Cefoperazone sodium and sulbactam sodium combination and preparation method thereof

A technology of cefoperazone sodium sulbactam sodium and cefoperazone sodium sulbactam sodium, which is applied in the field of compound preparations of cefoperazone sodium, can solve the problems of poor stability of cefoperazone sodium and no great improvement in stability, and achieve simple steps and improved Stable, easy-to-operate effect

Inactive Publication Date: 2008-10-15
管小明
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the relatively poor stability of cefoperazone sodium, in order to ensure that the product is qualified within the validity period, it must be stored in a dry and cool place
And after being combined with sulbactam sodium into a compound, the stability has not been greatly improved, s

Method used

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  • Cefoperazone sodium and sulbactam sodium combination and preparation method thereof
  • Cefoperazone sodium and sulbactam sodium combination and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0023] 1. Prescription A

[0024] Cefoperazone Sodium 100.0g

[0025] Sulbactam Sodium 100.0g

[0026] Sodium dihydrogen phosphate 3.5g

[0027] Disodium hydrogen phosphate 5.4g

[0028] Sodium chloride 3.4g

[0029] Purified water to 500ml

[0030] A total of 100 bottles were produced

[0031] 2. Preparation method

[0032] Step 1: take cefoperazone sodium, sulbactam sodium, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride by prescription quantity;

[0033] Step 2: add water to dissolve, and adjust the pH value to 5.0-6.5 with phosphoric acid or sodium hydroxide solution;

[0034] Step 3: The prepared solution is adsorbed by activated carbon and filtered through a microporous membrane, then filled, and finally freeze-dried to obtain a cefoperazone sodium-sulbactam sodium composition, and made into an injection.

Embodiment 2

[0036] 1. Prescription B

[0037] Cefoperazone Sodium 100.0g

[0038] Sulbactam Sodium 50.0g

[0039] Sodium dihydrogen phosphate 3.5g

[0040] Disodium hydrogen phosphate 5.4g

[0041] Sodium chloride 3.4g

[0042] Purified water to 400ml

[0043] A total of 100 bottles were produced

[0044] 2. Preparation method

[0045] Step 1: take cefoperazone sodium, sulbactam sodium, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride by prescription quantity;

[0046] Step 2: add water to dissolve, and adjust the pH value to 5.0-6.5 with phosphoric acid or sodium hydroxide solution;

[0047] Step 3: The prepared solution is adsorbed by activated carbon and filtered by a microporous membrane, then loaded into a large plate, freeze-dried, pulverized, sieved, and then aseptically packaged to prepare a compound preparation of cefoperazone sodium and sulbactam sodium for injection.

Embodiment 3

[0049] 1. Prescription C

[0050] Cefoperazone Sodium 100.0g

[0051] Sulbactam Sodium 25.0g

[0052] Sodium dihydrogen phosphate 3.5g

[0053] Disodium hydrogen phosphate 5.4g

[0054] Sodium chloride 3.4g

[0055] Purified water to 400ml

[0056] A total of 100 bottles were produced

[0057] 2. Preparation method

[0058] The first step: take cefoperazone sodium, sulbactam sodium, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride by prescription quantity;

[0059] The second step: add water to dissolve, adjust the pH value to 5.0-6.5 with phosphoric acid or sodium hydroxide solution, then fill it after activated carbon adsorption and microporous membrane filtration, and finally freeze-dry to make cefoperazone sodium sulbactam for injection Sodium compound preparation.

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Abstract

The invention provides a cefoperazone sodium/sulbactam sodium composition, comprises the following components of: cefoperazone sodium, sulbactam sodium, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride. The invention also provides a preparation method of the cefoperazone sodium/sulbactam sodium composition. The method comprises the following steps of: weighing components as prescription; dissolving the components in water, and adjusting pH to 5.0-6.5 with phosphoric acid or sodium hydroxide solution; and adsorbing with activated carbon, filtering with microporous filtering film, filling, freeze drying, subpackaging under aseptic condition, or freeze drying, pulverizing, sieving and then subpackaging under aseptic condition. The composition adds sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium chloride in the prescription, so as to improve the stability of the compound preparation. The composition can be stored in a dark, cool and dry place, so as to ensure product quality within validity period.

Description

technical field [0001] The invention relates to the field of compound preparations of cefoperazone sodium, in particular to a cefoperazone sodium sulbactam sodium composition and a preparation method thereof. Background technique [0002] Cefoperazone sodium mainly inhibits the synthesis of bacterial cell walls. Sulbactam sodium itself has weak antibacterial effect and is a competitive and irreversible β-lactamase inhibitor. After combined application with cefoperazone sodium, it can increase the ability of cefoperazone sodium to resist the degradation of various β-lactamases. Produce obvious synergistic effect. The compound preparation of cefoperazone sodium and sulbactam sodium for injection has entered China in the 1990s and has been recorded in the second part of the Chinese Pharmacopoeia 2005 edition. Because the stability of cefoperazone sodium is relatively poor, in order to ensure that the product is qualified within the validity period, it must be stored in a dry ...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K31/43A61K47/04A61K9/08A61P31/04
Inventor 管小明龚拥军
Owner 管小明
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