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Pharmaceutical lansoprazole composite granules for treating digestive system diseases

A technology for digestive system diseases and lansoprazole, applied in the field of medicine, can solve problems such as affecting drug quality and unsatisfactory results, and achieve the effects of good stability, excellent fluidity, and improved dissolution rate

Inactive Publication Date: 2015-12-02
QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] However, according to the chemical structure characteristics of lansoprazole, lansoprazole easily produces the following impurity A, impurity B and impurity E during production and storage, and these trace impurities will affect the quality of the drug
Although some crystal forms of the above-mentioned lansoprazole have improved its hygroscopicity, solubility or stability to a certain extent, the inventors' results are not ideal after investigating the impurities of the above-mentioned certain crystal forms

Method used

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  • Pharmaceutical lansoprazole composite granules for treating digestive system diseases
  • Pharmaceutical lansoprazole composite granules for treating digestive system diseases
  • Pharmaceutical lansoprazole composite granules for treating digestive system diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1 Preparation of Lansoprazole Crystals

[0043] (1) Take the raw material of lansoprazole and add it to methanol. The volume of methanol is 5 times the mass of lansoprazole, and the temperature is raised to 35°C

[0044] (2) Stir until all dissolved;

[0045] (3) Add activated carbon to decolorize and filter to obtain a clear solution;

[0046] (4) Transfer the clear solution into a pressure vessel, and under the condition of controlling the pressure in the pressure vessel at 2.0Mpa and stirring, add dropwise a mixed solvent of ethyl acetate and ether at 5°C. The stirring speed is controlled at 35rpm, ethyl acetate , The volume consumption of ether is 5 times the volume of deionized water, and the volume ratio of ethyl acetate and ether is 3:1;

[0047] (5) After dripping, release the pressure, cool the solution to -5°C at a rate of 5°C / min, let it stand for 3 hours, filter, wash, and dry under reduced pressure to obtain lansoprazole crystals.

[0048] The prepared lanso...

Embodiment 2

[0049] Example 2 Preparation of Lansoprazole Granules

[0050] Prescription: In parts by weight, 0.15 parts of lansoprazole crystal compound prepared in Example 1, 2.4 parts of sucrose, 0.5 parts of anhydrous sodium carbonate, 0.4 parts of croscarmellose sodium, nordihydrogen 0.04 parts of lignoic acid, 0.7 parts of 95% ethanol, 0.02 parts of talc.

[0051] Preparation:

[0052] 1) Raw and auxiliary materials processing: use a vibrating sieve powder machine to pass the raw material lansoprazole through an 80-mesh sieve, and use a pulverizer to crush anhydrous sodium carbonate and pass a 120-mesh sieve;

[0053] 2) Weigh according to the technological prescription;

[0054] 3) Mixing granulation: Add the prescription amount of lansoprazole, sucrose, anhydrous sodium carbonate, croscarmellose sodium, and nordihydroguaiaretic acid to the wet mixing granulator, turn on Stir the motor for dry mixing for 10 minutes, add the prescription amount of 95% ethanol, wet-mix for 90-120 seconds to ...

Embodiment 3

[0058] Example 3 Preparation of Lansoprazole Granules

[0059] Prescription: In parts by weight, 0.15 parts of lansoprazole crystal compound prepared in Example 1, 2.6 parts of sucrose, 0.6 parts of anhydrous sodium carbonate, 0.5 parts of croscarmellose sodium, nordihydrogen 0.05 parts of lignoic acid, 0.8 parts of 95% ethanol, 0.03 parts of talc.

[0060] Preparation:

[0061] 1) Raw and auxiliary materials processing: use a vibrating sieve powder machine to pass the raw material lansoprazole through an 80-mesh sieve, and use a pulverizer to crush anhydrous sodium carbonate and pass a 120-mesh sieve;

[0062] 2) Weigh according to the technological prescription;

[0063] 3) Mixing granulation: Add the prescription amount of lansoprazole, sucrose, anhydrous sodium carbonate, croscarmellose sodium, and nordihydroguaiaretic acid to the wet mixing granulator, turn on Stir the motor for dry mixing for 10 minutes, add the prescription amount of 95% ethanol, wet-mix for 90-120 seconds to ...

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Abstract

The invention relates to pharmaceutical lansoprazole composite granules for treating digestive system diseases and belongs to the technical field of medicine. The granules are made from lansoprazole, cane sugar, anhydrous sodium carbonate, croscarmellose sodium, nordihydroguaiaretic acid, 95% ethyl alcohol and talcum powder. The lansoprazole is a new crystal form compound, an X-ray powder diffraction pattern of the lansoprazole measured by using Cu-Ka ray is shown in figure 1, the lansoprazole is different from those reported in the prior art, experiments show that the lansoprazole, the new crystal form compound, provided by the invention has no impurity E, in the lansoprazole, the contents of impurity A and impurity B are evidently decreased and slightly change over storage time, the lansoprazole has good fluidity and evidently improved solubility, and the lansoprazole granules made using the new crystal form compound are good in stability and low in impurity content.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a lansoprazole composition granule for treating digestive system diseases. Background technique [0002] Lansoprazole is a benzimidazole derivative with anti-acid effect developed by Takeda Corporation of Japan in December 1991. It acts on the H+-K+-ATPase of the gastric parietal cells, so that the H+ of the parietal cells cannot be transported into the stomach It is used to treat gastric ulcer, duodenal ulcer and reflux esophagitis, and to eradicate Helicobacter pylori. [0003] Lansoprazole is a new type of proton pump inhibitor, which is an upgraded product of omeprazole. Lansoprazole has introduced fluorine into the side chain at the 4-position of the pyridine ring and has a trifluoroethoxy substituent, so that its bioavailability is relatively low. Omeprazole is increased by more than 30%, and its lipophilicity is stronger than that of omeprazole. Therefore, under acidic con...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4439C07D401/12A61P1/04
Inventor 邢继华
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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