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Diclofenac sodium sustained-release tablet and its preparation process

A technology for diclofenac sodium and its preparation process, which is applied in the field of diclofenac sodium sustained-release tablets and its preparation, and can solve problems such as limitations in the industrial production and application of the full powder direct compression method

Active Publication Date: 2011-12-14
SINOPHARM GRP ZHIJUN SHENZHEN PINGSHAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the high requirements for excipients and preparation equipment, the industrial production and application of full powder direct compression method is subject to many restrictions

Method used

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  • Diclofenac sodium sustained-release tablet and its preparation process
  • Diclofenac sodium sustained-release tablet and its preparation process
  • Diclofenac sodium sustained-release tablet and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] formula:

[0076]

[0077] Preparation Process:

[0078] Accurately weigh 1000.0g of diclofenac sodium, 567.5g of hydroxypropyl methylcellulose, 403.0g of methylcellulose, 1341.1g of calcium hydrogen phosphate, 152.0g of micropowder silica gel, 50.0g of talcum powder, 70.6g of magnesium stearate, Ouba Substitute (film coating material is hydroxypropyl methylcellulose) 100.0g, set aside.

[0079] Take diclofenac sodium, micropowder silica gel, and talcum powder, pass through an 80-mesh sieve and mix until uniform, add calcium hydrogen phosphate, hydroxypropyl methylcellulose, and methylcellulose, mix for 30 minutes, then add magnesium stearate, mix for 5 minutes, and press into tablets 10,000 diclofenac sodium sustained-release tablets were prepared after coating with Opadry, the specification was 0.36g, and the yield was 98.23%.

Embodiment 2

[0081] formula:

[0082]

[0083]

[0084] Preparation Process:

[0085] Accurately weigh 1000.0 g of diclofenac sodium, 390.5 g of hydroxypropyl methylcellulose, 895.4 g of microcrystalline cellulose, 51.5 g of micropowdered silica gel, 67.3 g of stearic acid, and 159.1 g of polyvinylpyrrolidone, and set aside.

[0086] Take diclofenac sodium and micropowder silica gel and pass through a 100-mesh sieve and mix until uniform, add microcrystalline cellulose, hydroxypropyl methylcellulose, and polyvinylpyrrolidone and mix for 60 minutes, then add stearic acid and mix for 5 minutes, and press into tablets to obtain diclofenac 10,000 sodium sustained-release tablets, the specification is 0.26g, and the yield is 99.14%.

Embodiment 3

[0088] formula:

[0089]

[0090] Preparation Process:

[0091] Accurately weigh 1000.0g of diclofenac sodium, 439.6g of hydroxypropyl methylcellulose, 2459.2g of lactose, 251.7g of micropowdered silica gel, 100.0g of talcum powder, 59.0g of polyvinylpyrrolidone, and 60.0g of Eudragit (the film coating is acrylic resin) ,spare.

[0092] Take diclofenac sodium, micropowder silica gel, and talcum powder and pass through a 120-mesh sieve and mix until uniform, add lactose, hydroxypropyl methylcellulose, and polyvinylpyrrolidone, mix for 10 minutes, press into tablets, and coat with acrylic resin to prepare diclofenac sodium sustained-release 10,000 pieces, the specification is 0.43g, and the yield is 98.47%.

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Abstract

The invention relates to the technical field of medicine, in particular to diclofenac sodium sustained release tablets and a preparation process thereof. The diclofenac sodium sustained release tablets provided by the invention comprise the following components in percentage by mass: 16.5 to 39.0 percent of diclofenac sodium, 10.0 to 35.5 percent of sustained release agent, 33.5 to 65.0 percent of filling agent, 2.01 to 8.0 percent of glidant, 0 to 2.5 percent of lubricating agent, and 0 to 8.0 percent of adhesive. According to the diclofenac sodium sustained release tablets and a whole-powder direct tabletting method thereof provided by the invention, by changing the components and the preparation method, the production process is simplified, the production cost is reduced, the production efficiency is improved, the yield is improved to 98.0 to 100 percent, granule condensation is avoided, the surface of the tablets is smooth, meanwhile, consumption of high-concentration alcohol is avoided, and the potential safety hazard in the production process is reduced.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a diclofenac sodium sustained-release tablet and a preparation process thereof. Background technique [0002] Diclofenac sodium, the chemical name is [o-(2,6-dichloroaniline)] sodium phenylacetate, the molecular formula is Cl 4 h 10 Cl 2 NNaO 2 , the molecular weight is 318.13, and the molecular structural formula is as follows: [0003] [0004] Diclofenac is a light yellow crystal, odorless, soluble in water, ethanol and other non-polar organic solvents, it is a non-steroidal anti-inflammatory analgesic derived from phenylacetic acid, which can inhibit the activity of cyclooxygenase, thereby Block the transformation of arachidonic acid into prostaglandins; at the same time, it can also promote the combination of arachidonic acid and triglyceride (triacylglycerol), reduce the concentration of free arachidonic acid in cells, and indirectly inhibit leukotrienes, slow The ...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/36A61K31/196A61K47/32A61K47/38A61P29/00
CPCA61K9/2013A61K9/2054A61K9/2027A61K31/196A61P29/00
Inventor 闫志刚邓宝军黄艳曾环想王泳陈芳晓李娟权超
Owner SINOPHARM GRP ZHIJUN SHENZHEN PINGSHAN PHARMA CO LTD
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