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Method for controlling quality of Ceftezole sodium used for injection

A technology for ceftizole sodium and injection, which is applied in the field of medicine, can solve the problems of not exceeding 5.5%, affecting the difference in filling amount, affecting the stability of preparations, etc., and achieves accurate filling amount, good powder fluidity and good clarity. Effect

Inactive Publication Date: 2010-08-11
天津新丰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] The stability of ceftezole sodium for injection is closely related to the water content. High water content will affect the stability of the preparation. Too low water content will lead to static electricity of ceftezole sodium powder and affect the difference in loading capacity.
In the existing ceftezole sodium drug standard, the moisture content shall not exceed 5.5%. In the standard control, the ceftezole content is 90.0% to 110.0% of the labeled amount. There is no more accurate water content for ceftezole sodium at present. Control Method

Method used

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  • Method for controlling quality of Ceftezole sodium used for injection
  • Method for controlling quality of Ceftezole sodium used for injection
  • Method for controlling quality of Ceftezole sodium used for injection

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Embodiment

[0021] A quality control method of ceftezole sodium for injection includes the following steps:

[0022] (1) Control the moisture content of cefotiazole sodium in the range of 2% to 4%;

[0023] (2) Control the humidity of the packaging environment at 40%-45%.

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Abstract

The invention discloses a method for controlling the quality of Ceftezole sodium used for injection, comprising the steps as follows: (1) controlling the moisture content of a Ceftezole sodium raw material to be 2-4%; and (2) controlling the humidity of the encapsulation environment to be 40-45%. By controlling the raw material moisture and the humidity of the encapsulation environment in the invention, the moisture content of a drug preparation can be controlled better so as to obtain a preparation with the characteristics of good clarity, favorable powder mobility and more accurate charging amount, thus being more applicable to clinic use.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and relates to a method for quality control of cephalosporin drugs, in particular to a method for controlling the quality of cefotizole sodium for injection. Background technique [0002] Ceftezole Sodium (Ceftezole Sodium, molecular weight 462.47, molecular formula C 13 H 11 N 8 NaO 4 S 3 ), the chemical name is (6R,7R)-3-([1,3,4-thiadiazol-2-yl)thio]methyl)-7-((1H-tetrazol-1-yl)acetamido )-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sodium salt, white to light yellow powder or crystalline powder, odorless, hygroscopic. [0003] Cefotizole sodium is the first generation of cephalosporin antibiotics for injection. It is a semi-synthetic cephalosporin derivative. Its mechanism of action is to inhibit the synthesis of bacterial cell walls to exert antibacterial activity. It has antibacterial activity against gram-positive bacteria, especially cocci. For example, Staphylococcus aureus, Strept...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/546A61P31/04
Inventor 刘文玖王春玲李红梅李相君王原闫晓楠
Owner 天津新丰制药有限公司
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