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Sterilization medicine ceftezole sodium compound and preparation method thereof

A technology of ceftezole sodium and its compound, which is applied in the field of bactericidal drug ceftezole sodium compound and its preparation, can solve the problems of unfavorable stability, great harm to patients, unstable β-lactam ring, etc., and is suitable for clinical application , The preparation method is simple, the effect of high stability

Inactive Publication Date: 2015-11-18
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The structure of ceftezole sodium contains an unstable β-lactam ring, which is prone to hydrolysis and rearrangement reactions, resulting in the destruction of the structure and the loss of antibacterial activity. Some degradation products may cause allergic reactions, so this type of antibiotics in the infusion The stability of the
At the same time, because its basic structure is the same as that of many semi-synthetic β-lactam antibiotics on the market, it will also form a high molecular weight polymer, which will also cause immediate allergic reactions in clinical use, which is extremely harmful to patients
At the same time, ceftezole sodium is very easy to attract moisture, which has a very adverse effect on its stability.

Method used

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  • Sterilization medicine ceftezole sodium compound and preparation method thereof
  • Sterilization medicine ceftezole sodium compound and preparation method thereof
  • Sterilization medicine ceftezole sodium compound and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Preparation of Ceftezole Sodium Crystalline Compound

[0023] (1) Add the crude product of ceftezole sodium into the mixed solution of water and acetonitrile whose volume is 5 times the weight of ceftezole sodium, the volume ratio of water and acetonitrile is 2:1, heat up to 25°C, stir until completely dissolved ;

[0024] (2) In a sound field with a frequency of 30KHz and an output power of 45W, add a mixed solution of ethanol, chloroform, and cyclohexane whose volume is 10 times the weight of ceftezole sodium while stirring, ethanol, chloroform, and cyclohexane The volume ratio of hexane is 2:1:1, the stirring speed is 85 rev / min, and the adding speed is 80 ml / min;

[0025] (3) After adding the mixed solution of ethanol, chloroform and cyclohexane, under a sound field with a frequency of 25KHz and an output power of 40W, cool down to -5°C at 10°C / hour, grow crystals for 3 hours, and wash. Vacuum-dried to obtain ceftezole sodium compound.

[0026] The X...

experiment example 1

[0027] Experimental Example 1: Accelerated Test

[0028] Take the ceftezole sodium crystalline compound prepared in Example 1 and the commercially available ceftezole sodium raw material, simulate the marketing package, put them in a sealed clean container, and place 6 ceftezole sodium under the conditions of 25°C ± 2°C and humidity 60% ± 5%. During the test period, samples were taken at the end of 1, 2, 3, and 6 months to inspect the key stability inspection items. The results are shown in Table 1.

[0029] Table 1 Acceleration experiment results

[0030]

experiment example 2

[0031] Experimental Example 2: Hygroscopicity Test

[0032] 1 instrument

[0033] PL203 electronic balance, LRH-250-S constant temperature and humidity incubator, HH-400SD drug stability test box;

[0034] 2 methods

[0035] Take a glass desiccator with a supersaturated solution of salt at the bottom (in order to ensure the saturation of the salt solution, there should be excess salt at the bottom of the desiccator), with a built-in weighing bottle in the desiccator, and place it in a constant temperature box for 48 hours to constant humidity. Take about 2g of the sample, put it in a weighing bottle, weigh it accurately, open the bottle cap, put it into the upper part of the desiccator, store it in a constant temperature and humidity incubator at 25°C or a stability test box at 20°C according to different temperature requirements, and operate in parallel 3 parts were weighed at different times to calculate the moisture absorption rate at different times.

[0036] Calculat...

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Abstract

The invention relates to a sterilization medicine ceftezole sodium compound and a preparation method thereof, and belongs to the technical field of medicine. An X-ray powder diffraction pattern, obtained by measuring by using a Cu-K alpha ray, of the ceftezole sodium compound is shown in the Figure I of the description. Through a research of the hygroscopicity of the ceftezole sodium compound, the inventor surprisingly discovers that the hygroscopicity of the compound provided by the invention is greatly lower than that of an existing crystalline compound, and that the purity is high, the liquidity is good, and the content of a polymer is low, thus, the ceftezole sodium crystalline compound provided by the invention is more stable, and is more suitable for the preparation of preparations, and clinical application is safe and reliable.

Description

Technical field [0001] The invention is a pharmaceutical technology field involving a sodium cephalopidazole sodium compound and its preparation method. Background technique [0002] Sodium cephalosporium is the first -generation injection of cephalosporin, developed by Japan, and is first listed in Japan, South Korea, Italy and other countries.The structure of cephalosporium sodium contains unstable β-lactam ring, which is prone to hydrolysis and reactive reactions, resulting in damage to the structure and losing antibacterial activity. Some degradable products may cause allergic reactions. Therefore, such antibiotics are in infusionStability should attract widespread attention.At the same time, because its basic structure is the same as many semi-synthetic β-laidide internal antibiotics, it will also form polymer polymer, which will also cause allergic reactions in clinical use, which is extremely harmful to patients.At the same time, cephalosporium sodium is easily wet, which ...

Claims

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Application Information

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IPC IPC(8): C07D501/36C07D501/12A61P31/04
CPCC07D501/36C07B2200/13C07D501/12
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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