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Dexlansoprazole sustained-release capsule and preparation method thereof

A technology of dexlansoprazole and sustained-release capsules, applied in the field of dexlansoprazole sustained-release capsules and its preparation, can solve the problems of dexlansoprazole instability, difficulty in development, unstable properties of aqueous solution, etc.

Inactive Publication Date: 2015-04-22
BEIJING RED SUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, there is a chemical structure of sulfinylbenzimidazole in the structure of dexlansoprazole, which is easily affected by various factors such as light, heavy metal ions, oxidizing and reducing components, etc.
Especially in acidic conditions, dexlansoprazole is extremely unstable, prone to discoloration and polymerization, and the properties of its aqueous solution are also very unstable, making it difficult to develop its prescription and process

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

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Effect test

Embodiment 1

[0029] Embodiment 1 A kind of dexlansoprazole sustained-release capsule and preparation method thereof

[0030] Dexlansoprazole sustained-release capsules consist of enteric-coated pellets and sustained-release pellets.

[0031] 1. Composition of enteric-coated pellets:

[0032]

[0033] 2. Sustained-release pellets

[0034]

[0035] 3. Preparation process

[0036] Preparation process of enteric-coated pellets: (1) Mix the prescription amount of dexlansoprazole, magnesium carbonate, sucrose, and low-substituted hydroxypropyl cellulose evenly to obtain solid powder, disperse with hydroxypropyl methylcellulose (HPMC E5) A 3% solution of the binder in water was obtained. Fill 200g of blank microcrystalline cellulose pellet cores (28-32 mesh) into a centrifugal coating granulator, and spray with the above-mentioned spray solution under the following conditions: inlet air temperature: 25-30°C, spray the coating solution Rate: 1.0g / min, spray pressure 0.5kg / cm 2 , the obt...

Embodiment 2

[0045] Embodiment 2 A kind of dexlansoprazole sustained-release capsule and preparation method thereof

[0046] Dexlansoprazole sustained-release capsules consist of enteric-coated pellets and sustained-release pellets.

[0047] 1. Composition of enteric-coated pellets:

[0048]

[0049] 2. Sustained-release pellets

[0050]

[0051] 3. Preparation process

[0052] Preparation process of enteric-coated pellets: (1) Mix the prescription amount of dexlansoprazole, magnesium carbonate, sucrose, and low-substituted hydroxypropyl cellulose evenly to obtain solid powder, disperse with hydroxypropyl methylcellulose (HPMC E5) A 3% solution of the binder in water was obtained. Fill 200g of blank microcrystalline cellulose pellet cores (28-32 mesh) into a centrifugal coating granulator, and spray with the above-mentioned spray solution under the following conditions: inlet air temperature: 25-30°C, spray the coating solution Rate: 1.0g / min, spray pressure 0.5kg / cm 2 , the obt...

Embodiment 3

[0061] Embodiment 3 a kind of dexlansoprazole sustained-release capsules and preparation method thereof

[0062] Dexlansoprazole sustained-release capsules consist of enteric-coated pellets and sustained-release pellets.

[0063] 1. Composition of enteric-coated pellets:

[0064]

[0065] 2. Sustained-release pellets

[0066]

[0067] 3. Preparation process

[0068] Preparation process of enteric-coated pellets:

[0069] (1) Mix the prescription amount of dexlansoprazole, magnesium carbonate, sucrose, and low-substituted hydroxypropyl cellulose evenly to obtain solid powder, and disperse hydroxypropyl methylcellulose (HPMC E5) in water to obtain 3% bonding agent solution. Fill 200g of blank microcrystalline cellulose pellet cores (28-32 mesh) into a centrifugal coating granulator, and spray with the above-mentioned spray solution under the following conditions: inlet air temperature: 25-30°C, spray the coating solution Rate: 1.0g / min, spray pressure 0.5kg / cm 2 , th...

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Abstract

The invention relates to a dexlansoprazole sustained-release capsule and a preparation method thereof. The capsule comprises two dexlansoprazole micropills, wherein the two micropills consist of hollow pill cores, active medicine layers, isolating coating layers and sustained-release coating layers. The dexlansoprazole sustained-release capsule provided by the invention can be released in the intestinal tract in position so as to persistently inhibit acid release.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a sustained-release capsule of dexlansoprazole and a preparation method thereof. Background technique [0002] Gastroesophageal reflux disease is a common and frequently-occurring disease in gastroenterology, and its incidence varies around the world. In Western Europe and North America, the incidence rate of gastroesophageal reflux disease is 10%-20%, in South America it is about 10%, in my country the incidence rate is about 7%-8%. Heartburn is the most prominent symptom of gastroesophageal reflux disease. It is manifested as a burning sensation behind the sternum or under the xiphoid process, often extending upward from the lower part of the sternum, and usually occurs one hour after a meal. It is aggravated when lying down, bending over or when abdominal pressure increases. Sometimes heartburn feels like being scalded in boiling water. Other ...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/4439A61K47/02A61P1/04
Inventor 林德良
Owner BEIJING RED SUN PHARMA
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