Enteric-coated pellets containing esomeprazole magnesium and preparation method thereof

A technology of esomeprazole magnesium and enteric-coated pellets is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, pharmaceutical formulas, etc., and can solve the problem that the effect of improving stability is unsatisfactory And other issues

Active Publication Date: 2020-01-17
湖南千金湘江药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In addition, attempts have been made to prepare it in the form of crystals or trihydrates, however, the effect of improving stability is still unsatisfactory

Method used

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  • Enteric-coated pellets containing esomeprazole magnesium and preparation method thereof
  • Enteric-coated pellets containing esomeprazole magnesium and preparation method thereof
  • Enteric-coated pellets containing esomeprazole magnesium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0080] The preparation method of esomeprazole magnesium enteric-coated pellets is as follows:

[0081] ⑴Isolation gown layer

[0082] Purpose: To isolate the sugar pill from the active ingredient layer, so that the surface of the sugar pill is smoother and rounder.

[0083] prescription:

[0084]

[0085] Preparation process: ① Weigh purified water and pour it into a container, add the above three auxiliary materials while stirring, and stir for 10-20 minutes to obtain a solution for later use.

[0086] ② Pour the medicinal pellet core into the bottom spray coating pot, set the inlet air temperature: 40-65℃, air volume: 200-1500m 3 / h, control the liquid supply speed: 8-50rpm for spraying, drying, and coating weight gain of 5%-12%.

[0087] ⑵ drug layer

[0088] Purpose: To coat the active ingredient layer.

[0089] prescription:

[0090]

[0091] Preparation process: ① Weigh purified water and pour it into a container, add esomeprazole magnesium and the above two ...

Embodiment 1

[0122] Preparation of enteric-coated pellets of esomeprazole magnesium

[0123] ⑴Isolation gown layer

[0124] prescription:

[0125]

[0126] Preparation process: ① Weigh 4 kg of purified water and pour it into a container, add the above three auxiliary materials while stirring, and stir for 15 minutes to obtain a solution for later use.

[0127] ② Pour the medicinal pellet sugar core (sucrose core, 160μm average particle size) into the bottom spray coating pan, set the inlet air temperature: 40-65℃, air volume: 800m 3 / h, control the liquid supply speed: spray liquid at 35rpm, dry, and the coating weight increases by 7.5%.

[0128] ⑵ drug layer

[0129] Purpose: To coat the active ingredient layer.

[0130] prescription:

[0131]

[0132] Preparation process: ① Weigh purified water and pour it into a container, add esomeprazole magnesium and the above two excipients while stirring, stir for 55 minutes, set aside,

[0133] ② Pour the dry coated product obtained in...

Embodiment 2

[0162] The pellets and auxiliary materials obtained in Example 1 were mixed evenly, and compressed into tablets to prepare tablets.

[0163] prescription:

[0164]

[0165] Preparation process: Add esomeprazole magnesium enteric-coated pellets, microcrystalline cellulose, crospovidone, and polyethylene glycol into a three-dimensional mixer and mix for 15 minutes, then add magnesium stearate and mix for 5 minutes, and the Material, tablet. Made in different doses. That is, the dosage is that each tablet contains 20 mg and 40 mg of esomeprazole magnesium respectively.

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Abstract

The invention provides an enteric micro-pellet containing esomeprazole magnesium. The enteric micro-pellet at least comprises a hollow white sugar pellet core (A), an insulating coating layer (B), an esomeprazole magnesium medicine layer (C) and an alkaline insulating coating layer (D), wherein the alkaline insulating coating layer wraps the esomeprazole magnesium medicine layer so that the enteric micro-pellet can have improved stability.

Description

technical field [0001] The present invention relates to storage-stable enteric-coated pellets containing esomeprazole magnesium and a preparation method thereof, more specifically, relates to a method of coating an alkaline isolation coating layer outside the esomeprazole magnesium drug layer A storage-stable enteric-coated pellet containing esomeprazole magnesium and a preparation method thereof. Background technique [0002] Esomeprazole magnesium for gastroesophageal reflux disease: treatment of erosive reflux esophagitis, long-term maintenance treatment to prevent recurrence of cured esophagitis patients, symptom control of gastroesophageal reflux disease; also used It is used in combination with appropriate antimicrobial therapy to eradicate Helicobacter pylori and heal duodenal ulcers associated with Helicobacter pylori infection to prevent the recurrence of peptic ulcers associated with Helicobacter pylori. [0003] However, in view of the poor storage stability and ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/22A61K9/52A61K31/4439A61K47/38A61K47/32A61K47/10A61P1/04A61P31/04
Inventor 郭伟王琼瑶姚亮元袁秀菊钟爱军袁红波赵静芝
Owner 湖南千金湘江药业股份有限公司
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