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Faropenem sodium particles and preparation method thereof

A technology for faropenem sodium and granules, which is applied in the field of faropenem sodium granules and its preparation, and can solve the problems of simple preparation process, small toxic and side effects, and low polymer content

Inactive Publication Date: 2020-05-29
JIANGSU ALICORN PHARMATECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] 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 particles and preparation method thereof
  • Faropenem sodium particles and preparation method thereof
  • Faropenem sodium particles and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027]

[0028] Preparation Process:

[0029] Mix faropenem sodium passed through a 80-mesh sieve with sucrose powder, mannitol, hyprolose, edetate calcium sodium, aspartame, and flavors respectively passed through a 100-mesh sieve, and dissolve tartrazine in the purified Use water as a wetting agent, use a fluidized bed for granulation, dry at 40±5°C until the water content is within 2%, sieve with a 10-mesh sieve and an 80-mesh sieve, and take 10-80 mesh granules for later use; Another appropriate amount of fine powder under 80 mesh (equivalent to 5% of the total prescription amount) is added to the desiccant passed through a 120 mesh sieve and mixed, and then the prescription amount of 10-80 mesh granules is added to mix, the filling amount is measured, and packaged.

Embodiment 2

[0031] prescription composition Prescription volume (g) Proportion (%) Faropenem Sodium 123.5 12.35 Hypromellose 20 2 Edetate Calcium Sodium 1 0.1 sucrose 548 54.8 Mannitol 297 29.7 Lemon yellow pigment 0.5 0.05 aspartame 3 0.3 orange flavor 1 0.1 diatomite 6 0.6 purified water Appropriate amount /

[0032] Preparation Process:

[0033] Mix faropenem sodium passed through a 80-mesh sieve with sucrose powder, mannitol, hyprolose, edetate calcium sodium, aspartame, and flavors respectively passed through a 100-mesh sieve, and dissolve tartrazine in the purified Use water as a wetting agent, use a fluidized bed for granulation, dry at 40±5°C until the water content is within 2%, sieve with a 10-mesh sieve and an 80-mesh sieve, and take 10-80 mesh granules for later use; Another appropriate amount of fine powder under 80 mesh (equivalent to 5% of the total prescription amount) is added to the d...

Embodiment 3

[0035]

[0036] Preparation Process:

[0037] Mix faropenem sodium passed through a 80-mesh sieve with sucrose powder, mannitol, hyprolose, edetate calcium sodium, aspartame, and flavors respectively passed through a 100-mesh sieve, and dissolve tartrazine in the purified Use water as a wetting agent, use a fluidized bed for granulation, dry at 40±5°C until the water content is within 2%, sieve with a 10-mesh sieve and an 80-mesh sieve, and take 10-80 mesh granules for later use; Another appropriate amount of fine powder under 80 mesh (equivalent to 5% of the total prescription amount) is added to the desiccant passed through a 120 mesh sieve and mixed, and then the prescription amount of 10-80 mesh granules is added to mix, the filling amount is measured, and packaged.

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparations, and relates to faropenem sodium particles and a preparation method thereof. The invention provides the faropenem sodium particles with a simple production process, stable and controllable quality and a safe and reliable curative effect. The particles contain the following components in percentages by weight: 5-20% of faropenem sodium, 75-95% of an excipient, and 0.3-1% of a desiccant. The stability of the faropenem sodium particles prepared by the method is greatly improved, the quality indicators of the substances, related tothe main components, such as related substances, polymers and moisture are well controlled, and the safety and shelf life standards of medication are improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a faropenem sodium granule and a preparation method thereof. Background technique [0002] Faropenem is an atypical β-lactam antibiotic belonging to the carbapenem antibiotics. Faropenem shows broad-spectrum antibacterial activity against aerobic and anaerobic Gram-positive bacteria and Gram-negative bacteria, especially against drug-resistant Staphylococcus and other Gram-positive bacteria and Bacteroides and other anaerobic bacteria. Superior to existing oral antimicrobials. Faropenem has good binding ability to penicillin-binding protein and good β-lactam stability, is stable to renal dehydropeptidase and various lactamases, and rarely produces drug resistance. Mainly used for respiratory system infection, urinary system infection, reproductive system infection, biliary tract infection, etc. caused by sensitive bacteria [0003] Faropenem sodium was developed by...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/431A61K47/26A61K47/02A61K47/04A61K47/38A61P31/04
CPCA61K9/1611A61K9/1623A61K9/1652A61K9/1694A61K31/431A61P31/04
Inventor 董海红舒欣陈磊陆平波廖正菲
Owner JIANGSU ALICORN PHARMATECH CO LTD
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