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Intravenous formulation of ornidazole and its preparation method

A technology for intravenous administration of ornidazole, which is applied in the field of intravenous administration of ornidazole and its preparation, can solve the problems of increased production risk and long biological half-life, and achieve reliable product quality, feasible preparation process, and high-quality products. good stability effect

Inactive Publication Date: 2006-05-10
NANJING SANHOME PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Human pharmacokinetics show that ornidazole has a very long biological half-life and has good clinical use value. Most of the domestic marketed products are tablets, and tablets, as oral preparations, have great limitations in clinical efficacy; the Czech Republic has Ornidazole injection is on the market, but it uses a mixed solution of propylene glycol and absolute ethanol as a solvent, which reduces production costs but increases production risks

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] The prescription consists of:

[0073] (a) Oxynitrate 25mg / ml

[0074] (b) Mannitol 8mg / ml

[0075] (c) Add water for injection to 10ml

[0076] Taking the preparation of 100 bottles of ornidazole preparation for injection as an example, the specific preparation method is to first weigh the prescribed amount of ornidazole and mannitol, add part of water for injection at 45°C, stir, and dissolve; adjust with 0.1mol / L hydrochloric acid pH 4.5, water for injection at 45°C to the full amount; add 0.1% activated carbon for needles, stir well, let stand for 15 minutes, decarbonize with 5 μm titanium rod, and then filter through the microporous filter membrane of 0.45 μm and 0.22 μm in the cartridge filter; fill in In vials; freeze-dried; with rubber stoppers and crimped caps.

Embodiment 2

[0078] The prescription consists of:

[0079] (a) Ornidazole 0.11mol

[0080] (b) Hydroxypropyl-β-cyclodextrin 0.11mol

[0081] (c) Add water for injection to 10ml

[0082] Taking the preparation of 100 bottles of ornidazole preparation for injection as an example, the specific preparation method is to first weigh the prescribed amount of ornidazole and hydroxypropyl-β-cyclodextrin, add part of 45°C water for injection, stir, and dissolve; 0.1mol / L hydrochloric acid to adjust the pH to 4.5, 45 ℃ water for injection to the full amount; add 0.1% activated carbon for needles, stir well, let stand for 15min, decarbonize with 5μm titanium rod, and then pass through the cartridge filter 0.45μm and 0.22μm microporous membrane Fine filtration; filled in vials; freeze-dried; plugged with rubber stoppers and crimped caps.

Embodiment 3

[0084] The prescription consists of:

[0085] (a) Ornidazole 0.11mol

[0086] (b) Carboxymethyl-β-cyclodextrin 0.11mol

[0087] (c) Add water for injection to 10ml

[0088] Taking the preparation of 100 bottles of ornidazole preparation for injection as an example, the specific preparation method is to first weigh the prescribed amount of ornidazole and carboxymethyl-β-cyclodextrin, add part of 45°C water for injection, stir, and dissolve; Adjust the pH to 4.5 with 0.1mol / L hydrochloric acid, add water for injection at 45°C to the full amount; add 0.1% activated carbon for needles, stir well, let stand for 15 minutes, decarbonize with a 5 μm titanium rod, and then pass through a cartridge filter of 0.45 μm and 0.22 μm microporous filter Membrane fine filtration; filled in vials; freeze-dried; plugged with rubber stoppers and crimped caps.

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PUM

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Abstract

The invention provides the process for preparing Ornidazole intra-vascular preparations in the dosage forms of freeze-dried injections, which comprises, (1) weighing prescription amount of Ornidazole and adjuvant, charging water for injection, stirring and dissolving, (2) adjusting pH to 3.5-6.0 with acids, charging 35-55 deg C. water for injection to full amount, charging 0.05-0.2% of activated charcoal for injection, homogenizing, removing charcoal and carrying out refined filtration, (3 loading, (4) making preparations through freeze drying.

Description

technical field [0001] The invention relates to an intravenous administration preparation of ornidazole and a preparation method thereof. Background technique [0002] Ornidazole (CAS 16773-42-5), a nitroimidazole derivative, is a powerful drug against anaerobic bacteria and antiprotozoal infections. It is also a newly developed drug after metronidazole with higher efficacy and shorter treatment course , The third generation of nitroimidazole derivatives 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 resisting broad-spectrum fungal infections (see NO.CN1335132). In vivo and in vitro pharmacodynamic experiments, ornidazole is more effec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4164A61K9/08A61P31/04A61P33/02
Inventor 张仓滕再进
Owner NANJING SANHOME PHARMACEUTICAL CO LTD
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