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Compound tablet and preparation method thereof

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

Active Publication Date: 2015-04-01
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 the compound amoxicillin and clavulanate potassium tablets in this example is controlled at 180±13.5 mg when compressed, and each tablet is prepared according to the following components and dosages:

[0030]

[0031]

[0032] The potassium clavulanate mixture is a mixture of potassium clavulanate and microcrystalline cellulose in a mass ratio of 1:1. Crospovidone, red iron oxide and anhydrous ethanol are configured as a binder and added during the tablet preparation process. The anhydrous ethanol volatilizes during the tablet preparation process, and there is no remaining in the tablet variety.

[0033] The preparation method of compound amoxicillin and clavulanate potassium tablets of this embodiment includes the following specific steps:

[0034] A. Ingredients: Weigh an appropriate amount of amoxicillin powder, potassium clavulanate mixture, microcrystalline cellulose, calcium hydrogen phosphate, crospovidone, silicon dioxide, glyceryl behenate and beef flav...

Embodiment 2

[0041] The rest of the compound amoxicillin clavulanate potassium tablet of this example is the same as that of example 1, except that:

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

[0043]

[0044]

[0045] The rest of the preparation method of the compound amoxicillin clavulanate potassium tablet of this example is the same as that of Example 1, except that: in step B, the prepared amoxicillin powder, microcrystalline cellulose, and phosphoric acid Calcium hydrogen and crospovidone are 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 are added to the three-dimensional motion mixer, mixed for 12 minutes and then discharged. In step D, the raw materials are compressed into 900±45 mg tablets.

Embodiment 3

[0047] The rest of the compound amoxicillin clavulanate potassium tablet of this example is the same as that of example 1, except that:

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

[0049]

[0050] The rest of the preparation method of the compound amoxicillin clavulanate potassium tablet of this example is the same as that of Example 1, except that: in step B, the prepared amoxicillin powder, microcrystalline cellulose, and phosphoric acid Calcium hydrogen and crospovidone are 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 are added to the three-dimensional motion mixer, mixed for 8 minutes and then discharged. In step D, the raw materials are compressed into 1800±36 mg tablets.

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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 the application date being July 16, 2013, the application number being 201310297361.2, and the invention title being "Compound Amoxicillin and Clavulanate Potassium Tablets and Preparation Method thereof". Technical field [0002] The invention relates to a medicine and a preparation process of the medicine, in particular to a tablet, belonging to the technical field of pharmaceutical preparations. Background technique [0003] Amoxicillin and clavulanate potassium tablets are compound preparations composed of amoxicillin and potassium clavulanate. Amoxicillin is a spectral penicillin antibiotic. Potassium clavulanate has only weak antibacterial activity, but has a strong spectrum. The β-lactamase hydrolyses. In vitro antibacterial studies have shown that clavulanic acid can increase the antibacterial activity of amoxicillin against a small number of intestinal enzyme-producing bacilli such as Klebsiella vulgaris by 4 to 32 ...

Claims

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Application Information

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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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