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A kind of aspirin enteric-coated tablet and preparation method thereof

A technology of aspirin and enteric-coated tablets, which is applied in anti-inflammatory agents, pharmaceutical formulas, non-central analgesics, etc. It can solve the problems of accelerated aspirin hydrolysis, free salicylic acid exceeding the standard, and greater impact on the content, so as to improve the release rate , easy industrial production, uniform color effect

Active Publication Date: 2018-05-25
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the excipients in small-dose aspirin enteric-coated tablets account for a relatively large proportion of the total tablet weight, the excipients have a greater impact on the content of small-dose aspirin enteric-coated tablets and the content of free salicylic acid. Improper use will accelerate the hydrolysis of aspirin. Lead to excessive free salicylic acid, resulting in product instability
Currently, domestically produced aspirin enteric-coated tablets are valid for 2 years, but after being stored for more than one year or even half a year, the free salicylic acid test will exceed the standard
In addition, aspirin enteric-coated tablets also have unqualified release within the validity period, and some tablets do not even disintegrate. These quality problems have seriously affected their clinical application.

Method used

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  • A kind of aspirin enteric-coated tablet and preparation method thereof
  • A kind of aspirin enteric-coated tablet and preparation method thereof
  • A kind of aspirin enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 Preparation of aspirin enteric-coated tablets according to the present invention (specification 100mg / tablet, 1000 tablets)

[0025] Chip composition:

[0026]

[0027] Coating composition:

[0028]

[0029]

[0030] Preparation:

[0031] (1) Adhesive preparation: take 8 g of starch and 92 g of purified water to prepare 8% starch slurry, add disodium edetate, hypromellose acetate succinate, and ammonium oxalate, stir and dissolve, and use it as an adhesive;

[0032] (2) Granulation: Weigh aspirin and half of the prescribed amount of starch into the fluidized bed, pre-mix for 6 minutes, spray into the above-mentioned binder to granulate, dry until the moisture is 2.5%, add microcrystalline cellulose and the other half Recipe amount and dried starch at 100℃ for 24 hours, granulated with Φ1.5mm nylon screen;

[0033] (3) Tablet compression: add the granulated material into the mixer, mix for 5 minutes, and compress to obtain tablet cores. The tablet h...

Embodiment 2

[0036] Example 2 Preparation of aspirin enteric-coated tablets according to the present invention (specification 100mg / tablet, 1000 tablets)

[0037] Chip composition:

[0038]

[0039] Coating composition:

[0040]

[0041]

[0042] Preparation:

[0043] (1) Adhesive preparation: Take 7.6g of starch and 87.4g of purified water to prepare 8% starch slurry, add disodium edetate, hypromellose acetate succinate, and ammonium oxalate, stir and dissolve, and use it as an adhesive agent;

[0044](2) Granulation: Weigh aspirin and half of the prescribed amount of starch into the fluidized bed, pre-mix for 3 minutes, spray into the above-mentioned binder to granulate, dry until the moisture is 2.0%, add microcrystalline cellulose and the other half Recipe amount and dried starch at 100℃ for 24 hours, granulated with Φ1.5mm nylon screen;

[0045] (3) Tablet compression: add the granulated material into the mixer, mix for 2 minutes, and compress to obtain tablet cores. The ...

Embodiment 3

[0048] Example 3 Preparation of aspirin enteric-coated tablets according to the present invention (specification 100mg / tablet, 1000 tablets)

[0049] Chip composition:

[0050]

[0051] Coating composition:

[0052]

[0053] Preparation:

[0054] (1) Adhesive preparation: Take 8.4g starch and 96.6g purified water to prepare 8% starch slurry, add disodium edetate, hypromellose acetate succinate, ammonium oxalate, stir and dissolve, and use as adhesive agent;

[0055] (2) Granulation: Weigh aspirin and half of the prescribed amount of starch into the fluidized bed, pre-mix for 4 minutes, spray into the above-mentioned binder to granulate, dry until the moisture is 1.5%, add microcrystalline cellulose and the other half Recipe amount and dried starch at 100℃ for 24 hours, granulated with Φ1.5mm nylon screen;

[0056] (3) Tablet compression: add the granulated material into the mixer, mix for 4 minutes, and compress to obtain tablet cores. The tablet hardness is controll...

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Abstract

The invention relates to an aspirin enteric-coated tablet and a preparation method thereof, belonging to the technical field of medicine. The aspirin enteric-coated tablet consists of a core layer and an enteric coating layer. The aspirin enteric-coated tablet has the characteristics of flat and smooth tablet surface, uniform color, etc., and the release rate of aspirin is improved, and the stability of the product is improved, which is conducive to the safe use and long-term storage of clinical drugs, and improves the clinical application of aspirin enteric-coated tablets Effect. In addition, compared with the existing preparation process, the preparation method of the aspirin enteric-coated tablet of the present invention does not need to wrap the isolation layer between the tablet core layer and the enteric coating layer, and directly wraps the enteric coating outside the tablet core, and the process steps are shortened. The operation is simple and easy, the production cost is greatly reduced, and the industrial production is easy.

Description

technical field [0001] The invention relates to a tablet and a preparation method thereof, in particular to an aspirin enteric-coated tablet and a preparation method thereof, which belong to the technical field of medicine. Background technique [0002] Aspirin, also known as acetylsalicylic acid, belongs to non-steroidal anti-inflammatory drugs, and its chemical name is 2-(acetyloxy)benzoic acid. It was born on March 6, 1899. So far, it has been used for a hundred years and has become a medicine. One of the three classic drugs in history. It is still the most widely used antipyretic, analgesic, anti-rheumatic and anti-inflammatory drug in the world. It is the drug of choice for rheumatoid arthritis and often used as a standard preparation for comparing and evaluating other drugs . [0003] In recent years, it has been found that aspirin has anti-platelet aggregation and anti-blood viscosity increase effects, and has been used to prevent cardiovascular diseases. Now it is m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/32A61K31/616A61K47/38A61K47/18A61K47/14A61K47/04A61P29/00A61P7/02
Inventor 孙成勇韩丽霞张文静姚翠翠韩彩霞
Owner CSPC OUYI PHARM CO LTD
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