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A kind of amoxicillin-clavulanate potassium orally disintegrating tablet and preparation method thereof

A technology of amoxicillin-clavulanate potassium and orally disintegrating tablets, which is applied in the field of orally disintegrating tablets, can solve the problems of difficulty in administration, low brittleness, and long disintegration time, and achieve shortening of disintegration time limit, crushing Low brittleness and good product stability

Active Publication Date: 2020-12-15
山东华辰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Aiming at the shortcomings of current orally disintegrating tablets, the present invention provides an orally disintegrating tablet of amoxicillin-clavulanate potassium, which overcomes the shortcomings of conventional tablet administration difficulties and long disintegration time, and has the advantages of disintegrating With the advantages of quick solution, good stability and low brittleness, it is very suitable for pet drug delivery and has great application prospects in the pet medicine market

Method used

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  • A kind of amoxicillin-clavulanate potassium orally disintegrating tablet and preparation method thereof
  • A kind of amoxicillin-clavulanate potassium orally disintegrating tablet and preparation method thereof
  • A kind of amoxicillin-clavulanate potassium orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The prescription of amoxicillin and clavulanate potassium orally disintegrating tablets is shown in the table below:

[0032] name Prescription amount (kg) function Amoxicillin 0.08 Main drug Potassium clavulanate 0.02 Main drug polyethylene glycol 6000 0.01 suspending agent γ-polyglutamic acid 0.01 suspending agent fructose 0.66 Skeleton support agent Anhydrous Sodium Carbonate 0.22 Skeleton support agent

[0033] The preparation method is as follows:

[0034] a. Dissolving: Take purified water 1.2 times the total weight of the prescription, heat it to 80°C, add the prescribed amount of skeleton support agent and suspending agent, stir to make it even, after cooling down to room temperature, add the prescribed amount of amoxicillin and clavula Potassium acid, stirred to make a uniform suspension;

[0035] b. Degassing: Ultrasonic waves are used to remove the bubbles in the suspension;

[0036] c. Inject...

Embodiment 2

[0042] The prescription of amoxicillin and clavulanate potassium orally disintegrating tablets is shown in the table below:

[0043] name Prescription amount (kg) function Amoxicillin 0.08 Main drug Potassium clavulanate 0.02 Main drug polyethylene glycol 6000 0.0067 suspending agent γ-polyglutamic acid 0.0133 suspending agent fructose 0.66 Skeleton support agent Anhydrous Sodium Carbonate 0.22 Skeleton support agent

[0044] The preparation method was the same as in Example 1, and a total of 10,000 orally disintegrating tablets were obtained, with a tablet weight of 100 mg and a specification of 10 mg / tablet (8 mg amoxicillin, 2 mg potassium clavulanate).

Embodiment 3

[0046] The prescription of amoxicillin and clavulanate potassium orally disintegrating tablets is shown in the table below:

[0047] name Prescription amount (kg) function Amoxicillin 0.16 Main drug Potassium clavulanate 0.04 Main drug polyethylene glycol 6000 0.01 suspending agent γ-polyglutamic acid 0.02 suspending agent fructose 0.57 Skeleton support agent Anhydrous Sodium Carbonate 0.20 Skeleton support agent

[0048] The preparation method was the same as in Example 1, and a total of 10,000 orally disintegrating tablets were obtained, with a tablet weight of 100 mg and a specification of 20 mg / tablet (16 mg amoxicillin, 4 mg potassium clavulanate).

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Abstract

The invention provides an amoxycillin clavulanate potassium orally disintegrating tablet and a preparation method thereof. The orally disintegrating tablet is prepared from an active ingredient, a framework supporting agent and a suspending aid. The amoxycillin clavulanate potassium orally disintegrating tablet disclosed by the invention has the advantages of simple process and easiness for operation; the obtained product is high in disintegrating speed, is orally taken without needing water, is instantly dissolved in 0.5s most quickly once the orally disintegrating tablet is put into a mouth,is good in stability, is difficult to fragment, is convenient to carry, and has great application prospect in the pet medicine market.

Description

technical field [0001] The invention relates to an orally disintegrating tablet of amoxicillin and clavulanate potassium and a preparation method thereof, belonging to the technical field of orally disintegrating tablets. Background technique [0002] Amoxicillin, also known as amoxicillin, belongs to the β-lactam antibiotics. It can kill sensitive bacteria by inhibiting the synthesis of mucopeptides in the cell wall of microorganisms, causing the microorganisms to produce defective barriers and infiltrate unstable spheroplasts. Most Gram-positive bacteria such as Staphylococcus, Streptococcus, Corynebacterium, Clostridium tetani, and Bacillus anthracis are sensitive to amoxicillin, and Amoxicillin is sensitive to Gram-negative bacteria such as Escherichia coli, Proteus, Salmonella, Haemophilus, Brucella and Pasteurella also have strong effects, but amoxicillin is easily hydrolyzed by β-lactamase and loses its antibacterial activity. [0003] Potassium clavulanate is a β-la...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/10A61K47/34A61K47/26A61K47/02A61K31/43A61K31/424A61P31/04
CPCA61K9/0056A61K9/2009A61K9/2018A61K9/2031A61K9/2045A61K31/424A61K31/43A61P31/04A61K2300/00
Inventor 姜正军王建国匡宝晓王少娟刘海罗贝贝刘翠陈晓华张全景
Owner 山东华辰制药有限公司