Levofloxacin composition freeze-dried powder for injection

A technology of levofloxacin and freeze-dried powder injection, which is applied in the field of medicine and medicine manufacturing

Inactive Publication Date: 2014-02-19
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in order to be pharmaceutically effective, this single dosage form must meet various scalability requirements such as stability

Method used

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  • Levofloxacin composition freeze-dried powder for injection
  • Levofloxacin composition freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1, preparation of levofloxacin composition freeze-dried powder for injection, in 1000 pieces.

[0029] Prescription:

[0030] Levofloxacin 200g

[0031] Chitosan Nanoparticles 120g

[0032] Water for injection 2000ml

[0033] 2. Preparation process:

[0034] The chitosan nanoparticle that takes by weighing 120g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0035] Add 200 g of levofloxacin and stir to dissolve until clear.

[0036] 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 levofloxacin 0.2g per bottle to calculate the filling volume.

[0037] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C...

Embodiment 2

[0038] Embodiment 2, preparation of levofloxacin composition freeze-dried powder for injection, in 1000 pieces.

[0039] 1. Prescription:

[0040] Levofloxacin 200g

[0041] Chitosan Nanoparticles 109g

[0042] Water for injection 2000ml

[0043] 2. Preparation process:

[0044] The chitosan nanoparticle that takes by weighing 109g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0045] Add 200 g of levofloxacin and stir to dissolve until clear.

[0046] 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 levofloxacin 0.2g per bottle to calculate the filling volume.

[0047] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -4...

Embodiment 3

[0048] Embodiment 3, preparation of levofloxacin composition freeze-dried powder for injection, in 1000 pieces.

[0049] Prescription:

[0050] Levofloxacin 200g

[0051] Chitosan Nanoparticles 135g

[0052] Water for injection 2000ml

[0053] 2. Preparation process:

[0054] The chitosan nanoparticle that takes by weighing 135g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0055] Add 200 g of levofloxacin and stir to dissolve until clear.

[0056] 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 levofloxacin 0.2g per bottle to calculate the filling volume.

[0057]Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C,...

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Abstract

The invention provides levofloxacin composition freeze-dried powder for injection, relates to the technical field of medicaments and medicament preparation, and comprises the following raw material components in parts by weight: 7.26-9.17 parts of levofloxacin, 4.65-6.76 parts of chitosan nanoparticles and 73.34-87.10 parts of water for injection. The levofloxacin composition freeze-dried powder for injection disclosed by the invention has the advantages that the composition can maintain a higher drug concentration for a long term, and thus the levofloxacin composition freeze-dried powder has a certain slow release function; compared with the single used levofloxacin, the composition has an obvious colon specific targeted drug release characteristic during in-vivo drug release; the antibacterial activity is obviously enhanced and the medication period of a patient is shortened, and the probability of side reaction caused by accumulated levofloxacin is reduced; and the chitosan nanoparticles can replace mannitol to be used as a freeze-drying skeleton agent for freeze-dried powder, thus eliminating activation of mannitol to a human body.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a levofloxacin composition freeze-dried powder for injection. Background technique: [0002] Levofloxacin is the L-body of ofloxacin, and its in vitro antibacterial activity is about twice that of ofloxacin. Its mechanism of action is to prevent bacterial DNA synthesis and replication by inhibiting the activity of bacterial DNA gyrase, leading to bacterial death. The drug has achieved good curative effect in the treatment of respiratory tract infection, genitourinary system infection and skin and soft tissue infection. [0003] The colon is the largest library of bacteria and toxins in the human body, and bacteria account for one-half of the dry weight of the contents of the colon. source of infection. Normal intestinal mucosal tissue has a strong barrier function, but when the colon is damaged, it not only leads to severe pollution in the abdominal ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/5383A61K47/36A61P31/04A61K31/722
Inventor 汪六一汪金灿汪宁卿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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