Cefpodoxime proxetil composition freeze-dried powder injection for injection

A technology of cefpodoxime axetil and freeze-dried powder injection, which is applied in the field of medicine and medicine manufacturing, can solve the problems of not containing chitosan nanoparticles, avoid nephrotoxicity and hemolysis, reduce dosage, and be beneficial to clinical application Effect

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

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 ant

Method used

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  • Cefpodoxime proxetil composition freeze-dried powder injection for injection
  • Cefpodoxime proxetil composition freeze-dried powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1. Preparation of lyophilized powder injection of cefpodoxime axetil composition for injection (specification: 100 mg, calculated as cefpodoxime axetil), in 1000 vials.

[0035] 1. Prescription:

[0036] Cefpodoxime Proxetil 100g

[0037] Chitosan Nanoparticles 50g

[0038] Water for injection 2000ml

[0039] 2. Preparation process:

[0040] 1) Slowly add the prescribed amount of chitosan nanoparticles into the prescribed amount of water for injection, and stir until dissolved while adding.

[0041] 2) Add the prescribed amount of cefpodoxime axetil and stir to dissolve until clear.

[0042] 3) Use sodium hydroxide to adjust the pH to 6.0, 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, calculated as cefpodoxime axetil 0.2g per bottle is calculated as filling volume.

[0043] 4) Fill according to the test re...

Embodiment 2

[0044] Example 2. Preparation of lyophilized powder injection of cefpodoxime axetil composition for injection (specification: 100 mg, calculated as cefpodoxime axetil), calculated in 1000 vials.

[0045] 1. Prescription:

[0046] Cefpodoxime Proxetil 100g

[0047] Chitosan Nanoparticles 60g

[0048] Water for injection 2000ml

[0049] 2. Preparation process:

[0050] 1) Slowly add the prescribed amount of chitosan nanoparticles into the prescribed amount of water for injection, and stir until dissolved while adding.

[0051] 2) Add the prescribed amount of cefpodoxime axetil and stir to dissolve until clear.

[0052] 3) Use sodium hydroxide to adjust the pH to 6.0, 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, calculated as cefpodoxime axetil 0.2g per bottle is calculated as filling volume.

[0053] 4) Fill according to ...

Embodiment 3

[0054] Example 3. Preparation of lyophilized powder injection of cefpodoxime axetil composition for injection (specification: 100 mg, calculated as cefpodoxime axetil), calculated in 1000 vials.

[0055] 1. Prescription:

[0056] Cefpodoxime Proxetil 100g

[0057] Chitosan Nanoparticles 40g

[0058] Water for injection 2000ml

[0059] 2. Preparation process:

[0060] 1) Slowly add the prescribed amount of chitosan nanoparticles into the prescribed amount of water for injection, and stir until dissolved while adding.

[0061] 2) Add the prescribed amount of cefpodoxime axetil and stir to dissolve until clear.

[0062] 3) Use sodium hydroxide to adjust the pH to 6.0, 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, calculated as cefpodoxime axetil 0.2g per bottle is calculated as filling volume.

[0063] 4) Fill according to th...

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Abstract

The invention provides a cefpodoxime proxetil composition freeze-dried powder injection for injection and relates to the field of medicines and medicine manufacturing technique. The cefpodoxime proxetil composition freeze-dried powder injection comprises the following raw materials: by weight, 1 part of cefpodoxime proxetil, 0.1-1.0 part of chitosan nanoparticles and 10-20 parts of water for injection. The invention has advantages as follows: 1) the composition can raise water solubility of cefpodoxime proxetil and shorten dissolution time of cefpodoxime proxetil and is beneficial to clinic application, and chitosan in the composition can be used as a cosolvent to replace beta-cyclodextrin so as to avoid renal toxicity and hemolytic activity of beta-cyclodextrin to human body; 2) the composition can remarkably enhance the antibacterial effect of cefpodoxime proxetil, can be used to reduce dosage of cefpodoxime proxetil in clinic and reduce adverse reaction of cefpodoxime proxetil, and in vitro experiments show that 0.1g of the cefpodoxime proxetil composition freeze-dried powder injection containing the chitosan nanoparticles has the same antibacterial efficacy with 0.2g of cefpodoxime proxetil 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 cefpodoxime axetil composition freeze-dried powder for injection. Background technique: [0002] Cefpodoxime proxetil (CPDX-PR) is the third-generation cephalosporin, which was first launched in Japan in 1990. Its structural feature is that the 7th position of the cephalosporin skeleton is connected with a methoxyiminothiazolyl group, and the 3rd position is connected with a methoxymethazolyl group. There is a roxetil group on the 4-position carboxylic acid, and its chemical structure is as follows. Cefpodoxime axetil is easily soluble in methanol or acetonitrile, easily soluble in ethanol, slightly soluble in ether, and very slightly soluble in water. [0003] [0004] CPDX-PR is the prodrug of cefpodoxime (CPDX), which itself has no antibacterial activity. It is absorbed through the intestinal tract after oral administration, and is hydrolyzed i...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/546A61K47/36A61K31/722A61P31/04
Inventor 汪六一汪金灿顾建军
Owner HAINAN WEI KANG PHARMA QIANSHAN
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