Beta-cyclodextrin / amoxicillin inclusion compound and its composition with clavulanic kalium and preparation thereof

A technology of potassium clavulanate and amoxicillin, applied in the field of preparation of pharmaceutical compositions

Inactive Publication Date: 2005-11-23
NANJING J ONE MEDICAL TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently, amoxicillin and its compound preparations with potassium clavulanate have not yet...

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0052] Example 1, mix 100 ml of pure water with 100 g of β-cyclodextrin, add 33 g of amoxicillin at room temperature at 20°C, grind thoroughly for 8 hours, then place at 5°C for 12 hours; filter, and wash the solid with water 2 times. Vacuum-dry at 40°C for 12 hours to obtain a white solid clathrate. The solid clathrate is crushed through a 100-mesh sieve, mixed with 2.36 grams of potassium clavulanate, passed through an 80-mesh sieve twice, dry-granulated, and ground into a powder to obtain a pharmaceutical composition. In the composition, amoxicillin-clavulanate potassium The dose ratio is 14:1.

Embodiment 2

[0053] Embodiment 2: substantially the same as embodiment 1, but add 200 milliliters of pure water, fully grind for 5 hours.

Embodiment 3

[0054] Embodiment 3: substantially the same as embodiment 1, but add 20 grams of amoxicillin. The obtained white solid clathrate was mixed with 1.4 g of potassium clavulanate to prepare a powdery pharmaceutical composition.

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PUM

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Abstract

The invention provides a beta-cyclodextrin / amoxicillin inclusion compound medicinal composition which comprises amoxicillin and beta cyclodextrin by the weight ratio of 1:2.5-1:5. In a preferred embodiment, the composition also comprises clavulanate potassium, wherein the mass ratio of amoxicillin and clavulanate potassium is 14:1-2:1, the supplementary materials are selected from crystalline cellulose, maize starch, citric acid, talcum powder, sodium carboxymethylstarch, stearic acid, calcium stearate, magnesium stearate, amylopectin, lactose, mannitol, crosslinked povidone, talcum powder, polyethylene glycol 4000, and low substituted methylcellulose propylene glycol ether. The invention also discloses the preparing process.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing amoxicillin contained in β-cyclodextrin, a pharmaceutical composition composed of the pharmaceutical composition compounded with potassium clavulanate, and a preparation method of the two pharmaceutical compositions. Background technique [0002] The β-lactam antibiotic amoxicillin / clavulanate potassium compound preparation was originally researched and developed by the world-renowned GlaxoSmithKline pharmaceutical company, and was approved by the FDA on August 6, 1984. So far, this product has maintained its status as the world's best-selling drug for 13 consecutive years, ranking first in the world's anti-infective drugs. This product has been recorded in Chinese Pharmacopoeia. [0003] Amoxicillin combined with clavulanic acid can inhibit staphylococcus, Haemophilus influenzae, catarrhalis, Escherichia coli, Klebsiella, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Legio...

Claims

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Application Information

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IPC IPC(8): A61K31/43
Inventor 任勇陆亚鹏王亚娜
Owner NANJING J ONE MEDICAL TECH DEV
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