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Dexibuprofen slow release pellet and preparation method thereof

A technology of dextro-ibuprofen and sustained-release pellets, applied in the field of medicine, can solve the problems of sudden drug release, difference in release degree, increase of related substances, etc., achieve low content of total related substances, improve patient compliance, and improve the frequency of taking medicine reduced effect

Active Publication Date: 2015-07-01
LUNAN BETTER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN102293759A discloses a dextroibuprofen sustained-release tablet preparation and its preparation method. When the sustained-release tablet is mass-produced, it is easy to cause the drug to melt and cause stickiness, resulting in spots on the surface of the tablet and elevated levels of related substances. Visible tablet is not the ideal dosage form of dextrobuprofen sustained-release preparation; Chinese patent CN101269041A discloses a kind of dextrobuprofen sustained-release dripping pill and its preparation method, and in the process of dripping pill preparation, medicine is easily caused by high temperature melting Regarding the increase of substances, Chinese patents CN102228441A and CN102526000A respectively disclose a preparation method of dextroibuprofen sustained-release pellets, in which the medicine is dissolved or suspended in a suitable solvent on the basis of a blank pellet core, and the drug is dissolved or suspended in a suitable solvent, and then injected into The blank pill core is loaded with drug, and the release of the drug is controlled by the coating film control method. The preparation process is complicated, and the control of drug release by the coating film is affected by many factors (coating weight gain, coating film integrity, porogen Dosage, etc.), in industrial production, it is easy to produce differences in release between batches, and even drug burst release, which brings greater difficulty to industrial production

Method used

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  • Dexibuprofen slow release pellet and preparation method thereof
  • Dexibuprofen slow release pellet and preparation method thereof
  • Dexibuprofen slow release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Prepare Dexibuprofen sustained-release pellets according to the following ratio:

[0038]

[0039] Weigh D-ibuprofen and auxiliary materials according to the prescription amount, mix them evenly, add 80ml of 10% ethanol aqueous solution to make soft materials, sieve the soft materials to make wet granules, and spheronize the wet granules in a centrifugal granulator to obtain D-ibuprofen microparticles. Dried the dextrobuprofen pellets at 40°C to obtain the dextrobuprofen sustained-release pellets.

Embodiment 2

[0041] Prepare Dexibuprofen sustained-release pellets according to the following ratio:

[0042]

[0043]Weigh dextroibuprofen and auxiliary materials according to the prescription amount, mix them evenly, add 100ml of purified water to make soft material, sieve the soft material to make wet granules, and round the wet granules in a sugar-coated pan to obtain dextroibuprofen pellets, dextrobuprofen pellets The ibuprofen sustained-release pellets were obtained by drying the ibuprofen pellets at 35°C.

Embodiment 3

[0045] Prepare Dexibuprofen sustained-release pellets according to the following ratio:

[0046]

[0047] Weigh D-ibuprofen and auxiliary materials according to the prescription amount and mix evenly, add 110ml of purified water to make soft materials, sieve the soft materials to make wet granules, and spheronize the wet granules in a centrifugal granulator to obtain D-ibuprofen pellets. Dexibuprofen pellets were dried at 30°C to obtain Dexibuprofen sustained-release pellets.

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Abstract

The invention discloses a dexibuprofen slow release pellet and a preparation method thereof, and belongs to the field of medicinal preparations. The dexibuprofen slow release pellet comprises 50-80% of dexibuprofen, 0-5% of a slow release material, 0-2.5% of an adhesive, 8.75-47.5% of a filler, and 1.25-6.25% of a disintegrating agent, and all above percentages are based on the total weight of the pellet. The dexibuprofen slow release pellet has the advantages of good stability, stable quality, simple device and process, strong operationality, and suitableness for industrial large scale production. In vitro dissolution test shows that the accumulative release rate within 1h is 10-35%, the accumulative release rate within 2h is 25-55%, the accumulative release rate within 4h is 50-80%, and the accumulative release rate within 7h is 75% or above, so the dexibuprofen slow release pellet has a good release curve.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a dextrobuprofen sustained-release pellet and a preparation method thereof. Background technique [0002] Ibuprofen is a non-steroidal anti-inflammatory drug, clinically used for the long-term treatment of rheumatoid arthritis and osteoarthritis, and also for the treatment of fever, various moderate pain and inflammation, with definite curative effect. Ibuprofen is composed of equal amounts of ibuprofen and ibuprofen. Studies have shown that the enantiomer of ibuprofen in racemic ibuprofen is the active ingredient and plays a therapeutic role, while ibuprofen Enantiomers are inactive ingredients and are involved in potential toxic effects. [0003] At present, the dosage forms of dexibuprofen on the market in China mainly include ordinary tablets, capsules, suppositories and oral suspensions. Due to the short half-life of dexibuprofen, frequent and repeated administ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/192A61K47/36A61K47/38A61K47/32A61K47/14A61K47/12A61P29/00A61P19/02
Inventor 赵志全李海刚秦守刚刘海成
Owner LUNAN BETTER PHARMA
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