Levo-ornidazole freeze-dried powder injection

A technology of levo-ornidazole and needle injections, which is applied in the field of pharmaceuticals, and can solve the problems of preparation methods of levo-ornidazole freeze-dried powder injections, infusion preparations, injection transportation, inconvenient storage, and levo-ornidazole oral preparations. Low efficacy and other issues, to achieve excellent curative effect, convenient transportation, and good stability

Inactive Publication Date: 2006-08-23
GUANGDONG XIANQIANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Due to the low drug efficacy of oral preparations of levonidazole, and inconvenient transportation and storage of infusion preparations and injections, etc., and stability will also be affected, it i

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The levo-ornidazole freeze-dried powder injection was prepared according to the following formula.

[0027] Specific formula:

[0028] Levonidazole 250g

[0029] Dextran 50g

[0030] Propylene glycol 2500ml

[0031] Add water for injection to 3000ml

[0032] A total of 1000 bottles of freeze-dried products were produced

[0033] Specific steps are as follows:

[0034] Preparation of liquid medicine:

[0035] Weigh L-ornidazole, add it to propylene glycol, add an appropriate amount of water for injection, stir and dissolve; add the prescribed amount of dextran to the above solution, stir well, add water for injection to the full amount, stir evenly, and use 0.1mol / L hydrochloric acid Adjust the pH of the solution to 4.0.

[0036] Depyrogenation and sterilization:

[0037] Add 0.1% (W / V) activated carbon for needles to the above solution, stir for 20 to 30 minutes, and then filter and sterilize with a 0.22 μm microporous membrane;

[0038] Filling:

[0039] (1) ...

Embodiment 2

[0046] The levo-ornidazole freeze-dried powder injection was prepared according to the following formula.

[0047] Specific formula:

[0048] Levonidazole 125g

[0049]Mannitol 25g

[0050] Propylene glycol 1250ml

[0051] Add water for injection to 2000ml

[0052] A total of 1000 bottles of freeze-dried products were produced

[0053] Specific steps are as follows:

[0054] Preparation of liquid medicine:

[0055] Weigh L-ornidazole, add it to propylene glycol, add an appropriate amount of water for injection, and stir to dissolve; add the prescribed amount of mannitol to the above solution, stir well, add water for injection to the full amount, stir evenly, and use 0.1mol / L The pH of the solution was adjusted to 4.0 with hydrochloric acid.

[0056] Depyrogenation and sterilization:

[0057] Add 0.1% (W / V) activated carbon for needles to the above solution, stir for 20 to 30 minutes, and then filter and sterilize with a 0.22 μm microporous membrane;

[0058] Filling:...

Embodiment 3

[0066] The levo-ornidazole freeze-dried powder injection was prepared according to the following formula.

[0067] Specific formula:

[0068] Levonidazole 250g

[0069] Dextran 50g

[0070] Polyethylene glycol 100g

[0071] Add water for injection to 2000ml

[0072] A total of 1000 bottles of freeze-dried products were produced

[0073] Specific steps are as follows:

[0074] Preparation of liquid medicine:

[0075] Weigh L-ornidazole and polyethylene glycol, add them to about 1600ml of water for injection, stir well to dissolve them, then add the prescribed amount of dextran to the above solution, stir to dissolve, add water for injection to the full amount, stir evenly, Adjust the pH of the solution to 4.0 with 0.1 mol / L hydrochloric acid.

[0076] Depyrogenation and sterilization:

[0077] Add 0.1% (W / V) activated carbon for needles to the above solution, stir for 20 to 30 minutes, and then filter and sterilize with a 0.22 μm microporous membrane;

[0078] Filling:...

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PUM

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Abstract

The present invention discloses freeze dried levo-ornidazole powder for injection as one anaerobic bacteria infection resisting medicine. The freeze dried levo-ornidazole powder for injection includes levo-ornidazole as main medicinal component and pharmaceutically acceptable carrier, includes solvent selected from one or several of ethanol, propylene glycol, glycerin, polyethylene glycol, Tween-80, etc. The freeze dried levo-ornidazole powder for injection may be prepared into specification containing levo-ornidazole of 1-2000 mg, preferably 0.25-1.5g and especially 0.25g, 0.5g and 1.0g. It has high stability, high curative effect and other features.

Description

technical field [0001] The invention relates to a medicine, more specifically, the invention relates to a freeze-dried powder injection of L-ornidazole, an anti-anaerobe infection drug, and a preparation method thereof. Background technique [0002] Levo-ornidazole is the left-handed form of ornidazole (Omidazole, CAS 16773-42-5), and its chemical name is 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole , the molecular formula is C 7 h 10 ClN 2 o 3 , the molecular weight is 219.6. [0003] Ornidazole is a third-generation nitroimidazole derivative, which is a powerful drug against anaerobic bacteria and antiprotozoal infections. The antibacterial effect of ornidazole is through the reduction of the nitro group in the molecule to an amino group in an oxygen-free environment, or through the formation of free radicals to interact with cell components, resulting in the death of microorganisms. [0004] At present, all ornidazole preparations on the market use ornidaz...

Claims

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Application Information

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IPC IPC(8): A61K31/4164A61K9/19A61P31/04
Inventor 刘春平康秋萍李云霞李绍安
Owner GUANGDONG XIANQIANG PHARMA
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