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A kind of anti-infection drug ceftazidime crystal compound and its pharmaceutical composition

A crystalline compound, a technology for ceftazidime, applied in the field of medicine, can solve the problems of difficult and accurate quantification of ceftazidime, increased risk of adverse reactions, large differences in loading, etc., and achieves low pyridine and polymer content, good clarity, and different loadings. small effect

Active Publication Date: 2018-08-31
SHANDONG LUOXIN PHARMA GRP HENGXIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ceftazidime for injection is usually prepared by aseptically mixing ceftazidime and pharmaceutical excipients. The particle size is large, the mixing is uneven, and the filling volume varies greatly, which makes it difficult to accurately quantify the effective and active ingredient ceftazidime during use.
At the same time, due to the different purity of ceftazidime, ceftazidime for injection has various problems such as coloring, degradation, polymerization and stability, and the risk of adverse reactions increases

Method used

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  • A kind of anti-infection drug ceftazidime crystal compound and its pharmaceutical composition
  • A kind of anti-infection drug ceftazidime crystal compound and its pharmaceutical composition
  • A kind of anti-infection drug ceftazidime crystal compound and its pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The preparation of embodiment 1 ceftazidime crystal compound

[0042] 1) Dissolving the ceftazidime crude product in a mixed solvent A of ethanol and water whose volume is 6 times the weight of ceftazidime at 15°C, the volume ratio of ethanol to water is 1:2.5;

[0043] 2) First add the mixed solvent B of N-methylpyrrolidone and dichloromethane whose total volume is 6 times the weight of ceftazidime at a speed of 20ml / min, and the volume ratio of N-methylpyrrolidone and dichloromethane is 1:4 , Stir while adding, control the temperature at 15°C, and grow the crystal for 0.5 hours;

[0044] 3) Add the mixed solvent C of N-methylpyrrolidone and dichloromethane whose total volume is 9 times the weight of ceftazidime at a speed of 12ml / min, and the volume ratio of N-methylpyrrolidone and dichloromethane is 1:3 , after growing the crystal for 4 hours, lower the temperature to -5°C at a rate of 20°C / hour, then stir and crystallize, and grow the crystal for 2 hours;

[0045]...

Embodiment 2

[0053] The preparation of embodiment 2 ceftazidime crystal compound

[0054] 1) Dissolving the ceftazidime crude product in a mixed solvent A of ethanol and water whose volume is 8 times the weight of ceftazidime at 10° C., the volume ratio of ethanol to water is 1:2.5;

[0055] 2) First add the mixed solvent B of N-methylpyrrolidone and dichloromethane whose total volume is 7 times the weight of ceftazidime at a speed of 15ml / min, and the volume ratio of N-methylpyrrolidone and dichloromethane is 1:4 , Stir while adding, control the temperature at 25°C, and grow the crystal for 0.5 hours;

[0056] 3) Add the mixed solvent C of N-methylpyrrolidone and dichloromethane whose total volume is 10 times the weight of ceftazidime at a speed of 10ml / min, and the volume ratio of N-methylpyrrolidone and dichloromethane is 1:3 , after growing the crystal for 5 hours, lower the temperature to -5°C at a rate of 15°C / hour, then stir and crystallize, and grow the crystal for 1 hour;

[005...

Embodiment 3

[0059] The preparation of embodiment 3 ceftazidime crystal compound

[0060] 1) Dissolving the ceftazidime crude product in a mixed solvent A of ethanol and water whose volume is 4 times the weight of ceftazidime at 25° C., the volume ratio of ethanol to water is 1:2.5;

[0061] 2) First add the mixed solvent B of N-methylpyrrolidone and dichloromethane whose total volume is 5 times the weight of ceftazidime at a speed of 24ml / min, and the volume ratio of N-methylpyrrolidone and dichloromethane is 1:4 , Stir while adding, control the temperature at 10°C, and grow the crystal for 1 hour;

[0062] 3) Add the mixed solvent C of N-methylpyrrolidone and dichloromethane whose total volume is 8 times the weight of ceftazidime at a speed of 15ml / min, and the volume ratio of N-methylpyrrolidone and dichloromethane is 1:3 , after growing crystals for 2 hours, cool down to -5°C at a rate of 20°C / hour, then stir and crystallize, and grow crystals for 3 hours;

[0063] 4) Filtration, was...

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PUM

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Abstract

The invention belongs to the technical field of medicine and discloses an anti-inflection pharmaceutical ceftazidime crystal compound and a ceftazidime pharmaceutical composition. The ceftazidime crystal compound has a structural formula (I) as shown below, and by measuring the crystal compound by powder X-ray diffraction measurement, an X-ray powder diffraction pattern represented by 2Theta+ / -0.2 DEG is shown as in 1. The crystal compound has high purity, low pyridine and polymer content and good stability, rarely adsorbs moisture, has good mobility and has greatly improved solubility; the pharmaceutical composition made with the crystal compound has high purity, low impurity content and good clarity, subpackaging efficiency and small content non-uniformity in the production can be guaranteed, occurrence of adverse reaction is greatly reduced, and the stability is better.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an anti-infection drug ceftazidime crystal compound and a pharmaceutical composition thereof. Background technique [0002] Ceftazidime pentahydrate is the antibiotic with the strongest anti-Pseudomonas aeruginosa among the third-generation cephalosporins created by GlaxoSmithKline. It is used for sepsis, lower respiratory tract infection, abdominal cavity and biliary tract infection, Complicated urinary tract infection and severe skin and soft tissue infection, etc. It is especially suitable for infection of immunocompromised persons caused by multiple drug-resistant Gram-negative bacilli, nosocomial infections, and central nervous system infections caused by Gram-negative bacilli or Pseudomonas aeruginosa. Its structural formula is: [0003] [0004] In order to ensure the safety of human medicine, the National Pharmacopoeia stipulates that for ceftazidime antibiotics, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D501/46A61K31/546A61P31/00
CPCC07B2200/13C07D501/46
Inventor 李晓峰李震高瑞照
Owner SHANDONG LUOXIN PHARMA GRP HENGXIN PHARMA CO LTD