Cefotaxime sodium composition freeze-dried powder for injection

A technology of cefotaxime sodium and freeze-dried powder injection, which is applied in the field of medicine and medicine manufacturing, and can solve problems such as failure of clinical treatment plans

Inactive Publication Date: 2014-02-19
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

With the widespread use of cefotaxime sodium in clinical practice, many clinical pathogens ...

Method used

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  • Cefotaxime sodium composition freeze-dried powder for injection
  • Cefotaxime sodium composition freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1, preparation of cefotaxime sodium composition freeze-dried powder for injection, in 1000 pieces.

[0027] Prescription:

[0028] Cefotaxime Sodium 1000g

[0029] Chitosan Nanoparticles 800g

[0030] Water for injection 2000ml

[0031] 2. Preparation process:

[0032] The chitosan nanoparticle that weighs 800g is slowly added in the water for injection of 2000ml, stirs while adding, until dissolving.

[0033] Add 1000 g of cefotaxime sodium and stir to dissolve until clear.

[0034] 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, filter the liquid through 0.45 μm and 0.22 μm microporous membranes, and detect the content of intermediates , according to 1.0g per bottle of cefotaxime sodium to calculate the filling volume.

[0035] Fill according to the test requirements, put it into a freeze dryer after half-tamping, ...

Embodiment 2

[0036] Embodiment 2, preparation of cefotaxime sodium composition freeze-dried powder for injection, in 1000 pieces.

[0037] 1. Prescription:

[0038] Cefotaxime Sodium 1000g

[0039] Chitosan Nanoparticles 865g

[0040] Water for injection 2000ml

[0041] 2. Preparation process:

[0042] The chitosan nanoparticle that weighs 865g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0043] Add 1000 g of cefotaxime sodium and stir to dissolve until clear.

[0044] 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, filter the liquid through 0.45 μm and 0.22 μm microporous membranes, and detect the content of intermediates , according to 1.0g per bottle of cefotaxime sodium to calculate the filling volume.

[0045] Fill according to the test requirements, put it into a freeze dryer after half-tamping, coo...

Embodiment 3

[0046] Embodiment 3, preparation of cefotaxime sodium composition freeze-dried powder for injection, in 1000 pieces.

[0047] Prescription:

[0048] Cefotaxime Sodium 1000g

[0049] Chitosan Nanoparticles 757g

[0050] Water for injection 2000ml

[0051] 2. Preparation process:

[0052] The chitosan nanoparticle that takes by weighing 757g is slowly added in the water for injection of 2000ml, stirs while adding to dissolving.

[0053] Add 1000 g of cefotaxime sodium and stir to dissolve until clear.

[0054] 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, filter the liquid through 0.45 μm and 0.22 μm microporous membranes, and detect the content of intermediates , according to 1.0g per bottle of cefotaxime sodium to calculate the filling volume.

[0055] Fill according to the test requirements, put it into a freeze dryer after half-ta...

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Abstract

The invention provides cefotaxime sodium composition freeze-dried powder for injection, relates to the technical field of medicaments and medicament manufacture, and comprises the following raw material components in parts by weight: 7.26-9.17 parts of cefotaxime sodium, 5.78-7.67 parts of chitosan nanoparticles and 81.38-87.10 parts of water for injection. The cefotaxime sodium composition freeze-dried powder for injection disclosed by the invention has the advantages that the chitosan nanoparticles plays a special role in improving the specific surface area and reactivity of the cefotaxime sodium, thus improving the antibacterial effect of the powder; the antibacterial spectrum is widened and the drug resistance is obviously reduced; the medication period of a patient is shortened due to the strengthened activity, and the probability of side reaction caused by accumulated cefotaxime sodium is reduced; and the chitosan nanoparticles can replace mannitol to be used as a freeze-drying skeleton agent for freeze-dried powder, thus eliminating activation of mannitol to a human body.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a cefotaxime sodium composition freeze-dried powder for injection. Background technique: [0002] Cefotaxime sodium belongs to the third generation of semi-synthetic cephalosporins, which has a broad antibacterial spectrum and has good antibacterial activity against Gram-negative bacteria, Gram-positive bacteria, aerobic bacteria and some anaerobic bacteria, especially for The killing effect of Gram-negative bacteria is stronger. With the widespread use of cefotaxime sodium in clinical practice, many clinical pathogens develop resistance to cefotaxime sodium, which leads to the failure of clinical treatment programs. The failure of these treatments is usually caused by the β-lactamase produced by bacteria. The β-lactamase produced by bacteria leads to the hydrolysis of the β-lactam ring in the structure of cefotaxime sodium. In view of the increasing n...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/546A61K31/722A61K47/36A61P31/04
Inventor 汪六一汪金灿朗朗
Owner HAINAN WEI KANG PHARMA QIANSHAN
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