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Faropenem sodium granules

A technology of faropenem sodium and faropenem, which is applied in the field of pharmaceutical preparations, can solve the problems that affect the clinical use of faropenem, such as drug adaptability, poor preparation stability, and increased substances, and achieve good water solubility, good stability, and long-lasting effect. Effect

Inactive Publication Date: 2017-05-17
HAINAN HONZ PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are few oral preparations of faropenem sodium clinically, all of which need to be taken three times a day, which seriously affects the clinical use of faropenem and the adaptability of patients to take medicine.
[0004] Compared with tablets and capsules, the administration of granules is easier to be accepted by children and people with dysphagia. However, the existing faropenem granules generally have problems of poor preparation stability and a significant increase in related substances

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Prescription (specification: 0.1g):

[0022]

[0023] Preparation Process:

[0024] (1) The faropenem sodium is pulverized and sieved, and the sucrose, mannitol, saccharin sodium and edetate calcium sodium are all sieved;

[0025] (2), step (1) component is mixed homogeneously;

[0026] (3), hypromellose and tartrazine are dissolved in 50% ethanol to form a solution;

[0027] (4), adding the material obtained in step (2) to the solution prepared in step (3), mixing evenly and making wet granules;

[0028] (5) The wet granules prepared in step (4) are dried under reduced pressure at 35° C. to 40° C., sized, and packed.

Embodiment 2

[0030] Prescription (specification: 0.1g):

[0031]

[0032] Preparation Process:

[0033] (1) Crush and sieve faropenem sodium, sieve sucrose, mannitol, sodium saccharin, edetate calcium sodium, and orange essence;

[0034] (2), step (1) component is mixed homogeneously;

[0035] (3), hypromellose and sunset yellow are dissolved in 50% ethanol to form a solution;

[0036] (4), adding the material obtained in step (2) to the solution prepared in step (3), mixing evenly and making wet granules;

[0037] (5) The wet granules prepared in step (4) are dried under reduced pressure at 35° C. to 40° C., sized, and packed.

Embodiment 3

[0039] Prescription (specification: 0.1g):

[0040]

[0041] Preparation Process:

[0042] (1) The faropenem sodium is pulverized and sieved, and the sucrose, mannitol, aspartame and edetate calcium sodium are all sieved;

[0043] (2), step (1) component is mixed homogeneously;

[0044] (3), hypromellose and tartrazine are dissolved in 50% ethanol to form a solution;

[0045] (4), adding the material obtained in step (2) to the solution prepared in step (3), mixing evenly and making wet granules;

[0046] (5) The wet granules prepared in step (4) are dried under reduced pressure at 35° C. to 40° C., sized, and packed.

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Abstract

The invention provides faropenem sodium granules. The faropenem sodium granules are characterized by being prepared from the following components in parts by weight: 100 parts of faropenem sodium calculated on the basis of faropenem, 300 to 400 parts of saccharose, 400 to 575 parts of mannitol, 8.0 to 80 parts of hydroxypropyl methylcellulose, 0.1 to 0.2 part of sodium calcium edentate, 0 to 50 parts of a taste correcting agent and 0 to 0.2 part of a color correcting agent. The prepared faropenem sodium granules have good granule hardness, high water solubility and moderate taste and color, solve the defect of low stability of the conventional granules, and are stable in release, durable in action, stable in curative effect, small in toxic and side effect and particularly favorable for children and people suffering from dysphagia to take.

Description

technical field [0001] The invention relates to a solid pharmaceutical preparation, in particular to a faropenem sodium granule. It belongs to the field of pharmaceutical preparations. Background technique [0002] Faropenem Sodium (Faropenem Sodium) is a penem-type β-lactam antibiotic, and is the first marketed broad-spectrum antibiotic that is stable to β-lactamase and can be taken orally. Like other β-lactam antibiotics, faropenem sodium plays a bactericidal effect by inhibiting the synthesis of bacterial cell walls. The drug has strong antibacterial activity, especially for Gram-positive bacteria such as Staphylococcus aureus, penicillin-resistant pneumococcus, streptococcus faecalis, and anaerobic bacteria such as Bacteroides fragilis, which is significantly better than the existing cephalosporins , such as cefoxitin, cefditoren, cefixime, cefaclor, etc. The activity against Gram-negative bacteria is similar to that of oral cephalosporins, and the anti-Pseudomonas ae...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/431A61K47/26A61K47/38A61K47/18A61P31/04
Inventor 洪丽萍王稳奇何清凌日金
Owner HAINAN HONZ PHARMA
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