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Amoxicillin/potassium clavulanate sustained-release preparation composition and preparation method thereof

A technology of potassium clavulanate and amoxicillin, which is applied in the field of medicine, can solve problems such as poor patient compliance, achieve the effects of delayed release speed, controllability and stability of the preparation process quality, and reduce the number of administrations

Inactive Publication Date: 2010-11-24
北京瑞伊人科技发展有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] In order to overcome the shortcomings of amoxicillin / potassium clavulanate taking medicine many times a day, resulting in poor patient compliance, the invention provides amoxicillin / potassium clavulanate slow-release preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Sustained Release Tablets (Specification: Amoxicillin / Clavulanic Acid 0.3g / 0.075g)

[0028] prescription:

[0029] Amoxicillin 300.00g

[0030] Potassium clavulanate 89.30g (calculated as clavulanic acid 75.00g)

[0031] Hydroxypropyl methylcellulose 58.00g

[0032] Starch 50.00g

[0033] Microcrystalline Cellulose 47.70g

[0034] Magnesium Stearate 5.00g

[0035] 80% ethanol appropriate amount

[0036]

[0037] Makes 1000 pieces

[0038] Preparation Process:

[0039] Pass amoxicillin, potassium clavulanate, hydroxypropyl methylcellulose, starch, microcrystalline cellulose, and magnesium stearate through an 80-mesh sieve respectively for later use, and weigh hydroxypropyl methylcellulose, After the starch and microcrystalline cellulose are mixed evenly in a mixer, they are mixed with amoxicillin and potassium clavulanate in equal increments, and an appropriate amount of 80% ethanol is added, granulated and sized, dried at 55°C...

Embodiment 2

[0041] Sustained Release Tablets (Specification: Amoxicillin / Clavulanic Acid 0.75g / 0.09375g)

[0042] Prescription: plain tablet

[0043]Amoxicillin trihydrate 860.96g (calculated as amoxicillin 750.00g)

[0044] Potassium clavulanate 111.63g (calculated as clavulanic acid 93.75g)

[0045] Starch 54.00g

[0046] Lactose 60.00g

[0047] Magnesium Stearate 15.00g

[0048] 4% polyvinylpyrrolidone 80% ethanol solution appropriate amount

[0049]

[0050] Makes 1000 pieces

[0051] Prescription: Sustained-release coating solution

[0052] 25 parts of hydroxypropyl methylcellulose

[0053] 10 parts ethyl cellulose

[0054] Propylene glycol 5 parts

[0055] Titanium dioxide 6 parts

[0056] 4 parts talcum powder

[0057] 2% ethyl cellulose ethanol solution appropriate amount

[0058] Preparation Process:

[0059] Pass amoxicillin trihydrate, potassium clavulanate, starch, lactose, and magnesium stearate through a 100-mesh sieve ...

Embodiment 3

[0061] Sustained-release capsules (specification: amoxicillin / clavulanic acid 0.3g / 0.02143g)

[0062] prescription:

[0063] Amoxicillin 300.00g

[0064] Potassium clavulanate 25.52g (calculated as clavulanic acid 21.43g)

[0065] Hydroxypropyl methylcellulose 63.00g

[0066] Ethyl cellulose 21.00g

[0067] Lactose 16.00g

[0068] Magnesium Stearate 4.30g

[0069] 4% polyvinylpyrrolidone 80% ethanol solution appropriate amount

[0070]

[0071] Makes 1000 capsules

[0072] Preparation Process:

[0073] Pass amoxicillin, potassium clavulanate, hydroxypropyl methylcellulose, ethyl cellulose, lactose, and magnesium stearate through 80 mesh sieves respectively, and weigh hydroxypropyl methylcellulose, ethyl cellulose, Cellulose, lactose, and magnesium stearate were placed in a mixer and mixed evenly, and then mixed with amoxicillin and potassium clavulanate in equal increments, and 4% polyvinylpyrrolidine 80% ethanol solution was...

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PUM

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Abstract

The invention discloses an amoxicillin / potassium clavulanate sustained-release preparation composition and a preparation method thereof. The compound is mainly prepared from amoxicillin, potassium clavulanate, sustained-release materials and other appropriate accessories. The amoxicillin / potassium clavulanate sustained-release preparation provided by the invention can delay the release speed of a main drug, reduce the times of taking the medicine and improve the compliance of a patient. The amoxicillin / potassium clavulanate sustained-release preparation composition provided by the invention has quality controllability and quality and good stability of the of preparation process.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an amoxicillin / potassium clavulanate slow-release preparation composition and a preparation method thereof. Background technique [0002] Amoxicillin / potassium clavulanate, their chemical names are: (2S, 5R, 6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4 -Hydroxyphenyl)acetamido]-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and (Z)-(2S,5R)-3 Potassium -(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate. [0003] Amoxicillin / potassium clavulanate compound preparation is composed of amoxicillin and potassium clavulanate. It is a broad-spectrum enzyme-resistant and highly effective first-line anti-infective drug for severe infections commonly seen in clinical practice. Among them, amoxicillin is a broad-spectrum penicillin β-lactam semi-synthetic antibiotic, the mechanism of action is to inhibit the synthesis of bacterial cell walls, has a ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K31/424A61J3/10A61J3/07A61J3/00A61K47/34A61K47/38A61K47/36A61K47/14A61P31/04A61K47/10
Inventor 安英张慧英张玲玲
Owner 北京瑞伊人科技发展有限公司
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