Stable cefoperazone tazobactam medicine compound preparation

Abstract

The invention discloses a stable compound preparation of cefoperazone-tazobactam drug, which is comprised by cefoperazone acid, tazobactam and latent solvent, which weight ratio is 8~1:1:5.6~0.06. The latent solvent is preferred selected from sodium carbonate and sodium bicarbonate. Related substances of the compound preparation in the invention are lower than standard of Chinese pharmacopoeia (2005 edition) in influencing factor and accelerated test in 40 DEG C, labelled content accords with the standard of the pharmacopoeia and changes very little in the experiment, and the product quality is stable.

Description

technical field The invention relates to a drug compound preparation of cefoperazone, in particular to a stable cefoperazone compound powder for injection with a synergistic effect for clinical use. technical background The compound recipe of cefoperazone sodium and tazobactam sodium for injection was approved for marketing in 2003, and only one company is currently on the market. Due to the 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 cold place. After combination with tazobactam sodium, the stability was not improved. This is the deficiency of all compound preparations of cefoperazone sodium. Currently, cefoperazone acid is generally not used clinically due to its water insoluble properties. But through the comparison test of cefoperazone acid and cefoperazone sodium, it can be drawn that cefoperazone acid is more stable than cefoperazone sodium. Because the main comp...

AI Technical Summary

Problems solved by technology

For the poor stability of cefoperazone sodium, the object of the present invention is to provide the composition of cefoperazone acid, tazobactam and cosolvent, which has stable quality when stored at room temperature, and dissolves rapidly in clinical use.

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