Stable cefoperazone sulbactam medicine compound preparation

A compound preparation, the technology of cefoperazone is applied in the field of compound preparations of cefoperazone and sulbactam for injection, and can solve the problems of poor stability of cefoperazone sodium and the like

Active Publication Date: 2011-04-27
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, sulbactam 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 sulbactam medicine compound preparation
  • Stable cefoperazone sulbactam medicine compound preparation
  • Stable cefoperazone sulbactam medicine compound preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] When the mass ratio of cefoperazone acid and sulbactam sodium is 1:1, the ratio of sodium bicarbonate and the pH value of solubilization:

[0052] Cefoperazone acid: sodium bicarbonate

[0053] As can be seen from the above table, according to the pH range of 5.5 to 7.5, the value range of cefoperazone acid: sulbactam sodium: sodium bicarbonate: 1: 1: 0.25 to 0.13. Its color is not darker than the yellow No. 3 color, and the dissolution time is not more than 60S.

Embodiment 2

[0055] When the mass ratio of cefoperazone acid and sulbactam sodium is 1:1, the ratio of sodium carbonate and the pH value of solubilization:

[0056] Cefoperazone acid: sodium carbonate

[0057] 1∶0.082

[0058] 1∶0.105

[0059] As can be seen from the above table, according to the pH range of 5.5 to 7.5, the value range of cefoperazone acid:sulbactam sodium:sodium carbonate is 1:1:0.115 to 0.082. Its color is not darker than the yellow No. 2 color, and the dissolution time is not more than 60S.

Embodiment 3

[0061] When the mass ratio of cefoperazone acid and sulbactam sodium is 2:1, the ratio of sodium bicarbonate and the pH value of solubilization:

[0062] Cefoperazone acid: sodium bicarbonate

[0063] 2∶0.42

[0064] As can be seen from the above table, according to the pH range of 5.5 to 7.5, the value range of cefoperazone acid: sulbactam sodium: sodium bicarbonate: 2: 1: 0.54 to 0.28. Its color is not darker than the yellow No. 3 color, and the dissolution time is not more than 60S.

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Abstract

The invention discloses a stable compound preparation of cefoperazone-sulbactam drug, which is comprised by cefoperazone acid, sulbactam and latent solvent, which weight ratio is 8~1:1:6~0.06. 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 more stable than cefoperazone sodium and sulbac during period of validity.

Description

technical field [0001] The invention relates to a pharmaceutical compound preparation of cefoperazone, in particular to a stable cefoperazone-sulbactam compound preparation for injection with synergistic effect in clinical use. technical background [0002] The compound formula of cefoperazone sodium and sulbactam sodium for injection entered China in the 1990s and is now included in the Chinese Pharmacopoeia (2005 edition). 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 sulbactam sodium into a compound, the stability has not been improved, so the preservation conditions of the Chinese Pharmacopoeia (2000 edition) were changed from "stored in a cool, dark and dry place" to "in the Chinese Pharmacopoeia (2005 edition). Store in a cold place", which is the disadvantage of all compound preparations of cefoperazone sodium. [0003]...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/546A61K47/02A61K9/08A61P31/04A61K31/43
Inventor 谭胜连傅红燕林宝儿陈颖唐润珊
Owner GUANGZHOU BAIYUSN TIANXIN PHARMA
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