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Ceftezole sodium composition powder for injection

A kind of technology of ceftiazole sodium and composition, applied in the field of medicine and medicine manufacture

Inactive Publication Date: 2014-01-29
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in order to be pharmaceutically effective, this single dosage form must meet various scalability requirements such as stability

Method used

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  • Ceftezole sodium composition powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1, preparation of ceftezole sodium composition freeze-dried powder for injection, in 1000 pieces.

[0033] Prescription:

[0034] Ceftezole Sodium 40g

[0035] Chitosan Nanoparticles 32g

[0036] Water for injection 2000ml

[0037] 2. Preparation process:

[0038] The chitosan nanoparticle that takes by weighing 32g is slowly added in the water for injection of 2000ml, stirs while adding, until dissolving.

[0039] Add 40 g of ceftezole sodium and stir to dissolve until clear.

[0040] 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 ceftezole sodium 40mg per bottle to calculate the filling volume.

[0041] Fill according to the test requirements, put it into a freeze dryer after half-tamping, ...

Embodiment 2

[0042] Embodiment 2, preparation of ceftezole sodium composition freeze-dried powder for injection, in 1000 pieces.

[0043] 1. Prescription:

[0044] Ceftezole Sodium 40g

[0045] Chitosan Nanoparticles 25g

[0046] Water for injection 2000ml

[0047] 2. Preparation process:

[0048] The chitosan nanoparticle that takes by weighing 25g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0049] Add 40 g of ceftezole sodium and stir to dissolve until clear.

[0050] 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 ceftezole sodium 40mg per bottle to calculate the filling volume.

[0051] Fill according to the test requirements, put it into a freeze dryer after half-tamping, coo...

Embodiment 3

[0052] Embodiment 3, preparation of ceftezole sodium composition freeze-dried powder for injection, in 1000 pieces.

[0053] Prescription:

[0054] Ceftezole Sodium 40g

[0055] Chitosan Nanoparticles 39g

[0056] Water for injection 2000ml

[0057] 2. Preparation process:

[0058] The chitosan nanoparticle that takes by weighing 39g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0059]Add 40 g of ceftezole sodium and stir to dissolve until clear.

[0060] 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 ceftezole sodium 40mg per bottle to calculate the filling volume.

[0061] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool do...

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Abstract

The invention provides a ceftezole sodium composition powder for injection, and belongs to the field of medicine and medicine preparation technology. The ceftezole sodium composition powder comprises following raw material ingredients, by weight, 7.26 to 9.17 parts of ceftezole sodium, 5.78 to 7.67 parts of chitosan nanoparticle, and 81.38 to 87.10 parts of injection water. Advantages of the ceftezole sodium composition powder are that: 1) in vitro antibacterial activity spectrum is wider, and poor antibacterial activity of ceftezole sodium on pneumococcus, pseudomonas aeruginosa and acinetobacter is improved greatly; 2) the nanoparticle medicine carrier is capable of changing membrane transport mechanisms, and increasing medicine permeability against biological membranes, and is beneficial for exhibition of pharmacological functions in cells; 3) ceftezole sodium coated by the nanoparticle carrier is rapidly gathered at primary organs, such as liver and spleen, of the reticuloendothelial system along veins, so that toxicity caused by nonspecific gathering of medicine is reduced; and 4) the chitosan nanoparticle can be used as a freeze-dried skeleton agent of the freeze-dried powder injection instead of mannitol so as to avoid active effects of mannitol on human bodies.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a ceftezole sodium composition freeze-dried powder for injection. Background technique: [0002] The chemical name is: (6R,7R)-3-[(1,3,4-thiadiazol-2-yl)thiomethyl]-8-oxo-7-[2-(1H-tetrazole- Sodium 1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. [0003] Properties: This product is white to light yellow crystalline powder, odorless, hygroscopic, and its structural formula is as follows: [0004] [0005] Ceftezole sodium is a semi-synthetic cephalosporin derivative, and its mechanism of action is to exert antibacterial activity by inhibiting the synthesis of bacterial cell walls. This product is widely distributed in the body, among which the kidney is the highest, followed by serum, liver, lung, heart and spleen. Indications are respiratory system infection, urinary system infection, sepsis, peritonitis. [0006] Ceftezole sod...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/546A61K31/722A61K47/36A61P31/04
Inventor 汪六一汪金灿汪宁卿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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