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Sodium rabeprazole enteric-coated orally disintegrating tablets and preparation method thereof

A technology of rabeprazole sodium and orally disintegrating tablets, which is applied in the field of rabeprazole sodium enteric-coated orally disintegrating tablets and its preparation, and can solve the problems of unstable proton pump inhibitors, decreased bioavailability, and drug inactivity , to achieve the effect of preventing children's dental caries, improving utilization, and good disintegration effect

Active Publication Date: 2011-05-04
成都迪康药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the process of this patent is simple, because the proton pump inhibitors are unstable when exposed to light, heat, and acid, it is easy to cause the drug to lose its activity; and it cannot be guaranteed that every particle in the dispersible tablet can be in an alkaline environment, which will also cause decreased bioavailability

Method used

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  • Sodium rabeprazole enteric-coated orally disintegrating tablets and preparation method thereof
  • Sodium rabeprazole enteric-coated orally disintegrating tablets and preparation method thereof
  • Sodium rabeprazole enteric-coated orally disintegrating tablets and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1 The preparation method of rabeprazole sodium enteric-coated orally disintegrating tablet

[0045] 1.1 Prescription:

[0046] First coating:

[0047] Rabeprazole Sodium 11g

[0048] Sodium bicarbonate 20g

[0049] Hydroxypropyl Methyl Cellulose 606 2g

[0050] Blank ball core 62.5g

[0051] Ethanol 450ml

[0052] Pure water 100ml

[0053] 95.5g

[0054] Second coating:

[0055] The first coating product 90g

[0056] Hydroxypropyl methylcellulose 606 10.25g

[0057] Ethanol 500ml

[0058] Pure water 125ml

[0059] 110.25g

[0060] The third coating:

[0061] The second coating product: 90g

[0062] Colorcon Enteric Coating Powder 16g

[0063] (oprdry-Enteric)

[0064] Ethanol 300ml

[0065] water 100ml

[0066] 106g

[0067] Tablets:

[0068] The third coating product: 90g

[0069] Mannitol 115g

[0070] Xylitol 25g

[0071] Micro...

Embodiment 2

[0088] Example 2 Research on the release rate of rabeprazole sodium enteric-coated orally disintegrating tablets

[0089] 2.1 Instruments and reagents

[0090] 2.1.1 Instruments

[0091] ZRS-8G Intelligent Dissolution Tester (Tianjin Tianda Tianfa Technology Co., Ltd.); UV / VIS-4802S Double-beam UV-Vis Spectrophotometer (Shanghai Unic Instrument Factory), METLLE AE240 Electronic Balance (Mettlerto) Lido company), MP220 pH meter (Mettler Toledo).

[0092] 2.1.2 Drug testing

[0093] Rabeprazole sodium reference substance (>99.5%) (batch number: 0805003, Xi’an Xintong Drug Research Co., Ltd.), rabeprazole sodium enteric-coated orally disintegrating tablets (specification: 10mg, batch number: 008025, Xi’an Xintong Drug Research Co., Ltd.), commercially available products: Rabeprazole Sodium Enteric-Coated Tablets (Polite) (Lot Number: 060873, Specification: 10mg, Misato Plant of Eisai Co., Ltd.), used in Reagents were all analytically pure.

[0094] 2.2 Methods and results

[...

Embodiment 3

[0102] Example 3 Study on Bioavailability of Rabeprazole Sodium Enteric-coated Orally Disintegrating Tablets in Human Body

[0103] 1.1 Research object:

[0104] 18 male volunteers, aged 21-30 years, height 166-178cm, weight within ±10% of the standard weight, no past medical history and drug allergy history, good mental state, liver, kidney function, electrocardiogram were normal.

[0105] After fasting for 10 hours, the subjects took the medicine on an empty stomach on the morning of the test day according to the prescribed dosage and method, and ate a unified standard meal 4 hours and 10 hours after taking the medicine. After taking the medicine, the subjects rested indoors. During the blood collection period, smoking, alcohol, caffeine and juice drinks were prohibited, and strenuous exercise was avoided.

[0106] 1.2 Drugs:

[0107] Test preparation: rabeprazole sodium enteric-coated orally disintegrating tablets (specification: 10mg, batch number: 008025, Xi'an Xintong ...

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Abstract

The invention relates to a Rabeprazole sodium enteric-coated orally disintegrating tablet and a method for preparing the same. The Rabeprazole sodium enteric-coated orally disintegrating tablet comprises the following components in percentage by weight: 1 to 5 percent of Rabeprazole sodium, 8 to 10 percent of blank pill core, 2 to 5 percent of stabilizer, 10 to 15 percent of isolation layer, 15 to 20 percent of enteric coating, 35 to 70 percent of filling agent and 10 to 20 percent of disintegrating agent. The invention provides the Rabeprazole sodium enteric-coated orally disintegrating tablet having the advantages of small grain size, quick absorption, high bioavailability, good taste, easy swallowing, good disintegrated effect, strong compressibility, and convenient use for patients and the method for preparing the same.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a rabeprazole sodium 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 an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/32A61K31/4439A61K47/38A61P1/04
Inventor 张登科
Owner 成都迪康药业股份有限公司
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