Cefoperazone sodium and sulbactam sodium combination and preparation method thereof

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 ...

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, so the storage conditions are changed from the previous "preservation in a cool, dark and dry place (Chinese Pharmacopoeia 2000 edition two)" to the current "in Cold storage (Chinese Pharmacopoeia 2005 edition two) ", this is the shortcoming of all cefoperazone sodium compound preparations

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