Ornidazole injection and preparation method thereof

An ornidazole injection and a technology for injection, which are applied in directions such as pharmaceutical formulations, drug delivery, and antibacterial drugs, can solve the problems of excessive insoluble particles, strong vascular irritation, potential safety hazards, and the like, and achieve a simple preparation method, suitable for The effect of safety in industrial production and clinical use

Inactive Publication Date: 2017-12-22
SHANDONG HUBBLE KISEN BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] (1) The original preparation Tiberal contains a large amount of propylene glycol to keep ornidazole injection stable, and the safe range of propylene glycol is that the dosage does not exceed 25mg/kg per day. Each tube of Tiberal contains about 1.4g of propylene glycol, which is the first in clinical use. Ornidazole is 1g for a single dose, and the specification of Tiberal is 0.5g/cartridge, so two cartridges are needed, that is, propylene glycol is about 2.8g, which is 40mg/kg for a 70kg person, which exceeds the safe range of the human body and has potential safety hazards
[0005] (2) Most of the domestic generic drug preparations use water for injection as the solvent, but the water solubility of ornidazole is not good under neutral conditions. It is basically

Method used

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

Examples

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Effect test

Embodiment 1

[0029] An ornidazole injection, wherein the content of ornidazole is 450g, and the remainder is added with a solvent to make the total volume 3000ml. The solvent is a mixed solution of absolute ethanol and polyethylene glycol-15-hydroxystearate, wherein the mass ratio of polyethylene glycol-15-hydroxystearate is 4%.

[0030] Its preparation method adopts the following steps:

[0031] (1) Equipment treatment: Filter the high-heat compressed air at 180°C through the liquid distribution tank and pipelines for sterilization, depyrogenation, and water removal, and put the equipment into the sterilization cabinet for high-temperature sterilization;

[0032] (2) Solvent preparation: melt polyethylene glycol-15-hydroxystearate in a water bath at 37°C, add the liquid polyethylene glycol-15-hydroxystearate in the formulated amount to the formulated amount of ethanol, and stir Disperse evenly.

[0033] (3) Prepare the liquid medicine: first inject 80% of the solvent into the preparatio...

Embodiment 2

[0042] An ornidazole injection, wherein the content of ornidazole is 600g, and the remainder is added with a solvent to make the total volume 3000ml. The solvent is a mixed solution of absolute ethanol and polyethylene glycol-15-hydroxystearate, wherein the mass ratio of polyethylene glycol-15-hydroxystearate is 6%.

[0043] The preparation method is the same as in Example 1.

Embodiment 3

[0045] An ornidazole injection, wherein the content of ornidazole is 750g, and the remainder is added with a solvent to make the total volume 3000ml. The solvent is a mixed solution of absolute ethanol and polyethylene glycol-15-hydroxystearate, wherein the mass ratio of polyethylene glycol-15-hydroxystearate is 8%.

[0046] The preparation method is the same as in Example 1.

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Abstract

The invention discloses an ornidazole injection and a preparation method thereof. Mixed liquid of absolute ethyl alcohol and polyethylene glycol-15-hydroxystearate serves as a solvent of the ornidazole injection, wherein the polyethylene glycol-15-hydroxystearate accounts for 6-14% in terms of the mass percentage of the injection. The use of a propylene glycol solvent can be prevented, and the preparation (the injection) is good in stability and good in clinical safety. The invention also discloses a preparation method of the injection; and the preparation process (the preparation method) is simple and easy to implement.

Description

technical field [0001] The invention relates to an ornidazole injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Ornidazole (Omidazole) is a drug against anaerobic bacteria and antiprotozoal infection. It is a nitroimidazole derivative without disulfiram-like effect. The antimicrobial effect of ornidazole is through the reduction of the nitro group in its molecule to amino in an anaerobic environment or through the interaction of free radicals with microbial cell components, resulting in the death of microorganisms. It is used for the treatment of anaerobic bacteria, amoeba Various diseases caused by protozoa, giardia, trichomonas, etc., have the advantages of high curative effect, good tolerance, good tissue penetration, wide distribution in the body, etc. It is a substitute for metronidazole and tinidazole. Ornidazole's good anti-oxidative bacteria and anti-protozoal (such as trichomonas, etc.) ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/10A61K47/14A61K31/4164A61P31/04A61P33/02
CPCA61K9/0019A61K9/08A61K31/4164A61K47/10A61K47/14
Inventor 张震郭太明董朋伟张茂博王秀红徐宇超
Owner SHANDONG HUBBLE KISEN BIOLOGICAL TECH CO LTD
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