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Stable ornidazole and S-ornidazole injections and a preparing method thereof

A technology of ornidazole injection and ornidazole, applied in the field of medicine, can solve problems such as product stability, compatibility and safety, rise of related substances in injections, non-compliance with prescriptions and process development evaluation, etc. , to achieve the effect of good compatibility stability and overcoming compatibility taboos

Active Publication Date: 2017-08-15
NANJING CAVENDISH BIO ENG TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] However, the experiment found that the above prescription was under the conditions of aqueous solvent and pH value less than 5.5, under the conditions of 121°C and 30 minutes of over-sterilization, the related substances of the injection increased significantly, and the content decreased significantly, which did not meet the prescription and process development evaluation. requirements
The above-mentioned technical solutions all start from one or two aspects of stability or compatibility, and have not yet comprehensively solved the problems of product stability, compatibility and safety under overkill sterilization conditions.

Method used

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  • Stable ornidazole and S-ornidazole injections and a preparing method thereof
  • Stable ornidazole and S-ornidazole injections and a preparing method thereof
  • Stable ornidazole and S-ornidazole injections and a preparing method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0039]

[0040]

[0041] Preparation:

[0042] (1) 1,2-propanediol and ethanol are placed in a container and fully mixed;

[0043] (2) Add ornidazole (or) S-ornidazole, heat and stir at 40-45°C to dissolve;

[0044] (3) Add acetic acid-sodium acetate buffer solution to adjust the pH value to 5.6;

[0045] (3) Add medicinal charcoal (about 0.1% by weight), heat and stir at 40°C for 30 minutes, filter and decarbonize;

[0046] (4) finely filtering the filtrate of step (3) through a 0.45 μm microporous membrane to obtain an intermediate solution;

[0047] (5) The intermediate solution is measured, filled into ampoules after being qualified, filled with nitrogen, sealed, and leak detected;

[0048] (6) Sterilize by autoclaving at 121°C for 30 minutes, let cool, inspect with lights, and pack.

Embodiment 2

[0050]

[0051] Preparation:

[0052] (1) 1,2-propanediol and ethanol are placed in a container and fully mixed;

[0053] (2) Add ornidazole (or) S-ornidazole, heat and stir at 35-40°C to dissolve;

[0054] (3) adding acetic acid-sodium acetate aqueous solution to adjust the pH value to 5.8;

[0055] (3) Add medicinal charcoal (about 0.1% by weight), heat and stir at 40°C for 15 minutes, filter and decarbonize;

[0056] (4) finely filtering the filtrate of step (3) through a 0.45 μm microporous membrane to obtain an intermediate solution;

[0057] (5) The intermediate solution is measured, filled into ampoules after being qualified, filled with nitrogen, sealed, and leak detected;

[0058] (6) Sterilize by autoclaving at 121°C for 15 minutes, let cool, inspect with lights, and pack.

Embodiment 3

[0060]

[0061] Preparation:

[0062] (1) 1,2-propanediol and ethanol are placed in a container and fully mixed;

[0063] (2) Add ornidazole (or) S-ornidazole, heat and stir at 40-45°C to dissolve;

[0064] (3) acetic acid-sodium acetate aqueous solution, adjust the pH value;

[0065] (3) Add medicinal charcoal (about 0.1% by weight), heat and stir at 45°C for 15 minutes, filter and decarbonize;

[0066] (4) finely filtering the filtrate of step (3) through a 0.45 μm microporous membrane to obtain an intermediate solution;

[0067] (5) The intermediate solution is measured, filled into ampoules after being qualified, filled with nitrogen, sealed, and leak detected;

[0068] (6) Sterilize by autoclaving at 121°C for 30 minutes, let cool, inspect with lights, and pack.

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Abstract

Stable ornidazole and S-ornidazole injections are disclosed. Based on 1 g of ornidazole or S-ornidazole, the injections comprise 1 g of the ornidazole or the S-ornidazole, 2-4 g of 1,2-propanediol, 1-3 g of absolute alcohol, acetic acid and sodium acetate, wherein the acetic acid and the sodium acetate are pH adjusting agents, and the using amounts of the acetic acid and the sodium acetate are amounts allowing the pH value of the ornidazole and S-ornidazole injections to be 5.4-6.5. In addition, a preparing method of the injections is also disclosed. Compared with the prior art, stability of related compounds and contents of the injections under filtration and sterilization conditions is good, compatibility with other products is good and irritation is low.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a stable ornidazole injection and S-ornidazole injection and a preparation method thereof. Background technique [0002] Ornidazole, the chemical name is 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole; S-ornidazole, the chemical name is S-(-)-1-( 3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole is the third-generation nitroimidazole broad-spectrum anti-anaerobe and anti-antiprotozoal drug after metronidazole and tinidazole. Good curative effect, good tolerance, and wide distribution in the body. Therefore, ornidazole and S-ornidazole injection are the first choice for the prevention and treatment of anaerobic infection. [0003] Ornidazole and S-ornidazole are poor in water solubility. At present, acidic co-solvents are usually used. The prepared ornidazole injection is a slightly acidic solution with a pH value between 2.5 and 3.5. Poor solubility and s...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4164A61K47/10A61K47/12A61P31/04A61P33/02
CPCA61K47/10A61K47/12A61K9/0019A61K9/08A61K31/4164A61P31/04A61P33/02
Inventor 许永翔
Owner NANJING CAVENDISH BIO ENG TECH
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