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Ornidazole injection and preparation method thereof

An ornidazole injection and a technology for ornidazole, which are applied in the field of medicines, can solve the problems of decreased ornidazole content, intolerance of side effects, increased medical risks, etc., so as to increase dosage, ensure stability, and avoid toxicity. Effects of side effects

Active Publication Date: 2014-06-11
JINAN RUIFENG PHARMA +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ornidazole injections are already on the market in China, but after the existing ornidazole injections are sterilized by high temperature, the content of ornidazole will decrease, so it is necessary to add propylene glycol as a stabilizer to make the ornidazole injections Keep stable, and consumption is bigger, but adopt propylene glycol to make stabilizing agent, have bigger side effect, exceed the side effect that the propylene glycol administration dose of 25mg / kg every day can cause human body intolerance, as injection solvent, propylene glycol also has certain stimulant effect, increasing the medical risk

Method used

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  • Ornidazole injection and preparation method thereof
  • Ornidazole injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The ornidazole injection comprises 500 g of ornidazole, and the remaining amount is added with a solvent to make the total solution volume reach 2000 ml.

[0022] The solvent is a mixed solution of absolute ethanol and water for injection, wherein the absolute ethanol is 1600ml, and the balance is water for injection.

[0023] The preparation method of this ornidazole injection adopts the following steps:

[0024] (1) Preparation of medicinal liquid: first inject 1200ml of solvent into the liquid preparation tank, then add 500g of ornidazole into the liquid preparation tank, stir to dissolve, then add the remaining amount of solvent, stir and mix to obtain the total medicinal liquid;

[0025] (2) Impurity removal and pyrogen removal: add 7g gac to the total medicinal liquid prepared in step (1), stir and absorb for 30 minutes, filter with 0.22 micron microporous membrane, check;

[0026] (3) Filling and packaging: the total liquid medicine qualified in step (2) is fill...

Embodiment 2

[0032] The ornidazole injection comprises 500 g of ornidazole, and the remaining amount is added with a solvent to make the total solution volume reach 2000 ml.

[0033] The solvent is a mixed solution of absolute ethanol and water for injection, wherein the absolute ethanol is 1300ml, and the balance is water for injection.

[0034] The preparation method of this ornidazole injection adopts the following steps:

[0035] (1) Preparation of medicinal liquid: first inject 1200ml of solvent into the liquid preparation tank, then add 500g of ornidazole into the liquid preparation tank, stir to dissolve, then add the remaining amount of solvent, stir and mix to obtain the total medicinal liquid;

[0036] (2) Impurity removal and pyrogen removal: add 4g gac to the total medicinal liquid prepared in step (1), stir and absorb for 30 minutes, filter with 0.22 micron microporous membrane, check;

[0037] (3) Filling and packaging: the total liquid medicine qualified in step (2) is fill...

Embodiment 3

[0042] The ornidazole injection comprises 500 g of ornidazole, and the remaining amount is added with a solvent to make the total solution volume reach 2000 ml.

[0043] The solvent is absolute ethanol.

[0044] The preparation method of this ornidazole injection adopts the following steps:

[0045] (1) Preparation of medicinal liquid: first inject 1200ml of solvent into the liquid preparation tank, then add 500g of ornidazole into the liquid preparation tank, stir to dissolve, then add the remaining amount of solvent, stir and mix to obtain the total medicinal liquid;

[0046] (2) Impurity removal and pyrogen removal: add 10 g of gac to the total medicinal solution prepared in step (1), stir and adsorb for 30 minutes, filter with a 0.22 micron microporous membrane, and check;

[0047] (3) Filling and packaging: the total liquid medicine qualified in step (2) is filled and sealed, sterilized, leak tested, light checked, and packaged.

[0048] During the above preparation pro...

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Abstract

The invention relates to the technical field of medicines, and particularly discloses an ornidazole injection and a preparation method thereof. The ornidazole injection comprises 500 grams of ornidazole and the balance of solvents added till the volume of total liquid medicine is 2000-3000 milliliters. The ornidazole injection and the preparation method thereof which are disclosed by the invention have the advantages of simple process, low cost, safety and reliability. Compared with the traditional ornidazole injection, the ornidazole injection increases the using amount of anhydrous ethanol without adding propanediol, plays cosolvent and stabilizer roles through the anhydrous ethanol, ensures the stability of the injection by reducing the impurity content of the injection, is convenience for clinical application, prevents the toxic and side effects of the propanediol on human bodies because the ethanol is safer than the propanediol and reduces the medical risk.

Description

(1) Technical field [0001] The invention relates to the technical field of medicines, in particular to an ornidazole injection and a preparation method thereof. (2) Background technology [0002] Ornidazole (Ornidazole), whose chemical name is 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole, is a powerful anti-anaerobic and antiprotozoal drug. The third generation of nitroimidazole derivatives after nitrazole and tinidazole, which play a role in microorganisms through the reduction of the nitro group in its molecules to amino groups in an oxygen-free environment or through the formation of free radicals, interacting with cellular components , leading to the death of microorganisms, can be widely used to treat various diseases caused by anaerobic bacteria, amoeba, giardia, trichomonas and other infections, with high curative effect, good tolerance and good tissue permeability , wide distribution in the body and so on. Since its listing in the 1970s, due to its good a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4164A61P31/04A61P33/02
Inventor 刘效祥许馨文翁莉霞李红侠姚冬娜
Owner JINAN RUIFENG PHARMA
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