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Amoxicillin and clavulanate potassium dispersible tablet

A technology of amoxicillin-clavulanate potassium and clavulanate potassium, which is applied in the direction of organic active ingredients, active ingredients of heterocyclic compounds, medical preparations of non-active ingredients, etc., and can solve the problems of poor fluidity and disintegration time limit of prescription mixed powder Long, poor stability and other issues, to achieve the effect of good stability, good fluidity, rapid disintegration

Active Publication Date: 2014-05-07
NORTHEAST PHARMA GRP SHENYANG SHIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are problems such as long disintegration time, poor fluidity of the prescription mixed powder, easy sticking, complex prescription, poor taste and poor stability.

Method used

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  • Amoxicillin and clavulanate potassium dispersible tablet
  • Amoxicillin and clavulanate potassium dispersible tablet
  • Amoxicillin and clavulanate potassium dispersible tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Table 1 When croscarmellose sodium is used as the disintegrant, the formula of diatomaceous earth in different dosages

[0012]

[0013] It is prepared by powder direct compression method, the specific method is as follows:

[0014] Weigh various active ingredients and excipients according to the prescription, and pass them through a 100-mesh sieve. Among them, the microcrystalline cellulose is dried at 60°C for 2 hours. The various excipients are added to the amoxicillin trihydrate and potassium clavulanate in equal increments. In the mixed powder, after being uniformly mixed in a mixer, the material is discharged and compressed with an oval shaped die to obtain amoxicillin and clavulanate potassium (4:1) dispersible tablets.

Embodiment 2

[0016] Table 2 When using sodium carboxymethyl starch as the disintegrant, the prescription of diatomaceous earth in different addition amounts

[0017]

[0018] It is prepared by powder direct compression method, the specific method is as follows:

[0019] Weigh various active ingredients and excipients according to the prescription, and pass them through a 100-mesh sieve. Among them, the microcrystalline cellulose is dried at 60°C for 2 hours. The various excipients are added to the amoxicillin trihydrate and potassium clavulanate in equal increments. In the mixed powder, after being uniformly mixed in a mixer, the material is discharged and compressed with an oval shaped die to obtain amoxicillin and clavulanate potassium (4:1) dispersible tablets.

Embodiment 3

[0021] Table 3 When using cross-linked povidone as the disintegrant, the formula of diatomaceous earth in different addition amounts

[0022]

[0023] It is prepared by powder direct compression method, the specific method is as follows:

[0024] Weigh various active ingredients and excipients according to the prescription, and pass them through a 100-mesh sieve. Among them, the microcrystalline cellulose is dried at 60°C for 2 hours. The various excipients are added to the amoxicillin trihydrate and potassium clavulanate in equal increments. In the mixed powder, after being uniformly mixed in a mixer, the material is discharged and compressed with an oval shaped die to obtain amoxicillin and clavulanate potassium (4:1) dispersible tablets.

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Abstract

The invention discloses an amoxicillin and clavulanate potassium dispersible tablet applied to the field of a preparation of the amoxicillin and clavulanate potassium dispersible tablet. The dispersible tablet is prepared from the following components: amoxicillin trihydrate, clavulanate potassium, microcrystalline cellulose, a disintegrant, diatomite, a sweetener and an aromatic, wherein the disintegrant is selected from one of croscarmellose sodium, carboxymethyl starch sodium and polyvinylpolypyrrolidone; the disintegrant is preferably selected from croscarmellose sodium; the sweetener is selected from one of aspartame and sucralose; the aromatic is selected from one of a blueberry flavor and a lemon essence; the sweetener is preferably selected from sucralose; the aromatic is preferably selected from the blueberry flavor; the weight ratio of amoxicillin trihydrate to clavulanate potassium in the dispersible tablet is 4:1 based on amoxicillin and clavulanate; the dispersible tablet is prepared from powder by a direct compression method. The amoxicillin and clavulanate potassium dispersible tablet is rapid to disintegrate, still can be rapidly disintegrated at low water temperature, and is good in stability, good in mouthfeel, simple in prescription, good in mobility of mixed powder in the prescription, and not sticking in the tabletting process.

Description

Technical field [0001] The invention relates to an amoxicillin and clavulanate potassium dispersible tablet in the field of amoxicillin and clavulanate potassium compound preparations. Background technique [0002] Amoxicillin and clavulanate potassium dispersible tablets are composed of amoxicillin trihydrate and potassium clavulanate. Amoxicillin and clavulanate potassium compound preparation is a compound preparation composed of β-lactam inhibitor and semi-synthetic penicillin launched by the British Beechem Company in the 1980s. The molecular formula of amoxicillin trihydrate is C 16 H 19 N 3 O 5 S·3H 2 O, the molecular weight is 419.46, and the molecular formula of amoxicillin is C 16 H 19 N 3 O 5 S, the molecular weight is 365.4042. The molecular formula of potassium clavulanate is C 8 H 8 KNO 5 , The molecular weight is 237.25, the molecular formula of clavulanic acid is C 8 H 9 NO 5 , The molecular weight is 199.16. The ratios of amoxicillin and clavulanate potassium ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K9/20A61K47/04A61K47/46A61P31/04A61K31/424
Inventor 李家杰周联波何睦一孙瑞峰王慧颖
Owner NORTHEAST PHARMA GRP SHENYANG SHIDE PHARMA
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