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Levo ornidazole vein administration agent and its preparation method

A technology of levornidazole and intravenous administration, which is applied in directions such as pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery, and achieves the effects of good stability and feasible preparation process.

Active Publication Date: 2005-10-26
NANJING SANHOME PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no relevant report on L-ornidazole preparations in China

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The prescription consists of:

[0029] (a) L-ornidazole 5mg / ml

[0030] (b) Sodium chloride 8.30mg / ml

[0031] (c) Add water for injection to 100ml

[0032] Take the preparation of 100 bottles of L-ornidazole and sodium chloride injection as an example, the specific preparation method is to weigh the prescribed amount of L-ornidazole and sodium chloride, add 8L of water for injection at 40°C, stir, and dissolve; mol / L hydrochloric acid to adjust the pH to 4.0; add 40°C water for injection to the full amount; add 0.1% activated carbon to the above solution, stir, and let it stand for 15 minutes, decarbonize with a 5 μm titanium rod, and then pass through a cylindrical filter of 0.45 μm and 0.22 μm micro Pore ​​membrane fine filtration; potting in a 100ml glass infusion bottle, sterilized by flowing steam at 100°C for 45 minutes.

Embodiment 2

[0034] The prescription consists of:

[0035] (a) L-ornidazole 2.5mg / ml

[0036] (b) Sodium chloride 8.60mg / ml

[0037] (c) Add water for injection to 100ml

[0038]Take the preparation of 100 bottles of L-ornidazole and sodium chloride injection as an example, the specific preparation method is to weigh the prescribed amount of L-ornidazole and sodium chloride, add 8L of water for injection at 40°C, stir, and dissolve; mol / L citric acid to adjust the pH to 4.5; add 40°C water for injection to the full amount; add 0.1% activated carbon to the above solution, stir, and let it stand for 15 minutes, decarbonize with a 5 μm titanium rod, and then pass through a cartridge filter 0.45 μm and 0.22 μm Microporous membrane filter; potted in a 100ml glass infusion bottle, sterilized by steam at 100°C for 45 minutes.

Embodiment 3

[0040] The prescription consists of:

[0041] (a) L-Ornidazole 1.25mg / ml

[0042] (b) Sodium chloride 8.80mg / ml

[0043] (c) Add water for injection to 100ml

[0044] Take the preparation of 100 bottles of L-ornidazole and sodium chloride injection as an example, the specific preparation method is to weigh the prescribed amount of L-ornidazole and sodium chloride, add 8L of water for injection at 40°C, stir, and dissolve; mol / L lactic acid to adjust the pH to 3.5; add 40°C water for injection to the full amount; add 0.2% activated carbon to the above solution, stir, and let it stand for 15 minutes, decarbonize the 5μm titanium rod, and then pass through the cartridge filter 0.45μm and 0.22μm micro Pore ​​membrane fine filtration; potting in a 100ml glass infusion bottle, sterilized by flowing steam at 100°C for 45 minutes.

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PUM

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Abstract

An intravenous injection or perfusion of levo-ornidazole is prepared from levo-ornidazole, auxiliary and the water for injection through proportionally mixing, stirring for dissolving, regulating pH=3.5-5.5, adding the water and activated carbon for injection, stirring, laying aside, decarbonizing by titanium rod, fine filtering, and sterilizing.

Description

technical field [0001] The invention relates to an intravenous administration preparation of levo-ornidazole and a preparation method thereof, in particular to a levo-ornidazole transfusion preparation and an injection. Background technique [0002] Levo-ornidazole (1-(3-chloro-2-S-(-)hydroxypropyl)-2-methyl-5-nitroimidazole) is Ornidazole (Ornidazole, CAS 16773-42-5) L-body. Ornidazole is a nitroimidazole derivative, which is a powerful anti-anaerobic bacteria and anti-protozoal infection drug. Wide third-generation nitroimidazole derivatives. The antimicrobial effect of scavenging 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. In China, there are left- and right-ornidazole (see CN 1400312A) obtained from the ornidazole racemate by enzymatic resolution, but it is not disclosed that i...

Claims

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Application Information

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IPC IPC(8): A61K31/4164
Inventor 张仓滕再进李莉
Owner NANJING SANHOME PHARMACEUTICAL CO LTD
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