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Colon-targeted orally-administered preparation with double-layer coatings and preparation thereof

A technology for colon-targeted and oral preparations, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve problems such as inability to achieve colon-targeted drug delivery and insoluble dissolution

Inactive Publication Date: 2008-07-09
TIANJIN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to overcome the shortcomings of the prior art that the pH-sensitive colon-targeted preparation cannot be dissolved after the pH value of the colon is lowered to achieve colon-targeted administration, and to provide a double-coated colon-targeted oral preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] A method for preparing a double-coated colon-targeted oral preparation, comprising the steps of:

[0018] Metronidazole, lactose, starch, microcrystalline cellulose, and magnesium stearate are made into tablet cores according to a conventional method, and are coated with an aqueous solution of chitosan with a mass ratio of 0.5% to 2%. An inner coating layer, and then an outer coating layer is coated with an aqueous dispersion of acrylic resin dissolved at a pH>6.5.

[0019] The inner coating layer is a polymer material that can be degraded by enzymes in the colon, and the outer coating layer is an acrylic resin series material that can be dissolved in an environment with pH>6.5 but insoluble in an environment with pH<6.

Embodiment 2

[0021] A method for preparing a double-coated colon-targeted oral preparation, comprising the steps of:

[0022] 5-fluorouracil, lactose, starch, microcrystalline cellulose, and magnesium stearate are made into ball cores according to conventional methods, and the inner bag is wrapped with an aqueous solution of 0.5% to 2% pectin by mass ratio. The coating layer is coated with an aqueous dispersion of acrylic resin dissolved at a pH > 6.5 to coat the outer coating layer.

Embodiment 3

[0024] A method for preparing a double-coated colon-targeted oral preparation, comprising the steps of:

[0025] Sulfasalazine, lactose, starch, microcrystalline cellulose, and magnesium stearate are made into tablet cores according to a conventional method, and spray coating method is used to coat them with an aqueous solution of xanthan gum with a mass ratio of 0.5% to 2%. An inner coating layer is applied, and then an outer coating layer is coated with an aqueous dispersion of acrylic resin dissolved at a pH>6.5.

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PUM

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Abstract

The present invention discloses a double-layer coated colon targeting oral preparation consisting of a tablet core or a pill core, an inner coated layer and an outer coated layer. The tablet core or the pill core is made from pharmic acceptable auxiliary material. The inner coated layer is chitosan, pectin, guar gum or xanthan. The outer coated layer is acrylic resin which is soluble when pH value is more than 6.5. A double-layer coated colon targeting oral preparation of the present invention not only ensures that drug can still be released at the colon, but also can ensure that the drug is not released inside a stomach and small intestines when the environmental pH value of the colon is reduced, which takes effect of targeting oriented treatment towards the colon disease.

Description

technical field [0001] The invention relates to a colon-targeting oral preparation, in particular to a double-coated colon-targeting oral preparation and a preparation method. Background technique [0002] The colon is an important part of the digestive tract, and it is also a frequent site of diseases. Common diseases include colitis, colon cancer, and constipation. After the application of traditional oral administration preparations, the release of drugs is mainly concentrated in the stomach. Affected by dissolved substances in the stomach and pH, the drugs enter the colon from the stomach through the small intestine, and drug loss will occur to varying degrees. and local stimulation of the small intestine, the existing pH-dependent oral colon-targeting preparations are designed based on the difference in pH between the colon and the small intestine, and rely on the coating film to be insoluble in the small intestine and dissolve in the colon to achieve colon targeting P...

Claims

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Application Information

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IPC IPC(8): A61K9/34A61K9/22A61K31/4164A61K31/513A61K31/635A61K31/665A61K47/36A61K47/32A61P1/00
Inventor 魏振平唐小凤丁慧娟刘文钊刘晓燕杨扬
Owner TIANJIN UNIV
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