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Pefloxacin mesylate composition freeze-dried powder for injection

A technology of pefloxacin mesylate and freeze-dried powder injection, which is applied in the field of freeze-dried powder injection of pefloxacin mesylate composition for injection, and can solve the problem of increasing drug targeting, reducing toxicity, and increasing drug solubility and other problems to achieve the effect of avoiding rapid removal, eliminating active effects, and overcoming biological barriers

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

[0007] Chitosan nanoparticles are microparticles with a particle size of less than 100nm. As a drug delivery system, they can increase drug solubility, prolong the residence time of drugs in the body, increase drug targeting and reduce toxicity, and have broad-spectrum antibacterial properties. The growth of all kinds of bacteria has a certain inhibitory effect, but there is no pharmaceutical dosage form containing chitosan nanoparticles in clinical practice.

Method used

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  • Pefloxacin mesylate composition freeze-dried powder for injection
  • Pefloxacin mesylate composition freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1, preparation of pefloxacin mesylate composition freeze-dried powder for injection, in 1000 pieces.

[0031] prescription:

[0032] Pefloxacin Mesylate 200g

[0033] Chitosan Nanoparticles 140g

[0034] Water for injection 2000ml

[0035] 2. Preparation process:

[0036] The chitosan nanoparticle that takes by weighing 140g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0037] Add 200 g of pefloxacin mesylate and stir to dissolve until clear.

[0038] 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 pefloxacin mesylate 0.2g per bottle to calculate the loading.

[0039] Fill according to the test requirements, put it into a freeze dryer after half-tam...

Embodiment 2

[0040] Embodiment 2, preparation of pefloxacin mesylate composition freeze-dried powder for injection, in 1000 pieces.

[0041] 1. Prescription:

[0042] Pefloxacin Mesylate 200g

[0043] Chitosan Nanoparticles 128g

[0044] Water for injection 2000ml

[0045] 2. Preparation process:

[0046] The chitosan nanoparticle that takes by weighing 128g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0047] Add 200 g of pefloxacin mesylate and stir to dissolve until clear.

[0048] 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 pefloxacin mesylate 0.2g per bottle to calculate the loading.

[0049] Fill according to the test requirements, put it into a freeze dryer after half-...

Embodiment 3

[0050] Example 3. Preparation of lyophilized powder injection of pefloxacin mesylate composition for injection, in 1000 vials.

[0051] prescription:

[0052] Pefloxacin Mesylate 200g

[0053] Chitosan Nanoparticles 152g

[0054] Water for injection 2000ml

[0055] 2. Preparation process:

[0056] The chitosan nanoparticle that takes by weighing 152g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0057] Add 200 g of pefloxacin mesylate and stir to dissolve until clear.

[0058] 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 pefloxacin mesylate 0.2g per bottle to calculate the loading.

[0059] Fill according to the test requirements, put it into a freeze dryer after ...

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Abstract

The invention provides a pefloxacin mesylate composition freeze-dried powder for injection, and belongs to the field of medicine and medicine preparation technology. The pefloxacin mesylate composition freeze-dried powder comprises following raw material ingredients, by weight, 7.26 to 9.17 parts of pefloxacin mesylate, 5.45 to 6.84 parts of chitosan nanoparticle, and 83.99 to 89.29 parts of injection water. Advantages of the pefloxacin mesylate composition freeze-dried powder are that: 1) the pefloxacin mesylate composition is capable of increasing antibacterial activities of pefloxacin mesylate on klebsiella, enterobacter and serratia significantly; 2) the size of the chitosan nanoparticle is ultra small, so that the chitosan nanoparticle is capable of passing through capillary vessels with a smallest diameter, and overcoming biological barriers, and rapid removing of the chitosan nanoparticle by macrophage is avoided, so that lasting time of the pefloxacin mesylate composition in blood is prolonged greatly; and 3) 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 pefloxacin mesylate composition freeze-dried powder for injection. Background technique: [0002] Pefloxacin mesylate is a quinolone antibacterial drug with broad-spectrum antibacterial activity. By acting on the A subunit of bacterial DNA helicase, it inhibits DNA synthesis and replication, leading to bacterial death. The currently marketed dosage forms are mainly creams, capsules, and tablets, and their structural formulas are as follows: [0003] [0004] For a long time, suppurative meningitis and septicemia caused by Klebsiella, Enterobacter, and Serratia have fewer antibacterial varieties, and similar drugs are often used repeatedly and in excess, and drug-resistant strains continue to appear, resulting in continuous drug consumption. increased, with poor results. Some antibacterial drugs have great side effects on the human body, and even...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/496A61K47/36A61P31/04A61K31/722
Inventor 汪六一汪金灿胡珍珍
Owner HAINAN WEI KANG PHARMA QIANSHAN
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