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Rabeprazole sodium compound

A technology for rabeprazole sodium and hydrate, which is applied in the directions of digestive system, organic chemistry, drug combination, etc., can solve the problems of moisture absorption and weight gain, high impurities, and difficulty in product purification.

Inactive Publication Date: 2014-06-18
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] It is difficult to purify the product of the above-mentioned rabeprazole method. Rabeprazole is made into its sodium salt, which can effectively reduce impurities and purify the product, but the impurities are still relatively high, and there is also a certain amount of moisture absorption and weight gain.

Method used

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  • Rabeprazole sodium compound
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  • Rabeprazole sodium compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] In a 5l reaction kettle equipped with stirring, thermometer, and condenser, add 240 grams of rabeprazole sodium, 970.0ml isopropanol, 16.5ml piperidine, and 980.0ml water, start stirring, heat to dissolve, and the filtrate is naturally cooled to At 28°C, keep it still for 6 hours to precipitate crystals, filter, and dry indoors to obtain 230.6 grams of white crystals of rabeprazole sodium hydrate. Impurities are less than 0.06%. Determined by Karl Fischer method, it contains 4.57% (weight percent) of water.

[0054] The X-ray diffraction pattern of the crystal is shown in figure 1 . Instrument model and measurement conditions: Rigaku D / max 2500 diffractometer; CuKa 40Kv 100mA; 2θ scanning range: 0-50 ° .

[0055] Microparticles or microspheres are prepared by combining the compounds of the present invention with a pharmaceutically acceptable solid or liquid carrier, and optionally with pharmaceutically acceptable adjuvants and vehicles, using standard and conventio...

Embodiment 2

[0057] Tablets containing rabeprazole sodium hydrate

[0058] Prescription: Rabeprazole Sodium Hydrate 10.7g, Microcrystalline Cellulose 12g, Pregelatinized Starch 16g, Carboxymethyl Starch Sodium 5g, Lactose 210g, PEG-4000 25g, Magnesium Stearate 6g, 30 gram of povidone K30, 33 grams of croscarmellose sodium, appropriate amount of distilled water, made into 10,000 tablets.

[0059] Process:

[0060] Preparation of tablet core: according to the determined prescription, the main ingredient and auxiliary materials are mixed uniformly, granulated, and the granules are ventilated and dried below 40°C, granulated with a 16 mesh sieve, added magnesium stearate and remaining starch, and compressed into tablets to obtain final product .

[0061] Isolation layer coating: add talcum powder to 5% polyvinylpyrrolidone (PVP) absolute ethanol solution, stir evenly, and prepare a 20% suspension as the isolation layer coating solution. Coating is carried out in a fluidized bed, and the pro...

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Abstract

The invention belongs to the technical field of medicines, and concretely relates to a rabeprazole sodium hydrate and its preparation method. The rabeprazole sodium hydrate obtained in the invention contains one crystal water, has a good stability, and has an unobvious moisture absorption weight increment under highly humid conditions, and the gastric acid secretion inhibition effect of the hydrate is 20% higher than that of a rabeprazole sodium tablet. The invention also relates to applications of compositions of the hydrate in the treatment of digestive system diseases comprising duodenal ulcer, gastric ulcer, reflux esophagitis and the like.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to rabeprazole sodium hydrate and a preparation method thereof. The invention also relates to the use of the hydrate composition to treat duodenal ulcer, gastric ulcer, reflux esophagitis and other digestive diseases. Application to systemic diseases. Background technique [0002] With the progress of society and the quickening pace of life, the incidence of digestive system diseases is also increasing year by year. According to statistics, the incidence of digestive system diseases in the world accounts for 10%-12% of the human incidence; the incidence of digestive system diseases in cities and towns in China reaches 11.43%, of which excessive gastric acid secretion is an important cause of digestive system diseases, H2 receptor antagonists and proton pump inhibitors are the two most commonly used drugs for the treatment of acid-related digestive diseases, they both inc...

Claims

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Application Information

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IPC IPC(8): C07D401/12A61K31/4439A61P1/04
CPCC07D401/12
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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