Compound tablet and preparation method thereof

A compound tablet and filler technology, which is applied in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc. It can solve the problems of unsatisfactory tablet appearance, difficult process stability, and tablet stability, etc. problems, to achieve the effect of bright surface, improved appearance and good molding quality

Active Publication Date: 2018-05-01
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.
[0007] Both of the above are typical dry granulation tableting methods, which are widely used in the preparation of compound amoxicillin-clavulanate potassium tablets, but the tablets produced by the dry granulation tableting method will cause crystal transformation and The activity is reduced, which affects the stability of the tablet. In addition, it is particularly prone to phenomena such as capping and sticking, and the appearance of the tablet is not ideal.

Method used

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  • Compound tablet and preparation method thereof
  • Compound tablet and preparation method thereof
  • Compound tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The quality of each tablet is controlled at 180 ± 13.5mg when the compound recipe amoxicillin and clavulanate potassium tablet of the present embodiment is compressed, and each tablet is formulated according to the following components and dosage:

[0030]

[0031]

[0032] The potassium clavulanate mixture is a mixture of potassium clavulanate and microcrystalline cellulose in a mass ratio of 1:1. Cross-linked povidone, red iron oxide and dehydrated alcohol are formulated into binders and added during tablet preparation, and dehydrated alcohol volatilizes during the tablet preparation process, leaving no residue in the finished tablet.

[0033] The preparation method of the compound recipe amoxicillin-clavulanate potassium tablet of the present embodiment comprises the following concrete steps:

[0034] A. Ingredients: Weigh an appropriate amount of amoxicillin powder, potassium clavulanate mixture, microcrystalline cellulose, calcium hydrogen phosphate, crospovi...

Embodiment 2

[0041] The remainder of the compound recipe amoxicillin-clavulanate potassium tablet of the present embodiment is identical with embodiment 1, and difference is:

[0042] The quality of each tablet is controlled at 900±45mg during tablet compression, and each tablet is formulated according to the following components and dosage:

[0043]

[0044]

[0045] The rest of the preparation method of the compound amoxicillin-clavulanate potassium tablet of the present embodiment is the same as in Example 1, the difference is 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 the three-dimensional motion mixer, and the mixture is discharged after 12 minutes. In step D, the raw materia...

Embodiment 3

[0047] The remainder of the compound recipe amoxicillin-clavulanate potassium tablet of the present embodiment is identical with embodiment 1, and difference is:

[0048] The quality of each tablet is controlled at 1800±36mg during tablet compression, and each tablet is formulated according to the following components and dosage:

[0049]

[0050] The rest of the preparation method of the compound amoxicillin-clavulanate potassium tablet of the present embodiment is the same as in Example 1, the difference is 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 int...

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Abstract

The invention relates to a compound tablet and a preparation method thereof. The compound tablet comprises components in percentage by mass as follows: 15%-30% of amoxicillin, 5%-15% of a clavulanate potassium mixture, 30%-65% of a filling agent, 1.5%-8% of polyvinylpolypyrrolidone, 0.6%-3% of povidone K30, 1%-3% of silicon dioxide and 1%-5% of glyceryl behenate. The preparation method comprises steps as follows: povidone K30 is added to absolute ethyl alcohol, and a bonding agent is prepared; amoxicillin, the filling agent and polyvinylpolypyrrolidone are added to a granulator for mixing, and the bonding agent is added in the mixing process; prepared amoxicillin particles, the clavulanate potassium mixture, silicon dioxide and glyceryl behenate are added to a mixer for mixing, and discharging and tabletting are performed. The compound tablet adopts a semi-wet method for granulation, clavulanate potassium cannot be degraded easily, and medicine stability is effectively guaranteed.

Description

[0001] This application is a divisional application with an application date of July 16, 2013, an application number of 201310297361.2, and an invention title of “Compound Potassium Amoxicillin and Clavulanate Tablet and Preparation Method thereof”. technical field [0002] 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 [0003] 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 ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/43A61K9/20A61K47/38A61P31/04A61K31/424
CPCA61K9/0056A61K9/2013A61K9/2054A61K31/424A61K31/43A61K47/14A61K2300/00
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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