Ornidazole injection and preparing method thereof

A technology for ornidazole injection and injection, which can be used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve problems such as potential safety hazards, and achieve clinical use safety and quality , suitable for industrial production

Active Publication Date: 2014-09-03
江苏凌霄科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

safety

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  • Ornidazole injection and preparing method thereof
  • Ornidazole injection and preparing method thereof
  • Ornidazole injection and preparing method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0021] A kind of ornidazole injection, wherein, the content of ornidazole is 5000g, the balance is added with solvent to make the total solution volume about 10000ml, and the solvent is absolute ethanol.

[0022] Its preparation method adopts the following steps:

[0023] (1) Equipment treatment: Filter the high-heat compressed air at 180°C and pass it into the liquid distribution tank and pipeline for sterilization, depyrogenation and water removal, and put the utensils into the sterilization cabinet for high-temperature sterilization;

[0024] (2) Preparation of liquid medicine: first inject about 20% solvent (about 2000ml) into the liquid preparation tank, add 5000g ornidazole into the liquid preparation tank under stirring, add the remaining amount of solvent, seal it, and heat it to 45 ~55℃ dissolves to obtain about 10000ml of liquid medicine;

[0025] (3) carbon adsorption: add 20g gac to medicinal liquid, 60 revs / min stirring and adsorbing for 30 minutes, filter with 0...

Embodiment 2

[0033] An ornidazole injection, containing 5000g of ornidazole, the balance is added with a solvent to make the total solution volume about 15000ml, and the solvent is absolute ethanol.

[0034] The preparation method of above-mentioned ornidazole injection adopts following steps:

[0035] (1) Equipment treatment: Filter high-temperature compressed air at 200°C and pass it into the liquid distribution tank and pipeline for sterilization, depyrogenation, and moisture removal, and put the equipment into the sterilization cabinet for high-temperature sterilization.

[0036] (2) Preparation of liquid medicine: first inject 40% solvent (about 6000ml) into the liquid preparation tank, add ornidazole into the liquid preparation tank under stirring, add the remaining amount of solvent, seal and heat to 45-55°C Dissolved to obtain about 15000ml of liquid medicine;

[0037] (3) Carbon adsorption: add 15g of activated carbon to the medicinal liquid, stir and adsorb at 60 rpm for 30 minu...

Embodiment 3

[0045] An ornidazole injection, containing 5000g of ornidazole, the balance is added with a solvent to make the total solution volume about 18000ml, and the solvent is absolute ethanol.

[0046] The preparation method of above-mentioned ornidazole injection adopts the following steps:

[0047] (1) Equipment treatment: Filter the high-heat compressed air at 250°C and pass it into the liquid distribution tank and pipeline for sterilization, depyrogenation and moisture removal, and put the utensils into the sterilization cabinet for high-temperature sterilization.

[0048] (2) Preparation of liquid medicine: first inject about 70% (12600ml) of solvent into the liquid preparation tank, add ornidazole into the liquid preparation tank under stirring, add the remaining amount of solvent, seal and heat properly at 45-55°C to dissolve Liquid about 18000ml;

[0049] (3) Carbon adsorption: add 20 g of activated carbon to the medicinal liquid, stir and adsorb for 30 minutes at 80 rpm, an...

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Abstract

The invention discloses an ornidazole injection and a preparing method thereof. The metric injection volume of the ornidazole injection is 1-2 mL. The ornidazole concentration is 0.25-0.5 g/mL. The solvent of the injection is absolute ethyl alcohol or a mixture of absolute ethyl alcohol and glycerol. A finished product of the ornidazole injection is extremely low in impurity content, good in stability and extremely stable in guarantee period. Compared with originally developed ornidazole injections, the ornidazole injection provided by the invention is free of propylene glycol, and is better in clinical using safety, less in medical risk and simpler in preparation process.

Description

technical field [0001] The invention relates to the technical field of medicine manufacture, in particular to an ornidazole injection and a preparation method thereof. Background technique [0002] Ornidazole (Omidazole) is a drug against anaerobic bacteria and antiprotozoal infection. It is a nitroimidazole derivative without disulfiram-like effect. Its antimicrobial effect is through the reduction of nitro groups in its molecules to amino groups in an oxygen-free environment or through the interaction of free radicals with microbial cell components, resulting in the death of microorganisms. It is used to treat various diseases caused by anaerobic bacteria, amoeba, giardia, trichomonas and other infections. It has the advantages of high curative effect, good tolerance, good tissue permeability and wide distribution in the body. A substitute for metronidazole and tinidazole. Its good anti-anaerobic bacteria and anti-protozoal (such as trichomonas, etc.) infection effect ma...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4164A61K47/10A61P31/04A61P33/02
Inventor 魏国林
Owner 江苏凌霄科技发展有限公司
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