A kind of preparation method of cefotaxime sodium

A technology of cefotaxime sodium and cefotaxime acid, which is applied in the field of raw material drug preparation in medical technology, can solve the problems of poor fluidity, poor fluidity of cefotaxime sodium raw material drug, etc., and achieve the effect of improving fluidity

Active Publication Date: 2016-10-26
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] What the present invention is to solve is the problem of poor fluidity of cefotaxime sodium crude drug, thereby overcoming a series of problems caused by poor fluidity

Method used

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  • A kind of preparation method of cefotaxime sodium
  • A kind of preparation method of cefotaxime sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Control the temperature at 26°C, add 350g of anhydrous sodium acetate to 500mL of purified water, stir to dissolve, add 1000g of cefotaxime acid, stir until the solution is clear, add 2g of activated carbon for decolorization for 10min, then use a sterile membrane to filter, and pour into the filtrate Add 500 mL of butanol, stir for 5 minutes, control the stirring at 150 rpm, control the temperature at 12°C, add acetone, and observe the change of the solution. When solids are found in the solution, stop adding acetone, stop stirring, and add acetone to share 1h, stand still for crystal growth for 30min, then start stirring, control the stirring speed at 150 rpm, control the temperature at 12°C, continue to feed 3L of acetone within 2 hours, after the acetone is added, cool the feed solution to 0°C, and raise After crystallization for 50 minutes, the feed liquid was suction-filtered, the filter cake was washed three times with acetone, placed in an oven, controlled at a t...

Embodiment 2

[0031] Control the temperature at 30°C, add 3.25kg of anhydrous sodium acetate to 4.64L of purified water, stir to dissolve, add 10kg of cefotaxime acid, stir until the solution is clear, add 18g of activated carbon for decolorization for 10min, and then use a sterile membrane to filter, Add 4.64 L of butanol to the filtrate, stir for 5 minutes, control the stirring at 180 rpm, control the temperature at 18°C, add acetone, observe the change of the solution, stop adding acetone, stop stirring, and add When sharing acetone for 1.5 hours, let the crystal grow for 40 minutes, then start stirring, control the stirring speed at 180 rpm, and control the temperature at 18°C. Continue to add 32.48L of acetone within 3 hours. After the acetone is added, cool down the temperature of the feed solution to 5°C, grow the crystal for 60 minutes, filter the feed liquid with suction, wash the filter cake three times with acetone, put it in an oven, control the temperature at 63-65°C, and dry un...

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Abstract

The invention discloses a preparation method of cefotaxime sodium. Ceftizoxime acid used as the initial raw material reacts with anhydrous sodium acetate to generate the cefotaxime sodium. In such process, purified water, butanol and acetone are selected as crystallizing solvents to control the mixing speed and crystallization temperature in the crystallization process, so that the finally obtained cefotaxime sodium has favorable flowability and can satisfy the subpackaging requirements in production. Various quality indexes of the obtained cefotaxime sodium conform to the requirements for medicinal standard, and thus, the cefotaxime sodium can satisfy the demands for clinical application.

Description

technical field [0001] The invention belongs to the technical field of preparation of raw materials in medical technology, and in particular relates to a preparation method of antibiotic cefotaxime sodium. Background technique [0002] Cefotaxime sodium is a commonly used clinical antibiotic, powder injection, intramuscular injection or intravenous injection, used for various infections caused by sensitive bacteria. [0003] Cefotaxime sodium for injection is obtained by aseptic subpackaging of cefotaxime sodium bulk drug. The subpackaging process is all mechanically operated, and the filling volume can be adjusted according to actual needs. Since the filling volume is automatically controlled, mechanical subpackaging has high requirements on the fluidity of the cefotaxime sodium raw material drug. In the case of poor fluidity, the filling volume of cefotaxime sodium has a large deviation, resulting in unqualified products for subpackaging. Excessive quantity will not only ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D501/02C07D501/12C07D501/34
CPCC07D501/04C07D501/34
Inventor 徐永龙刘健陈英新郝金恒袁国强靳献蕊梅玉龙李银
Owner 石药集团中诺药业(石家庄)有限公司
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