Amoxicillin and clavulanate potassium preparation and preparation method thereof

A technology of amoxicillin-clavulanate potassium and filler, applied in the field of medicine, can solve the problems of poor stability, complicated preparation process, slow dissolution and the like, and achieve the effects of ensuring stability, good taste and simple prescription

Active Publication Date: 2019-01-22
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to overcome the shortcomings and deficiencies of the prior art, the primary purpose of the present invention is to provide a dispersible tablet of amoxicillin-clavulanate potassium, which solves the problems of slow dissolution, poor stability and complicated preparation process in the prior art

Method used

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  • Amoxicillin and clavulanate potassium preparation and preparation method thereof
  • Amoxicillin and clavulanate potassium preparation and preparation method thereof
  • Amoxicillin and clavulanate potassium preparation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0033] Prescription for 1000 dispersible tablets:

[0034] Amoxicillin: 200g, trehalose: 50g, potassium clavulanate: 30g, β-cyclodextrin: 30g, microcrystalline cellulose: 40g, sorbitol: 10g, crospovidone: 115g, carboxymethyl starch Sodium: 115g, Magnesium stearate: 5g.

[0035] (a) Dissolve an appropriate amount of amoxicillin and trehalose in a sodium citrate buffer solution with a pH value of 4.5, and rotate to evaporate to obtain a mixture of trehalose and amoxicillin, add an appropriate amount of povidone K30 to granulate, and dry ;

[0036] (b) Potassium clavulanate is pulverized and sieved, suspended in absolute ethanol containing β-cyclodextrin, and dried to remove ethanol to obtain potassium clavulanate wrapped in β-cyclodextrin;

[0037] (c) Mix the granulated amoxicillin and potassium clavulanate wrapped in β-cyclodextrin evenly, then add filler, disintegrating agent and lubricant, mix and compress into tablets.

Embodiment 2

[0039] Amoxicillin: 200g, trehalose: 10g, potassium clavulanate: 30g, β-cyclodextrin: 15g, microcrystalline cellulose: 12g, sorbitol: 3g, crospovidone: 50g, carboxymethyl starch Sodium: 50g, magnesium stearate: 1g.

[0040] The pH value of sodium citrate buffer solution is 3, and other preparation methods are the same as in Example 1.

Embodiment 3

[0042] Prescription for 1000 dispersible tablets:

[0043] Amoxicillin: 200g, trehalose: 100g, potassium clavulanate: 30g, β-cyclodextrin: 45g, microcrystalline cellulose: 120g, sorbitol: 30g, crospovidone: 250g, carboxymethyl starch Sodium: 250g, magnesium stearate: 10g.

[0044] The pH value of the sodium citrate buffer solution is 6, and the preparation method is the same as in Example 1.

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Abstract

The invention belongs to the technical field medicines, and provides an amoxicillin and clavulanate potassium preparation and a preparation method thereof. According to the dispersed tablet (the preparation) prepared by the technology, the amoxicillin and clavulanate potassium is high in stability, relatively good in dissolution effect and relatively low in related materials. The method provided by the invention can effectively shorten a technological process, reduce a production cycle and explosion time of medicines in time, guarantee stability of medicines and further improve quality of thefinished product (the amoxicillin and clavulanate potassium preparation).

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a potassium amoxicillin-clavulanate preparation and a preparation method thereof Background technique [0002] Amoxicillin, also known as amoxycillin or amoxycillin, has the molecular formula C 16 h 19 N 3 o 5 S, molecular weight 365.4042. It is one of the most commonly used semi-synthetic penicillin broad-spectrum β-lactam antibiotics. It is a white powder with a half-life of about 61.3 minutes. It is one of the most widely used oral semi-synthetic penicillins, potassium clavulanate, molecular formula C 8 h 8 KNO 5 , the molecular weight is 237.25, and the chemical name is (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo-3.2.0-heptane Potassium alkane-2-carboxylate. Calculated as anhydrous, it contains 81.0-85.6% of clavulanic acid (C8H9NO5). The ratio of amoxicillin to potassium clavulanate is 2:1, 4:1, 5:1, 7:1, 10:1, 14:1 and 16:1, etc. cou...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/43A61K47/36A61K47/26A61K47/32A61P31/04A61K31/424
CPCA61K9/2018A61K9/2027A61K9/2059A61K9/2095A61K31/424A61K31/43A61K2300/00
Inventor 张贵民秦启飞
Owner LUNAN PHARMA GROUP CORPORATION
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