Unlock instant, AI-driven research and patent intelligence for your innovation.

A kind of pharmaceutical composition of amoxicillin sodium clavulanate potassium compound

A technology of amoxicillin sodium clavulanate potassium and amoxicillin sodium is applied in the field of pharmaceutical compositions of amoxicillin sodium clavulanate potassium compounds, and can solve the problems of poor stability of amoxicillin sodium clavulanate potassium and the like, Achieve the effect of ensuring efficacy and safety, improving stability and rapid dissolution

Active Publication Date: 2020-07-21
SUZHOU ERYE PHARMA CO LTD
View PDF4 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problem of poor stability of the existing amoxicillin sodium clavulanate potassium, the present invention provides a stable compound preparation of amoxicillin sodium clavulanate potassium and a preparation method thereof

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A kind of pharmaceutical composition of amoxicillin sodium clavulanate potassium compound
  • A kind of pharmaceutical composition of amoxicillin sodium clavulanate potassium compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Example 1 Preparation of Amoxicillin Sodium Clavulanate Potassium (4:1) Suspension Powder Injection

[0016] Prescription (200 bottles):

[0017] Amoxicillin sodium 100g;

[0018] Potassium clavulanate 25g;

[0019] Sodium octanoate 12.5g;

[0020] Glycine 12.5g;

[0021] Trehalose 30g.

[0022] Preparation

[0023] Under the protection of an inert gas, dissolve amoxicillin sodium, potassium clavulanate, trehalose, sodium octanoate and glycine with 2000ml of water for injection, add 10g of activated carbon for needles, stir for 30min, and filter to remove carbon; use a 0.22μm microporous membrane Sterile filtration, filling, semi-tamponing, and freeze-drying to obtain amoxicillin sodium clavulanate potassium suspension powder injection.

Embodiment 2

[0024] Example 2 Preparation of Amoxicillin Sodium Clavulanate Potassium (4:1) Suspension Powder Injection

[0025] Prescription (400 bottles):

[0026] Amoxicillin sodium 200g;

[0027] Potassium clavulanate 50g;

[0028] Sodium octanoate 25g;

[0029] Glycine 25g;

[0030] Trehalose 60g.

[0031] Preparation

[0032] Under the protection of an inert gas, dissolve amoxicillin sodium, potassium clavulanate, trehalose, sodium octanoate and glycine with 4000ml of water for injection, add 10g of activated carbon for needles, stir for 30min, and filter to remove carbon; use a 0.22μm microporous membrane Sterile filtration, filling, semi-tamponing, and freeze-drying to obtain amoxicillin sodium clavulanate potassium suspension powder injection.

Embodiment 3

[0033] Embodiment 3 long-term stability test

[0034] Batch number 1: 459630 Batch size: 1000 bottles Specification: 0.6g / bottle Packaging: vials

[0035] Inspection conditions: 25±2℃ / 60±10%RH

[0036]

[0037] Through the long-term stability test, it can be found that the amoxicillin sodium and clavulanate potassium composition of the present invention has good stability during preparation and storage, which ensures the curative effect and safety of clinical use.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention relates to a medicine composition of an amoxicillin sodium and clavulanate potassium compound. Sodium caprylate and glycine are used for forming a stabilizing agent; trehalose is used asa freeze-drying support agent; the stability of the amoxicillin sodium and clavulanate potassium in the preparation and storage process is effectively improved; the curative effects and the safety inthe clinic use are ensured.

Description

technical field [0001] The invention relates to a pharmaceutical composition of amoxicillin sodium clavulanate potassium compound. Background technique [0002] Amoxicillin is the most commonly used semi-synthetic penicillin broad-spectrum β-lactam antibiotic. It has strong bactericidal effect and strong ability to penetrate cell membranes. It is currently one of the most widely used oral semi-synthetic penicillins. [0003] Clavulanic acid is an irreversible competitive β-lactamase inhibitor, which will inactivate the enzyme after being firmly combined with the enzyme, so it has a strong effect, not only on the β-lactamase of Staphylococcus aureus, but also on Gram The β-lactamase of negative bacilli also plays a role. Combined with penicillins and cephalosporins, the antibacterial activity is greatly improved, and the minimum inhibitory concentration (MIC) can be significantly reduced. The drug can increase the efficacy by several to ten times, and restore the sensitivity...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/12A61K47/18A61K47/26A61K31/424A61K31/43A61P31/04
Inventor 张健徐军华军杰顾利芬何星慧宗姣
Owner SUZHOU ERYE PHARMA CO LTD