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L-ornidazole prepn

A preparation technology of L-ornidazole, which is applied in the field of preparation of nitroimidazole antibiotics L-ornidazole, can solve the problems of high toxicity and poor activity of ornidazole racemate, and achieve long half-life, no special toxicity, The effect of 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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Make 1000 L-ornidazole tablets with the raw materials in the following weight ratio, and the tablet weight is 435mg

[0019] Levonidazole 250g

[0020] Pregelatinized starch 50g

[0021] Microcrystalline Cellulose 100g

[0022] 3% HPMC 40% ethanol solution appropriate amount

[0023] Sodium carboxymethyl starch 30g

[0024] Magnesium Stearate 3g

[0025] Preparation Process:

[0026] 1. Raw materials and auxiliary materials of L-ornidazole are pulverized separately and passed through a 100-mesh sieve.

[0027] 2. Take L-ornidazole, pregelatinized starch, and microcrystalline cellulose and mix well, use 3% HPMC 40% ethanol solution to make soft material, granulate, and granulate after drying.

[0028] 3. Add sodium carboxymethyl starch and magnesium stearate, mix well, and press into tablets.

Embodiment 2

[0030] 1. Prepare 6% ethanol solution of Opadry enteric coating solution;

[0031] 2. Take the plain tablet obtained in Example 1 and pour it into a coating pan for coating to obtain L-ornidazole enteric-coated tablet. Coating powder relative to tablet core weight gain: 4.0-5.0%.

Embodiment 3

[0033] Prepare 1000 L-ornidazole tablets with the raw materials in the following weight ratio, and the tablet weight is 230 mg.

[0034] Levonidazole 125g

[0035] 30g pregelatinized starch

[0036] Microcrystalline Cellulose 50g

[0037] 3% HPMC 40% ethanol solution appropriate amount

[0038] Sodium carboxymethyl starch 20g

[0039] Magnesium Stearate 2g

[0040] Preparation Process:

[0041] 1. Separately pulverize the L-ornidazole raw material and auxiliary materials, and pass through a 100-mesh sieve.

[0042] 2. Take L-ornidazole, pregelatinized starch, and microcrystalline cellulose and mix well, use 3% HPMC 40% ethanol solution to make soft material, granulate, and granulate after drying.

[0043] 3. Add sodium carboxymethyl starch and magnesium stearate, mix well, and press into tablets.

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Abstract

The present invention discloses L-ornidazole preparation as one kind of nitroimidazole antibiotics. The L-ornidazole 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 preparation is prepared with L-ornidazole and supplementary material, and may be prepared in tablet, dispersant tablet, coated tablet, enteric tablet, capsule or granule. 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 a 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 a preparation of single optical isomer levo-ornidazole. [0004] In order to achieve the above object, the present invention adopts the following technical scheme: a levo-ornidazole preparation, which comprises levo-ornidazole or its salt or their hydrates shown in the following structural formula; chemical name is: S-(+)- 1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole; it is oral ordinary tablet, dispersible tablet, Film-coated tablets, enteric-coated tablets, hard capsules and granules. [0005] [0006] The molecular formula is: C 7 h 10 ClN 3 o ...

Claims

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Application Information

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IPC IPC(8): A61K31/4164A61P31/10A61P33/02
Inventor 蔡伟金波乔阳李浩冬
Owner YANGTZE RIVER PHARM GRP CO LTD
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