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Lansoprazole enteric coated tablet and preparing method thereof

A technology of lansoprazole enteric and lansoprazole is applied in the field of lansoprazole enteric-coated tablets and its preparation, which can solve the problems of inappropriate large-scale mechanized production, complicated manufacturing process and high production cost, and achieve dissolution rate and The effect of good bioavailability, simple preparation method, and small difference in drug content

Active Publication Date: 2008-07-30
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] It can be seen that in the prior art, no matter whether it is to prepare enteric-coated capsules or enteric-coated tablets, in order to improve the stability of the drug, it is necessary to wrap a layer of isolation layer, so the production process is complicated, the production volume is small, and the production cost is high, so it is not suitable for large-scale mechanized production

Method used

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  • Lansoprazole enteric coated tablet and preparing method thereof
  • Lansoprazole enteric coated tablet and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Prescription (make 1000 tablets):

[0058] (1) Tablet core composed of lansoprazole and pharmaceutically acceptable excipients

[0059] Lansoprazole 15g

[0060] Starch 90g

[0061] Microcrystalline Cellulose 20g

[0062] Hypromellose 10g

[0063] Proper amount of ethanol

[0064] Carboxymethyl starch sodium 8g

[0065] Magnesium Stearate Appropriate amount

[0066] (2) Enteric-coated layer

[0067] Polyacrylic resin No. II 5g

[0068] Diethyl phthalate 2ml

[0069] Castor oil 1ml

[0070] Tween-80 2ml

[0071] Ethanol 90ml

[0072] Preparation:

[0073] 1) Preparation of tablet core

[0074] Get the prescription amount of Lansoprazole, microcrystalline cellulose, hydroxypropyl cellulose, pulverize and sieve, mix, add binder ethanol, mix and granulate, dry, 16 mesh sieve granulate, add appropriate amount, carboxymethyl starch sodium, Magnesium stearate, compressed into tablets, that is, Lansoprazole tablet core;

[0075] 2) Preparation of Enteric Layer Co...

Embodiment 2

[0080] Prescription (make 1000 tablets):

[0081] (1) Tablet core composed of lansoprazole and pharmaceutically acceptable excipients

[0082] Lansoprazole 15g

[0083] Starch 110g

[0084] Microcrystalline Cellulose 10g

[0085] Proper amount of ethanol

[0086] Magnesium Stearate Appropriate amount

[0087] (2) Enteric-coated layer

[0088] Polyacrylic resin No. III 5g

[0089] Diethyl phthalate 2ml

[0090] Castor oil 1ml

[0091] Tween-80 2ml

[0092] Ethanol 90ml

[0093] Preparation:

[0094] 1) Preparation of tablet core

[0095] Get the prescription amount of lansoprazole, starch, microcrystalline cellulose, pulverize and sieve, mix, add binder ethanol, mix and granulate, dry, 16 mesh sieve granulate, add appropriate amount of magnesium stearate, tabletting, namely Delansoprazole tablet core;

[0096] 2) Preparation of Enteric Layer Coating

[0097] Dissolve polyacrylic acid resin No. II in ethanol, add prescription amount of diethyl phthalate, Tween-80 a...

Embodiment 3

[0101] Prescription (make 1000 tablets):

[0102] (1) Tablet core composed of lansoprazole and pharmaceutically acceptable excipients

[0103] Lansoprazole 15g

[0104] Starch 90g

[0105] Microcrystalline Cellulose 20g

[0106] Hypromellose 10g

[0107] Proper amount of ethanol

[0108] Carboxymethyl Starch Sodium 3g

[0109] Magnesium Stearate Appropriate amount

[0110] (2) Enteric-coated layer

[0111] Polyacrylic resin No. II 5g

[0112] Diethyl phthalate 2ml

[0113] Castor oil 1ml

[0114] Tween-80 2ml

[0115] Ethanol 90ml

[0116] Preparation:

[0117] 1) Preparation of tablet core

[0118] Take the prescription amount of lansoprazole, starch, microcrystalline cellulose, and hydroxypropyl cellulose, pulverize and sieve, mix, add binder ethanol, mix and granulate, dry, granulate with a 16-mesh sieve, add an appropriate amount of sodium carboxymethyl starch , magnesium stearate, compressed into tablets, that is, lansoprazole tablet core;

[0119] 2) Prepa...

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Abstract

The invention belongs to the technical field of pharmaceutical preparation, in particular to a lansoprazole enteric-coated tablet; wherein, the enteric-coated tablet consists of the following components: a) tablet core consisting of lansoprazole and pharmaceutical excipient; b) a enteric coating layer consisting of castor oil, polyacrylic resin II and pharmaceutical excipient. The enteric coating layer of the invention contains castor oil which is water insoluble plasticizer and has good compatibility with the polyacrylic resin II, thereby effectively preventing the lansoprazole of the raw material from being damaged by the polyacrylic resin II which is the acidic and intestinal-lysis coating material; therefore, an isolated layer is not needed to be packed between an enteric-coated layer and a tablet core, and fatherly allowing the invention has the advantages of simplifying the preparation process, reducing production cost, high dissolution rate of the prepared enteric-coated tablet, high bioavailability and good stability.

Description

technical field [0001] The invention relates to a pharmaceutical dosage form, in particular to a lansoprazole enteric-coated tablet and a preparation method thereof. Background technique [0002] The chemical structural formula of Lansoprazole: [0003] [0004] Lansoprazole (Lansoprazole) is the second proton pump inhibitor anti-ulcer drug in the world after omeprazole. It is a strong inhibitor of the intramembrane proton pump secreted by the parietal cell tip. Its mechanism of action is similar to that of omeprazole. Like azoles, it also inhibits the last link of gastric acid secretion, H + -K + -ATPase (proton pump) to play a role. Since this product is a weakly alkaline drug, the original drug has very little activity. After being absorbed into the blood, it is transported to the gastric mucosal cells, and finally reaches the secretory duct and the acidic cavity. Continuously enriched and converted into biologically active drugs in the form of sulfenic acid and su...

Claims

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Application Information

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IPC IPC(8): A61K9/42A61K31/4439A61K47/38A61P1/04
Inventor 刘保起李明华李明杰
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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