Esomeprazole magnesium contained enteric-coated tablet and preparation method thereof

A technology of esomeprazole magnesium and esomeprazole, which is applied in the field of pharmaceutical preparations, can solve the problems of destructive changes in chemical structure, discoloration and polymerization, poor stability of esomeprazole magnesium, etc., and achieve uniform coating , dense coating layer, ensuring safe and effective effect

Active Publication Date: 2013-02-27
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Esomeprazole magnesium has poor stability and is very sensitive to light, heat, oxygen, water, etc., especially under acidic conditions, its chemical structure can undergo destructive changes, discoloration and polymerization

Method used

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  • Esomeprazole magnesium contained enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Tablet core prescription containing esomeprazole magnesium (specification: 20mg):

[0032] Esomeprazole magnesium (calculated as esomeprazole) 10.0 kg (in dry form)

[0033] Lactose 45.0 kg

[0034] Magnesium oxide 5.0 kg

[0035] 10% starch solution appropriate amount

[0036] Magnesium stearate 1.0 kg

[0037] A total of 500,000 pieces were made

[0038] Prescription of coating solution for intermediate isolation layer:

[0039] Hypromellose 12.0 kg

[0040] Titanium dioxide 2.5 kg

[0041] Polyethylene glycol-6000 1.2 kg

[0042] Sodium dihydrogen phosphate 0.8 kg

[0043] Purified water 120.0 kg

[0044] Enteric coating layer coating liquid prescription:

[0045] Eudragit L30D-55 40.0 kg

[0046] Talc powder 3.5 kg

[0047] Polyethylene glycol-6000 1.2 kg

[0048] 0.1mol / L KOH solution Appropriate amount

[0049] Purified water 40.0 kg

[0050] Preparation: ...

Embodiment 2

[0065] Tablet core prescription containing esomeprazole magnesium (specification: 20mg):

[0066] Esomeprazole magnesium (calculated as esomeprazole) 10.0 kg (in dry form)

[0067] Mannitol 45.0 kg

[0068] Magnesium oxide 5.0 kg

[0069] 3% hypromellose solution appropriate amount

[0070] Talc powder 1.5 kg

[0071] A total of 500,000 pieces were made

[0072] Prescription of coating solution for intermediate isolation layer:

[0073] Hypromellose 12.0 kg

[0074] Titanium dioxide 2.2 kg

[0075] Polyethylene glycol-6000 1.2 kg

[0076] Disodium hydrogen phosphate 1.0 kg

[0077] Purified water 120.0 kg

[0078] Enteric coating layer coating liquid prescription:

[0079] Eudragit L30D-55 42.0 kg

[0080] Talc powder 3.5 kg

[0081] Polyethylene glycol-6000 1.2 kg

[0082] 0.5mol / L NaOH solution appropriate amount

[0083] Purified water 42.0 kg

[0084] Preparation: ...

Embodiment 3

[0099] Tablet core prescription containing esomeprazole magnesium (specification: 20mg):

[0100] Esomeprazole magnesium (calculated as esomeprazole) 10.0 kg (in dry form)

[0101] Mannitol 45.0 kg

[0102] Calcium carbonate 5.0 kg

[0103] 2% PVP-K30 solution appropriate amount

[0104] Micronized silica gel 1.2 kg

[0105] A total of 500,000 pieces were made

[0106] Prescription of coating solution for intermediate isolation layer:

[0107] Hypromellose 12.0 kg

[0108] Titanium dioxide 2.4 kg

[0109] Polyethylene glycol-6000 1.2 kg

[0110] Sodium phosphate 1.0 kg

[0111] Purified water 120.0 kg

[0112] Enteric coating layer coating liquid prescription:

[0113] Eudragit L30D-55 42.0 kg

[0114] Talc powder 3.5 kg

[0115] Polyethylene glycol-6000 1.2 kg

[0116] 0.5mol / L NaOH solution appropriate amount

[0117] Purified water 42.0 kg

[0118] Preparation:

[...

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Abstract

The invention provides an esomeprazole magnesium contained enteric-coated tablet and a preparation method thereof. The enteric coated tablet is composed of an inner tablet core layer which uses esomeprazole as an active ingredient, an intermediate insulation layer and an enteric coating protection layer. According to the esomeprazole magnesium contained enteric-coated tablet, the conditions that basic remedies are instable and prone to be oxidized and decomposed are overcome, the prepared enteric-coated tablet is even in coating, compact in coating layer, stable and reliable in quality and capable of meeting large-scale production requirements of enterprises at the present stage and has good market development prospects, the releasing rate can reach over 90%, the bioavailability is obviously improved, and safe and effective drug using is guaranteed.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an enteric-coated tablet containing esomeprazole magnesium and a preparation method thereof. The invention also provides an enteric-coated esomeprazole magnesium with good quality, safety and stability piece. Background technique [0002] Esomeprazole (Esomeprazole) is a new type of proton pump inhibitor (PPI), which is the S-optical isomer of omeprazole, and its mechanism of action is similar to that of omeprazole. The sub-pump reduces gastric acid secretion. A large number of clinical experiments and drug studies have confirmed that compared with PPIs such as omeprazole, it has a lower first-pass effect in the liver, a slower plasma clearance rate, higher drug plasma concentration, and a longer time to maintain pH>4 in the stomach. The acid efficiency is higher, the curative effect is better than the previous two generations of PPI, and the individual dif...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/32A61K31/4439A61P1/04
Inventor 陈敏张静贺莲吴健民吴锋朱敏刘娟
Owner KAMP PHARMA
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