(-)-pantoprazole sodium enteric coated tablet and preparation method thereof

A technology of levopantoprazole sodium and enteric-coated tablets, applied in the field of medicine, can solve the problems of low bioavailability, poor compatibility of excipients, poor disintegration, etc., and achieve high bioavailability, fast dissolution rate, good effect

Inactive Publication Date: 2014-08-20
广东永正药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Although there are literature reports on the preparation technology of L-pantoprazole sodium enteric-coated tablets at present, there are still technical defects such as po

Method used

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  • (-)-pantoprazole sodium enteric coated tablet and preparation method thereof
  • (-)-pantoprazole sodium enteric coated tablet and preparation method thereof
  • (-)-pantoprazole sodium enteric coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0022] Example 1

[0023] (1) Chip

[0024] Tablet prescription:

[0025] Material name Dosage Levopantoprazole sodium 1.5hydrate 22.6g Anhydrous sodium carbonate 15.0g Mannitol 94.0g Croscarmellose sodium 5.6g PVP K30 1.4g Magnesium stearate 1.4g 1000 pieces

[0026] [0026] Preparation of Chips:

[0027] L-pantoprazole sodium 1.5 hydrate is dry mixed with anhydrous sodium carbonate of 80% of the recipe, mannitol and croscarmellose sodium of 60% of the recipe, and put into the wet granulator after mixing. container, ready to use. PVP K30 and the remaining anhydrous sodium carbonate were dissolved in water to make a granulation solution, and the granulation solution was added to the mixture in a wet granulator vessel under agitation and shear to prepare granules. After drying, the granules are mixed with the remaining croscarmellose sodium and magnesium stearate. After mixing, the mixture is compressed to obta...

Example Embodiment

[0038] Example 2

[0039] (1) Chip

[0040] Tablet prescription:

[0041] Material name Dosage Levopantoprazole sodium 1.5hydrate 22.6g sodium bicarbonate 25.0g lactose 82.8g Sodium Carboxymethyl Starch 7.0g HPMC 2910 1.6g Magnesium stearate 1.0g 1000 pieces

[0042] [0042] Preparation of Chips:

[0043] L-pantoprazole sodium 1.5 hydrate was dry mixed with 70% sodium bicarbonate, lactose and sodium carboxymethyl starch, mixed and put into a container of a wet granulator for later use, HPMC 2910 was mixed with the remaining carbonic acid. Sodium hydrogen is dissolved in water to form a granulation liquid, and the granulation liquid is added to the above mixture under agitation and shear to prepare granules. After drying, the granules are mixed with magnesium stearate, and after mixing, the mixture is compressed into tablets to obtain tablet cores. Each tablet core weighs about 140 mg, corresponding to 20 mg of ...

Example Embodiment

[0054] Example 3

[0055] (1) Chip

[0056] Tablet prescription:

[0057] Material name Dosage Levopantoprazole sodium 1.5hydrate 11.3g Anhydrous sodium carbonate 10.0g Mannitol 30.0g lactose 42.6g PVPP 4.5g PVP K90 0.6g Magnesium stearate 1.0g 1000 pieces

[0058] [0058] Preparation of Chips:

[0059] The lev-pantoprazole sodium 1.5 hydrate is dry mixed with anhydrous sodium carbonate, mannitol, lactose and 80% of the recipe quantity, and put into the container of the wet granulator after mixing. PVP K90 and the remaining anhydrous sodium carbonate were dissolved in water to form a granulation liquid, and the granulation liquid was added to the above mixture under stirring and shearing to prepare granules. After drying, the granules are mixed with the remaining PVPP and magnesium stearate, and the mixture is compressed after mixing to obtain tablet cores. Each tablet core has a weight of about 100 mg, c...

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Abstract

A provided (-)-pantoprazole sodium enteric coated tablet consists of a tablet core containing (-)-pantoprazole sodium, a separation layer and an enteric layer, the increased weight of the separation layer accounts for 2-9%, and the increased weight of the enteric layer accounts for 7-15%. In dissolution tests using a system with pH of 5.5 or more, 85% or more of the main drug is dissolved in 30 min. The prepared (-)-pantoprazole sodium enteric coated tablet is an oral preparation with stable quality and high bioavailability.

Description

technical field [0001] The invention belongs to the technical field of medicine. The invention specifically relates to a levo-pantoprazole sodium enteric-coated tablet and a preparation method thereof. Background technique [0002] The chemical name of pantoprazole sodium is 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzimidazole Sodium salt, the structural formula is as follows: [0003] [0004] Pantoprazole is a new generation of proton pump inhibitors after omeprazole and lansoprazole. It directly acts on the proton pump in the stomach wall, inhibits the secretion of gastric acid, and can treat peptic ulcer (gastric ulcer, duodenal ulcer, etc.) and its bleeding, reflux esophagitis and other diseases. Compared with body blockers, it has the advantages of high curative effect, quick onset, small side effects, and short treatment cycle. Pantoprazole is more stable than omeprazole and lansoprazole in a slightly acidic environment, its bioavailab...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K31/4439A61K47/32A61P1/04
Inventor 陆荣政闫笑笑誉妙贤
Owner 广东永正药业有限公司
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