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Levofloxacin composition

A technology of levofloxacin hydrochloride and composition, which is applied in the field of levofloxacin hydrochloride composition, can solve problems such as the increase of impurity E, and achieve the effect of improving dissolution rate

Inactive Publication Date: 2021-01-08
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Purpose of the invention: to provide a levofloxacin hydrochloride composition with stable quality to solve the defect of impurity E rising during storage

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1. Levofloxacin hydrochloride 100g, citric acid 10g, sodium acetate 26g, micropowder silica gel 60g, microcrystalline cellulose 60g, crospovidone 8g, magnesium stearate 1g. Wherein, the mass ratio of citric acid to sodium acetate is 1:2.6. Prepare 1000 tablets according to the preparation method described in the technical scheme of the specification.

Embodiment 2

[0023] Example 2. Levofloxacin hydrochloride 100g, citric acid 14g, sodium acetate 22.4g, micronized silica gel 80g, microcrystalline cellulose 120g, crospovidone 15g, magnesium stearate 2g. Wherein, the mass ratio of citric acid and sodium acetate is 1:1.6. Prepare 1000 tablets according to the preparation method described in the technical scheme of the specification.

Embodiment 3

[0024] Example 3. Levofloxacin hydrochloride 100g, citric acid 12g, sodium acetate 25g, micronized silica gel 70g, microcrystalline cellulose 90g, crospovidone 10g, magnesium stearate 1.5g. Wherein, the mass ratio of citric acid and sodium acetate is 1:2.08. Prepare 1000 tablets according to the preparation method described in the technical scheme of the specification.

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PUM

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Abstract

The invention relates to a levofloxacin hydrochloride composition, and belongs to the technical field of pharmaceutical preparations. Every 1000 tablets of the levofloxacin hydrochloride composition disclosed by the invention contain 100g of levofloxacin hydrochloride, 10-14g of citric acid, a proper amount of sodium acetate, 60-80g of aerosil, 60-120g of microcrystalline cellulose, 8-15g of polyvinylpolypyrrolidone and 1-2g of magnesium stearate, wherein the mass ratio of the citric acid to the sodium acetate is 1: (1.8 to 2.2). The invention provides the stable levofloxacin composition.

Description

technical field [0001] The invention relates to a levofloxacin hydrochloride composition and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Levofloxacin chemical name (S)-(-)-9-fluoro-2,3-dihydro-3-methyl-10-[4-methyl-1-piperazinyl]-7-oxo-7-hydrogen Pyrido[1,2,3-de]-[1,4]benzoxazine-6-carboxylic acid, a fluoroquinolone antibacterial drug developed by Daiichi Pharmaceutical Co., Ltd., is a clinical first-line antibacterial drug and belongs to the national Essential medicines. [0003] Levofloxacin hydrochloride is slightly soluble in water. In order to improve the dissolution rate, surfactants are often added to the prescription. The stability test found that levofloxacin hydrochloride oral preparations had degradation problems during storage, and the growth of impurity E was positively correlated with the storage time, which brought certain safety hazards to clinical medication. [0004] The 201610184636.5 patent improves the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/5383A61K47/38A61K47/32A61K47/12A61K47/04A61P31/04
CPCA61K31/5383A61K9/2013A61K9/2009A61K9/2054A61K9/2027A61K9/2095A61P31/04
Inventor 王江涛张明涛张友凯王成杨德斌
Owner DISHA PHARMA GRP
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