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Diclofenac sodium sustained release tablet and preparation method thereof

A technology of diclofenac sodium and sustained-release tablets, which is used in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc. Good release profile and good formulation stability

Active Publication Date: 2013-01-02
DEZHOU DEYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, in the diclofenac sodium sustained-release tablets of the prior art, there are still some problems, for example, there are still deficiencies in indicators such as release rate, so that the release of the drug sometimes cannot meet the clinical needs

Method used

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  • Diclofenac sodium sustained release tablet and preparation method thereof
  • Diclofenac sodium sustained release tablet and preparation method thereof
  • Diclofenac sodium sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Diclofenac sodium, lactose, calcium sulfate, ethyl cellulose, acrylic resin, hypromellose, and magnesium stearate were weighed according to the amounts in Table 1.

[0025] Get the above-mentioned amount of diclofenac sodium, pass through a 60-mesh sieve, get the described amount of lactose and calcium sulfate, pass through an 80-mesh sieve, get the described amount of ethyl cellulose, pass through a 100-mesh sieve for pulverization, and pass through an 80-mesh sieve.

[0026] The above-mentioned amount of acrylic resin and hypromellose were dissolved in 95% ethanol.

[0027] Mix the above diclofenac sodium, calcium sulfate, lactose and ethyl cellulose evenly, add acrylic resin, hypromellose and 95% ethanol binder to make a soft material, granulate with 18-mesh nylon mesh, and ventilate at 70°C Dried, granulated with 18 mesh wire mesh, mixed with the above-mentioned amount of magnesium stearate, compressed into tablets, and packaged to obtain the diclofenac sodium susta...

Embodiment 2-6

[0029] Except that the amount of each raw material is weighed according to Table 1, other method steps are all the same as in Example 1. The diclofenac sodium sustained-release tablets of Examples 2-6 were prepared.

[0030] Table 1

[0031]

[0032] Wherein, all numerical values ​​are the dosage of diclofenac sodium per 1000 tablets, and the unit is g.

[0033] The beneficial effect of the technical solution provided by the present invention will be illustrated through experiments below.

[0034] Determination of release: get this product, according to release assay (Chinese Pharmacopoeia edition in 2000 two appendix X D first method), adopt the device of dissolution assay (Chinese Pharmacopoeia edition two appendix XC first method in 2000), with phosphoric acid 900ml of salt buffer solution (pH value 7.4) is the solvent, and the rotating speed is 100 revolutions per minute. Operate according to the law. Take 5ml of the solution for filtration in 2 hours, 6 hours, and 12...

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PUM

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Abstract

The invention relates to a sustained release pharmaceutical formulation, and in particular relates to a diclofenac sodium sustained release tablet and a preparation method thereof. The diclofenac sodium sustained release tablet is prepared from diclofenac sodium, lactose, calcium sulfate, ethylcellulose, acrylic resin, hydroxypropyl methylcellulose, magnesium stearate and 95% ethanol in certain proportions. The diclofenac sodium sustained release tablet is simple in preparation process, low in cost, good in formulation stability and excellent in release rate.

Description

technical field [0001] The invention relates to a sustained-release pharmaceutical preparation, in particular to a diclofenac sodium sustained-release tablet and a manufacturing method thereof. Background technique [0002] Diclofenac sodium, the chemical name is [o-(2,6-dichloroaniline)] sodium phenylacetate, the molecular formula is C14H10C12NNaO2, the molecular weight is 318.13, and the molecular structural formula is as follows: [0003] [0004] Diclofenac sodium is a non-steroidal anti-inflammatory analgesic derived from phenylacetic acid, which can block the transformation of arachidonic acid into prostaglandins by inhibiting the activity of cyclooxygenase; at the same time, it can also promote the conversion of arachidonic acid and The combination of triglyceride (triacylglycerol) reduces the concentration of free arachidonic acid in cells, and indirectly inhibits the production of leukotrienes, bradykinin and other products to exert antipyretic, analgesic and ant...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/196A61P29/00
Inventor 卞建钢潘秀芝牟金香李成文宋晓丽马玉梅宋桓肖梅花
Owner DEZHOU DEYAO PHARMA
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