Faropenem sodium granule and preparation method thereof

A technology for faropenem sodium and granules, which is applied in the field of faropenem sodium granules and the preparation thereof, can solve the problems of simple preparation process, small toxic and side effects, good stability and the like, and achieves simple preparation process, small toxic and side effects, and good stability. Effect

Active Publication Date: 2014-12-24
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the invention has the following defects: ① the preparation process is complex, the production cycle is long, and the production cost is high; ② during the preparation process, faropenem sodium needs to be dissolved in water and then freeze-dried, and faropenem sodium is extremely sensitive to water, and the dissolution process caused The increase of the polymer; and its stability in the storage process mainly lies in the vacuum environment in the vial after freeze-drying, which avoids the influence of moisture and oxygen on it, and does not fundamentally solve the problem of its polymer increase; ③Injection is required, and professionals are required to administer the drug, which is inconvenient to use
[0013] In the prior art, there is no way to provide a faropenem sodium preparation with low polymer content, good stability, simple preparation process, and less toxic and side effects

Method used

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  • Faropenem sodium granule and preparation method thereof
  • Faropenem sodium granule and preparation method thereof
  • Faropenem sodium granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription:

[0027]

[0028] Preparation Process:

[0029] Faropenem sodium, polyvinyl alcohol, dextran and aspartame were pulverized through a 100-mesh sieve, weighed and mixed evenly according to the prescription amount, added 50% ethanol solution to granulate, passed through a 20-mesh sieve for granulation, dried at 40°C, passed through 10 Mesh and 80 mesh sieves, determine the content of semi-finished products, and pack.

Embodiment 2

[0031] prescription:

[0032]

[0033] Preparation Process:

[0034] Faropenem sodium, polyvinyl alcohol, dextran and stevia were crushed through a 100-mesh sieve, weighed and mixed evenly according to the prescription amount, added 50% ethanol solution to granulate, passed through a 20-mesh sieve for granulation, dried at 40°C, passed through 10 mesh, Sieve with 80 mesh sieve, determine the content of semi-finished products, and pack.

Embodiment 3

[0036] prescription:

[0037]

[0038] Preparation Process:

[0039] Faropenem sodium, polyvinyl alcohol, dextran and sodium saccharin were crushed through a 100-mesh sieve, weighed and mixed evenly according to the prescription amount, added 50% ethanol solution to granulate, passed through a 20-mesh sieve for granulation, dried at 40°C, passed through 10 mesh, Sieve with 80 mesh sieve, determine the content of semi-finished products, and pack.

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PUM

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Abstract

The invention provides a faropenem sodium granule and a preparation method thereof. The faropenem sodium granule contains faropenem sodium, polyvinyl alcohol, dextran and a sweetening agent. The faropenem sodium granule has the advantages of low polymer content, good stability and simple preparation technology.

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. 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-lactamase, less drug resistance, mainly used for respiratory system infection, urinary system infection, reproductive system infection, biliary tract infection caused by sensitive bacteria infection etc. [0003] Faropenem sodium, molecular formula...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/431A61K47/36A61K47/32
Inventor 赵志全陈小伟徐志杰丁兵
Owner SHANDONG NEWTIME PHARMA
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