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Stable cefoperazone potassium clavulanatein medicine compound preparation

A technology of potassium perazone clavulanate and cefoperazone acid, which is applied in the field of compound drug preparations of cefoperazone, and can solve the problems of poor stability of cefoperazone sodium and the like

Inactive 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 weak point of the poor stability of cefoperazone sodium, the object of the present invention is to provide the composition of cefoperazone acid, clavulanate potassium 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 potassium clavulanatein medicine compound preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Cefoperazone Acid: Sodium Carbonate

[0052]As can be seen from the above table, according to the pH range of 5.5-7.5, the value range of cefoperazone acid: potassium clavulanate: sodium carbonate is 16:1:1.28-1.60. None of its colors are greater than yellow No. 3 color, and the dissolution time is not greater than 100S.

Embodiment 2

[0054] Cefoperazone Acid: Sodium Bicarbonate

[0055] As can be seen from the above table, according to the pH range of 5.5-7.5, the value range of cefoperazone acid: potassium clavulanate: sodium bicarbonate is 16:1:2.15-2.09. None of its colors are deeper than the yellow No. 3 color, and the dissolution time is not more than 80S.

Embodiment 3

[0057] Cefoperazone Acid: Sodium Carbonate

[0058] 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: potassium clavulanate: sodium carbonate is 8:1:0.70-0.66. Its color is not greater than yellow No. 2 color, and the dissolution time is not greater than 80S.

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Abstract

The invention discloses a stable compound preparation of cefoperazone-piperacillin clavulanate drug, which is comprised by cefoperazone acid, piperacillin clavulanate and latent solvent, which weight ratio is 16~1:1:8.8~0.06. The latent solvent is preferred selected from sodium carbonate and sodium bicarbonate. Related substances content of the compound preparation, labelled content of the cefoperazone acid and the piperacillin clavulanate in the invention do not change much in influencing factor test, long-term sample tests and accelerated test in 40 DEG C. which accord with the standard of pharmacopoeia with stable product quality.

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] 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. And after combining with potassium clavulanate to form a compound, the stability has not been 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. Because the main component that plays a curative effect clinically is cefoperazone, therefore, through the effect of cosolvent on ce...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61P31/04A61K31/424
Inventor 谭胜连傅红燕林宝儿陈颖唐润珊
Owner GUANGZHOU BAIYUSN TIANXIN PHARMA
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