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Amoxicillin sodium and clavulanate potassium composition powder for injection

A technology of amoxicillin sodium and clavulanate potassium and its composition, which is applied in the field of freeze-dried powder injection of amoxicillin sodium and clavulanate potassium composition for injection, and can solve problems such as precipitation, content decrease, molecular destruction, etc.

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

[0003] Amoxicillin is molecularly unstable, prone to degradation, and has poor water solubility, so its sodium salt is often used in powder injections
Clavulanic acid has poor water solubility, and its potassium salt is often used in powder injections, and clavulanic acid also has certain instability problems. Due to the influence of pH, temperature, humidity, oxidation and other factors, its β-lactam structure is easy to open the ring , resulting in the destruction of the entire molecule, a decrease in content, and an increase in related substances
Marketed products generally have instability problems such as dissolution, discoloration and precipitation during dilution

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1. Preparation of amoxicillin sodium clavulanate potassium composition freeze-dried powder for injection, in 1000 vials.

[0034] Prescription:

[0035] Amoxicillin Sodium Clavulanate Potassium 600g

[0036] Chitosan Nanoparticles 480g

[0037] Water for injection 2000ml

[0038] 2. Preparation process:

[0039] The chitosan nanoparticle that takes by weighing 480g is slowly added in the water for injection of 2000ml, while adding, stir until dissolving.

[0040] Add 600 g of amoxicillin sodium clavulanate potassium and stir to dissolve until clear.

[0041] Adjust the pH to 5.1 with the buffer salt 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 amoxicillin sodium clavulanate potassium 0.6g per bottle to calculate the filling volume. ...

Embodiment 2

[0043] Example 2: Preparation of amoxicillin sodium clavulanate potassium composition freeze-dried powder for injection, in 1000 vials.

[0044] 1. Prescription:

[0045] Amoxicillin Sodium Clavulanate Potassium 600g

[0046] Chitosan Nanoparticles 525g

[0047] Water for injection 2000ml

[0048] 2. Preparation process:

[0049] The chitosan nanoparticle that takes by weighing 525g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0050] Add 600 g of amoxicillin sodium clavulanate potassium and stir to dissolve until clear.

[0051] Adjust the pH to 5.1 with the buffer salt 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 amoxicillin sodium clavulanate potassium 0.6g per bottle to calculate the filling volume.

...

Embodiment 3

[0053] Example 3: Preparation of amoxicillin sodium clavulanate potassium composition freeze-dried powder for injection, in 1000 vials.

[0054] Prescription:

[0055] Amoxicillin Sodium Clavulanate Potassium 600g

[0056]Chitosan Nanoparticles 439g

[0057] Water for injection 2000ml

[0058] 2. Preparation process:

[0059] The chitosan nanoparticle that takes by weighing 439g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0060] Add 600 g of amoxicillin sodium clavulanate potassium and stir to dissolve until clear.

[0061] Adjust the pH to 5.1 with the buffer salt 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 amoxicillin sodium clavulanate potassium 0.6g per bottle to calculate the filling volume.

[00...

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Abstract

The invention discloses an amoxicillin sodium and clavulanate potassium composition powder for injection, and belongs to the field of medicine and medicine preparation technology. The amoxicillin sodium and clavulanate potassium composition powder comprises following raw material ingredients, by weight, 7.26 to 9.17 parts of amoxicillin sodium and clavulanate potassium, 5.93 to 7.67 parts of chitosan nanoparticle, and 81.38 to 87.10 parts of injection water. Advantages of the amoxicillin sodium and clavulanate potassium composition powder are that: medicine water solubility is increased, and excellent medicine stability is ensured; 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; it is shown by long-term experiment of stability that the amoxicillin sodium and clavulanate potassium composition powder can be stored for 2 years at a temperature of 30 DEG C, and medicine stability and clinical medicine safety in transporting be ensured; amoxicillin sodium and clavulanate potassium coated by the nanoparticle carrier are rapidly gathered at primary organs, such as liver and spleen, in the reticuloendothelial system along veins, so that toxicity caused by nonspecific gathering of medicine is reduced; and 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 freeze-dried powder injection of amoxicillin sodium clavulanate potassium composition for injection. Background technique: [0002] Amoxicillin sodium clavulanate potassium is a compound preparation composed of amoxicillin sodium and clavulanate potassium at a ratio of 7:1, in which amoxicillin sodium mainly acts on the reproduction stage of microorganisms by inhibiting the biosynthesis of cell wall mucopolypeptides And work. Potassium clavulanate has only weak antibacterial activity, but it has a β-lactam structure similar to penicillin, which can block the active site of β-lactamase and inactivate these enzymes produced by most bacteria, especially for Clinically important, plasmid-mediated β-lactamases work better. [0003] Amoxicillin is molecularly unstable, prone to degradation, and has poor water solubility, so its sodium salt is often used i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/722A61K9/19A61K47/36A61P31/04A61K31/43A61K31/424
Inventor 汪六一汪金灿胡珍珍
Owner HAINAN WEI KANG PHARMA QIANSHAN
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