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Ceftazidime compound and pharmaceutical composition thereof

A ceftazidime and compound technology, applied in the directions of antibacterial drugs, organic chemistry, pharmaceutical formulations, etc., can solve the problems of poor ceftazidime fluidity, affect the accuracy and uniformity of dispensing, and be unsuitable for industrial production, and achieve good bioavailability, Improved medication safety and little change in polymer content

Active Publication Date: 2014-06-18
YOUCARE PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the ceftazidime prepared by the method of the prior art has poor fluidity, which seriously affects the accuracy and uniformity of its packaging, and is not suitable for industrial production

Method used

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  • Ceftazidime compound and pharmaceutical composition thereof
  • Ceftazidime compound and pharmaceutical composition thereof
  • Ceftazidime compound and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] [embodiment 1] the preparation of ceftazidime compound

[0047] 1) Preparation of crude product solution: Add 20g of crude ceftazidime into 110ml of mixed solvent prepared from dimethyl sulfoxide and methanol (the volume ratio of dimethyl sulfoxide and methanol is 6:1), control the temperature at 22°C, and add ceftazidime 0.01% active carbon decolorization of crude product weight, filter, obtain ceftazidime crude product solution, standby;

[0048] 2) Crystal nucleation process: control the temperature of the crude ceftazidime solution within the range of 22°C, add deionized water to the solution at a rate of 11ml / min under stirring at a stirring speed of 150r / min, turbidity appears, and obtain cloudy solution;

[0049] 3) Nucleation and crystal growth process: put the turbid solution obtained in step 2) at a frequency of 4kHz and an intensity of 3W·cm -2 Under the ultrasonic field, control the temperature of the solution at 22°C, add 1210ml of chloroform to it at a r...

Embodiment 2

[0051] [embodiment 2] the preparation of ceftazidime compound

[0052] 1) Preparation of crude product solution: Add 20g of crude ceftazidime into 150ml of a mixed solvent prepared from dimethyl sulfoxide and methanol (the volume ratio of dimethyl sulfoxide and methanol is 4:1), control the temperature at 28°C, and add ceftazime 0.01% active carbon decolorization of crude product weight, filter, obtain ceftazidime crude product solution, standby;

[0053] 2) Crystal nucleation process: control the temperature of the crude ceftazidime solution within the range of 28°C, add 1050ml of deionized water to the solution at a rate of 14ml / min under stirring at a stirring speed of 180r / min, and turbidity appears. A cloudy solution was obtained;

[0054] 3) Nucleation and crystal growth process: put the turbid solution obtained in step 2) at a frequency of 4.8kHz and an intensity of 1W·cm -2 Under the ultrasonic field, control the solution temperature at 28°C, add 1500ml chloroform to...

Embodiment 3

[0056] [embodiment 3] the preparation of ceftazidime compound

[0057] 1) Preparation of crude product solution: Add 20g of crude ceftazidime into 130ml of a mixed solvent prepared from dimethyl sulfoxide and methanol (the volume ratio of dimethyl sulfoxide and methanol is 5:1), control the temperature at 25°C, and add ceftazidime 0.01% active carbon decolorization of crude product weight, filter, obtain ceftazidime crude product solution, standby;

[0058] 2) Crystal nucleation process: Control the temperature of the crude ceftazidime solution within the range of 25°C, add 1040ml of deionized water to the solution at a rate of 12ml / min under stirring at a stirring speed of 160r / min, turbidity appears, A cloudy solution was obtained;

[0059] 3) Nucleation and crystal growth process: place the turbid solution obtained in step 2) at a frequency of 5.0kHz and an intensity of 2W·cm -2 Under the ultrasonic field, control the temperature of the solution at 25°C, add 1170ml of chl...

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Abstract

The invention relates to a ceftazidime compound and a pharmaceutical composition thereof. The structural formula of the ceftazidime compound is shown in a formula (I) described in the specification. The compound is determined by a powder X-ray diffraction determination method, an X-ray powder diffraction pattern represented by a diffraction angle of 2theta+ / -0.2 degrees is shown in the figure 1. The compound not only has good thermal stability, but also has excellent mobility. Pharmacokinetic study surprisingly finds out that the ceftazidime compound disclosed by the invention has good bioavailability.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a ceftazidime compound, a preparation method thereof and a pharmaceutical composition in the form of aseptic mixed powder. Background technique [0002] Ceftazidime, chemical name (6R,7R)-7-[[(2-amino-4-thiazolyl)-[(1-hydroxy-1-methylethoxy)imino]acetyl]amino]-2 -Carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-3-methylpyridinium inner salt pentahydrate, a cephalosporin widely used in clinical element, its structural formula is: [0003] [0004] In order to ensure the safety of human medicine, the National Pharmacopoeia stipulates that for ceftazidime antibiotics, the content of ceftazidime pentahydrate is not less than 95%, the content of polymer is not more than 0.3%, and its color is not higher than No. 6 color. During storage, ceftazidime antibiotics, especially when subjected to high temperature (>50°C), often undergo degradation and polymerization reactions to ...

Claims

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Application Information

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IPC IPC(8): C07D501/46C07D501/12A61K31/546A61P31/04
CPCC07D501/12C07D501/46
Inventor 李琦杨磊
Owner YOUCARE PHARMA GROUP
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