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Ornidazole injection and preparation method thereof

An ornidazole injection and a technology for ornidazole are applied in the field of medicine and can solve the problems of being easily affected by light, heat and alkaline conditions, but not completely solving the problems of easily degradable related substances and hidden dangers.

Inactive Publication Date: 2014-11-05
ZHUHAI EBANG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ornidazole is white or slightly yellow crystalline powder, odorless, bitter in taste, gradually turns yellow when exposed to light, easily soluble in ethanol, slightly soluble in water, easily hydrolyzed under the influence of light, heat and alkaline conditions to form rings Oxides further generate diols, which have potential safety hazards during clinical use
Chinese patents 200410092247, 200510068419, 200510094489, 200610086416, etc. disclose ornidazole injection, but do not fundamentally solve the problem of stability of ornidazole injection
Although Chinese patent 201210214992.9 optimizes the sterilization process of ornidazole injection, it does not completely solve the problem that ornidazole injection is easily degraded and produces related substances during terminal sterilization

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] (1) Rinse the liquid distribution tank and pipeline with absolute ethanol to ensure that there is no water residue in the liquid distribution tank and pipeline.

[0024] (2) Take 1400ml of absolute ethanol and add it to the concentrated preparation tank, raise the temperature to 50°C, add the prescribed amount of ornidazole, and stir to dissolve.

[0025] (3) Add medicinal charcoal, and circulate and stir for half an hour at 50°C for adsorption.

[0026] (4) Decarbonize and filter through a 1.0 μm titanium rod filter element, then filter through a microporous filter element with a primary pore size of 0.45 μm, filter through a microporous filter element with a primary pore size of 0.22 μm, transfer to a dilute tank, add the remaining 30% absolute ethanol to volume to the full amount.

[0027] (5) The content of the test liquid complies with the internal control standard for intermediate products.

[0028] (6) The qualified medicinal liquid is filtered through a microp...

Embodiment 2

[0055] Get 500g ornidazole in the dehydrated alcohol of different amounts, detect its dissolving situation and burning distance (cm) at different temperatures, the results are shown in Table 3.

[0056] Table 3: Screening of the amount and temperature of absolute ethanol in the concentrated preparation tank

[0057]

[0058] (Note) Burning distance: the distance between the flame and the liquid surface when the flame causes the liquid to burn.

[0059] It can be seen from the data in Table 3 that when 1400ml of absolute ethanol is injected first, 500g of ornidazole can be completely dissolved at 50°C, and relatively safe can be guaranteed.

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Abstract

The invention discloses ornidazole injection and a preparation method thereof. According to the ornidazole injection provided by the invention, ornidazole subjected to terminal sterilization is not degraded, and related substances are not increased. According to the preparation method of the ornidazole injection provided by the invention, risk caused due to use of absolute ethyl alcohol can be reduced, and ornidazole in a prescription amount can be completely dissolved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an intravenous administration preparation of ornidazole and a preparation method thereof. Background technique [0002] Ornidazole (CAS16773-42-5), a nitroimidazole derivative, is a powerful drug against anaerobic bacteria and antiprotozoal infections. A third-generation nitroimidazole derivative with better tolerance and wider distribution in the body. The antimicrobial effect of ornidazole is through the reduction of the nitro group in its molecule to an amino group in an oxygen-free environment, or through the formation of free radicals to interact with cell components, resulting in the death of microorganisms. Studies have found that ornidazole also plays an important role in the fight against spectrum fungal infections. In the pharmacodynamic experiments in vivo and in vitro, ornidazole has a stronger curative effect than metronidazole on mice and rats infecte...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4164A61K47/10A61P31/04A61P33/02A61J3/00
Inventor 张在富吴浩山许馨文
Owner ZHUHAI EBANG PHARMA