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Indometacin sustained release tablet, preparation method thereof, as well as release controlling method and standard

A technology of indomethacin sustained-release tablets and indomethacin, which is applied in the field of medicine, can solve problems such as the direct preparation process of indomethacin sustained-release tablet powder and the method and standard of controlled release, and achieve production The process is simple and controllable, the standard method is accurate, and the effect of improving clinical efficacy

Inactive Publication Date: 2013-05-15
深圳国源国药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, most preparations of indomethacin sustained-release tablets are prepared by wet granulation, and there are no reports on the methods and standards for controlling the direct preparation process of indomethacin sustained-release tablet powder and controlled release.

Method used

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  • Indometacin sustained release tablet, preparation method thereof, as well as release controlling method and standard
  • Indometacin sustained release tablet, preparation method thereof, as well as release controlling method and standard
  • Indometacin sustained release tablet, preparation method thereof, as well as release controlling method and standard

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0203] Preparation:

[0204] (1) Take the following components by weight:

[0205] components

unit (g)

Indomethacin

198

Hydroxypropyl Methyl Cellulose E50

660

Hydroxypropyl Methyl Cellulose K15M-CR

550

microcrystalline cellulose

217.8

lactose

541.2

Micropowder silica gel

22

Magnesium stearate

11

production

10000 pieces

[0206] (2) Pass the prescribed amount of indomethacin, hydroxypropyl methylcellulose K15M-CR and micropowdered silica gel through a 100-mesh sieve for 3 times, mix for 10 minutes, and set aside;

[0207] (3) Pass the hydroxypropyl methylcellulose E50 of the prescribed amount through an 80-mesh sieve once, add the materials in the above (2), mix for 9 minutes, and set aside;

[0208] (4) Pass the prescribed amount of microcrystalline cellulose and lactose through an 80-mesh sieve once, add the materials in the above (3), mix for 6 minutes, and s...

Embodiment 2

[0213] Preparation:

[0214] (1) Take the following components by weight:

[0215] components

unit (g)

Indomethacin

528

Hydroxypropyl Methyl Cellulose E50

550

Hydroxypropyl Methyl Cellulose K15M-CR

286

microcrystalline cellulose

242

lactose

440

Micropowder silica gel

121

Magnesium stearate

33

production

10000 pieces

[0216] (2) Pass the prescribed amount of indomethacin, hydroxypropyl methylcellulose K15M-CR and micropowdered silica gel through a 100-mesh sieve for 3 times, mix for 6 minutes, and set aside;

[0217] (3) Pass the hydroxypropyl methylcellulose E50 of the prescription amount through an 80-mesh sieve once, add the materials in the above (2), mix for 6 minutes, and set aside;

[0218] (4) Pass the prescribed amount of microcrystalline cellulose and lactose through an 80-mesh sieve once, add the materials in the above (3), mix for 10 minutes, and se...

Embodiment 3

[0223] Preparation:

[0224] (1) Take the following components by weight:

[0225] components

unit (g)

Indomethacin

396

Hydroxypropyl Methyl Cellulose E50

660

Hydroxypropyl Methyl Cellulose K15M-CR

462

microcrystalline cellulose

242

lactose

330

Micropowder silica gel

77

Magnesium stearate

33

production

10000 pieces

[0226] (2) Pass the prescribed amount of indomethacin, hydroxypropyl methylcellulose K15M-CR and micropowdered silica gel through a 100-mesh sieve for 3 times, mix for 15 minutes, and set aside;

[0227] (3) Pass the hydroxypropyl methylcellulose E50 of the prescription amount through an 80-mesh sieve once, add the materials in the above (2), mix for 8 minutes, and set aside;

[0228] (4) Pass the prescribed amount of microcrystalline cellulose and lactose through an 80-mesh sieve once, add the materials in the above (3), mix for 8 minutes, and set...

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Abstract

The invention relates to an indometacin sustained release tablet, a preparation method thereof, as well as a release controlling method and standard. The indometacin sustained release tablet is prepared from the following components in percentage by weight: 8.0-25.0% of indometacin, 25.0-40.0% of hydroxypropyl methyl cellulose, 12.0-25.0% of microcrystalline cellulose K15M-CR, 8.0-15.0% of microcrystalline cellulose, 15.0-25.0% of lactin, 1.0-6.0% of gum acacia and 0.5-1.5% of magnesium stearate. A full-powder direct compression process is adopted; the production process is simplified; the methoxyl content of prepared mid-product methoxyl is 8.2-18%; and the propoxyl content is 2.6-7.8%. The quality of the indometacin sustained release tablet disclosed by the invention reaches the standard; a reference product has release similarity; mass control is carried out before production; rework can be reduced; the production cost is saved; the energy consumption is reduced; and the production efficiency is improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an indomethacin sustained-release tablet, a preparation method thereof, and a release-controlled method and standard. Background technique [0002] Indomethacin has anti-inflammatory, antipyretic and analgesic effects, and is used for rheumatoid arthritis, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and acute gout attack period, etc. Its mechanism of action is to reduce the synthesis of prostaglandins by inhibiting cyclooxygenase. Inhibit the formation of pain nerve impulses in inflammatory tissues, inhibit inflammatory reactions, including inhibition of leukocyte chemotaxis and release of lysosomal enzymes. As for the antipyretic effect, because it acts on the hypothalamic thermoregulation center, it causes peripheral blood vessels to dilate and sweat, which increases heat dissipation. This central antipyretic effect may also be related to inhibition of prost...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/405A61K47/48A61P29/00A61K47/61
Inventor 张凯谢隆谢雁鸣伍彪陈腊梅艾风
Owner 深圳国源国药有限公司
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