Tablet and preparation method thereof

A 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, difficult process stability, and tablet stability, etc. problems, to achieve the effect of bright surface, improved appearance and good molding quality

Active Publication Date: 2015-04-29
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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  • Tablet and preparation method thereof
  • Tablet and preparation method thereof
  • Tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

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

[0030]

[0031]

[0032] 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.

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

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

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 configured 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 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

[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 configured 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 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 tablet and a preparation method thereof. The tablet comprises the following components in percentage by weight: 15-30% of amoxicillin, 5-15% of a potassium clavulanate mixture, 30-65% of a filler, 1.5-8% of crospovidone, 0.6-3% of povidone K30, 1-3% of silicon dioxide and 1-5% of glyceryl behenate. The preparation method comprises the following steps: adding povidone K30 into absolute ethanol to prepare a bonder; adding amoxicillin, the filler and crospovidone into a granulator, mixing, and adding the bonder while mixing; adding prepared amoxicillin particles, the potassium clavulanate mixture, silicon dioxide and glyceryl behenate into a mixer, mixing, discharging, and tabletting. According to the tablets, a semi-wet method is adopted for granulation and potassium clavulanate still cannot be easily degraded, so that the stability of drugs 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 Applications(China)
IPC IPC(8): A61K31/43A61K9/20A61K47/32A61K47/14A61P31/04A61K31/424
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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