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Preparation method of aspirin enteric-coated sustained-release preparation

A technology for aspirin and sustained-release preparations, which is applied in the field of preparation of enteric-coated sustained-release preparations, can solve the problems of decreased drug dissolution, more enteric-coated materials, and increased hardness, and achieves reduced dosage, smooth release, and compliance. improved effect

Active Publication Date: 2012-08-22
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method can achieve the effect of enteric-coated sustained release, but the problem is that more enteric-coated materials are used (the main drug, enteric-coated material Eudragit L-100 and enteric-coated material Eudragit RD100 are the best in this literature). The ratio is 1:1:1.5, if the main drug is 100mg per tablet, the enteric-coated material is 250mg), which makes the tablet larger (at least 350mg without other excipients); After storage, the hardness increases, crystals precipitate, and the drug dissolution rate decreases are also a worrying problem (Edited by Lu Bin. New Drug Formulations and New Technologies (Second Edition). Beijing: People's Health Publishing House: 24)

Method used

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  • Preparation method of aspirin enteric-coated sustained-release preparation
  • Preparation method of aspirin enteric-coated sustained-release preparation
  • Preparation method of aspirin enteric-coated sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] prescription

[0049] ⑴ Chip core

[0050]

[0051] ⑵Enteric coating layer

[0052]

[0053] craft

[0054] (1) Take aspirin for tablet core, add hypromellose K15M, microcrystalline cellulose PH102, lactose and sodium lauryl sulfate, and mix well. Put it in a rotary tablet press (C&C800, Beijing Chuangbo Jiawei Technology Co., Ltd., the same below), use a shallow concave circular punching tablet with a diameter of 6mm, adjust the tablet weight and pressure, control the hardness to 50-80N, and prepare a total of 1000 pieces.

[0055] (2) For the enteric coating layer, take Eudragit RS 30D and Eudragit RL 30D aqueous dispersions (both are products of Rohm, Germany), add triethyl citrate talcum powder, 95% ethanol (v / v) and water, Stir well. Put the above-mentioned tablets in a coating machine (BGB-5B type, Wenzhou Pharmaceutical Equipment Factory, the same below), adjust the coating machine speed, liquid spray speed, inlet air temperature, inlet air pressure, a...

Embodiment 2

[0058] prescription

[0059] ⑴ Chip core

[0060]

[0061] ⑵Isolation gown layer

[0062] Hypromellose 17g

[0063] Macrogol 400 3g

[0064] 60% ethanol solution (v / v) 280g

[0065] ⑶ enteric coating layer

[0066]

[0067] craft

[0068] (1) Take aspirin for tablet core, add hypromellose K4M, microcrystalline cellulose PH102, pregelatinized starch and sodium lauryl sulfate, and mix well. Put it in a rotary tablet press, adopt a shallow concave circular punching tablet with a diameter of 6.5mm, adjust the tablet weight and pressure, control the hardness to 60-100N, and prepare 1000 tablets in total.

[0069] (2) For the isolation layer, dissolve hypromellose and polyethylene glycol 400 in 60% ethanol solution and stir to dissolve completely. The above-mentioned tablets are placed in the coating machine, and the rotating speed of the coating machine, the liquid spray speed, the air inlet temperature, the air inlet air pressure, the atomization pressure, and the spr...

Embodiment 3

[0072] prescription

[0073] ⑴ Chip core

[0074]

[0075] ⑵Enteric coating layer

[0076]

[0077] craft

[0078] (1) Take aspirin for tablet core, add hydroxymethylcellulose Klucel HF (manufactured by Aqualon), tartaric acid, and dextrin, and mix well. Put it in a rotary tablet press, adopt a shallow concave circular punching tablet with a diameter of 6.5mm, adjust the tablet weight and pressure, control the hardness to 60-100N, and prepare 1000 tablets in total.

[0079] (2) Take acetone for the enteric coating layer, add hypromellose phthalate, triacetin and glycerin, stir well, then add water and talcum powder, mix well. The above-mentioned tablets are placed in the coating machine, and the rotating speed of the coating machine, the liquid spray speed, the air inlet temperature, the air inlet air pressure, the atomization pressure, and the spray distance of the tablet are adjusted, and the temperature of the tablet is controlled to be 35-43° C. The weight is abo...

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Abstract

The invention relates to a preparation method of an enteric-coated sustained-release preparation, in particular to a preparation method of an aspirin enteric-coated sustained-release preparation. According to the preparation method, a prepared aspirin sustained-release tablet is used as a core tablet, and an enteric coating is packaged on the outer layer of the core tablet. In order to prevent aspirin in the core tablet from interacting with an enteric-coated material, an isolating layer can be packaged between the core tablet and the enteric coating. After the aspirin is prepared into the enteric-coated sustained-release preparation provided by the invention, the aspirin is not released or a little aspirin is released in a stomach, the release time in intestines is greatly extended, the phenomena of violent disintegration and dissolution do not occur in the intestines, the aspirin is released more slowly, the bioavailability is greatly increased, the degradation reaction of the aspirin in water is avoided, the frequency of administration is lower, and the compliance of a patient is improved.

Description

technical field [0001] The invention relates to a preparation method of an enteric-coated sustained-release preparation, in particular to a preparation method of an aspirin enteric-coated sustained-release preparation. Background technique [0002] Aspirin, also known as acetylsalicylic acid (ASA), was first synthesized by Charles Gerhardt in 1853 and was first listed by Bayer in 1899 as a non-steroidal anti-inflammatory drug. It has a wide range of pharmacological effects, such as anti-inflammatory, anti-rheumatism, analgesic, antipyretic, and inhibition of platelet aggregation. There are many dosage forms on the market, including capsules, sustained-release capsules, enteric-coated capsules, tablets, orally disintegrating tablets, sublingual tablets, sustained-release tablets, enteric-coated tablets, granules, gels, Creams, injections, chewing gums, powders, solutions, drops, suppositories, etc. [0003] The medicinal salts of aspirin include aspirin lysine salt, aspirin...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/616A61K47/32A61K47/34A61K47/36A61K47/38A61P7/02A61P29/00
Inventor 汪洋王翀陈岐信郑忠辉
Owner SHANDONG XINHUA PHARMA CO LTD
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