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Dexlansoprazole sustained release capsule and preparation method thereof

A technology for dexlansoprazole and sustained-release capsules is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, and can solve the problems that the preparation method is unfavorable to safe production, environmental protection, toxic and side effects high, poor stability of dexlansoprazole, etc., to avoid damage, simplify the production process, and reduce production costs.

Active Publication Date: 2015-09-30
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In order to solve the problem of poor stability of dexlansoprazole under acidic conditions and improve bioavailability, the object of the present invention is to provide a sustained-release capsule of dexlansoprazole to prevent dexlansoprazole from being dissolved in human gastric juice destroy, enhance bioavailability
[0011] Aiming at the existing dexlansoprazole sustained-release capsule listing product DEXILANT, the residual amount of ethanol exceeds the requirements of the Chinese Pharmacopoeia, which leads to higher toxic and side effects when the human body is taken, and the existing preparation method is not conducive to the current situation of safe production and environmental protection. Purpose is to provide a kind of dexlansoprazole sustained-release capsule and preparation method to solve the above problems

Method used

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  • Dexlansoprazole sustained release capsule and preparation method thereof
  • Dexlansoprazole sustained release capsule and preparation method thereof
  • Dexlansoprazole sustained release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055]

[0056] Preparation Process:

[0057] Weigh the raw and auxiliary materials according to the prescription amount, pass through an 80-mesh sieve three times and mix evenly. Put 200g sucrose ball cores (30 mesh-40 mesh) in the centrifugal granulation coating pan, spray 3% hypromellose aqueous solution, adjust machine parameters and centrifugally powder. After the powdering is completed, the pellets are dried in a fluidized bed at 40°C for 2 hours, and then sieved to obtain the product.

Embodiment 2

[0059]

[0060] Preparation Process:

[0061]Weigh the prescribed amount of hypromellose and fully swell it in water, add talcum powder, and stir evenly to obtain the coating solution. 500g of the pellets obtained in Example 1 were placed in a fluidized bed for coating. After the coating is completed, the pellets are dried in a fluidized bed at 40°C for 1 hour to obtain the final product.

Embodiment 3

[0063]

[0064] Preparation Process:

[0065] Weigh Eudragit S100, add a small amount of water and stir for 5 minutes, slowly add ammonia water (about 10 minutes), continue stirring for 30 minutes after the addition, add triethyl citrate and talcum powder for later use. Get 200g embodiment 2 gained pellets and place in fluidized bed, carry out coating. After the coating is completed, the pellets are dried in a fluidized bed at 40°C for 2 hours to obtain the final product.

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Abstract

The invention belongs to the technical field of pharmaceutical preparation and aims at improving bioavailability of dexlansoprazole in vivo. The dexlansoprazole sustained release capsule provided by the invention is hardly released in gastric acid, and can be disintegrated in intestines, and active ingredients are dissolved out, so that destruction of dexlansoprazole in the gastric acid is avoided; the dexlansoprazole sustained release capsule provided by the invention contains two different types of enteric micropelets, so that two-time dual drug release (DDR) is realized; in a process of preparing eudragit S100 aqueous dispersion, different amounts of alkaline substances are added, different mol numbers of carboxyls in polymers are neutralized, and an enteric-coating material is controlled to be dissolved at different pH values, so that two-time release is realized; besides, an aqueous dispersion coating is adopted, so that ethanol residue is effectively avoided.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a sustained-release capsule of dexlansoprazole and a preparation method thereof. Background technique [0002] Dexlansoprazole is the dextrorotatory isomer of lansoprazole, and its properties are similar to those of lansoprazole. [0003] Chemical name: (+)-2-[3-methyl-4-(2,2,2-trifluoroethyl)pyridin-2-yl]methyl}sulfinyl]-1H-benzimidazole; right Lansoprazole; Dexlansoprazole structure: [0004] [0005] Molecular formula: C 16 h 14 f 3 N 3 o 2 S [0006] Dexlansoprazole belongs to the prazole class PPIs anti-ulcer drug, and its structure contains sulfinyl benzimidazole, and its stability is easily affected by various factors such as light, heavy metal ions, temperature, etc., especially under acidic conditions, its sub- The sulfonyl group undergoes destructive changes, discoloration and polymerization. Therefore, gastric juice can degrade and destr...

Claims

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Application Information

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IPC IPC(8): A61K9/62A61K31/4439A61K47/04A61P1/04
Inventor 颜东张雯林振广董世波刘宪华张宁
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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