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A kind of sulbactam sodium compound and its pharmaceutical composition with mezlocillin sodium

A technology of mezlocillin sodium and sulbactam sodium, applied in the field of medicine, can solve the problems of poor storage stability, high impurity content, poor use safety and the like, and achieve the effects of less impurity content, good storage stability and high safety performance.

Active Publication Date: 2014-10-08
SHANXI C&Y PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The concentration of 2 μg / ml has strong inhibitory effect on Richmond-Syks Ⅱ, Ⅲ, Ⅳ and Ⅴ type β-lactamase, but has no effect on type I β-lactamase
[0007] The storage stability of sulbactam sodium in the prior art is relatively poor, and its related substances will increase significantly in light and humid environments, and its pharmaceutical composition with mezlocillin sodium is stored for a long time, and the impurity content is relatively high. Poor safety, in order to obtain a pharmaceutical composition of mezlocillin sodium and sulbactam sodium with better performance, the present invention is proposed

Method used

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  • A kind of sulbactam sodium compound and its pharmaceutical composition with mezlocillin sodium
  • A kind of sulbactam sodium compound and its pharmaceutical composition with mezlocillin sodium
  • A kind of sulbactam sodium compound and its pharmaceutical composition with mezlocillin sodium

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Experimental program
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Effect test

Embodiment 1

[0036] Preparation of sulbactam sodium compound

[0037] N,N-dimethylformamide and water are formulated into a mixed solvent at a volume ratio of 3:1, and the raw material drug of sulbactam sodium is taken, and the mixed solvent of N,N-dimethylformamide and water is added, and the The ratio of the volume of the mixed solvent to the mass of sulbactam sodium is 5ml:1g, heat up to 70°C, stir until completely dissolved, keep warm, adjust the pH of the solution to 5.5, and flow the solution through 0.5T at a speed of 5m / s DC magnetic field, the direction of the magnetic field is perpendicular to the flow direction of the solution, add activated carbon to the solution after magnetic treatment for decolorization, the amount of activated carbon is 0.3% (g / ml) of the volume of the mixed solvent, stir for 30min, filter to obtain a clear solution, and pour it into the clear solution Add ethanol to the solution, the volume ratio of the ethanol to the mixed solvent is 5:1, filter to obtain...

Embodiment 2

[0040] Preparation of sulbactam sodium compound

[0041]N,N-dimethylformamide and water are prepared into a mixed solvent at a volume ratio of 1:1, and the raw material drug of sulbactam sodium is taken, and the mixed solvent of N,N-dimethylformamide and water is added, and the The ratio of the volume of the mixed solvent to the mass of sulbactam sodium is 3ml:1g, heat up to 60°C, stir until completely dissolved, keep warm, adjust the pH of the solution to 5.0, and flow the solution through 0.5T at a speed of 10m / s DC magnetic field, the direction of the magnetic field is perpendicular to the flow direction of the solution, add activated carbon to the solution after magnetic treatment for decolorization, the amount of activated carbon is 0.3% (g / ml) of the volume of the mixed solvent, stir for 30min, filter to obtain a clear solution, and pour it into the clear solution Add ethanol to the solution, the volume ratio of the ethanol to the mixed solvent is 10:1, filter to obtain ...

Embodiment 3

[0044] Preparation of Mezlocillin Sodium and Sulbactam Sodium Powder Injection

[0045] Take by weighing mezlocillin sodium and the sulbactam sodium that embodiment 1 prepares under aseptic condition, wherein the mass ratio of mezlocillin sodium and sulbactam sodium is 4:1, is placed in the solid powder mixer and evenly mixed, The raw materials obtained are transferred to the aseptic preparation workshop, where they are precisely measured and packaged. Each bottle contains 0.5 g of sulbactam sodium, which is stoppered and capped. The finished product is packaged and put into storage for inspection.

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a sulbactam sodium compound and a medical composition of the sulbactam sodium compound and mezlocillin sodium. The sulbactam sodium compound is shown as by an X-ray powder diffraction spectrogram I measured by a Cu-K alpha ray. The sulbactam sodium compound provided by the invention has better storage stability. The invention further provides a preparation method of the sulbactam sodium compound as well as a medical composition of the sulbactam sodium compound and mezlocillin sodium. The medical composition has better storage stability and higher using safety performance.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a sulbactam sodium compound and a pharmaceutical composition thereof with mezlocillin sodium. Background technique [0002] Sulbactam sodium Chinese alias: (2S,5R)-3,3-Dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate sodium- 4,4-Dioxide; (2S-CIS)-3,3-Dimethyl-7-oxo-4-thio-1-azabicyclo[3,2,0]heptane-2-carboxy Acid 4,4-dioxide sodium salt; English name Sulbactam Sodium; Molecular formula: C 8 h 10 NNaO 5 S; Molecular weight: 255.22; Molecular structural formula is shown in the figure below: [0003] [0004] Sulbactam sodium is an irreversible competitive β-lactamase inhibitor, which can inhibit the β-lactamase produced by Gram-positive and negative bacteria (except Pseudomonas aeruginosa), and has an irreversible reaction with the enzyme After the enzyme is inactivated, the activity of the enzyme cannot be restored after the inhibitor is removed....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D499/86C07D499/18A61K31/431A61K31/43A61P31/04
Inventor 闫晓晔
Owner SHANXI C&Y PHARMACEUTICAL GROUP CO LTD
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