Novel cefoperazone sodium and sulbactam sodium pharmaceutical composition for injection

A technology of cefoperazone sodium sulbactam sodium and cefoperazone sodium, which is applied in the field of new injection cefoperazone sodium sulbactam sodium pharmaceutical composition, can solve the problems of unguaranteed, potential safety hazards for patients, insufficient stability, etc., and achieve simple and easy steps. The effect of operation, stability number

Inactive Publication Date: 2017-01-11
南昌立健药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Most of the existing pharmaceutical compositions of cefoperazone sodium and sulbactam sodium have insufficient stability

Method used

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Examples

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Comparison scheme
Effect test

Embodiment 1

[0028] A novel pharmaceutical composition of cefoperazone sodium and sulbactam sodium for injection, comprising the following components: sulbactam sodium, cefoperazone sodium with a specific rotation of -23°, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride, wherein, The weight ratio of sulbactam sodium, cefoperazone sodium, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride is 1:2:0.27:0.18:0.13.

[0029] The preparation method of described novel injection cefoperazone sodium sulbactam sodium pharmaceutical composition, the steps are as follows:

[0030] 1) Stir the sodium acetate solution into the cefoperazone acid acetone solution at 3°C, and control the pH value at 6.8, wherein the total moles of sodium acetate and sodium bicarbonate are equal to the moles of cefoperazone acid, The molar fraction of sodium acetate is 20% of cefoperazone acid, and the molar fraction of sodium bicarbonate is 80% of cefoperazone acid;

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Embodiment 2

[0041] A novel pharmaceutical composition of cefoperazone sodium and sulbactam sodium for injection, comprising the following components: sulbactam sodium, cefoperazone sodium with a specific rotation of -24°, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride, wherein, The weight ratio of sulbactam sodium, cefoperazone sodium, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride is 1:1:0.25:0.16:0.11.

[0042] The preparation method of described novel injection cefoperazone sodium sulbactam sodium pharmaceutical composition, the steps are as follows:

[0043] 1) Stir the sodium acetate solution into the cefoperazone acid acetone solution at 0°C, and control the pH value at 6.5, wherein the total moles of sodium acetate and sodium bicarbonate are equal to the moles of cefoperazone acid, The molar fraction of sodium acetate is 22% of cefoperazone acid, and the molar fraction of sodium bicarbonate is 78% of cefoperazone acid;

...

Embodiment 3

[0054] A novel pharmaceutical composition of cefoperazone sodium and sulbactam sodium for injection, comprising the following components: sulbactam sodium, cefoperazone sodium with a specific rotation of -23°, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride, wherein, The weight ratio of sulbactam sodium, cefoperazone sodium, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride is 1:3:0.28:0.18:0.13.

[0055] The preparation method of described novel injection cefoperazone sodium sulbactam sodium pharmaceutical composition, the steps are as follows:

[0056] 1) Stir the sodium acetate solution into the cefoperazone acid acetone solution at 2°C, the pH value is controlled at 6.6, wherein the total moles of sodium acetate and sodium bicarbonate are equal to the moles of cefoperazone acid, The molar fraction of sodium acetate is 18% of cefoperazone acid, and the molar fraction of sodium bicarbonate is 82% of cefoperazone acid; ...

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Abstract

The invention discloses a novel cefoperazone sodium and sulbactam sodium pharmaceutical composition for injection, including the following components: 23o-24o of sulbactam sodium, sodium cefoperazone of specific rotation, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride, of where the weight weight-ratio of sulbactam sodium, cefoperazone sodium, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride is 1:1-4:0.25-0.30:0.16-0.20:0.11-0.15. The invention also discloses a preparing method of the described new cefoperazone sodium and sulbactam sodium pharmaceutical composition for injection. The novel cefoperazone sodium and sulbactam sodium pharmaceutical composition has good stability, which can ensure qualified products within date expiration leads to clinically safe medication use.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a novel pharmaceutical composition of cefoperazone sodium and sulbactam sodium for injection. Background technique [0002] In recent years, with the wide application of antibacterial drugs in clinic, the drug resistance of bacteria has increased significantly, among which the drug resistance caused by β-lactamases, especially extended-spectrum β-lactamases, has attracted attention. According to reports, about 25% to 75% of patients with Gram-negative bacterial infection who fail or relapse are caused by bacteria producing β-lactamases. Therefore, the development of β-lactamase inhibitors and their compound preparations with β-lactam drugs has important clinical significance. Therefore, the compound preparation of cefoperazone sodium and sulbactam sodium for injection has also been successfully marketed. Cefoperazone sodium and sulbactam sodium are compound preparations with higher anti...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K31/43A61K9/19A61K47/02A61P31/04
CPCA61K31/546A61K9/0019A61K9/19A61K31/43A61K47/02A61K2300/00
Inventor 郑玲英
Owner 南昌立健药业有限公司
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