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

CN105193762BActive Publication Date: 2018-05-25CSPC OUYI PHARM CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Publication Date
2018-05-25

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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.
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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...

Examples

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...