Ilaprazole enteric orally disintegrating tablet and preparation method thereof

A technology of ilaprazole intestinal and orally disintegrating tablets, which is applied in the field of medicine, can solve the problems of undiscovered ilaprazole orally disintegrating tablets, and achieve the effects of good taste, good disintegration performance, and accelerated absorption

Active Publication Date: 2013-06-26
LIVZON GROUP LIVZON PHARMA FACTORY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, no ilaprazole orally disintegrating tablets have been found on the market, and the application of this patent can make up for this part of the gap

Method used

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  • Ilaprazole enteric orally disintegrating tablet and preparation method thereof
  • Ilaprazole enteric orally disintegrating tablet and preparation method thereof
  • Ilaprazole enteric orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1 prepares ilaprazole enteric-coated orally disintegrating tablet

[0042] Prescription 1:

[0043]

[0044] Preparation:

[0045] (1) Coating for the first time: Dissolve ilaprazole and sodium carbonate in 50ml of water, add 450ml of absolute ethanol, and place the blank pellet core on an inverted cone-shaped stainless steel with a bottom diameter of 188mm, a top diameter of 396mm, and a height of 1000mm. In the bed, the atomizing nozzle adopts a top-spraying two-stream nozzle, 200mm away from the material surface; air is used as the fluidized drying medium and the atomized gas of the material liquid. Set the frequency of the blower to 50HZ, the bed temperature of the fluidized bed to 40°C, the fluidization gas velocity to 2.0m / s, the flow velocity of the feed liquid to 0.5ml / min, and the atomizing pressure to 0.20mpa, start the fluidized bed, After the coating is complete, continue to keep warm for 10 minutes.

[0046] (2) Second coating: dissolving h...

Embodiment 2

[0058] Example 2 Stability study of ilaprazole enteric-coated orally disintegrating tablets

[0059] Influencing factor test: Ilaprazole orally disintegrating tablets with prescriptions 1 to 3 were subjected to high temperature test (placed at high temperature (60°C) for 10 days) and high humidity test (at 25°C compared to relative Humidity (90±5)% for 10 days), strong light test (10 days for illuminance of 5000±500Lx). Referring to ilaprazole orally disintegrating tablets, the storage condition of this product is to be sealed and stored in a cool and dry place.

[0060] The test results are shown in Table 2:

[0061] Table 2. Test results of influencing factors of prescription 1 ilaprazole enteric-coated orally disintegrating tablets

[0062]

[0063] Under the same conditions, the ilaprazole enteric-coated orally disintegrating tablet of prescription 2 was subjected to the experiment of influencing factors, and the experimental results were obtained.

[0064] Table 3. ...

Embodiment 3

[0070] Example 3 Pharmacological comparison experiment of ilaprazole enteric-coated orally disintegrating tablet, rabeprazole enteric-coating orally disintegrating tablet and rabeprazole sodium enteric-coating orally disintegrating tablet

[0071] Ilaprazole enteric-coated orally disintegrating tablets (prepared by using prescription 1 of Example 1 of the present invention) and rabeprazole enteric-coating orally disintegrating tablets, rabeprazole enteric-coating orally disintegrating tablets (specification: 10 mg, batch number: 008025 , Xi'an Xintong Drug Research Co., Ltd.) for comparison.

[0072] Rabeprazole enteric-coated orally disintegrating tablet: prepared by changing ilaprazole in the prescription to rabeprazole with reference to prescription 1 of Example 1 of the present invention.

[0073] pharmacological test

[0074] Effects on chronic ulcers in rats (chronic ulcers induced by acetic acid)

[0075] The specific test method is as follows:

[0076] The experimen...

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Abstract

The invention relates to an ilaprazole enteric orally disintegrating tablet and a preparation method thereof. The ilaprazole enteric orally disintegrating tablet comprises the components in percentage by weight as follows: 1-5% of ilaprazole, 8-10% of hollow pill core, 2-5% of stabilizer, 10-15% of isolating layer, 15-20% of enteric coating, 35-70% of filler and 10-20% of disintegrating agent. The invention provides the ilaprazole enteric orally disintegrating tablet which is small in grain size, quick to absorb, high in bioavailability, good in taste, easy to swallow, good in disintegrating effect, strong in compressibility and convenient for patients to take, and the preparation method thereof.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to an ilaprazole enteric-coated orally disintegrating tablet and a preparation method thereof. Background technique [0002] Peptic ulcer is a kind of common disease, frequently-occurring disease, is a kind of chronic and recurrent disease. Its mortality rate is very small, but it can bring great suffering to patients and increase the economic burden of the country and patients. Peptic ulcer is a well-defined mucosal disorder that penetrates the muscularis mucosa and occurs in areas of the gastrointestinal tract that come into contact with gastric juices. Can be found in the lesser curvature of the stomach (gastric ulcer), pyloric duct (pyloric ulcer), duodenal bulb (duodenal ulcer), duodenal retrobulbar (retrobulbar ulcer), lower esophagus (reflux Esophagitis) and marginal anastomotic ulcer or jejunal ulcer caused by gastrojejunostomy. The vast majority are located in the stomach and duode...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4439A61K47/38A61K47/26A61P1/04
Inventor 侯雪梅郭国岭金鑫徐晓陈剑解荷芝李菁
Owner LIVZON GROUP LIVZON PHARMA FACTORY
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