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Omeprazole enteric coated pellets formulation and preparation method

A technology of omeprazole intestinal and omeprazole, which is applied in the field of pharmaceutical preparations, can solve the unsatisfactory stability of omeprazole pellets, accelerated stability test and long-term sample retention test, interception effect To achieve the effect of good clinical effect, dense coating layer and stable release speed

Active Publication Date: 2009-02-18
SHOUGUANG FUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In CN1311824C, the coating material described in the isolation layer is mainly hydroxypropyl methyl cellulose (HPMC). Because this coating material is a water-soluble component, the interception effect on moisture content and light is relatively poor, and in practical applications, resulting in The stability of omeprazole pellets is not very satisfactory, and there are deficiencies in the accelerated stability test and long-term sample observation test

Method used

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  • Omeprazole enteric coated pellets formulation and preparation method
  • Omeprazole enteric coated pellets formulation and preparation method
  • Omeprazole enteric coated pellets formulation and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Each 100mg omeprazole pellets

[0031]

[0032]

[0033] Preparation:

[0034] (1), prepare 30% syrup: Sodium phosphate is dissolved in a small amount of purified water, then add powdered sugar to prepare adhesive as usual, set aside.

[0035] (2) Fully mix omeprazole, starch, powdered sugar, and sodium carboxymethyl starch, then pulverize, add 30% syrup to granulate, and make pellets with a particle size of 0.2-1.0mm, which will become Omeprazole after drying Azole active pellet core. Prepared by centrifugal coating granulator.

[0036] (3), corn protein, talcum powder are made into suspension with 50% ethanol, then spray and wrap on above-mentioned omeprazole active ball core, make film isolation coating layer. It can be prepared by centrifugal coating granulator and fluidized bed coating granulator.

[0037] (4), first make polyacrylic acid resin No. II, talcum powder, and diethyl phthalate into an enteric coating solution with purified water, then spray an...

Embodiment 2

[0048] Each 100mg omeprazole pellets

[0049]

[0050]

[0051]Prepared according to the method used in Example 1.

Embodiment 3

[0053] Each 100mg omeprazole pellets

[0054]

[0055]

[0056] Prepare according to the method used in example 1, the difference is, carry out industrialized scale-up production according to this prescription, prepare 100kg omeprazole pellets.

[0057] Stability Evaluation

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Abstract

The invention discloses an omeprazole enteric micropill preparation and a preparation method thereof. The preparation takes alkali salt containing omeprazole or a single antimer of the omeprazole as an active pill core, and contains a film isolating and coating layer and an enteric coating layer. The preparation takes zein as an isolating and coating material, thereby improving the stability of micropills. The preparation method uses alcohol as menstruum, thereby further improving the stability of the omeprazole micropills.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an omeprazole enteric-coated pellet preparation and a preparation method, and the invention relates to the application of special characteristic zein on the isolation layer in the preparation of omeprazole pharmaceutical preparations. Background technique [0002] Omeprazole (chemical name 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl]-1-benzimidazole) It is a potent inhibitor of acidic gastrointestinal secretion and can be used in the treatment of gastric and duodenal ulcers. European patent EP0005129 discloses the active compound of the proton pump inhibitor omeprazole. Omeprazole and its pharmaceutically acceptable salts are described in EP0005129 and EP0124495; EP0124495 and WO95 / 01977 disclose certain specific basic salts of omeprazole: WO94 / 27988 discloses a single enantiomer of omeprazole certain salts and their preparations. [00...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4439A61P1/04
Inventor 杨磊宋伟国宋成刚王旭东王福洲
Owner SHOUGUANG FUKANG PHARMA
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