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A kind of ornidazole injection and preparation method thereof

A technology for ornidazole injection and ornidazole, which is applied in the field of medicine, can solve problems such as the disulfiram reaction cannot be completely avoided, and achieve the effect of increasing stability

Active Publication Date: 2022-04-01
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese application CN110917135A solvent system for dissolving ornidazole is an organic solvent mixed with short-chain polyethylene glycol and ethanol. Although propylene glycol is used and the amount of ethanol is reduced, ethanol is still used, and the occurrence of disulfiram reaction cannot be completely avoided.

Method used

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  • A kind of ornidazole injection and preparation method thereof
  • A kind of ornidazole injection and preparation method thereof
  • A kind of ornidazole injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] According to the prescription amount in the following table 1, the injection is prepared according to the following method:

[0016] (1) Dissolve the prescribed amount of Poloxamer 188 in 2500ml of water for injection at 45°C, and adjust the pH to 2.3 with hydrochloric acid;

[0017] (2) Keep the temperature at 45°C, add the prescribed amount of sodium glycerophosphate and ornidazole in sequence, stir and dissolve, and add water for injection to 3000ml;

[0018] (3) Measure the pH value and content of the solution, filter it with a 0.22µm filter membrane, fill it into ampoules according to the specification of 3ml: 0.5g, and then sterilize at 121°C for 30 minutes to obtain ornidazole injection.

[0019] Table 1 Different prescription quantities of sodium glycerophosphate and poloxamer 188 injection

[0020]

[0021] The above 8 kinds of prescription samples were subjected to the influence factor test, and they were placed under the conditions of 60°C and strong ligh...

Embodiment 2

[0032] Preparation of Ornidazole Injection (Specification: 3ml: 0.5g)

[0033] prescription:

[0034] Ornidazole: 500g

[0035] Poloxamer 188: 7.5g

[0036] Sodium glycerophosphate: 10.5g

[0037] Add water for injection to 3000ml

[0038] Make 1000 pieces

[0039] Process:

[0040] (1) Dissolve the prescribed amount of Poloxamer 188 in 2500ml of water for injection at 45°C, and adjust the pH to 2.3 with hydrochloric acid;

[0041] (2) Keep the temperature at 45°C, add the prescribed amount of sodium glycerophosphate and ornidazole in sequence, stir and dissolve, and add water for injection to 3000ml;

[0042] (3) Measure the pH value and content of the solution, filter it with a 0.22µm filter membrane, fill it into ampoules according to the specifications, and then sterilize at 121°C for 30 minutes to obtain ornidazole injection.

Embodiment 3

[0044] Preparation of Ornidazole Injection (Specification: 3ml: 0.5g)

[0045] prescription:

[0046] Ornidazole: 500g

[0047] Poloxamer 188: 7.5g

[0048] Sodium glycerophosphate: 10.5g

[0049] Add water for injection to 3000ml

[0050] Make 1000 pieces

[0051] Process:

[0052] (1) Dissolve the prescribed amount of Poloxamer 188 in 2500ml of water for injection at 52°C, and adjust the pH to 2.5 with hydrochloric acid;

[0053] (2) Keep the temperature at 52°C, add the prescribed amount of sodium glycerophosphate and ornidazole in sequence, stir and dissolve, and add water for injection to 3000ml;

[0054] (3) Measure the pH value and content of the solution, filter it with a 0.22µm filter membrane, fill it into ampoules according to the specifications, and then sterilize at 121°C for 30 minutes to obtain ornidazole injection.

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PUM

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Abstract

The invention relates to an ornidazole injection and a preparation method thereof. In addition to 500g ornidazole per 3000ml injection, the injection also contains poloxamer 188 and sodium glycerophosphate, preferably, 7.5g poloxamer 188 and 10.5g sodium glycerophosphate per 1000ml, preferred specifications 3ml:0.5g or 6ml:1g, the ornidazole injection prepared by the prescription process of the present invention has very high quality stability, which is obviously better than the prior art.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an ornidazole injection and a preparation method thereof. Background technique [0002] Ornidazole, chemical name: 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole, is the third generation of nitroimidazole drugs. Ornidazole injection is the drug of choice for the treatment of anaerobic bacterial infections, and it also has a certain inhibitory effect on some aerobic bacteria. Ornidazole is insoluble in water, and its solubility increases under acidic conditions. Most injection preparations use water for injection as a solvent, but ornidazole has poor water solubility under neutral conditions. The existing technology adjusts the pH value to 1.8 by acid ~2.3, to dissolve ornidazole, and in order to ensure the stability of ornidazole, the prior art often adds propylene glycol, but adopts propylene glycol as a stabilizer, which has relatively large side effects, exceeding th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/26A61K47/24A61K31/4164A61P31/04
CPCA61K9/0019A61K9/08A61K47/26A61K47/24A61K31/4164A61P31/04
Inventor 曾艺杨三明胡成忠
Owner 湖北美林药业有限公司
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