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Faropenem sodiumcomposition for direct tabletcompression and preparation method of faropenem sodiumcomposition

A technology of faropenem sodium and its composition, which is applied in the field of faropenem sodium composition and its preparation, can solve problems such as poor stability, and achieve the effects of improving production efficiency, saving man-hours, and improving product stability

Active Publication Date: 2015-04-01
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, this method does not go through the process of exposure to heat and humidity, which is especially suitable for some drugs with poor stability under heat and humidity conditions
However, the use of direct compression of faropenem sodium has been less studied at present.

Method used

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  • Faropenem sodiumcomposition for direct tabletcompression and preparation method of faropenem sodiumcomposition
  • Faropenem sodiumcomposition for direct tabletcompression and preparation method of faropenem sodiumcomposition
  • Faropenem sodiumcomposition for direct tabletcompression and preparation method of faropenem sodiumcomposition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] 100g of faropenem sodium (calculated as faropenem) with an average particle size of 150μm-160μm, 50g of microcrystalline cellulose 112, 30g of pregelatinized starch, 20g of hydroxypropyl cellulose, 1g of pharmaceutical micropowder silica gel, and 1g of magnesium stearate. Into 1000 pieces.

[0016] Preparation method: Weigh faropenem sodium, microcrystalline cellulose 112, pregelatinized starch and hydroxypropyl cellulose according to the prescription amount, and mix them evenly. Then add medicinal micropowder silica gel and magnesium stearate, mix evenly, compress into tablets, and coat with a film to obtain the product.

Embodiment 2

[0018] 100g faropenem sodium with an average particle size of 180μm-190μm (calculated as faropenem), 60g anhydrous lactose, 40g pregelatinized starch, 30g calcium hydrogen phosphate, 1g pharmaceutical micropowder silica gel, 1g magnesium stearate, 3g talc powder, Made in 1000 pieces.

[0019] Preparation method: Weigh faropenem sodium, anhydrous lactose and pregelatinized starch according to the prescription amount, and mix them evenly. Then add medicinal micropowder silica gel, magnesium stearate and talcum powder, mix evenly, press into tablets, and coat with a film to obtain the product.

Embodiment 3

[0021] 100g of faropenem sodium (calculated as faropenem) with an average particle size of 180μm-190μm, 60g of anhydrous lactose, 40g of pregelatinized starch, 30g of calcium hydrogen phosphate, 1g of pharmaceutical micropowder silica gel, 1g of weight average molecular weight Mn=2.717×10 5 And number average molecular weight Mw=1.232×10 5 Seed melon polysaccharide sulfate, 1g magnesium stearate, 3g talc powder, made into 1000 tablets.

[0022] Preparation method: Weigh faropenem sodium, anhydrous lactose and pregelatinized starch according to the prescription amount, and mix them evenly. Then add medicinal micropowder silica gel, seed melon polysaccharide sulfate, magnesium stearate and talcum powder, mix evenly, press into tablets, and coat with film to obtain the product.

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Abstract

The invention belongs to the technical field of medicinepreparation, and particularly relates to faropenem sodiumcomposition for direct tabletcompression and a preparation method of the faropenem sodiumcomposition. The composition comprises, in percentage by weight, 40%-70% of faropenem sodium and 30%-60% of an auxiliary material, wherein the faropenem sodium is fine powder with theaverageparticle size ranging from 150 mum to 250 mu m; the auxiliary material comprises a disintegrating agent, a binding agent, 0%-5% of a lubricating agent, 0%-5% of a flow aid and one or more of microcrystalline cellulose, cellulose, starch, saccharides and inorganic salts. Compared with the prior art, thefaropenem sodiumcomposition has the advantages that tablets can be prepared from the faropenem sodiumcomposition with a direct tabletcompression method, processes that medicines are contacted with humid and heat are omitted, the product stability is improved, technological steps are reduced, work hours are saved, the production cost is reduced, and the production efficiency is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a faropenem sodium composition for direct tablet compression and a preparation method thereof. Background technique [0002] Faropenem sodium is a typical β-lactam antibiotic, which is a derivative of penems. It is so far the world's first orally effective, β-lactamase-stabilized carbapenem antibiotic. It is highly effective in inhibiting a wide range of G+ and G- bacteria and anaerobic bacteria, especially the most effective β-lactam antibiotics against anaerobic bacteria. From the perspective of the development trend of antibiotics, faropenem sodium is very promising. However, penem antibiotics also have obvious disadvantages, such as poor stability in hot and humid conditions. The preparation process of ordinary tablets needs to go through the processes of making soft materials, granulating and drying. In this process, the binder brings in a large am...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/30A61K31/431A61P31/04
Inventor 石井岗王静李大涛姚洪雷
Owner CISEN PHARMA
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