Stable cefoperazone tazobactam medicine compound preparation

A technology of tazobactam and cefoperazone, which is applied in the field of drug compound preparations of cefoperazone, and can solve problems such as poor stability of cefoperazone sodium

Active Publication Date: 2007-09-19
GUANGZHOU BAIYUSN TIANXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 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.

Method used

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  • Stable cefoperazone tazobactam medicine compound preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Cefoperazone Acid: Tazobactam Sodium

[0045] As can be seen from the above table, according to the pH range of 5.5-7.5, the value range of cefoperazone acid: tazobactam sodium: sodium carbonate is 4:1:0.504-0.420. None of its colors are deeper than the yellow No. 3 color, and the dissolution time is not more than 50S.

Embodiment 2

[0047] Cefoperazone Acid: Sodium Bicarbonate

[0048]It can be seen from the above table that according to the pH range of 5.5-7.5, the value range of cefoperazone acid: tazobactam sodium: sodium bicarbonate is 4:1:1.50-0.50. None of its colors are darker than the yellow No. 2 color, and the dissolution time is not longer than 60S.

Embodiment 3

[0050] Cefoperazone Acid: Tazobactam Acid: Sodium Bicarbonate

[0051] It can be seen from the above table that according to the pH range of 5.5-7.5, the value range of cefoperazone acid:tazobactam acid:sodium bicarbonate is 4:1:0.204-0.300. None of its colors are deeper than the yellow No. 3 color, and the dissolution time is not more than 50S.

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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 [0001] 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 [0002] 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. [0003] 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/08A61K47/02A61K47/16A61P31/04A61K31/431
Inventor 谭胜连傅红燕林宝儿陈颖唐润珊
Owner GUANGZHOU BAIYUSN TIANXIN PHARMA
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