Compound amoxicillin and clavulanate potassium tablet and preparation method thereof

A technology for amoxicillin potassium clavulanate and potassium clavulanate is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations with inactive ingredients, etc. Tablet stability and other issues, to achieve the effect of bright surface, improved appearance and good molding quality

Active Publication Date: 2013-10-09
上海汉维生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this preparation method, after mixing amoxicillin granules and potassium clavulanate, all auxiliary materials are added by an equal amount incremental method for mixing. The mixing time is relatively long, the requirements for adding materials are relatively strict, and it is difficult to control the stability of the process.
[0006] Both of the above are typical dry granulation tableting metho

Method used

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  • Compound amoxicillin and clavulanate potassium tablet and preparation method thereof
  • Compound amoxicillin and clavulanate potassium tablet and preparation method thereof
  • Compound amoxicillin and clavulanate potassium tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1）

[0028] When the compound amoxicillin-clavulanate potassium tablet of the present embodiment is compressed, the quality of each tablet is controlled at 180 ± 13.5 mg, and each tablet is configured according to the following components and dosage:

[0029]

[0030] The potassium clavulanate mixture is a mixture formed by mixing potassium clavulanate and microcrystalline cellulose according to a mass ratio of 1:1. Cross-linked povidone, red iron oxide and absolute alcohol are configured as binders and added during tablet preparation, and absolute alcohol volatilizes during tablet preparation, leaving no residue in the finished tablet.

[0031] The preparation method of the compound recipe amoxicillin-clavulanate potassium tablet of the present embodiment comprises the following specific steps:

[0032] A. Ingredients: Weigh an appropriate amount of amoxicillin powder, potassium clavulanate mixture, microcrystalline cellulose, calcium hydrogen phosphate, crospovidone, silicon ...

Embodiment 2）

[0039] The remainder of the compound recipe amoxicillin-clavulanate potassium tablet of the present embodiment is identical with embodiment 1, and difference is:

[0040] The quality of each tablet is controlled at 900±45mg during tablet compression, and each tablet is configured according to the following components and dosage:

[0041]

[0042]

[0043] The rest of the preparation method of the compound amoxicillin-clavulanate potassium tablet of the present embodiment is the same as that of Example 1, except that in step B, the prepared amoxicillin powder, microcrystalline cellulose, phosphoric acid Calcium hydrogen and crospovidone were added to the granulator and mixed for 8 minutes. In step C, the prepared amoxicillin granules and the prepared mixture of potassium clavulanate, silicon dioxide, glyceryl behenate and beef flavor essence are added into a three-dimensional motion mixer, mixed for 12 minutes, and then discharged. In step D, the raw material is compress...

Embodiment 3）

[0045] The remainder of the compound recipe amoxicillin-clavulanate potassium tablet of the present embodiment is identical with embodiment 1, and difference is:

[0046] The quality of each tablet is controlled at 1800±36mg during tablet compression, and each tablet is configured according to the following components and dosage:

[0047]

[0048] The rest of the preparation method of the compound amoxicillin-clavulanate potassium tablet of the present embodiment is the same as that of Example 1, except that in step B, the prepared amoxicillin powder, microcrystalline cellulose, phosphoric acid Calcium hydrogen and crospovidone were added to the granulator and mixed for 3 minutes. In step C, the prepared amoxicillin granules and the prepared mixture of potassium clavulanate, silicon dioxide, glyceryl behenate and beef flavor essence are added into a three-dimensional motion mixer, mixed for 8 minutes, and then discharged. In step D, the raw material is compressed into a ta...

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Abstract

The invention relates to a compound amoxicillin and clavulanate potassium tablet and a preparation method thereof. The tablet consists of the following components in percentage by weight: 15 to 30 percent of amoxicillin, 5 to 15 percent of a clavulanate potassium mixture, 30 to 65 percent of a filler, 1.5 to 8 percent of crosslinked povidone, 0.6 to 3 percent of povidone K30, 1 to 3 percent of silica and 1 to 5 percent of glyceryl behenate. The preparation method comprises the following steps: adding the amoxicillin, the filler and the crosslinked povidone into a pelletizer, mixing and adding an adhesive in a mixing process; and adding the prepared amoxicillin granules and clavulanate potassium mixture, the silica and the glyceryl behenate into a mixing machine, mixing, discharging and tabletting. Although the compound amoxicillin and clavulanate potassium tablet adopts a half-wet method to pelletize, the clavulanate potassium is unlikely to degrade, so that the stability of a medicine is guaranteed effectively.

Description

technical field [0001] The invention relates to a medicine and a preparation process of the medicine, especially a tablet, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Amoxicillin and Clavulanate Potassium Tablets are compound preparations composed of Amoxicillin and Clavulanate Potassium, in which Amoxicillin is a spectrum penicillin antibiotic, and Clavulanate Potassium itself has only weak antibacterial activity, but has a strong spectrum β-lactamase hydrolysis. In vitro antibacterial studies have shown that clavulanic acid can increase the antibacterial activity of amoxicillin against Klebsiella vulgaris Proteus and a small number of intestinal enzyme-producing bacteria by 4 to 32 times, and increase the antibacterial activity against Haemophilus influenzae by 32 times. Amoxicillin has 4 to 32 times the antibacterial activity against Canamola. Clinical application also shows that the amoxicillin-clavulanate potassiu...

Claims

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Application Information

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IPC IPC(8): A61K31/43A61K9/20A61K47/12A61K47/32A61P31/04A61K31/424
Inventor 韩志宏胡铃利
Owner 上海汉维生物医药科技有限公司
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