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Mezlocillin sodium composition freeze-dried powder injection for injection

A technology of mezlocillin sodium and freeze-dried powder injection is applied in the field of medicine and medicine manufacturing, and can solve the problem of no chitosan-containing nanoparticles and the like

Inactive Publication Date: 2014-02-05
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chitosan nanoparticles are microparticles with a particle size of less than 100nm. As a drug carrier, they have slow-release and targeting effects and broad-spectrum antibacterial properties. They have certain inhibitory effects on the growth of various bacteria. There are no pharmaceutical dosage forms containing chitosan nanoparticles

Method used

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

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Experimental program
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Effect test

Embodiment 1

[0029] Embodiment 1, the preparation of mezlocillin sodium composition freeze-dried powder for injection, in 1000 pieces.

[0030] 1. Prescription:

[0031] Mezlocillin Sodium 200g

[0032] Chitosan Nanoparticles 100g

[0033] Water for injection 2000ml

[0034] 2. Preparation process:

[0035] The chitosan nanoparticle that takes by weighing 100g is slowly added in the water for injection of 2000ml, stirs while adding, until dissolving.

[0036] Add 200 g of mezlocillin 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 , according to the calculation of 0.2g per bottle of mezlocillin sodium.

[0038] Fill according to the test requirements, put it into a freeze dryer after half...

Embodiment 2

[0039] Embodiment 2, preparation of mezlocillin sodium composition freeze-dried powder for injection, in 1000 pieces.

[0040] 1. Prescription:

[0041] Mezlocillin Sodium 200g

[0042] Chitosan Nanoparticles 130g

[0043] Water for injection 2000ml

[0044] 2. Preparation process:

[0045] The chitosan nanoparticle that takes by weighing 130g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0046] Add 200 g of mezlocillin sodium and stir to dissolve until clear.

[0047] 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 0.2g per bottle of mezlocillin sodium.

[0048] Fill according to the test requirements, put it into a freeze dryer after half-tamping, c...

Embodiment 3

[0049] Embodiment 3, preparation of the freeze-dried powder injection of mezlocillin sodium composition for injection, in 1000 pieces.

[0050] 1. Prescription:

[0051] Mezlocillin Sodium 200g

[0052] Chitosan Nanoparticles 80g

[0053] Water for injection 2000ml

[0054] 2. Preparation process:

[0055] The chitosan nanoparticle that takes by weighing 80g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0056] Add 200 g of mezlocillin sodium and stir to dissolve until clear.

[0057] 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 0.2g per bottle of mezlocillin sodium.

[0058]Fill according to the test requirements, put it into a freeze dryer after ...

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Abstract

The invention provides a mezlocillin sodium composition freeze-dried powder injection for injection and relates to the field of medicines and medicine manufacturing technique. The mezlocillin sodium composition freeze-dried powder injection comprises the following raw materials: by weight, 7.26-9.17 parts of mezlocillin sodium, 3.63-4.58 parts of chitosan nanoparticles and 85.25-89.11 parts of water for injection. The invention has advantages as follows: 1) the composition composed of mezlocillin sodium and the chitosan nanoparticles according to the ratio of 1: 0.5 can raise water solubility of mezlocillin sodium and shorten dissolution time of mezlocillin sodium, and is beneficial to clinic application; 2) the composition can remarkably enhance the antibacterial effect of mezlocillin sodium, minimize dosage of mezlocillin sodium in clinic and reduce adverse reaction of mezlocillin sodium, and in vitro experiments show that 0.2g of mezlocillin sodium containing the chitosan nanoparticles has the same antibacterial efficacy with 0.4g of mezlocillin sodium without the chitosan nanoparticles; and 3) the chitosan nanoparticles can replace mannitol to be used as a freeze-drying skeleton agent of the freeze-dried powder injection so as to eliminate the active effect of mannitol on human body.

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 mezlocillin sodium composition for injection. Background technique: [0002] The chemical name of mezlocillin sodium is (2S, 5R, 6R)-3,3-dimethyl-6-[(R)-2[3-(methylsulfonyl)-2-oxo-1-imidazolidine Acylamino]-2-phenylacetamido]-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic acid sodium salt. [0003] This product is white or off-white powder or crystal or loose block, easily soluble in water, methanol, dimethylformylane, insoluble in ethanol, extremely insoluble in acetone, almost insoluble in isopropanol, ether , chloroform, ethyl acetate, etc. This drug is a broad-spectrum penicillin antibiotic. As the third-generation semi-synthetic penicillin, it has been widely used at home and abroad. It is a commonly used antibacterial drug in clinical practice. It is mainly highly sensitive to Gram-positive bacteria, Gra...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/431A61K47/36A61P31/04
Inventor 汪六一汪金灿林立
Owner HAINAN WEI KANG PHARMA QIANSHAN
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