Lansoprazole enteric-coated tablet and preparation method thereof

A technology for lansoprazole enteric and lansoprazole, which is applied in the field of lansoprazole enteric-coated tablets and the preparation thereof, can solve the problems of unstable process quality control and the like, achieves improvement of oral bioavailability and reduction of batch-to-batch The effect of different release and rapid disintegration

Active Publication Date: 2014-12-10
JINAN LIMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, domestic lansoprazole enteric-coated tablets generally have process instability and quality control problems

Method used

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  • Lansoprazole enteric-coated tablet and preparation method thereof
  • Lansoprazole enteric-coated tablet and preparation method thereof
  • Lansoprazole enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1, a kind of Lansoprazole enteric-coated tablet, the composition of every 1000 is as follows,

[0031] Chip:

[0032]

[0033] Isolation layer coating: hydroxypropyl methylcellulose ethanol solution (containing 1% HPMC, 3% talc, 3% PEG 6000, 1% Tween 280, 1% diethyl phthalate, 80% 95% ethanol );

[0034] Enteric layer coating: polyacrylic acid resin EudragitL100-55 aqueous suspension (containing 13% EudragitL100-55, 0.1% sodium hydroxide, 2% PEG6000, 3.4% talc, 1.5% titanium dioxide)

[0035] Above-mentioned lansoprazole enteric-coated tablet preparation method is:

[0036] (1) Take by weighing a sufficient amount of starch, lactose, microcrystalline cellulose, hydroxypropyl cellulose, calcium hydrogen phosphate and 6g sodium carboxymethyl starch according to the prescription quantity and mix;

[0037] (2) measure 95% ethanol, add the sodium hydroxide of prescription quantity, stir and make dissolving; Add the povidone K30 of prescription quantity, stir...

Embodiment 2

[0044] Embodiment 2, a kind of Lansoprazole enteric-coated tablet, the composition of every 1000 is as follows,

[0045] Chip:

[0046]

[0047] Isolation layer coating: hypromellose ethanol solution (containing 1% HPMC, 3% talc, 3% PEG 6000, 1% Tween 280, 1% diethyl phthalate, 80% 95% ethanol );

[0048] Enteric layer coating: polyacrylic acid resin EudragitL100-55 aqueous suspension (containing 13% EudragitL100-55, 0.1% sodium hydroxide, 2% PEG6000, 3.4% talc, 1.5% titanium dioxide)

[0049] Above-mentioned lansoprazole enteric-coated tablet preparation method is:

[0050] (1) Take by weighing a sufficient amount of starch, lactose, microcrystalline cellulose, hydroxypropyl cellulose, calcium hydrogen phosphate and 4.8g sodium carboxymethyl starch according to the prescription and mix;

[0051] (2) measure 95% ethanol, add the sodium hydroxide of prescription quantity, stir and make dissolving; Add the povidone K30 of prescription quantity, stir and make dissolving; Ad...

Embodiment 3

[0058] Embodiment 3, a kind of Lansoprazole enteric-coated tablet, the composition of every 1000 is as follows,

[0059] Chip:

[0060]

[0061]

[0062] Isolation layer coating: hydroxypropyl methylcellulose ethanol solution (containing 1% HPMC, 3% talc, 3% PEG 6000, 1% Tween 280, 1% diethyl phthalate, 80% 95% ethanol );

[0063] Enteric layer coating: polyacrylic acid resin EudragitL100-55 aqueous suspension (containing 13% EudragitL100-55, 0.1% sodium hydroxide, 2% PEG6000, 3.4% talc, 1.5% titanium dioxide)

[0064] Above-mentioned lansoprazole enteric-coated tablet preparation method is:

[0065] (1) Take by weighing a sufficient amount of starch, lactose, microcrystalline cellulose, hydroxypropyl cellulose, calcium hydrogen phosphate and 7.38g sodium carboxymethyl starch according to the prescription and mix;

[0066] (2) measure 95% ethanol, add the sodium hydroxide of prescription quantity, stir and make dissolving; Add the povidone K30 of prescription quantity...

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PUM

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Abstract

The invention discloses a lansoprazole enteric-coated tablet and a preparation method thereof. The preparation method comprises the following steps: preparing lansoprazole and pharmaceutic adjuvants comprising starch, lactose, microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch, calcium hydrogen phosphate, povidone K30, sodium hydroxide, magnesium stearate and the like into a tablet core; coating the tablet core with an isolated layer, and finally coating the tablet core with an enteric-coated layer so as to obtain the lansoprazole enteric-coated tablet. According to the method, the solubility and releasing rate of the lansoprazole are effectively improved, so that the oral bioavailability of the lansoprazole is improved. The formula process for preparing the lansoprazole enteric-coated tablet is simple, convenient and stable, and is suitable for mass industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a lansoprazole enteric-coated tablet and a preparation method thereof. Background technique [0002] Lansoprazole is the second proton pump inhibitor anti-ulcer drug developed by Takeda in the world after omeprazole. At the beginning of 1992, this product was officially put on the market in France by Takeda Pharmaceutical Factory and Houde Company. [0003] Its chemical structural formula is: [0004] The chemical name is: 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole. Molecular formula: C 16 h 14 f 3 N 3 o 2 S. [0005] Lansoprazole is a proton pump inhibitor. It works by inhibiting H in parietal cells + / K + -APS enzyme to achieve the inhibition of acid secretion in the digestive tract. The active substance is linked to H + , K + - On the sulfhydryl group of adenosine triphosphate (ATP) enzyme (H + , K...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4439A61K47/36A61K47/38A61P1/04
Inventor 周爱霞秦怀国王翠莲
Owner JINAN LIMIN PHARMA
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