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Preparation method of amoxicillin and clavulanate potassium tablets

A technology of potassium amoxicillin and clavulanate tablets and potassium clavulanate, which is applied in the direction of medical preparations containing active ingredients, pill delivery, and pharmaceutical formulations, and can solve the problem of unsatisfactory tablet appearance, fluidity and Poor compressibility, capping and other problems, to achieve the effect of reducing dosage, reducing production cycle and improving quality

Inactive Publication Date: 2010-12-01
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the poor fluidity and compressibility of amoxicillin and potassium clavulanate technical powder, capping and sticking are prone to occur when directly compressed, and the appearance of the tablet is not ideal.

Method used

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  • Preparation method of amoxicillin and clavulanate potassium tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] (a) Weigh 136g of amoxicillin, 34g of potassium clavulanate, 32g of microcrystalline cellulose (P112), 2g of croscarmellose sodium (ADS), 2g of micropowder silica gel, and 2g of magnesium stearate, totaling 205g

[0018] (b) After amoxicillin is granulated, it is mixed with potassium clavulanate at a mass ratio of 4:1 to form the main ingredient.

[0019] (c) The auxiliary materials micropowder silica gel, croscarmellose sodium (ADS) and microcrystalline cellulose are added and mixed in equal amounts, and then added into the mixer with the same amount of main ingredients and mixed for 36-70 minutes.

[0020] During the whole process, the moisture content of the intermediate mixed powder is controlled to be less than or equal to 9.0%, and the marked content is controlled at 95.0% to 115.0%.

[0021] (d) Compressing the mixed powder into tablets.

[0022] Finally, the plain tablet is film-coated as usual. Packaging: Double aluminum packaging, the thickness of the bottom...

Embodiment 2

[0025] Weigh 136 g of amoxicillin, 34 g of potassium clavulanate, 30 g of microcrystalline cellulose (P112), 3 g of croscarmellose sodium (ADS), 3 g of micropowder silica gel, and 2 g of magnesium stearate, totaling 205 g.

[0026] Refer to Example 1 for the specific preparation method.

Embodiment 3

[0038] Product Stability Test

[0039] Adopt the quality comparison of the manufactured product of the inventive method and the manufactured product of prior art:

[0040] (See Table 1 for details)

[0041] Table 1

[0042]

[0043] It can be seen that the quality of the amoxicillin-clavulanate potassium tablet prepared by the method of the present invention is obviously due to the prior art.

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Abstract

The invention discloses a preparation method of amoxicillin and clavulanate potassium tablets, comprising the following steps: (a) weighing the following main and auxiliary materials: 120-135 parts of amoxicillin, 40-45 parts of clavulanate potassium, 27-32 parts of microcrystalline cellulose, 1-3 parts of croscarmellose sodium (ADS), 1-3 parts of superfine silica powder and 2-4 parts of magnesium stearate; (b) after pelletizing amoxicillin, mixing the pelletized amoxicillin with clavulanate potassium according to the mass ratio of 4:1 to form the main materials; (c) uniformly mixing the auxiliary materials including superfine silica powder, ADS and microcrystalline cellulose by the method of increment by equal quantity and throwing the main materials and the auxiliary materials into a mixer by the method of increment by equal quantity to be mixed for 36-70min; and (d) tabletting the mixed powder. The products prepared by the method have bright, clean and beautiful appearances and stable content and dissolution.

Description

technical field [0001] The invention relates to a method for preparing medicine, in particular to a method for preparing an oral preparation of amoxicillin-clavulanate potassium. Background technique [0002] Amoxicillin and Clavulanate Potassium Tablets are compound preparations composed of amoxicillin and clavulanate potassium. Among them, amoxicillin is a broad-spectrum penicillin antibiotic. Potassium clavulanate itself has only weak antibacterial activity, but it has a strong spectrum of β-lactamase inhibitory effect. The combination of the two can protect amoxicillin from β-lactam Enzymatic 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 4-32 times, and increase the antibacterial activity against Haemophilus influenzae by 32 times. Amoxicillin has 4-32 times the antibacterial activity again...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K31/424A61K9/20A61P31/04A61J3/10
Inventor 蔡丽红陈素婥杨坤王志良刘书睿赵霞路玉锋
Owner NORTH CHINA PHARMA COMPANY
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