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Cefepime arginine polymer as well as preparation method and application thereof

A technology of cefepime and cefepime hydrochloride, which is applied in the field of the new compound cefepime arginine polymer and its preparation, can solve the problems of high cost and long time consumption, and achieve the effect of improving drug safety

Active Publication Date: 2022-05-27
GUANGZHOU HC NEW DRUG RES CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the long time-consuming and high cost of the in vitro hemolysis test of drugs, in the current Chinese Pharmacopoeia, not only the product of cefepime hydrochloride for injection does not include the sample in vitro hemolysis test in the drug standard of the product, but other drugs also do not include the in vitro hemolysis test in the drug standard Therefore, in addition to the in vitro hemolysis test, there is no other low-cost, rapid screening of whether cefepime hydrochloride for injection will produce in vitro hemolysis, so the potential threat of blood system adverse reactions of the drug is unpredictable

Method used

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  • Cefepime arginine polymer as well as preparation method and application thereof
  • Cefepime arginine polymer as well as preparation method and application thereof
  • Cefepime arginine polymer as well as preparation method and application thereof

Examples

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Effect test

preparation Embodiment 1

[0065] Cefpiroxam hydrochloride (a sterile mixture of cefpiramide hydrochloride and L-arginine, wherein the concentration of L-arginine is about 725mg / g) 100g, dissolved in 100g of water, to be dissolved, to be dissolved, to give an aqueous solution; the aqueous solution was added to the preparation column, column chromatography separation was carried out to prepare cefepime arginine polymer, wherein the column was HJ-Dacao hydrophilic reversed C 18Column, acetonitrile / water (volume ratio 90:10) mixed liquid for eluate elution, by adjusting the column outlet valve, control the eluate flow rate of 5-6 ml / min, collect the eluate with a glass bottle, each bottle collects about 20 ml of eluate, replace the new glass bottle to collect, the collection retention time is 18.2±0.5 min elution fraction, combined with a purity greater than 70% of the eluent of the fraction, so that the resulting eluent is then concentrated under reduced pressure, and the concentration temperature is cont...

preparation Embodiment 2

[0071] Cefpiroxam hydrochloride (a sterile mixture of cefpiramide hydrochloride and L-arginine, wherein the concentration of L-arginine is about 725mg / g) 100g, dissolved in 120g of water, to be dissolved, to be dissolved, to be dissolved, to give an aqueous solution; the aqueous solution was added to the preparation column, column chromatography separation was carried out to prepare cefepime arginine polymer, wherein the column was HJ-Dacao hydrophilic reversed C 18 Column, acetonitrile / water (volume ratio 100: 15) mixed liquid for eluate elution, by adjusting the column outlet valve, control the eluate flow rate of 5-6 ml / min, collect the eluate with a glass bottle, each bottle collects about 20ml of eluate, collects a new glass bottle, collects the collection retention time is 18.2±0.5min elution fraction, combines the eluent of the fraction with a purity greater than 70%, so that the eluate obtained is then concentrated under reduced pressure, and the concentration temperat...

preparation Embodiment 3

[0074] Cefpirox hydrochloride (a sterile mixture of cefpiramide hydrochloride and L-arginine, wherein the concentration of L-arginine is about 725mg / g) 100g, dissolved in 150g of water, to be dissolved, to be dissolved, to give an aqueous solution; the aqueous solution was added to the preparation column, column chromatography separation was carried out to prepare cefepime arginine polymer, wherein the column was HJ-Dacao hydrophilic inverted C 18 Column, acetonitrile / water (volume ratio 100: 8) mixed liquid for eluate elution elution, by adjusting the column outlet valve, control the eluate flow rate of 5-6 ml / min, collect the eluate with a glass bottle, collect the eluate in a glass bottle, collect about 20 ml of eluate per bottle, collect it in a new glass bottle, collect the retention time is 18.2±0.5 min elution fraction, combine the eluent of the fraction with a purity greater than 70%, so that the eluent obtained is then concentrated under reduced pressure, and the conc...

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Abstract

The invention belongs to the field of medicinal chemistry, and relates to a cefepime arginine polymer as well as a preparation method and application thereof. The structural formula of the cefepime arginine polymer is shown in the specification, the cefepime arginine polymer is taken as a standard substance, and the content of the cefepime arginine polymer in the cefepime hydrochloride for injection is determined by an HPLC (High Performance Liquid Chromatography) method so as to identify whether the cefepime hydrochloride for injection causes hemolysis or not, so that the safety of clinical medication of the cefepime hydrochloride for injection is ensured.

Description

Technical field [0001] The present invention belongs to the field of medicinal chemistry, more particularly, relates to a new compound cefpiroxam arginine polymer and preparation methods and uses thereof. Background [0002] Cefepime belongs to the fourth generation of cephalosporins, and has strong antibacterial activity against a variety of gram-positive and negative bacteria, including Enterobacter, Pseudomonas aeruginosa and other non-fermenting bacilli, Haemophilus spp., Staphylococcus, etc., because of its broad antibacterial spectrum, strong antibacterial activity, precise clinical efficacy, good tolerance, and is clinically used to treat moderate to severe infections caused by the above sensitive bacteria, including lower respiratory tract infections (pneumonia and bronchitis), simple lower urinary tract infections and complex urinary tract infections (including pyelonephritis), etc. It plays an important role in the treatment of bacterial infections in humans. [0003] C...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/46C07D501/04C07D501/12G01N30/02
CPCC07D501/46C07D501/04C07D501/12G01N30/02G01N2030/027Y02A50/30
Inventor 冯胜昔林立东曹夏青冯彩云
Owner GUANGZHOU HC NEW DRUG RES CO LTD
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