinia, Enterobacter aerogenes, Vibrio and Aeromonas. Fosfomycin can inhibit the early synthesis of bacterial cell walls, and its molecular structure is similar to that of phosphoenolpyruvate, so it can compete with bacteria for the same transferase, inhibiting the synthesis of bacterial cell walls and leading to bacterial death. In recent years, in clinical application, problems such as instability to β-lactamases produced by Gram-negative bacteria and reduced sensitivity to Klebsiella pneumoniae have ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/665A61K47/36A61P31/04
Inventor 汪六一汪金灿李珠珠
Owner HAINAN WEI KANG PHARMA QIANSHAN
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