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Dexibuprofen sustained-release pellet and preparation method thereof

A technology of slow-release pellets and pellets, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, and medical preparations containing active ingredients. Problems such as irritating odor and difficulty in sustained-release preparations, etc., to achieve the effects of improving bioavailability, good fluidity, and reducing interactions

Active Publication Date: 2013-01-30
湖北舒邦药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Due to the low melting point of dextroibuprofen, which is 49-53°C, about 25°C lower than that of ibuprofen, it is insoluble in water, has a pungent smell, and sublimates within a period of time, resulting in greater difficulty in the preparation of sustained-release preparations , Dexibuprofen sustained-release preparations cannot be produced according to the ibuprofen sustained-release preparation process

Method used

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  • Dexibuprofen sustained-release pellet and preparation method thereof
  • Dexibuprofen sustained-release pellet and preparation method thereof
  • Dexibuprofen sustained-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] formula:

[0043]

[0044] First prepare the drug solution and coating solution, in the fluidized bed, control the temperature of the material at 30°C, spray the drug at the bottom, and obtain 18-20 mesh uncoated pellets, take 18-20 mesh uncoated pellets For coating, stir while adding the solution to avoid sedimentation of the talcum powder. Capsules are filled according to the content to obtain 200mg specification Dexibuprofen sustained-release capsules. The preparation process of the micropills was smooth, the appearance was round and beautiful, and the micropills were stored without adhesion. The uncoated micropills released relatively fast in the in vitro release test, and passed the coating after coating.

Embodiment 2

[0046] formula:

[0047]

[0048] First prepare the drug solution and coating solution, in the fluidized bed, control the temperature of the material at 30°C, spray the drug at the bottom, and obtain 18-20 mesh uncoated pellets, take 18-20 mesh uncoated pellets For coating, stir while adding the solution to avoid talcum powder settling. During the preparation and storage of pellets, pellet adhesion may occur. Add appropriate amount of talc powder to prevent adhesion. The adhesion of pellets after coating is good. Fill the capsules according to the content to obtain 200mg Dexibuprofen sustained-release capsules. In vitro release test The uncoated pellets were synthesized, and the release of coated pellets was slow.

Embodiment 3

[0050] formula:

[0051]

[0052] First prepare the drug solution and coating solution, in the fluidized bed, control the temperature of the material at 30°C, spray the drug at the bottom, and obtain 18-20 mesh uncoated pellets, take 18-20 mesh uncoated pellets For coating, stir while adding the solution to avoid talcum powder settling. During the preparation and storage of pellets, pellet adhesion may occur. Add appropriate amount of talc powder to prevent adhesion. The adhesion of pellets after coating is good. Fill the capsules according to the content to obtain 200mg Dexibuprofen sustained-release capsules. In vitro release test The uncoated pellets were synthesized, and the release of coated pellets was slow.

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Abstract

The invention discloses a dexibuprofen sustained-release pellet and a preparation method thereof. The dexibuprofen sustained-release pellet comprises a celphere, a drug layer and an external coating. In the terms of the total weight of the pellet, the celphere accounts for 15 % to 30 %. The drug layer consists of dexibuprofen, a binding agent and talcum powder, wherein the dexibuprofen accounts for 70-85 %, the binding agent accounts for 1-10 %, and the talcum powder accounts for 0.1-3 %. The external coating consists of a coating material and the talcum powder, the coating material accounts for 0.5-3 % and the talcum powder accounts for 0.1-3 %. The invention further provides the preparation method of the dexibuprofen sustained-release pellet. In the invention, the dexibuprofen sustained-release pellet has the advantages of good stability, high bioavailability, good mobility and wide application prospect and is beneficial to subpackage of preparations or is further pressed in a form of a tablet.

Description

technical field [0001] The invention relates to a sustained-release pellet and a preparation method thereof, in particular to a dexibuprofen sustained-release pellet and a preparation method thereof. Background technique [0002] Ibuprofen is an effective and safe non-steroidal anti-inflammatory, antipyretic and analgesic drug. It is clinically used for the long-term treatment of rheumatism, rheumatoid arthritis and osteoarthritis, and is also widely used for the treatment of various moderate pain, inflammation, fever and other diseases. , Indomethacin is small, so the market is expanding rapidly. Due to the better efficacy of ibuprofen and less adverse reactions, the United States and the United Kingdom have successively approved the transfer of ibuprofen from prescription drugs to over-the-counter drugs. [0003] Racemic ibuprofen is composed of equal amounts of dexibuprofen and levoibuprofen. It has been clinically used as an anti-inflammatory and analgesic drug for 30 ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/192A61K47/38A61K47/32A61P29/00A61P19/02A61P19/04
Inventor 谢斌张光勋
Owner 湖北舒邦药业有限公司
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