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

A technology of iludoline enteric and enteric-coated tablets, which is applied in the field of medicine, can solve the problems that the dissolution rate and slow-release effect are difficult to achieve the desired effect, and achieve the effects of reducing stomach discomfort, improving stability, and simple preparation process

Active Publication Date: 2018-08-14
江阴智产汇知识产权运营有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Compared with the above drugs, Iludoline has better effect and safety, but Iludoline is a poorly soluble substance, and its dissolution rate and sustained release effect are difficult to achieve the desired effect

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) Prescription for 1000 vegetarian tablets:

[0032]

[0033]

[0034] (2) Isolation layer:

[0035] Micronized silica gel 20g

[0036] Hydroxypropyl Methyl Cellulose 4g

[0037] (3) Enteric-coated layer

[0038]

[0039] 1) Mix the ilupolyline and the solubilizer; dissolve it in an appropriate amount of 95% ethanol solution, mix well, add an appropriate amount of lecithin, stir slowly, and dry at 50°C for 45 minutes to obtain dry granules;

[0040] 2) Mix well with filler and disintegrant, add appropriate amount of 50% ethanol solution of 3% hypromellose to make soft material, granulate with 30 mesh sieve, dry at 50°C for 45min, add lubricant in prescribed amount, mix Uniform, tablet;

[0041] 3) Wrapping the isolation layer: prepare 5% hydroxypropyl methylcellulose aqueous solution, weigh the prescribed amount of micropowder silica gel and hydroxypropyl methylcellulose aqueous solution and mix evenly, and set aside;

[0042] 4) Enteric-coated layer: we...

Embodiment 2

[0046] (1) Prescription for 1000 vegetarian tablets:

[0047]

[0048]

[0049] The isolation layer, the enteric layer and the preparation method are the same as in Example 1.

Embodiment 3

[0051] (1) Prescription for 1000 vegetarian tablets:

[0052]

[0053] The isolation layer, the enteric layer and the preparation method are the same as in Example 1.

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Abstract

The invention discloses an eluxadoline enteric coated tablet and a preparation method thereof. The preparation method includes: mixing eluxadoline with a solubilizer evenly, then dissolving the mixture in a 95% ethanol solution, mixing the substances evenly, then adding an appropriate amount of lecithin, conducting drying at 50DEG C for 45min to obtain dry particles, performing sieving by a 80-mesh sieve, then mixing the product with a filling agent and a disintegrating agent evenly, adding a lubricant tablet, and finally carrying out isolating coating and enteric coating. The eluxadoline enteric coated tablet provided by the invention does not contain basic ingredients, reduces stomach discomfort and other side effects, glyceryl monostearate is added in the enteric coating to significantly improve the dissolution degree of eluxadoline and its stability in gastric juice. Dissolution experiments find that the eluxadoline dissolution degree increases significantly and no burst release phenomenon occurs, the 6h dissolution degree is above 99%, acceleration tests find that the eluxadoline enteric coated tablet has good stability during preparation and storage, the preparation process is simple, has no need for complex preparation equipment, and is easy to realize industrial mass production.

Description

technical field [0001] The invention relates to the technical field of medicine, and relates to an enteric-coated tablet and a preparation method thereof, in particular to an iludoline enteric-coated tablet and a preparation method thereof which have undergone technological research and verification. Background technique [0002] The chemical name of Irudoline is 4-(aminocarbonyl)-N-[(1,1-dimethylethoxy)carbonyl]-2,6-dimethyl-L-phenylalanine Chinese name: 4 -(aminocarbonyl)-N-[(1,1-dimethylethoxy)carbonyl]-2,6-dimethyl-L-phenylalanine, English name: (s)-2-(tert -butoxycarbonylaMino)-3-(4-carbaMoyl-2,6-diMethylphenyl) propanoic acid. The chemical structure is [0003] [0004] On September 2, 2014, Actavis announced that the FDA has accepted the New Drug Application for Iludoline Enteric-Coated Tablets for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Priority approval has been granted by the FDA. [0005] Irritable bowel syndrome is a gastroi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/30A61K31/4164A61K47/14A61K47/54A61K47/32A61K47/40A61P1/00A61P1/12
Inventor 王磊殷源杰
Owner 江阴智产汇知识产权运营有限公司
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