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Pharmaceutical preparation of tebipenem pivoxil composition and preparation method of pharmaceutical preparation

A technology of tibipenem and pharmaceutical preparations, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of low solubility, increased cost, and adverse effects of tibipenem Problems such as promotion and use to achieve good dissolution effect

Active Publication Date: 2014-09-03
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The solubility of tibipenem in water is small. In order to meet the dissolution requirements, the existing tibipenem granules increase the dissolution of tibipenem by adding a disintegrant, which increases the cost and is not conducive to The promotion and use of tibipenem, so there is an urgent need for a new pharmaceutical preparation of tibipenem

Method used

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  • Pharmaceutical preparation of tebipenem pivoxil composition and preparation method of pharmaceutical preparation
  • Pharmaceutical preparation of tebipenem pivoxil composition and preparation method of pharmaceutical preparation
  • Pharmaceutical preparation of tebipenem pivoxil composition and preparation method of pharmaceutical preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Example 1 Preparation of tibipenem compound granules

[0075] Take the raw and auxiliary materials of the following weight, and set aside;

[0076]

[0077] Pass the raw materials through an 80-mesh sieve respectively, and set aside.

[0078] Preparation of resin suspension: Take Eudragit EPO (acrylic resin type E) and Eudragit RSPO (acrylic resin RS type) into a beaker, add 760g of purified water, add simethicone, lauryl sulfuric acid Sodium and talcum powder, stirred at a high speed, and mixed evenly to obtain a resin suspension, set aside.

[0079] Preparation of medicinal solution: Take 400g of the prepared resin suspension, add tibipenem ester, stir evenly, and get ready for use.

[0080] Preparation of adhesive: Take another beaker, add 437g of water into the beaker, add hypromellose, stir until dissolved, and get ready for use.

[0081] Take microcrystalline cellulose and add it to the fluidized bed for preheating for 3 minutes at a temperature of 31°C; the...

Embodiment 2

[0083] Example 2 Preparation of tibipenem compound granules

[0084] Take the raw and auxiliary materials of the following weight, and set aside;

[0085]

[0086]

[0087] Pass the raw materials through an 80-mesh sieve respectively, and set aside.

[0088] Preparation of resin suspension: add 1000g of water to a beaker, add the above-mentioned simethicone, sodium lauryl sulfate, Eudragit EPO (acrylic resin type E), talcum powder, and stir well to obtain 1220g of the first product ,spare.

[0089] Preparation of the medicinal solution: Weigh 488g of the prepared resin suspension, pour it into another beaker, add tibipenem, stir evenly, and get ready for use.

[0090] Preparation of adhesive: take another beaker, add 5000g of water into the beaker, add hypromellose, stir until dissolved, and get ready for use.

[0091] Take microcrystalline cellulose and add it to the fluidized bed for preheating for 2 minutes at a temperature of 25°C; then spray the prepared medicina...

Embodiment 3

[0092] Example 3 Preparation of tibipenem composition granules

[0093] Take the raw and auxiliary materials of the following weight, and set aside;

[0094]

[0095]

[0096] Pass the raw materials through an 80-mesh sieve respectively, and set aside.

[0097] Preparation of resin suspension: Add 400g of water into a beaker, add the above-mentioned simethicone, sodium stearyl sulfonate, Eudragit RSPO (acrylic resin RS type), micropowder silica gel, stir well, and get 422g of resin suspension liquid, spare.

[0098] Preparation of the medicinal solution: Weigh 253.2 g of the prepared resin suspension, pour it into another beaker, add tibipenem, stir evenly, and get ready for use.

[0099] Preparation of adhesive: take another beaker, add 250g of water and hydroxypropyl cellulose into the beaker, stir until dissolved, ready to use.

[0100] Take microcrystalline cellulose and add it to the fluidized bed for preheating for 5 minutes at a temperature of 35°C; then spray ...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations and discloses a pharmaceutical preparation of a tebipenem pivoxil composition and a preparation method of the pharmaceutical preparation. The pharmaceutical preparation of the tebipenem pivoxil composition comprises the following components in parts by weight: 10-100 parts of tebipenem pivoxil, 10-100 parts of a resin material, 200-1000 parts of a substrate material, 200-1000 parts of a filler, 1-10 parts of a defoamer, 1-10 parts of a surfactant, 10-100 parts of a lubricant and 20-100 parts of a binder. The pharmaceutical preparation of the tebipenem pivoxil composition has good dissolution rate and stability and also covers the bad taste of tebipenem pivoxil, and has a good taste. The preparation method provided by the invention further improve the dissolution rate of medicines, and the bitterness caused by tebipenem pivoxil is effectively covered, the effectiveness and safety of the preparation are guaranteed and the medicament compliance of the patient is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a pharmaceutical preparation of a tibipenem compound and a preparation method thereof. Background technique [0002] Tibipenem is a carbapenem antibiotic developed by Pfizer of the United States, and its chemical name is (1R,5S,6S)-1-methyl-6-[(1R)-1-hydroxyethyl ]-2-[1-(1,3-Thiazolin-2-yl)azetidin-3-yl]thio-1-carbapenicillin-2-ene-3-carboxylic acid methyl pivalate , which has a structure as shown in formula I: [0003] [0004] Tibipenem has a broad antibacterial spectrum and has strong antibacterial activity against both Gram-positive and Gram-negative bacteria, such as Staphylococcus, Streptococcus, Pneumococcus, Moraxella catarrhalis, and Influenza bacteria; Moreover, it has a stronger antibacterial effect on most clinically isolated strains than penicillin series and cephalosporin series. The study also found that tibipenem has a low inhibitory conc...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/427A61K47/32A61P31/04
Inventor 毕立军程莹莹曾环想王磊李喆王绛玉刘刚丁梅
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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