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Stable cefoperazone medicine prparation

A technology of cefoperazone and pharmaceutical preparations, which is applied in the field of cefoperazone pharmaceutical preparations, can solve problems such as poor stability of cefoperazone sodium, and achieve the effect of stable product quality

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

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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 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 medicine prparation

Examples

Experimental program
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Effect test

Embodiment 1

[0035] Cefoperazone Acid: Sodium Carbonate

[0036] It can be known from the above table that according to the pH range of 5.5-7.5, the value range of cefoperazone acid and sodium carbonate: 1:0.102-0.082. None of its colors are darker than the yellow No. 4 color, and the dissolution time is not longer than 60S.

Embodiment 2

[0038] Cefoperazone Acid: Sodium Bicarbonate

[0039] 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 and sodium bicarbonate: 1:0.20-0.10. None of its colors are deeper than the yellow No. 3 color, and the dissolution time is not more than 80S.

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Abstract

The invention discloses a stable compound preparation of cefoperazone drug, which is comprised by cefoperazone acid and latent solvent, which weight ratio is 1:0.62~0.06. The latent solvent is preferred selected from sodium carbonate and sodium bicarbonate. Related substances of the compound preparation in the invention and labelled content do not change much in influencing factor and accelerated test in 40 DEG C., which accord with the standard of pharmacopoeia, and the product quality is more stable than cefoperazone sodium during period of validity.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of cefoperazone, in particular to a stable cefoperazone powder for injection with 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. In the Chinese Pharmacopoeia (2005 edition), the dry product content of cefoperazone sodium preparations should not be less than 88%, the labeled amount should be 95% to 105%, and its related substances should not be greater than 6%. However, the restrictions on content and related substances of similar varieties are more stringent , thus indicating that cefoperazone sodium is unstable. This is the deficiency of all preparations of cefoperazone sodium. [0003] Currently, cefoperazone acid is generally not used clinically due to its water insoluble properties. But through the compari...

Claims

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Application Information

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