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Sulbactam sodium composition freeze-dried powder for injection

A technology of sulbactam sodium and freeze-dried powder injection, which is applied in the field of pharmaceuticals and pharmaceutical manufacturing, can solve problems such as cross-allergic phenomena, leukopenia, and elevated liver enzymes, and achieve high sensitivity rate, shortened medication cycle, and elimination of active effects Effect

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, this combined administration method has clinically caused cross-allergic phenomena, and long-term medication has seen adverse reactions such as elevated liver enzymes, anemia, thrombocytopenia, and leukopenia.

Method used

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  • Sulbactam sodium composition freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0033] prescription:

[0034] Sulbactam Sodium 60g

[0035] Chitosan Nanoparticles 42g

[0036] Water for injection 2000ml

[0037] 2. Preparation process:

[0038] The chitosan nanoparticle that takes by weighing 42g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0039] Add 60 g of sulbactam 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 the calculation of 60mg per bottle of sulbactam sodium.

[0041] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40...

Embodiment 2

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

[0043] 1. Prescription:

[0044] Sulbactam Sodium 60g

[0045] Chitosan Nanoparticles 35g

[0046] Water for injection 2000ml

[0047] 2. Preparation process:

[0048] The chitosan nanoparticle that takes by weighing 35g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0049] Add 60 g of sulbactam 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 the calculation of 60mg per bottle of sulbactam sodium.

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

Embodiment 3

[0052] Example 3: Preparation of sulbactam sodium composition freeze-dried powder for injection, in 1000 pieces.

[0053] prescription:

[0054] Sulbactam Sodium 60g

[0055] Chitosan Nanoparticles 56g

[0056] Water for injection 2000ml

[0057] 2. Preparation process:

[0058] The chitosan nanoparticle that takes by weighing 56g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0059] Add 60 g of sulbactam 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 the calculation of 60mg per bottle of sulbactam sodium.

[0061] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C,...

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PUM

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Abstract

The invention provides a sulbactam sodium composition freeze-dried powder for injection, and belongs to the field of medicine and medicine preparation technology. The sulbactam sodium composition freeze-dried powder comprises following raw material ingredients, by weight, 7.26 to 9.17 parts of sulbactam sodium, 6.02 to 7.97 parts of chitosan nanoparticle, and 81.34 to 87.55 parts of injection water. Advantages of the sulbactam sodium composition freeze-dried powder are that: 1) the sulbactam sodium composition freeze-dried powder possesses excellent synergistic antimicrobial effect with sulbactam sodium, antibiotic sensitive rate of various bacteria on the sulbactam sodium composition freeze-dried powder is high; 2) stability of sulbactam sodium against beta-lactamase is increased, and in vivo distribution is excellent; 3) improvement of activity is capable of shortening medication cycle of patients, and reducing occurrence likelihood of adverse reaction caused by accumulation of sulbactam sodium; 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 sulbactam sodium composition freeze-dried powder for injection. Background technique: [0002] Chemical name: (2S,5R)-3,3-Dimethyl-7-oxo-4-thia-1-azabicyclo[3,2,0]heptane-2-carboxylate sodium-4, 4-dioxide. [0003] Molecular formula: C8H10NNaO5S. Molecular weight: 255.22. [0004] Structural formula: [0005] Properties: Sulbactam Sodium is white or off-white crystalline powder, with slight peculiar smell and slightly bitter taste. Soluble in water, slightly soluble in methanol, very slightly soluble in ethanol, almost insoluble in acetone or ethyl acetate. [0006] Sulbactam sodium is a synthetic irreversible competitive β-lactamase inhibitor, which is usually used in combination with penicillins and cephalosporins to prevent it from being destroyed by β-lactamase and enhance antibacterial activity. Respiratory system, urinary system, skin an...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/43A61K47/36A61P31/04A61K31/722
Inventor 汪六一汪金灿周顶文
Owner HAINAN WEI KANG PHARMA QIANSHAN
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