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Flucloxacillin Sodium Amoxicillin Sodium Injection Powder

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

Inactive Publication Date: 2016-10-05
广州安健实业发展有限公司
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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 Amoxicillin Sodium Injection Powder
  • Flucloxacillin Sodium Amoxicillin Sodium Injection Powder
  • Flucloxacillin Sodium Amoxicillin Sodium Injection Powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Embodiment 1: preparation pharmaceutical composition

[0089] Ingredients ratio: the weight ratio of flucloxacillin to amoxicillin is 1:1.

[0090] 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 in contact with the saturated atmosphere; After airtight treatment, the mixture of the three materials is dried at a temperature of 55°C until the water content is lower than 2%, and 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

[0091] Embodiment 2: preparation pharmaceutical composition

[0092] Ingredients ratio: the weight ratio of flucloxacillin to amoxicillin is 1:0.8.

[0093] 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 in contact with the saturated atmosphere; After airtight treatment, the mixture of the three materials is dried at a temperature of 50°C until the moisture 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

[0094] Embodiment 3: preparation pharmaceutical composition

[0095] Ingredients ratio: the weight ratio of flucloxacillin to amoxicillin is 1:1.2.

[0096] 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, and the space atmosphere in the airtight container is saturated with 60% ethanol, so that the mixed material is fully in contact with the saturated atmosphere; After airtight treatment, the mixture of the three materials is dried at a temperature of 60°C until the moisture 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 injection powder. Specifically, the present invention relates to a stable pharmaceutical composition of flucloxacillin sodium and amoxicillin sodium for injection, which comprises flucloxacillin sodium and amoxicillin sodium, wherein flucloxacillin sodium is calculated as flucloxacillin, amoxicillin Cillin sodium is calculated as amoxicillin, and the weight ratio of flucloxacillin to amoxicillin is 1: (0.8-1.2). The pharmaceutical composition of the present invention has excellent pharmaceutical properties. For example, the amounts of impurity C and impurity D in the powder for injection of flucloxacillin sodium and amoxicillin sodium of the present invention are independently lower than 1.0% relative to the amount of flucloxacillin, And / or after the powder for injection of flucloxacillin sodium and amoxicillin sodium of the present invention is placed at 45°C for 3 months, the percentage increases in the content of impurity C and impurity D are respectively less than 50% relative to that before the high temperature treatment. It shows that the powder for injection of flucloxacillin sodium and amoxicillin sodium of the present invention not only has low impurity content, but also has excellent product stability.

Description

[0001] This application is a divisional application of the patent application No. 2013102925619 submitted on July 11, 2013. technical field [0002] 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 [0003] Each bottle of commercially available flucloxacillin sodium and amoxicillin sodium contains flucloxacillin sodium and amoxicillin sodium, respectively, the ratio of the marked amounts of ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/431A61K9/14A61P31/04A61K31/43
Inventor 贺立泽王佩贤王伟傅卫国
Owner 广州安健实业发展有限公司
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