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Enteric coating, dimethyl fumarate enteric preparation, and preparation method thereof

A technology of enteric and enteric coating of dimethyl fumarate, applied in the field of medicine, can solve the problems of stomach irritation and affect the patient's compliance with medication, achieve good stability, improve bioavailability, and avoid damage.

Active Publication Date: 2015-01-21
BEIJING AOTE SHUER HEALTH PROD DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to provide an enteric coating to solve the problem that active ingredients of medicines with adverse reactions are likely to cause gastric irritation and affect the patient's compliance with medication.

Method used

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  • Enteric coating, dimethyl fumarate enteric preparation, and preparation method thereof
  • Enteric coating, dimethyl fumarate enteric preparation, and preparation method thereof
  • Enteric coating, dimethyl fumarate enteric preparation, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The dimethyl fumarate enteric-coated preparation of this embodiment comprises an inner core, an isolation coating layer and an enteric coating layer sequentially from the inside to the outside;

[0051] Described inner core is tablet core, and described tablet core comprises the component of following mass percentage:

[0052]

[0053] The isolation coating layer is made of the following raw materials in percentage by weight:

[0054] Hypromellose (isolation coating material) 5%,

[0055] Water (solvent) 95%;

[0056] The enteric coating layer is made of the following raw materials in weight percentage:

[0057]

[0058] The mass ratio of the inner core, the isolation coating layer and the enteric coating layer is 100:3:8.24.

[0059] The isolation coating layer and the enteric coating layer constitute the enteric coating.

[0060] The preparation method of the dimethyl fumarate enteric-coated preparation of the present embodiment may further comprise the step...

Embodiment 2

[0068] The dimethyl fumarate enteric-coated preparation of this embodiment comprises an inner core, an isolation coating layer and an enteric coating layer sequentially from the inside to the outside;

[0069] Described inner core is tablet core, and described tablet core comprises the component of following mass percentage:

[0070]

[0071] The isolation coating layer is made of the following raw materials in parts by weight:

[0072] Povidone K30 (isolation coating material) 10%,

[0073] Water (solvent) 90%;

[0074] The enteric coating layer is made of the following raw materials in parts by weight:

[0075]

[0076] The mass ratio of the inner core, the isolation coating layer and the enteric coating layer is 100:1:3.03.

[0077] The isolation coating layer and the enteric coating layer constitute the enteric coating.

[0078] The preparation method of the dimethyl fumarate enteric-coated preparation of the present embodiment may further comprise the steps:

...

Embodiment 3

[0086] The dimethyl fumarate enteric-coated preparation of this embodiment comprises an inner core, an isolation coating layer and an enteric coating layer sequentially from the inside to the outside;

[0087] Described inner core is tablet core, and described tablet core comprises the component of following mass percentage:

[0088]

[0089]

[0090] The isolation coating layer is made of the following raw materials in parts by weight:

[0091]

[0092] The enteric coating layer is made of the following raw materials in parts by weight:

[0093]

[0094] The mass ratio of the inner core, the isolation coating layer and the enteric coating layer is 100:5:42.

[0095] The isolation coating layer and the enteric coating layer constitute the enteric coating.

[0096] The preparation method of the dimethyl fumarate enteric-coated preparation of the present embodiment may further comprise the steps:

[0097] 1) Dimethyl fumarate is pulverized and passed through a 80-...

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Abstract

The invention discloses an enteric coating, a dimethyl fumarate enteric preparation, and a preparation method thereof. The enteric coating comprises an isolated coating layer and an enteric coating layer from inside to outside in sequence, wherein the isolated coating layer is prepared from the following raw materials by weight: an isolated coating material and a solvent; the enteric coating layer is prepared from the following raw materials including an enteric coating material, a plasticizer, an anti-sticking agent and a solvent; a mass ratio of the isolated coating material to the enteric coating layer is 1-10:3-88. The enteric coating prepared by the invention coats inner core containing active pharmaceutical ingredients, has good stability, can effectively control medicine not to release in stomach after oral administration, and can be dissolved rapidly in an enteric part, so that the inner core can be disintegrated rapidly to release the active ingredients, thereby increasing bioavailability of the active pharmaceutical ingredients by a human body, preventing the medicine from being destroyed in the stomach, reducing adverse reaction in gastrointestinal tracts, increasing safe compliance of a medicine taker and meeting use requirements of the medicine taker.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an enteric coating, and also relates to a dimethyl fumarate enteric-coated preparation using the enteric coating and a preparation method thereof. Background technique [0002] Multiple sclerosis (MS) is an autoimmune inflammatory demyelinating disease of the central nervous system (CNS). The mutual coordination of the parts leads to muscle weakness and imbalance, which seriously reduces the quality of life of patients. MS is common in young people, and immunomodulators are commonly used in clinical treatment, mainly including interferon β (INF-β), synthetic peptide acetate glatiramer and anti-α 4 Integrin monoclonal antibody natalizumab, etc., but these therapeutic drugs need to be administered through non-gastrointestinal routes such as subcutaneous muscle or vein, which is inconvenient to use, so it is urgent to develop more convenient oral therapeutic drugs. Fu...

Claims

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Application Information

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IPC IPC(8): A61K47/38A61K47/32A61K9/30A61K9/36A61K31/225
Inventor 杨艳丽张胜华陈蕴郭奇根于振艳
Owner BEIJING AOTE SHUER HEALTH PROD DEV
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