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Aspirin enteric-coated tablet and preparation method thereof

A technology for aspirin and enteric-coated tablets, which can be applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. The effect of preventing water penetration and inhibiting hydrolysis

Active Publication Date: 2021-02-26
LEPU HENGJIUYUAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The invention provides a preparation method of aspirin enteric-coated tablets, which aims to solve the technical problem that the isolation layer affects the disintegration of aspirin enteric-coated tablets

Method used

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  • Aspirin enteric-coated tablet and preparation method thereof
  • Aspirin enteric-coated tablet and preparation method thereof
  • Aspirin enteric-coated tablet and preparation method thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0013] A preparation method for aspirin enteric-coated tablets, comprising the following steps:

[0014] S1, prepare aspirin tablet core;

[0015] In parts by weight, each part of the aspirin tablet core is a tablet core obtained by mixing 0.8-1.2 part of aspirin, 0.10-0.14 part of binder, 0.09-0.13 part of filler and 0.02-0.03 part of lubricant and directly compressing the tablet. Or the tablet core obtained by mixing 0.9-1.1 parts of aspirin, 0.11-0.13 parts of binder, 0.1-0.12 parts of filler and 0.023-0.029 parts of lubricant; or 1-1.05 parts of aspirin, 0.12-0.15 The tablet core obtained by directly compressing the mixture of 0.105-0.11 part of filler and 0.025-0.028 part of lubricant.

[0016] Aspirin is stable in dry air, and slowly hydrolyzes into salicylic acid and acetic acid when it encounters moisture. If aspirin is in contact with water, ethanol or other solvents, and then heated and dried under hot and humid conditions, it will promote the development of aspirin...

Embodiment 1

[0044] The present embodiment provides a kind of preparation method of aspirin enteric-coated tablet, comprises the following steps:

[0045] S1, prepare aspirin tablet core;

[0046] Prepare 560,000 aspirin enteric-coated tablets, mix 56Kg of aspirin, 5.8Kg of MCC-102, 6Kg of cornstarch and 1.4Kg of talcum powder and directly perform powder compression.

[0047] S2, preparing the first coating solution and the second coating solution;

[0048] S2.1, preparing the first coating solution;

[0049] Mix 2Kg methacrylic acid copolymer, 0.3Kg triethyl citrate, 1.0Kg talcum powder and 23Kg 95% ethanol to obtain the first coating solution. The methacrylic acid copolymer is a copolymer obtained by polymerization of methacrylic acid and acrylic acid thing.

[0050] S2.2, preparing the second coating solution;

[0051] Mix 2Kg of methacrylic acid copolymer, 0.15Kg of triethyl citrate, 0.3Kg of polysorbate 80, 1.0Kg of talc and 23Kg of 95% ethanol to obtain a second coating solution....

Embodiment 2-7

[0058] The preparation method of aspirin enteric-coated tablets provided in Examples 2-7 is basically the same as the preparation method of aspirin enteric-coated tablets provided in Example 1, except that the ratio of raw materials changes and the operating conditions are different.

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Abstract

The invention relates to the field of pharmaceutical engineering, in particular to an aspirin enteric-coated tablet and a preparation method thereof. The preparation method of the aspirin enteric-coated tablet comprises the following steps that a first enteric coating layer and a second enteric coating layer are sequentially arranged outside an aspirin tablet core without a solvent. The first enteric coating layer is a coating layer obtained after the first coating layer is sprayed to the aspirin tablet core. Each first coating solution is prepared from, by weight, 1.8-2.2 parts of enteric coating materials, 0.2-0.4 parts of plasticizer, 0.8-1.2 parts of anti-sticking agent and 20-25 parts of solvent. By arranging the first enteric coating layer and the second enteric coating layer to wrapthe aspirin tablet core, external moisture infiltration can be effectively prevented, aspirin hydrolysis is prevented, and meanwhile the phenomenon that aspirin disintegrates in gastric juice is prevented, but the disintegration and dissolution effects of the aspirin in the gastric juice can be guaranteed.

Description

technical field [0001] The invention relates to the field of pharmaceutical engineering, in particular to an aspirin enteric-coated tablet and a preparation method thereof. Background technique [0002] Aspirin (Aspirin, acetylsalicylic acid) is a white crystal or crystalline powder, odorless or slightly smelly of acetic acid, slightly soluble in water, easily soluble in ethanol, soluble in ether and chloroform, and its aqueous solution is acidic. Aspirin is stable in dry air, and slowly hydrolyzes into salicylic acid and acetic acid when exposed to moisture, which easily affects the stability and efficacy of aspirin. At the same time, aspirin is easily decomposed in an acidic environment, which in turn increases the toxic and side effects of aspirin and reduces its efficacy. . For this reason, aspirin is made into enteric-coated tablets in the prior art, but in the aspirin enteric-coated tablets of the prior art, the use of wet granulation of the tablet core causes aspirin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/30A61K47/38A61K47/36A61K47/02A61K31/616
CPCA61K9/2009A61K9/2054A61K9/2059A61K9/284A61K9/2886A61K31/616
Inventor 何志松杨双李家志闫明科杨涛刘鹏飞徐传香
Owner LEPU HENGJIUYUAN PHARMA CO LTD
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