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Diclofenac sodium dual-release enteric-coated preparation, as well as preparation method and control method thereof

A technology of diclofenac sodium and enteric-coated preparations, which is applied in the field of medicine, can solve problems such as hindering clinical application, many side effects, and short biological half-life, and achieve the effects of reducing gastrointestinal tract irritation and the number of medications, stable and reliable quality, and improving production efficiency

Active Publication Date: 2013-06-12
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

However, the oral absorption of diclofenac sodium is fast, the biological half-life is short, only 1.5-2 hours, and there are many side effects, which greatly hinder the clinical application

Method used

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  • Diclofenac sodium dual-release enteric-coated preparation, as well as preparation method and control method thereof
  • Diclofenac sodium dual-release enteric-coated preparation, as well as preparation method and control method thereof
  • Diclofenac sodium dual-release enteric-coated preparation, as well as preparation method and control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0131]

[0132] 1) Preparation method:

[0133] (1) Take the components by the above weight;

[0134] (2) Mix 73.6g diclofenac sodium, 43.08g microcrystalline cellulose, 9.2g ethyl cellulose and 16.1g povidone evenly, use distilled water as a wetting agent to make a soft material, put the prepared soft material into the extruder Out of the spheronizing granulator, the prepared pills are dried and set aside;

[0135] (3) 0.161g sodium hydroxide is configured into a 5% aqueous solution for subsequent use;

[0136] (4) Slowly add 9.2g of Eudragit S100 to 4 times the amount of distilled water, add 6.9g of talc powder and 0.23g of titanium dioxide, stir for 28 minutes, add the sodium hydroxide solution in the above (3), and then add 1.15g Propylene glycol, stir evenly, add 0.23g of simethicone dropwise, and set aside;

[0137] (5) Mix Eudragit 27.6g RL PO with Eudragit 13.8g RS PO, slowly add to 20 times the amount of 95% ethanol, add 13.8g of talcum powder and 0.46g of titan...

Embodiment 2

[0142]

[0143] 1) Preparation method:

[0144] (1) Take the components by the above weight;

[0145] (2) Mix 73.6g diclofenac sodium, 37.7g microcrystalline cellulose, 11.5g ethyl cellulose and 18.4g povidone evenly, use distilled water as a wetting agent to make a soft material, put the prepared soft material into an extruder Out of the spheronizing granulator, the prepared pills are dried and set aside;

[0146] (3) 0.21g sodium hydroxide is configured into a 4% aqueous solution for subsequent use;

[0147] (4) Slowly add 6.9g of Eudragit S100 to 3 times the amount of distilled water, add 6.9g of talc powder and 0.23g of titanium dioxide, stir for 20 minutes, add the sodium hydroxide solution in the above (3), and then add 1.84g Propylene glycol, stir evenly, add 0.23g of simethicone dropwise, and set aside;

[0148] (5) Mix Eudragit 20.7g RL PO with Eudragit 18.4g RS PO, slowly add to 18 times the amount of 95% ethanol, add 11.5g of talcum powder and 0.46g of titaniu...

Embodiment 3

[0153]

[0154] 1) Preparation method:

[0155] (1) take components by weight;

[0156] (2) Mix 73.6g diclofenac sodium, 48.76g microcrystalline cellulose, 11.5g ethyl cellulose and 23g povidone evenly, use distilled water as a wetting agent to make a soft material, put the prepared soft material into extrusion In the spheronizing granulator, the prepared pills are dried and set aside;

[0157] (3) 0.23g sodium hydroxide is configured into 8% aqueous solution, for subsequent use;

[0158] (4) Slowly add 11.5g of Eudragit S100 to 5 times the amount of distilled water, add 16.1g of talc powder and 0.23g of titanium dioxide, stir for 30 minutes, add the sodium hydroxide solution in the above (3), and then add 2.3g Propylene glycol, stir evenly, add 0.23g of simethicone dropwise, and set aside;

[0159](5) Mix Eudragit 6.9g RL PO with Eudragit 6.9g RS PO, slowly add to 10 times the amount of 95% ethanol, add 16.1g of talcum powder and 0.46g of titanium dioxide, stir for 25 m...

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Abstract

The invention relates to a diclofenac sodium dual-release enteric-coated preparation, as well as a preparation method and a control method thereof. The diclofenac sodium dual-release enteric-coated preparation comprises the following components in percentage by weight: 11%-44% of microcrystalline cellulose, 2%-5% of ethyl cellulose, 3%-10% of povidone, 1%-6% of Eudragit S100, 2%-16% of Eudragit RL PO, 2%-12% of Eudragit RS PO, 1.5%-12% of tributyl citrate, 0.01%-0.1% of sodium hydroxide, 0.05%-1% of propylene glycol, 6%-15% of talc powder, 0.1% of silicon dioxide, 0.3% of titanium dioxide and 0.3% of dimethyl silicone oil, A and B pills with two release mechanisms are respectively prepared, and double-layer tablets, capsules or granules are prepared, wherein a prepared intermediate product has the laser spectral band pass of 5.0nm, the transmission spectral band pass of 10.0nm, the excitation wavelength of 340nm and the fluorescence intensity of 330-380 under the condition that the transmission wavelength is 510nm. The quality of the diclofenac sodium dual-release enteric-coated preparation disclosed by the invention is in line with the standard, and quality control is performed before production, so that rework can be reduced, the production cost can be saved, the energy consumption can be reduced and the production efficiency can be improved.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a diclofenac sodium double-release enteric-coated preparation and a preparation method and control method 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 ret...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/24A61K9/16A61K31/196A61P29/00G01N21/64
Inventor 张凯谢隆谢雁鸣郭彧伍彪陈腊梅艾风
Owner 广东全瑞医药有限公司
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