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

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

Active Publication Date: 2009-08-19
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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Example 1 Preparation method of rabeprazole sodium enteric-coated orally disintegrating tablets

[0045] 1.1 Prescription:

[0046] First coating:

[0047]

[0048] Second coating:

[0049]

[0050]

[0051] The third coating:

[0052]

[0053] Tablets:

[0054]

[0055] 1.2 Preparation method:

[0056] (1) Coating for the first time: Dissolve rabeprazole sodium and sodium bicarbonate in 50ml of water, add 450ml of absolute ethanol, and set aside.

[0057] Place the blank pellet core in an inverted conical stainless steel fluidized bed with a bottom diameter of 188mm, a top diameter of 396mm, and a height of 1000mm. liquid atomizing gas. 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. ...

Embodiment 2

[0068] Example 2 Study on the release rate of rabeprazole sodium enteric-coated orally disintegrating tablets

[0069] 2.1 Instruments and reagents

[0070] 2.1.1 Instruments

[0071] 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).

[0072] 2.1.2 Reagent

[0073] 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.

[0074] 2.2 Methods and results

[0075] ...

Embodiment 3

[0082] Example 3 Study on human bioavailability of rabeprazole sodium enteric-coated orally disintegrating tablets

[0083] 1.1 Research object:

[0084] 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.

[0085] 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.

[0086] 1.2 Drugs:

[0087] Test preparation: rabeprazole sodium enteric-coated orally disintegrating tablets (specification: 10mg, batch number: 008025, Xi'an Xintong Pharmaceut...

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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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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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