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A kind of esomeprazole magnesium enteric-coated pellet preparation and preparation method thereof

A technology of enteric-coated pellets and preparations of esomeprazole magnesium, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the waste of manpower, material resources, and drug loading Reduced efficiency, long coating time, etc., to prevent mutual sticking, improve coating efficiency, and reduce weight and volume

Active Publication Date: 2017-12-19
SUZHOU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, adding an alkalizing agent to the drug-containing layer will lead to a decrease in the drug-loading efficiency of the drug, and at the same time, the coating time is too long, which wastes manpower and material resources.

Method used

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  • A kind of esomeprazole magnesium enteric-coated pellet preparation and preparation method thereof
  • A kind of esomeprazole magnesium enteric-coated pellet preparation and preparation method thereof
  • A kind of esomeprazole magnesium enteric-coated pellet preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Example 1: Preparation of esomeprazole magnesium enteric-coated pellets.

[0049] Prepare esomeprazole magnesium enteric-coated pellets according to the following formula.

[0050]

[0051] The specific preparation process of the above-mentioned enteric-coated pellets is as follows.

[0052] 1. Drug-loaded layer coating:

[0053] A. Add povidone K30 (Beijing Fengli Jingqiu Trading Co., Ltd.) into absolute ethanol (Sinopharm Chemical Reagent Co., Ltd.), stir slowly to make it fully dissolved, and then add esomeprazole magnesium three Hydrate (Jinan Hongfangde Pharmaceutical Technology Co., Ltd.), stirred evenly to obtain a clarified drug-loaded layer coating solution, set aside;

[0054] B. Turn on the fluidized bed coating machine (Shenzhen Xinyite Technology Co., Ltd.), put sucrose into the fluidized bed coating machine to carry out the coating operation of the drug-loaded layer (coating parameters: material temperature is 30°C, The air temperature is 45°C, the ato...

Embodiment 2

[0061] Example 2: Preparation of esomeprazole magnesium enteric-coated pellets.

[0062] Prepare esomeprazole magnesium enteric-coated pellets according to the following formula.

[0063]

[0064] The specific preparation process of the above-mentioned enteric-coated pellets is as follows.

[0065] 1. Drug-loaded layer coating:

[0066] A. Add povidone K30 (Beijing Fengli Jingqiu Trading Co., Ltd.) into absolute ethanol (Sinopharm Chemical Reagent Co., Ltd.), stir slowly to make it fully dissolved, and then add magnesium oxide (Beijing Fengli Jing Seeking Trading Co., Ltd.) slowly into the povidone K30 solution, stirring continuously to form a suspension, then adding esomeprazole magnesium trihydrate (Jinan Hongfangde Pharmaceutical Technology Co., Ltd.), stirring evenly, to obtain clarification The drug-loaded layer coating solution is set aside;

[0067] B. Turn on the fluidized bed coating machine (Shenzhen Xinyite Technology Co., Ltd.), put sucrose into the fluidized...

Embodiment 3

[0074] Embodiment 3: Preparation of esomeprazole magnesium enteric-coated pellets.

[0075] Prepare esomeprazole magnesium enteric-coated pellets according to the following formula.

[0076]

[0077] The specific preparation process of the above-mentioned enteric-coated pellets is as follows.

[0078] 1. Drug-loaded layer coating:

[0079] A. Add povidone K30 (Beijing Fengli Jingqiu Trading Co., Ltd.) into absolute ethanol (Sinopharm Chemical Reagent Co., Ltd.), stir slowly to make it fully dissolved, and then add esomeprazole magnesium three Hydrate (Jinan Hongfangde Pharmaceutical Technology Co., Ltd.), stirred evenly to obtain a clarified drug-loaded layer coating solution, set aside;

[0080] B. Turn on the fluidized bed coating machine (Shenzhen Xinyite Technology Co., Ltd.), put sucrose into the fluidized bed coating machine to carry out the coating operation of the drug-loaded layer (coating parameters: material temperature is 30°C, The air temperature is 45°C, th...

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Abstract

The invention discloses a preparation of esomeprazole magnesium enteric-coated pellets and a preparation method thereof. Specifically, the enteric-coated pellet preparation of the present invention consists of a blank core, a drug-loaded layer, an isolation layer, and an enteric-coated layer, wherein the drug-loaded layer is composed of esomeprazole magnesium trihydrate, a binder, and a drug-loaded layer. The layer solvent is made, the isolation layer is made of polymer materials, lubricants, acid-base regulators, and isolation layer solvents, and the enteric layer is made of film-forming agents, plasticizers, lubricants, opacifiers, and enteric layer solvents . The preparation method of the enteric-coated pellet preparation comprises the following steps in sequence: 1) drug-loading layer coating; 2) isolation layer coating; and 3) enteric-coating layer coating. By optimizing the formula and process, the coating efficiency is improved, the coating time is reduced, and the waste of manpower and material resources is avoided. The obtained enteric-coated pellet preparation can improve the stability of the drug and the drug compliance of the patient, is more suitable for the patient, and can be further processed into oral preparations such as capsules or tablets.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical preparation with esomeprazole magnesium as an active ingredient, in particular to an esomeprazole magnesium enteric-coated pellet preparation and a preparation method thereof. technical background [0002] Esomeprazole is the left-handed isomer of omeprazole, the world's first single-isomer proton pump inhibitor (PPI) developed by AstraZeneca, which mainly inhibits gastric parietal cytoplasmic Sub-pump, thereby reducing gastric acid secretion to treat gastroesophageal reflux disease (GERD), Helicobacter pylori (HP) positive peptic ulcer and digestive system disorders related to gastric acid. In 2002, the original research company launched the replacement product of omeprazole——esomeprazole. Compared with omeprazole, it has a lower liver metabolism rate, higher blood concentration and bioavailability, and is acid-suppressing. The effect is stron...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/4439A61P1/04A61K47/32A61K47/38
Inventor 曹青日刘疆燕曹悦崔京浩
Owner SUZHOU UNIV
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