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Esomeprazole enteric pellet tablets and preparation method thereof

A technology of esomeprazole enteric and enteric-coated pellets, which is applied in the direction of pill delivery, digestive system, and drug combination, and can solve the problems of large capsule size, single dosage, and unsatisfactory stability

Inactive Publication Date: 2012-12-05
SHOUGUANG FUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN100490790C discloses a kind of omeprazole enteric-coated micropill capsule and its preparation method, adopts blank pellet core, sprays and wraps active layer to five layers, and the isolation layer contains magnesium oxide and titanium dioxide at the same time, makes enteric-coated micropill and packs into capsule However, the stability is still not very ideal. At the same time, this traditional method simply puts enteric-coated pellets into capsules. The capsules are large in size and poor in patient compliance. The shell becomes soft and sticky and easily attached to the esophagus
In addition, the capsule is indivisible, and the dosage is single

Method used

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  • Esomeprazole enteric pellet tablets and preparation method thereof
  • Esomeprazole enteric pellet tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] a. Drug active pellet core

[0039] Esomeprazole 20g

[0040] 30% syrup 60g

[0041] Sodium carboxymethyl starch 1g

[0042] 50g powdered sugar

[0043] Sodium bicarbonate 2g

[0044] Tween-80 1.5g

[0045] Talc powder 1.5g

[0046] b. Isolation layer

[0047] Hydroxypropyl Methyl Cellulose 12g

[0048] Titanium dioxide 3g

[0049] Talc powder 6g

[0050] Purified water 240g

[0051] c. Enteric coating layer

[0052] Udrake L30D-55 110g

[0053] Talc powder 11g

[0054] Triethyl citrate 5g

[0055] Purified water 120g

[0056] d. Enteric-coated pellets

[0057] Microcrystalline Cellulose 13g

[0058] 15g pregelatinized starch

[0059] Croscarmellose Sodium 2g

[0060] Esomeprazole enteric-coated pellets 70g

[0061] Preparation:

[0062] (1) Preparation of pharmaceutically active pellet core: Prepared by centrifugal coating granulator and extrusion spheronizer, pulverized esomeprazole, disintegrant, filler, basic compound, surfactant and talcum powd...

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PUM

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Abstract

The invention relates to a preparation method for esomeprazole enteric pellet tablets. The method comprises the following steps of: preparing esomeprazole enteric pellets, and preparing mixed tablets of the pellets and excipient; the esomeprazole enteric pellets contain active pharmaceutical pellet cores, isolation layers and enteric coatings; the esomeprazole enteric pellets prepared by the method have certain elasticity and are pressureproof; the esomeprazole enteric pellets and the excipient are pressed to form tablets, so that the pellets can be isolated from air, and are more stable than pellet capsules; the validity period can reach over three years; and the esomeprazole enteric pellet tablets have the advantages of small size, dividable dose and the like, and the compliance of a patient is improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of esomeprazole enteric-coated pellets. Background technique [0002] Esomeprazole, namely esomeprazole, trade name Nexiumo (translated as "Nexium" in Chinese) is the S-optical isomer of omeprazole, which is separated and synthesized by the Swedish company AstraZeneca (AstraZeneca). One isomer proton pump inhibitor (PPI), omeprazole contains S-isomer and R-isomer, the former is esomeprazole, which has higher bioavailability than omeprazole And more consistent pharmacokinetics, so drug reaching the proton pump increases. Because of its remarkable curative effect and low dosage. Reduces gastric acid secretion by specifically inhibiting parietal cell proton pumps. It has been confirmed by a large number of clinical experiments and drug research that it maintains the pH in the stomach > 4 for a longer period of time, and the treatment ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4439A61P1/04
Inventor 宋伟国宋成刚王福洲王旭东王晓磊
Owner SHOUGUANG FUKANG PHARMA
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