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(-)-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 poor compatibility of some excipients, poor disintegration, and low bioavailability, and its preparation process uses non-aqueous solvents , can cause problems with organic residues

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
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Effect test

Embodiment 1

[0023] (1) chip

[0024] Tablet prescription:

[0025] Material name Dosage L-pantoprazole sodium 1.5 hydrate 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 tablet cores:

[0027] The croscarmellose sodium of levopantoprazole sodium 1.5 hydrate and prescription quantity 80% anhydrous sodium carbonate, mannitol and prescription quantity 60% is carried out dry mixing, puts into the wet granulator after mixing In a container, set aside. Dissolve PVP K30 and the remaining anhydrous sodium carbonate in water to make a granulation solution, and add the granulation solution to the mixture in the container of the wet granulator under stirring and shearing to prepare granules. Dry the granules and mix them with the remaining croscarmellose sodium and magnesium stearate, and then compress the mixture into ta...

Embodiment 2

[0039] (1) chip

[0040] Tablet prescription:

[0041] Material name Dosage L-pantoprazole sodium 1.5 hydrate 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 tablet cores:

[0043] Dry mix levopantoprazole sodium 1.5 hydrate with 70% sodium bicarbonate, lactose and sodium carboxymethyl starch, mix well and put it into the container of the wet granulator for later use, mix HPMC 2910 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 stirring and shearing to prepare granules. Dry the granules and mix them with magnesium stearate. After mixing evenly, the mixture is compressed to obtain tablet cores. The weight of each prepared tablet core is about 140 mg, corresponding to 20 mg of L-pantopraz...

Embodiment 3

[0055] (1) chip

[0056] Tablet prescription:

[0057] Material name Dosage L-pantoprazole sodium 1.5 hydrate 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 tablet cores:

[0059] Levopantoprazole sodium 1.5 hydrate and the PVPP of 60% anhydrous sodium carbonate, mannitol, lactose and prescription quantity 80% of prescription quantity are carried out dry mixing, put into the container of wet granulator after mixing, will PVP K90 and the remaining anhydrous sodium carbonate are dissolved in water to form a granulation liquid, and the granulation liquid is added to the above mixture under stirring and shearing to prepare granules. Dry the granules and mix them with the remaining PVPP and magnesium stearate. After mixing evenly, the mixture is compressed into tablets to obtain tablet cores. The weig...

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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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