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Lyophilized levofloxacin composition powder for injection

A technology of levofloxacin and freeze-dried powder injection, which can be used in freeze-dried delivery, drug combination, powder delivery and other directions, and can solve the problem of no chitosan-containing nanoparticle pharmaceutical dosage form.

Inactive Publication Date: 2014-03-05
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 sustained-release and targeting effects, but there is no clinically available pharmaceutical dosage form containing chitosan nanoparticles.

Method used

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  • Lyophilized levofloxacin composition powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1, the preparation of esomeprazole sodium freeze-dried powder for injection, in 1000 pieces.

[0029] 1. Prescription:

[0030] Esomeprazole Sodium 40g

[0031] Chitosan Nanoparticles 20g

[0032] Water for injection 2000ml

[0033] 2. Preparation process.

[0034] The chitosan nanoparticle that takes by weighing 20g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0035] Add 40 g of esomeprazole sodium and stir to dissolve until clear.

[0036] Adjust the pH to 10-11, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and then filter the liquid through 0.45μm and 0.22μm microporous membranes to detect the content of intermediates, calculated as per bottle of esomeprazole sodium 40mg calculated loading.

[0037] It is filled according to the inspection requirements, and then sent to the freeze dryer after half-tightening.

Embodiment 2

[0038] Embodiment 2, the preparation of esomeprazole sodium freeze-dried powder for injection, in 1000 pieces.

[0039] 1. Prescription:

[0040] Esomeprazole Sodium 40g

[0041] Chitosan Nanoparticles 14g

[0042] Water for injection 2000ml

[0043] 2. Preparation process.

[0044] The chitosan nanoparticle that takes by weighing 14g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0045] Add 40 g of esomeprazole sodium and stir to dissolve until clear.

[0046] Adjust the pH to 10-11, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and then filter the liquid through 0.45μm and 0.22μm microporous membranes to detect the content of intermediates, calculated as per bottle of esomeprazole sodium 40mg calculated loading.

[0047] It is filled according to the inspection requirements, and then sent to the freeze dryer after half-tightening.

Embodiment 3

[0048] Embodiment 3, the preparation of esomeprazole sodium freeze-dried powder for injection, in 1000 pieces.

[0049] 1. Prescription:

[0050] Esomeprazole Sodium 40g

[0051] Chitosan Nanoparticles 29g

[0052] Water for injection 2000ml

[0053] 2. Preparation process.

[0054] The chitosan nanoparticle that takes by weighing 29g is slowly added in the water for injection of 2000ml, stirs while adding, until dissolving.

[0055] Add 40 g of esomeprazole sodium and stir to dissolve until clear.

[0056] Adjust the pH to 10-11, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and then filter the liquid through 0.45μm and 0.22μm microporous membranes to detect the content of intermediates, calculated as per bottle of esomeprazole sodium 40mg calculated loading.

[0057] It is filled according to the inspection requirements, and then sent to the freeze dryer after half-tightening.

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Abstract

The present invention provides lyophilized levofloxacin composition powder for injection, and relates to the technical field of drugs and drug production. The lyophilized levofloxacin composition powder comprises the following raw material components, by weight: 1.75-2.14 parts of esomeprazole sodium, 0.87-1.07 parts of chitosan nanoparticles, and 94.80-97.38 parts of water for injection. The lyophilized levofloxacin composition powder has the following advantages that: 1) the poor stability problem of the principal agent is overcome, and long-term storage is easily achieved; 2) the composition has an in vivo synergistic effect, can be provided for clinically treating stomach ulcers, gastroesophageal reflux diseases, duodenal ulcers and the like, and has a characteristic of rapid efficacy, and in vitro experiment results verify that the 40 mg of esomeprazole sodium containing the chitosan nanoparticles provides the same gastric acid secretion inhibition effect as the 60 mg of chitosan nanoparticle-free esomeprazole sodium; 3) the patient treatment period is shortened with the enhanced activity, such that the possibility of adverse reaction occurrence caused by esomeprazole sodium is reduced; and 4) the chitosan nanoparticles can be adopted to replace mannitol so as to be adopted as the lyophilized skeleton agent of the lyophilized powder injection, such that the activity effect of mannitol on human body is eliminated.

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] The chemical name of esomeprazole sodium is S-5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]-3H-benzene And imidazole. Esomeprazole sodium is the S isomer of omeprazole, which reduces gastric acid secretion through a specific targeting mechanism and is a specific inhibitor of proton pumps in parietal cells. The site and mechanism of action are: esomeprazole sodium is a weak base, which is concentrated and converted into an active form in the high-acid environment of acid-secreting microtubules in parietal cells, thereby inhibiting the H+ / K+-ATPase (proton pump), inhibits both basal and stimulated gastric acid secretion. [0003] The storage stability and physical properties of esomeprazole sodium free base are not ideal. The melting point of ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K31/5383A61K47/36A61P1/04A61P31/04
Inventor 汪六一汪金灿江婷
Owner HAINAN WEI KANG PHARMA QIANSHAN
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