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Medicinal composition including piperacillin sodium and sulbactam sodium

A technology of piperacillin sodium and sulbactam sodium is applied in the field of sulbactam sodium compound and its pharmaceutical composition with piperacillin sodium, and can solve the problem that type I beta-lactamase has no effect, poor use safety, Problems such as poor storage stability, to achieve the effect of good bioavailability, good accumulation, and better bioavailability

Active Publication Date: 2013-06-05
HAINAN GENERAL & KANGLI PHARMA
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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
[0010] 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 piperacillin sodium is stored for a long time, and the impurity content is relatively high. Poor safety, in order to obtain a pharmaceutical composition of piperacillin sodium and sulbactam sodium with better performance, the present invention is proposed

Method used

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  • Medicinal composition including piperacillin sodium and sulbactam sodium
  • Medicinal composition including piperacillin sodium and sulbactam sodium
  • Medicinal composition including piperacillin sodium and sulbactam sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0035] Preparation of sulbactam sodium compound

[0036] 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

[0039] Preparation of sulbactam sodium compound

[0040]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

[0043] Preparation of piperacillin sodium and sulbactam sodium powder for injection

[0044] Take piperacillin sodium and the sulbactam sodium prepared in Example 1 under aseptic conditions, wherein the mass ratio of piperacillin sodium and sulbactam sodium is 6:1, place in a solid powder mixer and mix uniformly, 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 medicaments, and in particular relates to a medicinal composition including piperacillin sodium and sulbactam sodium. The medicinal composition is an injection, and an X-ray powder diffraction spectrogram, which is obtained through Cu-K alpha-ray measurement, of a sulbactam sodium compound in the medicinal composition is as shown in figure 1. The sulbactam sodium has very good storage stability, and the medicinal composition including the piperacillin sodium and the sulbactam sodium has better storage stability and high use safety; moreover, the medicinal composition including the piperacillin sodium and the sulbactam sodium has better accumulating, synergistic and complementary functions, and is better in bioavailability.

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 piperacillin 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 as follows: [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. In this case...

Claims

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Application Information

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IPC IPC(8): A61K31/496A61K31/43A61P31/04C07D499/86C07D499/18
Inventor 闫晓晔
Owner HAINAN GENERAL & KANGLI PHARMA