L-ornidazole injection prepn

A technology of levo-ornidazole and injection preparations, which is applied in the direction of antifungal agents, medical preparations containing active ingredients, and pharmaceutical formulas, which can solve the problems of poor activity and high toxicity of ornidazole racemates, and achieve no special Effects of toxicity, long half-life, and good application prospects

Inactive Publication Date: 2006-03-01
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, the ornidazole racemate is sold and clinically used in the market, and the ornidazole racemate has poor activity and relatively high toxicity.

Method used

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  • L-ornidazole injection prepn
  • L-ornidazole injection prepn

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] The levo-ornidazole concentrated solution injection preparation is made with the raw materials in the following weight ratio:

[0018] Levo-ornidazole 51.0g (102% feed intake)

[0019] 0.1mol / L hydrochloric acid appropriate amount

[0020] Add water for injection to 1000ml, pack into 200 vials, 5ml / vial, each injection contains 250mg of L-ornidazole

Embodiment 2

[0022] The levo-ornidazole concentrated solution injection preparation is made with the raw materials in the following weight ratio:

[0023] Levo-ornidazole 51.0g (102% feed intake)

[0024] 0.1mol / L hydrochloric acid appropriate amount

[0025] Add water for injection to 1000ml, pack into 100 vials, 10ml / vial, each injection contains 500mg of L-ornidazole

[0026] Above embodiment one, two sample preparation processes are as follows:

[0027] 1. Dosing: Take L-ornidazole, add water for injection (about 60°C) to the full amount, stir to dissolve, and adjust the pH to about 3.0 with 0.1mol / L hydrochloric acid. Add 0.05% activated carbon, keep stirring for 15 minutes. Activated carbon is removed by a 0.45 μm microporous membrane to obtain a coarse filtrate. After the pH value and content of the filtrate are determined to be qualified, the coarse filtrate is finely filtered through a 0.22 μm microporous membrane.

[0028] 2. Filling: Fill the fine filtrate into 5ml to 20ml ...

Embodiment 3

[0032] Make levo-ornidazole sterilizing solution with the raw materials of following weight ratio:

[0033] L-ornidazole 2.625g (105% feed intake)

[0034] Sodium chloride 9g

[0035] 0.1mol / L hydrochloric acid appropriate amount

[0036] Add water for injection to 1000ml, pack into 10 bottles, 100ml / bottle, each bottle of sterilized solution contains 250mg of L-ornidazole

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PUM

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Abstract

The present invention discloses L-ornidazole injection preparation as one kind of nitroimidazole antibiotics. The L-ornidazole injection preparation contains L-ornidazole or its salt or their hydrate. L-ornidazole is named chemically as S-(+)-1-(3-chloro-2-hydroxypropyl)-2-methyl-5- nitroimidazole. The L-ornidazole injection preparation is prepared with L-ornidazole, supplementary material and injection water, and may be prepared into injection for immediately injection, concentrated solution for injection after clinical re-compounding or powder for injection through further freeze drying. Compared with similar preparations, the L-ornidazole preparation has high pharmacodynamic activity, lower toxicity and stable quality.

Description

technical field [0001] The invention relates to an injection preparation of nitroimidazole antibiotic L-ornidazole. Background technique [0002] At present, the ornidazole racemate is sold and clinically used in the market, and the ornidazole racemate has poor activity and relatively high toxicity. Contents of the invention [0003] In order to improve the activity of medicines and reduce toxicity, the invention provides an injection preparation of single optical isomer levo-ornidazole. [0004] A kind of L-ornidazole injection preparation of the present invention, it comprises the L-ornidazole or its salt or their hydrate shown in following structural formula; Chemical name is: S-(+)-1-(3-chloro-2- Hydroxypropyl)-2-methyl-5-nitroimidazole; With a single dose, levo-ornidazole plus water for injection and additives can be made into a sterilized solution for injection into the body, and levo-ornidazole plus water for injection and The additive can be made into a concentra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4164A61K9/19A61P31/10A61P31/04
Inventor 蔡伟金波乔阳李浩冬
Owner YANGTZE RIVER PHARM GRP CO LTD
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