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Diclofenac sodium sustained-release tablet and method for preparing same

A technology of diclofenac sodium and sustained-release tablets, which is applied in the field of medicine, can solve the problems of large mucous membrane irritation, difficult drying of particles, and tearing of production personnel, and achieve the effects of reducing irritation, uniform porosity, and reducing hidden dangers in production

Active Publication Date: 2013-06-26
广东全瑞医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, diclofenac sodium sustained-release tablets mostly use hydroxypropyl methylcellulose as the skeleton material. At present, the domestically produced hydroxypropyl methylcellulose has poor stability between batches and is rarely used. The hydroxypropyl methylcellulose currently used in this product Base cellulose is an imported auxiliary material, which is expensive, exceeding 300 yuan / kg. Diclofenac sodium sustained-release tablets made of this kind of skeleton material are generally eroded after 12 hours
During the preparation process, due to the increased viscosity of hydroxypropyl methylcellulose and easy film formation, wet granulation is difficult to granulate and the granules are not easy to dry
The powder direct compression process is convenient, but it is easy to cause dust flying during the tablet compression process. Diclofenac sodium is highly irritating to the production personnel's eyes, nasal cavity and other mucous membranes, which may easily cause production personnel to shed tears and sneeze. The production personnel are labor-intensive and easy to Production accidents due to visual impact
Diclofenac sodium is also highly irritating to the gastric mucosa. At present, there are enteric-coated preparations of diclofenac sodium, which can be released by wrapping enteric coatings in the intestinal tract. The mechanical wear intensity caused by peristalsis is high, and the integrity of the film coating cannot be ensured when entering the intestinal tract

Method used

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  • Diclofenac sodium sustained-release tablet and method for preparing same
  • Diclofenac sodium sustained-release tablet and method for preparing same
  • Diclofenac sodium sustained-release tablet and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Components:

[0025]

[0026] Preparation:

[0027] (1) Take the following components by weight:

[0028]

[0029] (2) Get Diclofenac Sodium 250g, Magnesium Oxide 130g, Mannitol 24g to pass through 80 mesh sieves, mix well, get mixed material, set aside;

[0030] (3) Get 71.25g of palm wax, melt it at 90°C, and set aside;

[0031] (4) Get palm wax 23.75g, pulverize, cross 120 mesh sieves, set aside;

[0032] (5) Add the mixed material in (2) above to the melted palm wax in (3), stir evenly, make granules, cool to room temperature, and set aside;

[0033] (6) Take the granules in (5) above, put them in the coating pan, turn on the hot air at 80°C, and rotate at 12r / min, when the surface temperature of the granules reaches 70°C, gradually add the powder of (4) into the coating pan, Keep the surface temperature of the granules at 65°C and rotate for 30 minutes, cool to room temperature, size the granules, add 1g of silicon dioxide, mix well, press into tablets, ...

Embodiment 2

[0036] Components:

[0037]

[0038] Preparation:

[0039] (1) Take the following components by weight:

[0040]

[0041] (2) Get 500g of diclofenac sodium, 255g of calcium dihydrogen phosphate, 50g of talcum powder, and 150g of lactose and pass through a 100-mesh sieve, mix well to obtain a mixture, and set aside;

[0042] (3) Take 240g of glyceryl behenate, melt it at 80°C, and set aside;

[0043] (4) Get cetyl alcohol 80g, pulverize, cross 120 mesh sieves, set aside;

[0044] (5) Add the mixed material in (2) above to the melted glyceryl behenate in (3), stir evenly, make granules, cool to room temperature, and set aside;

[0045] (6) Take the granules in (5) above, put them in the coating pan, turn on the hot air at 55°C, and rotate at 8r / min, and when the surface temperature of the granules reaches 48°C, gradually add the powder of (4) into the coating pan, Keep the surface temperature of the granules at 48°C and rotate for 25 minutes, cool to room temperature, g...

Embodiment 3

[0048] Components:

[0049]

[0050] Preparation:

[0051] (1) Take the following components by weight:

[0052]

[0053] (2) Get 750g of diclofenac sodium, 185g of ethyl cellulose, 100g of calcium sulfate, 60g of microcrystalline cellulose, and 180g of sucrose and pass through a 120-mesh sieve, mix evenly to obtain a mixture, and set aside;

[0054] (3) Take 540 g of cetostearyl alcohol, melt it at 65° C., and set aside;

[0055] (4) Get stearic acid 180g, pulverize, cross 120 mesh sieves, set aside;

[0056] (5) Add the mixed material in (2) above to the melted cetearyl alcohol in (3), stir evenly, make granules, cool to room temperature, and set aside;

[0057] (6) Take the granules in (5) above, put them in the coating pan, turn on the hot air at 58°C, and rotate at 4r / min, and when the surface temperature of the granules reaches 42°C, gradually add the powder of (4) into the coating pan, Keep the surface temperature of the granules at 42°C and rotate for 30 min...

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Abstract

The invention relates to a diclofenac sodium sustained-release tablet and a method for preparing the same. By comprising the following components in percentage by weight: 15.0-60.0% of diclofenac sodium, 18.0-60.0% of retardant, 15.0-40.0% of filler, 3.0-20.0% of pore-foaming agent and 0.1-4.0% of lubricant, the diclofenac sodium sustained-release tablet is prepared by the processes of mixing the components, pelleting, thermally wrapping the retardant to the prepared particles, tabletting, heat treating, coating, and the like. The diclofenac sodium sustained-release tablet provided by the invention avoids the use dependence of hydroxypropyl methyl cellulose imported from abroad, reduces the irritation to the stomach when the clinical medication convenience is improved simultaneously, reduces the side effects, and is suitable for different age groups and in-vivo environments as the prepared sustained-release tablet can continuously release for 24hours. The preparation process of the product reduces the intensity of production. And the prepared product is safe and effective, and strong in convenience.

Description

technical field [0001] The invention relates to the field of medicine, in particular to diclofenac sodium sustained-release tablets and a preparation process thereof. Background technique [0002] Diclofenac sodium (diclofenacsodium) is a second-generation powerful non-steroidal anti-inflammatory drug, which has obvious analgesic, anti-inflammatory and antipyretic effects. This product inhibits the synthesis of arachidonic acid by inhibiting cyclooxygenase in the body, and reduces the synthesis of prostaglandins, thereby playing anti-rheumatic, anti-inflammatory, analgesic and antipyretic effects. [0003] At present, the prevalence rate of rheumatoid arthritis alone in my country is about 5‰, and the number of patients with rheumatism and rheumatoid diseases exceeds 10 million. The national anti-arthritic drug market scale is 1.3-1.5 billion yuan, with an annual growth rate of about 6%, reaching 1.8 billion yuan in 2006, of which the retail market occupies a considerable m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/196A61P29/00
Inventor 张凯谢隆谢雁鸣伍彪陈腊梅艾风
Owner 广东全瑞医药有限公司
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