A kind of faropenem sodium granule and preparation method thereof

A technology for faropenem sodium and granules, which is applied to the field of faropenem sodium granules and their preparation, can solve problems such as increasing the unsafety of injections, and achieve the effects of low crystal hygroscopicity, reduced production costs, and rapid dissolution.

Active Publication Date: 2021-02-09
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The application of above-mentioned antioxidant etc. has all increased the unsafety of injection

Method used

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  • A kind of faropenem sodium granule and preparation method thereof
  • A kind of faropenem sodium granule and preparation method thereof
  • A kind of faropenem sodium granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032]

[0033]

[0034] Preparation Process:

[0035] Dissolve faropenem sodium and sucrose in water, slowly add ethanol under continuous stirring, keep warm at 20°C until the crystals are completely precipitated, filter, and dry the obtained crystals at 40°C, sieve through 10 mesh and 80 mesh sieves respectively, and measure the content of semi-finished products , sub-packaged, that is.

Embodiment 2

[0037]

[0038] Preparation Process:

[0039] Dissolve faropenem sodium and sucrose in water, slowly add acetone under continuous stirring, keep warm at 20°C until the crystals are completely precipitated, filter, and dry the obtained crystals at 40°C, sieve through 10 mesh and 80 mesh sieves respectively, and measure the content of semi-finished products , sub-packaged, that is.

Embodiment 3

[0041]

[0042] Preparation Process:

[0043] Dissolve faropenem sodium and sucrose in water, slowly add ethyl acetate under continuous stirring, keep warm at 20°C until the crystals are completely precipitated, filter, and dry the obtained crystals at 40°C, pass through 10 mesh and 80 mesh sieves respectively, and determine Semi-finished product content, sub-package, that is.

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Abstract

The invention provides faropenem sodium granules and a preparation method thereof. The granules contain faropenem sodium and sucrose, and are prepared by adding a poor solvent to an aqueous solution of faropenem sodium and sucrose for eutectic crystallization. The obtained product has low polymer content, good stability and simple preparation process.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to faropenem sodium granules and a preparation method thereof. Background technique [0002] Faropenem (Faropenem) is an atypical β-lactam antibiotic, which belongs to the derivatives of carbapenems. It was developed by Suntory Company of Japan and was first listed in Japan in 1997. The trade name is At present, the dosage forms listed at home and abroad include ordinary tablets, dry suspensions for children, granules, capsules, etc. [0003] Faropenem shows broad-spectrum antibacterial activity against aerobic and anaerobic Gram-positive bacteria and Gram-negative bacteria, especially against drug-resistant Staphylococcus, Enterococcus and other Gram-positive bacteria and Bacteroides and other anaerobic bacteria. The activity is better than the existing oral antibacterial drugs. Faropenem has a good affinity with penicillin-binding protein and good stability of β-l...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K47/26A61K31/431A61P31/04
CPCA61K9/1623A61K31/431
Inventor 张贵民陈小伟马俊李姝影
Owner SHANDONG NEWTIME PHARMA
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