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Diflunisal enteric-coated tablet and preparation method thereof

A technology of diflunisal sausage and diflunisal, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve gastrointestinal irritation, monotonous dosage forms, Niliu enteric-coated tablets have no reported problems, and achieve the effect of increasing dissolution rate, improving stability, and improving bioavailability

Inactive Publication Date: 2019-05-17
ZHENGZHOU TAIFENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dosage form is relatively monotonous, and diflunisal is insoluble in water, which has strong irritation to the gastrointestinal tract
Diflunisal enteric-coated tablets are not reported in the prior art

Method used

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  • Diflunisal enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1 Diflunisal enteric-coated tablets

[0043] The prescription for 1000 tablets is:

[0044] Diflunisal 250g

[0045] Lactose 40g

[0046] Precrossed starch 60g

[0047] Poloxamer 40g

[0048] Micropowder silica gel 30g

[0049] Crospovidone 20g

[0050] Hypromellose 80g

[0051] Polysorbate 25g

[0052] Acrylic resin 75g

[0053] Shellac 30g

[0054] Polyethylene glycol 30g

[0055] Proper amount of polyvinylpyrrolidone K30

[0056] Proper amount of ethanol

[0057] Preparation method: pass the formula amount of diflunisal, lactose, pregelatinized starch, crospovidone and poloxamer through an 80-mesh sieve, add an appropriate amount of polyvinylpyrrolidone K30 (8.0%) ethanol solution, and granulate. Dry at 60°C for 2 hours, pass through a 20-mesh sieve, add micro-powder silica gel, mix evenly, and press into tablets to obtain tablet cores; dissolve the formulated amount of hydroxypropyl cellulose and polysorbate in an appropriate amount of ethanol as...

Embodiment 2

[0058] Example 2 Diflunisal enteric-coated tablets

[0059] The prescription for 1000 tablets is:

[0060] Diflunisal 250g

[0061] Lactose 70g

[0062] Precrossed starch 30g

[0063] Crospovidone 20g

[0064] Poloxamer 50g

[0065] Micropowder silica gel 25g

[0066] Hypromellose 75g

[0067] Polysorbate 25g

[0068] Acrylic resin 75g

[0069] Shellac 50g

[0070] Polyethylene glycol 50g

[0071] Proper amount of polyvinylpyrrolidone K30

[0072] Proper amount of ethanol

[0073] Preparation method: pass the formula amount of diflunisal, lactose, pregelatinized starch, crospovidone and poloxamer through an 80-mesh sieve, add an appropriate amount of polyvinylpyrrolidone K30 (8.0%) ethanol solution, and granulate. Dry at 60°C for 2 hours, pass through a 20-mesh sieve, add micro-powder silica gel, mix evenly, and press into tablets to obtain tablet cores; dissolve the formulated amount of hydroxypropyl cellulose and polysorbate in an appropriate amount of ethanol as...

Embodiment 3

[0074] Example 3 Diflunisal enteric-coated tablets

[0075] The prescription for 1000 tablets is:

[0076] Diflunisal 250g

[0077] Lactose 40g

[0078] Precrossed starch 60g

[0079] Poloxamer 40g

[0080] Micropowder silica gel 30g

[0081] Crospovidone 20g

[0082] Hypromellose 80g

[0083] Polysorbate 25g

[0084] Acrylic resin 75g

[0085] Polyethylene glycol 50g

[0086] Proper amount of polyvinylpyrrolidone K30

[0087] Proper amount of ethanol

[0088] Preparation method: pass the formula amount of diflunisal, lactose, pregelatinized starch, crospovidone and poloxamer through an 80-mesh sieve, add an appropriate amount of polyvinylpyrrolidone K30 (8.0%) ethanol solution, and granulate. Dry at 60°C for 2 hours, pass through a 20-mesh sieve, add micro-powder silica gel, mix evenly, and press into tablets to obtain tablet cores; dissolve the formulated amount of hydroxypropyl cellulose and polysorbate in an appropriate amount of ethanol as a coating for the isola...

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PUM

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Abstract

The invention relates to a diflunisal enteric-coated tablet and a preparation method thereof. The tablet is prepared from the following components by the weight percentage: diflunisal, a filling agent, a disintegrating agent, a proper amount of an adhesive, a proper amount of a lubricant, an isolation layer of a coating solution and a casing. The clinical curative effect of diflunisal is improved,the irritation of drugs in stomach is avoided, and the irritation of drugs in intestinal tracts is reduced, so the side effects are reduced, quick and efficient effects are achieved, and the bioavailability is significantly improved. Compared with the prior art, the diflunisal enteric-coated tablet has the advantages of novel dosage form, convenient taking, quick action, convenience in carrying,transportation and storage, convenience in use and the like.

Description

technical field [0001] The invention belongs to the field of diflunisal preparations, and in particular relates to diflunisal enteric-coated tablets and a preparation method thereof. Background technique [0002] Diflunisal, a non-steroidal anti-inflammatory analgesic, is the most promising alternative to aspirin. It is clinically used for the treatment of rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, sprains, strains and pain relief. Studies have shown that diflunisal and ibuprofen are equally effective in the treatment of rheumatoid arthritis and degenerative arthritis. During the observation, it was also found that diflunisal was significantly better than ibuprofen in improving the grip strength of patients with rheumatoid arthritis and relieving joint pain and tenderness in rheumatoid arthritis and degenerative arthritis. At the same time, diflunisal can reduce and relieve rheumatoid factor titer and morning stiffness in patients with rheumatoid arthritis...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/603A61K47/10A61K47/38A61K47/32A61K47/36A61P29/00
Inventor 沙薇张智佳李婷
Owner ZHENGZHOU TAIFENG PHARMA CO LTD
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