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Pharmaceutical composition containing amoxicillin trihydrate and clavulanate potassium

A technology of amoxicillin trihydrate and potassium clavulanate, which is applied in the field of novel sustained-release pharmaceutical preparations and can solve the problems of no pharmaceutical-grade product supply and the like

Inactive Publication Date: 2005-07-06
北京泛美华医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, xanthan gum, which is a slow-release material, does not have a pharmaceutical-grade product supply in China.

Method used

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  • Pharmaceutical composition containing amoxicillin trihydrate and clavulanate potassium
  • Pharmaceutical composition containing amoxicillin trihydrate and clavulanate potassium
  • Pharmaceutical composition containing amoxicillin trihydrate and clavulanate potassium

Examples

Experimental program
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Embodiment 1

[0046] The modified release formulation containing amoxicillin trihydrate and clavulanic acid potassium (weight ratio is 16: 1) of the present invention is a sustained-release three-layer tablet, wherein the weight is based on amoxicillin anhydrous and clavulanic acid respectively, Layer 1 is an immediate release layer containing potassium clavulanate and part of amoxicillin trihydrate; layer 2 is an immediate release layer containing part of amoxicillin trihydrate; layer 3 is a sustained release layer containing the rest of amoxicillin trihydrate.

[0047] The prescription is as follows:

[0048] Potassium Amoxicillin Clavulanate (2:1)

[0049] (Based on amoxicillin anhydrous and clavulanic acid) 93.75g

[0050] Layer 1 sodium starch glycolate 7.0g

[0051] Magnesium Stearate 2.0g

[0052] Micronized silica gel 1.0g

[0053]Amoxicillin trihydrate (calculated as anhydrous substance) 161.5g

[0054] Microcrystalline Cellulose 40.0g

[0...

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Abstract

The invention discloses a slow release medicament three-layer tablet which comprises Amoxicillin hydrate, clavulanate potassium and pharmaceutically acceptable excipient or carrier, the layer 1 is a rapid release layer comprising Amoxicillin hydrate and clavulanate potassium, the layer 2 is a rapid release layer comprising a portion of Amoxicillin hydrate, the layer 3 is a rapid release layer comprising rest portions of Amoxicillin hydrate, the slow release layer contains not only common medicinal adjuvant, but also slow release material of hydroxy propyl methyl cellulose E30.

Description

technical field [0001] The present invention relates to a novel sustained-release pharmaceutical preparation for the combined use of the antibiotic amoxicillin and the beta-lactamase inhibitor clavulanate potassium, wherein the amoxicillin exists in the form of amoxicillin trihydrate. Background technique [0002] Potassium amoxicillin and clavulanate (16:1) sustained-release tablets were developed by GlaxoSmithKline, and were launched in the U.S. in October 2002 under the trade name "AUGMENTIN XR". AUGMENTIN XR TM For the treatment of community-acquired pneumonia and acute bacterial sinusitis caused by confirmed or suspected β-lactamase-producing pathogens and Streptococcus pneumoniae with reduced penicillin susceptibility. AUGMENTIN XR TM In addition to amoxicillin and potassium clavulanate (main ingredients), the immediate-release layer prescription also contains microcrystalline cellulose (filler), sodium carboxymethyl starch (disintegra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/43A61P31/04
Inventor 佘树章
Owner 北京泛美华医药科技发展有限公司
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