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Cefuroxime sodium composition freeze-dried powder for injection

A technology of cefuroxime sodium and freeze-dried powder injection, which is applied in the field of medicine and medicine manufacturing, and can solve the problems of low bioavailability and large dosage

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

The drug concentration in the sputum after intramuscular injection of 0.75g every 8 hours is 0.1-7.8mg / L; the drug concentration in the bile 2.5 hours after injection is 1.5-15mg / L. It can be seen that the clinical dosage of this product is large, and the biological Utilization is low, in order to improve this shortcoming, the present invention proposes a kind of composition that cefuroxime sodium and chitosan nano-particles are mixed according to a certain ratio, and make the freeze-dried powder for injection and use as antibacterial drug in clinic

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1. Preparation of lyophilized powder injection of cefuroxime sodium composition for injection, in 1000 vials.

[0030] Prescription:

[0031] Cefuroxime Sodium 1000g

[0032] Chitosan Nanoparticles 500g

[0033] Water for injection 2000mL

[0034] Preparation Process:

[0035] The chitosan nanoparticles that take 500g are slowly added in the water for injection of 2000ml, stir to dissolve while adding.

[0036] Add 1000 g of cefuroxime 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 , Calculate the loading amount according to 0.1g of cefuroxime sodium per bottle.

[0038] Fill according to the test requirements, half-tighten the plug and send it to the freez...

Embodiment 2

[0039] Example 2, preparation of lyophilized powder injection of cefuroxime sodium composition for injection, calculated in 1000 vials.

[0040] 1. Prescription:

[0041] Cefuroxime Sodium 1000g

[0042] Chitosan Nanoparticles 350g

[0043] Water for injection 2000ml

[0044] 2. Preparation process:

[0045] (1) Weigh 350g of chitosan nanoparticles and slowly add them to 2000ml of water for injection, stir until dissolved while adding.

[0046] (2) Add 1000g of cefuroxime sodium and stir to dissolve until clear.

[0047] (3) 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 is calculated as 0.1g per bottle.

[0048] Fill according to the test requirements, half-tighten the plug and send it to the freeze dryer, cool down to -40°...

Embodiment 3

[0049] Example 3. Preparation of lyophilized powder injection of cefuroxime sodium composition for injection, calculated in 1000 vials.

[0050] Prescription:

[0051] Cefuroxime Sodium 1000g

[0052] Chitosan Nanoparticles 200g

[0053] Water for injection 2000ml

[0054](1) Weigh 200g of chitosan nanoparticles and slowly add them to 2000ml of water for injection, stir until dissolved while adding.

[0055] (2) Add 1000g of cefuroxime sodium and stir to dissolve until clear.

[0056] (3) 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 is calculated as 0.1g per bottle.

[0057] (4) Fill according to the testing requirements, put it into a freeze dryer after half-tightening, cool down to -40°C±2°C, keep it warm for 3 hours, the...

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Abstract

The invention provides a cefuroxime sodium composition freeze-dried powder for injection, and belongs to the field of medicine and medicine preparation technology. The cefuroxime sodium composition freeze-dried powder comprises following raw material ingredients, by weight, 7.26 to 9.17 parts of cefuroxime sodium, 6.02 to 7.97 parts of chitosan nanoparticle, and 81.34 to 87.55 parts of injection water. Advantages of the cefuroxime sodium composition freeze-dried powder are that: 1) the cefuroxime sodium composition freeze-dried powder possesses excellent synergistic antimicrobial effect with cefuroxime sodium, medicine bioavailability is increased, and administration dosage is reduced; 2) dosage of auxiliary materials is less, freeze-drying formability is excellent, and stability of cefuroxime sodium against beta-lactamase is increased; and 3) the cefuroxime sodium composition freeze-dried powder is safe for application, curative effect is accurate, quality is controllable, and occurrence likelihood of adverse reaction caused by accumulation of cefuroxime sodium is reduced.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a cefuroxime sodium composition freeze-dried powder for injection. Background technique: [0002] Cefuroxime sodium is white, off-white or light yellow powder or crystalline powder; odorless, bitter taste; hygroscopic. This product is soluble in water, slightly soluble in methanol, insoluble in ethanol or chloroform. [0003] Cefuroxime sodium is a second-generation cephalosporin antibiotic. The antibacterial activity against Gram-positive cocci is similar to or slightly worse than that of the first-generation cephalosporins, but it is quite stable against β-lactamase produced by Staphylococcus and Gram-negative bacilli. Methicillin-resistant Staphylococcus, Enterococcus and Listeria are drug-resistant, and other positive cocci (including anaerobic cocci) are sensitive to this product. The antibacterial activity against Staphylococcus aureus is worse...

Claims

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Application Information

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