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A kind of dexketoprofen tromethamine sustained-release tablet and preparation method thereof

A technology for dexketoprofen trometamol and sustained-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of decreased bioavailability and failure to achieve Treatment effect, damage to the structure and balance of hypromellose, etc., to achieve the effect of simple process and suitable for large-scale production

Active Publication Date: 2020-06-05
瑞博(杭州)医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the general skeleton material hypromellose will have a destructive effect when the pH value is less than 4. Under acidic conditions, the structure and balance of hypromellose will be destroyed, resulting in the release of Stagnated and then suddenly released, and the consistency of release in different pH environments cannot be guaranteed, resulting in a decrease in bioavailability and unable to achieve the expected therapeutic effect

Method used

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  • A kind of dexketoprofen tromethamine sustained-release tablet and preparation method thereof
  • A kind of dexketoprofen tromethamine sustained-release tablet and preparation method thereof
  • A kind of dexketoprofen tromethamine sustained-release tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] According to the amount of 1000 tablets, weigh 73.8g of dexketoprofen trometamol, 82.5g of hypromellose K15M, 2.5g of silicon dioxide, and 3.5g of magnesium stearate and mix evenly, and partly pregelatinized starch PC Mix -10 and Eudragit EPO in a ratio of 1:2.1 (w / w), mix for 20-30 minutes until the powder is fully adhered together, set aside, and then weigh 150g of the composition, and then mix all the materials evenly, according to each Tablet 312.3 mg is compressed, and the compression hardness is controlled at 6-12Kg.

Embodiment 2

[0038] According to the amount of 1000 tablets, weigh 73.8g of dexketoprofen trometamol, 92.5g of hypromellose K15M, 3.3g of silicon dioxide, and 3.3g of magnesium stearate and mix evenly, and partly pregelatinized starch PC -10 and Eudragit EPO are mixed in a ratio of 1:2.6 (w / w), and mixed for 20 to 30 minutes until the powder is fully adhered together, set aside, then weigh 140.8g of the composition, and mix all the materials evenly, according to each Tablet 313.7 mg is compressed, and the compression hardness is controlled at 6-12Kg.

Embodiment 3

[0040] According to the amount of 1000 pieces, take by weighing 73.8g of dexketoprofen tromethamine, hypromellose K15M 82.5g, microcrystalline cellulose 20g, silicon dioxide 3.3g, magnesium stearate 3.3g and mix evenly, Partially pregelatinized starch PC-10 and Eudragit EPO were mixed in a ratio of 1:3.5 (w / w), and mixed for 20 to 30 minutes until the powders were fully adhered together, and set aside, then weighed 150g of the composition, and mixed all the materials Mix evenly, carry out tabletting according to 332.9mg per tablet, hardness is controlled at 6~12Kg.

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Abstract

The invention relates to dexketoprofen trometamol sustained-release tablets and a preparation method thereof. The tablets are prepared from a framework material, a lubricant, a flow aid and composition of PC-10 and Eudragit EPO. A direct compression manner is adopted in a technology, the composition comprising fully mixed PC-10 and Eudragit EPO is selected as filler, the condition of sudden release after release stagnation due to limitations of the framework material at different pH values and the solubility of raw materials at different pH values or differences of release speeds in different release media is relieved, and the prepared dexketoprofen trometamol sustained-release tablets have similar release curves in the release media with the different pH values and can be uniformly released. The technology is simple, and the method is suitable for large-scale production.

Description

technical field [0001] The invention relates to a sustained-release preparation containing dexketoprofen tromethamine and a preparation method thereof, more specifically to a sustained-release tablet containing dexketoprofen tromethamine and a preparation method thereof. Background technique [0002] Drug name: dexketoprofen tromethamine, chemical name: (+)-(S)-α-methyl-3-benzoyl-phenylacetic acid-α-amino-2-(hydroxymethyl)- 1,3-propanediol salt, structural formula: [0003] [0004] Molecular formula: C 20 h 25 NO 6， Molecular weight: 375.42. [0005] Dexketoprofen trometamol is a derivative of propionic acid, which has analgesic, anti-inflammatory and antipyretic effects, and belongs to non-steroidal anti-inflammatory drugs. The mechanism of action of NSAIDs may be to reduce the synthesis of prostaglandins by inhibiting cyclooxygenase, especially the inhibition of arachidonic acid to cyclic internal oxides, PGG and PGH (which can generate PGE1, PGE2, PGF2α and PGD2 ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/192A61K47/36A61K47/32A61P29/00
Inventor 阮建山丁仲杰韩松陈祥伟
Owner 瑞博(杭州)医药科技有限公司
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