Cefminox sodium raw material as well as preparation method and preparation thereof

A technology of cefminox sodium and cefminox sodium powder, which is applied in the direction of medical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem that cefminox sodium cannot be injected completely, Achieve the effects of small change in impurity content, simple preparation process, and small increase

Pending Publication Date: 2019-07-12
HARBIN GLORIA PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The cefminox sodium preparation sold above is now a powder injection, but when the powder injection is used clinically, it needs to be injected within 4 hours after it is prepared, and the nurses in many hospitals have to deal with the workload of the medicine and the dosage of the medicine in clinical practice. The workload of patients injecting drugs is very large. Therefore, the injection of cefminox sodium that is currently prepared cannot be completed within 4 hours, which brings certain risks to patients. Therefore, the study of new cefminox sodium and its preparations has important meaning

Method used

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  • Cefminox sodium raw material as well as preparation method and preparation thereof
  • Cefminox sodium raw material as well as preparation method and preparation thereof
  • Cefminox sodium raw material as well as preparation method and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Take 100g of the crude product of cefminox sodium, add 350mL of tetrahydrofuran, heat up to 40°C, add 450mL of acetone, stir evenly, let it stand at 5°C-10°C, precipitate crystals, filter, wash the filter cake with acetone, and dry to obtain cefminox sodium The raw material is 78.2g; after testing, the residual solvent in the cefminox sodium raw material meets the Pharmacopoeia standard. After detection: (+)-(6R,7S)-7-[(S)-2-(2-amino-2-carboxyethylthio)acetamido]-7-methoxy-3-[[( l-Methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxy sodium heptahydrate. Calculated on the basis of anhydrous matter, containing cefminol (C 16 h 21 N 7 o 7 S 3 )99.7%. Related substance I: 0.014% for a single largest impurity, 0.078% for total impurities; Related substance II: 0.011% for impurities with a relative retention time between 0.82 and 0.10, and 0.011% for impurities with a relative retention time less than 0.82.

Embodiment 2

[0037] Take 100g of the crude product of cefminox sodium, add 500mL of tetrahydrofuran, heat up to 45°C, add 600mL of acetone, stir evenly, let it stand at 5°C-10°C, precipitate crystals, filter, wash the filter cake with acetone, and dry to obtain cefminox sodium Raw material 79.4g; After testing, the residual solvent in the cefminox sodium raw material complies with the Pharmacopoeia regulations. After detection: (+)-(6R,7S)-7-[(S)-2-(2-amino-2-carboxyethylthio)acetamido]-7-methoxy-3-[[( l-Methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxy sodium heptahydrate. Calculated on the basis of anhydrous matter, containing cefminol (C 16 h 21 N 7 o 7 S 3 )99.5%. Related substance I: the largest single impurity is 0.016%, and the total impurity is 0.124%; Related substance II: the impurity with a relative retention time between 0.82 and 0.10 is 0.014%, and the impurity with a relative retention time less than 0.82 is not detected.

Embodiment 3

[0039] Take 100g of the crude product of cefminox sodium, add 450mL of tetrahydrofuran, heat up to 50°C, add 550mL of acetone, stir evenly, let stand at 5°C-10°C, precipitate crystals, filter, wash the filter cake with acetone, and dry to obtain cefminox sodium Raw material 81.5g; After testing, the residual solvent in the cefminox sodium raw material complies with the Pharmacopoeia regulations. After detection: (+)-(6R,7S)-7-[(S)-2-(2-amino-2-carboxyethylthio)acetamido]-7-methoxy-3-[[( l-Methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxy sodium heptahydrate. Calculated on the basis of anhydrous matter, containing cefminol (C 16 h 21 N 7o 7 S 3 )99.8%. Related substance I: 0.010% for a single maximum impurity, 0.065% for total impurities; Related substance II: 0.011% for impurities with a relative retention time between 0.82 and 0.10, and 0.011% for impurities with a relative retention time less than 0.82.

[0040] 【Related Substan...

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Abstract

The invention belongs to the field of biomedical technology, and particularly relates to a cefminox sodium raw material as well as a preparation method and preparation thereof. After many years of creative experiments, applicants obtain the novel cefminox sodium crystal form provided by the invention, the crystal form drug and auxiliary material sodium citrate are combined to prepare the novel powder injection, after the powder injection and a sodium chloride injection or a glucose injection are mixed, the long-term stability is maintained, and insoluble microparticles and the like are hardlyincreased, so that the results further show that the preparation provided by the invention has better stability.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a cefminox sodium raw material and a preparation method and preparation thereof. Background technique [0002] Cefminox is the fourth-generation cephalosporin antibiotic developed by Japan's Meiji Pharmaceutical (trade name ), the 7α-methoxyl structure of cefminox is lacking in other cephalosporins. It has strong affinity with 1A, 1B and 3 of penicillin binding protein (PBP), inhibits the synthesis of bacterial cell wall, and binds Based on peptidoglycan, it inhibits the combination of peptidoglycan and ester protein to promote bacteriolysis, and can display strong bactericidal activity in a short time, thus playing a strong bactericidal effect. [0003] This product has broad-spectrum antibacterial activity against Gram-positive and Gram-negative bacteria, especially against Streptococcus (except Enterococcus), Escherichia coli, Klebsiella pneumoniae, Proteus, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/57C07D501/12A61K31/546A61P31/04A61K9/14A61K47/12
CPCA61K9/0019A61K9/145A61K31/546A61P31/04C07D501/12C07D501/57
Inventor 朱吉满何利群夏瑞雪宁夏王帆
Owner HARBIN GLORIA PHARMA
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