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Flucloxacillin sodium and amoxicillin sodium for injection

A technology of amoxicillin sodium and flucloxacillin sodium, applied in the direction of active ingredients of heterocyclic compounds, antibacterial drugs, etc., can solve problems affecting clinical efficacy, active ingredient flucloxacillin sodium protection, poor stability, etc.

Active Publication Date: 2013-10-02
广东安健医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method simply mixes and subpackages the two, and does not protect the active ingredients amoxicillin sodium and flucloxacillin sodium accordingly, resulting in poor stability of the product for long-term storage and seriously affecting the clinical efficacy

Method used

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  • Flucloxacillin sodium and amoxicillin sodium for injection
  • Flucloxacillin sodium and amoxicillin sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Embodiment 1: preparation pharmaceutical composition

[0088] Ingredients ratio: the weight ratio of flucloxacillin to amoxicillin is 1:1.

[0089] In the 100-level sterile powder injection workshop, under aseptic operation conditions, thoroughly mix the pulverized sterile flucloxacillin sodium and sterile amoxicillin sodium (both less than 80 mesh); (thickness less than 1cm) in a tray, place the tray in an airtight container, and place it at room temperature for 24 hours, the space atmosphere in the airtight container is saturated with 50% ethanol, so that the mixed material is fully contacted with the saturated atmosphere; After airtight treatment, dry the mixture of the three materials at a temperature of 55°C until the water content is lower than 2%, that is, the pharmaceutical composition is sealed and divided into glass bottles, and each bottle contains flucloxacillin and amoxicillin The amount of each is 0.5g.

Embodiment 2

[0090] Embodiment 2: preparation pharmaceutical composition

[0091] Ingredients ratio: the weight ratio of flucloxacillin to amoxicillin is 1:0.8.

[0092] In the 100-level sterile powder injection workshop, under aseptic operation conditions, thoroughly mix the pulverized sterile flucloxacillin sodium and sterile amoxicillin sodium (both less than 80 mesh); (thickness less than 1cm) in a tray, place the tray in an airtight container, and place it at room temperature for 20 hours, the space atmosphere in the airtight container is saturated with 40% ethanol, so that the mixed material is fully contacted with the saturated atmosphere; After airtight treatment, dry the mixture of the three materials at a temperature of 50°C until the water content is lower than 2%, that is, the pharmaceutical composition is sealed and divided into glass bottles, and the amount of flucloxacillin in each bottle is 0.5 g.

Embodiment 3

[0093] Embodiment 3: preparation pharmaceutical composition

[0094] Ingredients ratio: the weight ratio of flucloxacillin to amoxicillin is 1:1.2.

[0095] In the 100-level sterile powder injection workshop, under aseptic operation conditions, thoroughly mix the pulverized sterile flucloxacillin sodium and sterile amoxicillin sodium (both less than 80 mesh); (thickness less than 1cm) in a tray, place the tray in an airtight container, and place it at room temperature for 30 hours, the space atmosphere in the airtight container is saturated with 60% ethanol, so that the mixed material is fully contacted with the saturated atmosphere; After airtight treatment, dry the mixture of the three materials at a temperature of 60°C until the water content is lower than 2%, that is, the pharmaceutical composition is sealed and divided into glass bottles, and the amount of flucloxacillin in each bottle is 0.5 g.

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Abstract

The invention relates to flucloxacillin sodium and amoxicillin sodium for injection, in particular to a stable flucloxacillin sodium and amoxicillin sodium pharmaceutical composition for injection. The composition comprises flucloxacillin sodium and amoxicillin sodium, wherein flucloxacillin sodium is counted as flucloxacillin, amoxicillin sodium is counted as amoxicillin; and the weight ratio of flucloxacillin to amoxicillin is 1:(0.5-1.5). The pharmaceutical composition has an excellent pharmaceutical performance.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a compound antibiotic, in particular to a compound antibiotic drug composed of flucloxacillin sodium and amoxicillin sodium. The present invention also relates to the pharmaceutical composition of flucloxacillin sodium and amoxicillin sodium powder injection and its preparation method, and further relates to its new application in the preparation of medicines for treating infections such as pelvic infection. In particular, the present invention relates to stable flucloxacillin sodium and amoxicillin sodium for injection with new crystallinity. Background technique [0002] Each bottle of commercially available flucloxacillin sodium and amoxicillin sodium contains flucloxacillin sodium and amoxicillin sodium, respectively, the ratio of the marked amounts of flucloxacillin and amoxicillin is usually 1:1, and usually each bottle contains flucloxacillin and amoxicillin Amoxicillin is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/431A61P31/04A61K31/43
Inventor 贺立泽梅丹王佩贤王伟傅卫国
Owner 广东安健医药有限公司
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