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Esomeprazole enteric coated pellet preparation and preparation method thereof

A technology for esomeprazole magnesium enteric-coated pellets and preparations, which can be applied to pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of wasting manpower, material resources, and coating time. It can prevent the problems of long and drug loading efficiency, and achieve the effect of preventing mutual sticking, reducing weight and volume, and improving coating efficiency.

Active Publication Date: 2015-05-13
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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  • Esomeprazole enteric coated pellet preparation and preparation method thereof
  • Esomeprazole enteric coated pellet preparation and preparation method thereof
  • Esomeprazole 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 a...

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 an esomeprazole enteric coated pellet preparation and a preparation method thereof. Particularly, the esomeprazole enteric coated pellet preparation is prepared from the following parts including a hollow pellet core, a drug loading layer, an isolation layer and an enteric coated layer, wherein the drug loading layer is prepared from the following raw materials including esomeprazole trihydrate, an adhesive and a drug loading layer solvent; the isolation layer is prepared from the following raw materials including a polymer material, a lubricant, an acid and alkali regulator and a drug loading layer solvent; the enteric coated layer is prepared from the following raw materials including a film forming agent, a plasticizer, a lubricant, a sunscreen and a drug loading layer solvent. The preparation method of the esomeprazole enteric coated pellet preparation sequentially comprises the following steps: 1) coating the drug loading layer; 2) coating the isolation layer; and 3) coating the enteric coated layer. With the optimization of a formula and a technology, the preparation method is capable of improving the coating efficiency, reducing the coating time and preventing the manpower and material resource waste. The prepared enteric coated pellet preparation is capable of improving the stability of a medicament and the medicine taking compliance of a patient, is more suitable for the patient to use and can be further processed into an oral preparation such as a capsule or a tablet.

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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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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