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Aceclofenac enteric-coated tablet and preparing method thereof

A technology for aceclofenac and enteric-coated tablets, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. problem, to achieve the effect of easy industrialized large-scale production and simple preparation process

Active Publication Date: 2015-09-30
LUNAN BETTER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] It can be seen from the above that aceclofenac is slightly soluble in water, has a low dissolution rate, and is prone to sudden release during the use of excipients, which may cause stomach discomfort and reduce the curative effect of the drug itself.

Method used

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  • Aceclofenac enteric-coated tablet and preparing method thereof
  • Aceclofenac enteric-coated tablet and preparing method thereof
  • Aceclofenac enteric-coated tablet and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Tablet prescription:

[0029]

[0030] Isolation Layer Prescription:

[0031] Opadry 17K69000 12g

[0032] 95% ethanol 114mL

[0033] Enteric coating layer prescription:

[0034]

[0035] 1) Aceclofenac and polyethylene glycol 6000 are heated and melted at 100°C, and the molten solution is added to a 95% ethanol solution containing copovidone and dipotassium hydrogen phosphate, stirred evenly, dried at 50°C for 45min, and passed After a 30-mesh sieve, mix with fillers and disintegrants, mix with an appropriate amount of 10% povidone K30 aqueous solution to make a soft material, granulate with a 30-mesh sieve, dry at 50°C for 45 minutes, add lubricant, mix evenly, and compress into tablets;

[0036] 2) Take the aceclofenac tablet core, wrap it with an isolation coat at 40-50°C until the weight gain is 5%, take it out, dry it at room temperature, and set aside;

[0037] 3) Take the tablet core wrapped with an isolation coat, wrap it with an enteric coat at 50° C...

Embodiment 2

[0039] Tablet prescription:

[0040]

[0041] The binder is selected from 3% hypromellose in 50% ethanol solution, and the formulation of the isolation layer and the enteric layer are the same as in Example 1.

[0042] The preparation method is the same as in Example 1.

Embodiment 3

[0044] Tablet prescription:

[0045]

[0046] The prescription of the isolation layer and the prescription of the enteric-coated layer are the same as in Example 1.

[0047] The preparation method is the same as in Example 1.

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Abstract

The invention discloses an aceclofenac enteric-coated tablet and a preparing method thereof. The enteric-coated tablet comprises a tablet core, an isolation layer and a coating, wherein the tablet core contains aceclofenac, polyethylene glycol and copovidone. It is found through conventional experiments that the dissolution rate of the aceclofenac enteric-coated tablet is 99% or higher, it is found through acceleration experiments that aceclofenac is suitable for long-time storage, the preparing technology is easy, industrialization large-scale production is easy, and obvious advantages are achieved compared with the prior art.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an aceclofenac enteric-coated tablet and a preparation method thereof. Background technique [0002] The English name of aceclofenac is Aceclofenac, and the chemical name is 2-((2,6-dichlorophenyl) amino) phenylacetoxyacetic acid. It is a new type of oral and powerful drug first introduced to the market by the Spanish company Prodesfarma in 1992. Non-steroidal anti-inflammatory drugs. It is clinically applicable to the treatment of rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, spondylitis, etc. It is also suitable for pain and fever caused by various diseases. Its mechanism of action is mainly through the inhibition of cyclooxygenase activity, thereby reducing the synthesis of prostaglandins. [0003] Aceclofenac is an insoluble substance and is slightly soluble in water. It is found in the clinical process that it is easy to cause ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/216A61K47/34A61K47/32A61P29/00A61P19/02
Inventor 张贵民秦士慧
Owner LUNAN BETTER PHARMA
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