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Dexlansoprazole hemihydrate compound

A technology of lansoprazole times and dexlansoprazole, applied in the field of medicine, can solve the problems of high impurity content, patent protection of crystal form, moisture absorption and weight gain, etc.

Inactive Publication Date: 2015-05-27
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Dexlansoprazole has great advantages in terms of effectiveness and safety, but in the actual production process, the applicant found that the preparation process of dexlansoprazole has difficulties in purification, high impurity content, and crystal forms subject to patent Protection and some problems such as moisture absorption and weight gain

Method used

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  • Dexlansoprazole hemihydrate compound
  • Dexlansoprazole hemihydrate compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] In a 10L reaction kettle equipped with stirring, thermometer and condenser, add 320g of dexlansoprazole, 970.0ml of n-hexanol, 16.5ml of furan, and 980.0ml of water, start stirring, heat until dissolved, and cool the filtrate naturally to 25°C -30°C, then let it stand for 4 hours, precipitated crystals, filtered, and dried indoors to obtain 254.6 grams of white crystals of dexlansoprazole sesquihydrate, with a melting point of 196-198°C and a content of 99.76%. , a single impurity is less than 0.06%. As determined by thermogravimetric analysis, it contains 3.65% (weight percent) of moisture.

[0044] Microparticles or microspheres are prepared by combining the compounds of the invention with a pharmaceutically acceptable solid or liquid carrier, and optionally with pharmaceutically acceptable adjuvants and vehicles, using standard and conventional techniques. The composition is used for preparing oral preparations and injections. It is given by way of example only and i...

Embodiment 2

[0046] Tablets containing dexlansoprazole sesquihydrate

[0047] Prescription: dexlansoprazole sesquihydrate 10.7g, microcrystalline cellulose 12g, pregelatinized starch 16g, sodium starch glycolate 5g, lactose 210g, PEG-4000 25g, magnesium stearate 6g , 30 grams of povidone K30, 33 grams of croscarmellose sodium, appropriate amount of distilled water, made into 10,000 tablets.

[0048] Process:

[0049] Preparation of tablet core: according to the determined prescription, the main ingredient and auxiliary materials are mixed evenly, 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 .

[0050] 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 pr...

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Abstract

The invention belongs to the technical field of medicines, and concretely relates to a dexlansoprazole hemihydrate and a preparation method thereof. The dexlansoprazole hemihydrate obtained in the invention contains one and a half crystal waters. The dexlansoprazole hemihydrate has the advantages of high purity, good stability and unobvious moisture absorption weight increment under highly humid conditions; and the dexlansoprazole hemihydrates improves the gastric acid inhibition effect by near 20%. The invention also relates to an application of compositions containing the dexlansoprazole hemihydrate in digestion disease treatment.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to dexlansoprazole sesquihydrate and a preparation method thereof, and also relates to the application of the hydrate composition in treating digestive system diseases. Background technique [0002] Stomach acid can help digestion, but if there is too much stomach acid, it will damage the stomach and duodenum. When gastric acid is secreted too much, symptoms of acid regurgitation, acid regurgitation, and acid regurgitation will appear. In addition to gastric and duodenal ulcers, it can also cause reflux esophagitis. Gastric and duodenal ulcers are very common diseases. If left untreated, many serious complications can occur, such as bleeding, pyloric obstruction, perforation, and even cancer, which is life-threatening. The incidence of reflux esophagitis in my country is also increasing year by year. Therefore, it is particularly important to inhibit the excessive sec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12A61K31/4439A61P1/04
CPCC07D401/12C07B2200/13
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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