Medicine lansoprazole compound dry suspension treating gastropathy

A technology of lansoprazole and dry suspension, applied in the field of medicine, can solve problems such as unsatisfactory results and influence on drug quality, and achieve the effects of excellent fluidity, good stability and low impurity content

Inactive Publication Date: 2015-10-28
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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  • Medicine lansoprazole compound dry suspension treating gastropathy
  • Medicine lansoprazole compound dry suspension treating gastropathy
  • Medicine lansoprazole compound dry suspension treating gastropathy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1: Preparation of Lansoprazole Crystals

[0040] (1) Grind the crude product of lansoprazole, pass through a 60-mesh sieve, then add it into methanol whose volume is 7 times the weight of lansoprazole, and stir at 130 rpm for 10 minutes;

[0041] (2) Add acetone with a volume 5 times the weight of lansoprazole under stirring at 110 rpm, and raise the temperature to 30°C at the same time;

[0042] (3) After the solution is added, let it stand for 3 hours, and add dropwise a mixed solution of ether and chloroform with a volume of 8 times the weight of lansoprazole at 0°C under the condition of stirring at 150 rpm. The volume ratio is 2: 3, and the uniform dropwise addition is completed within 2h;

[0043] (4) After the dropwise addition was completed, the temperature was lowered to -10°C, and stirring was continued at a stirring rate of 95 rpm for 3 h, and the crystals were precipitated after standing for 1 h, filtered, washed, and vacuum-dried to obtain lansop...

Embodiment 2

[0045] Example 2: The preparation of lansoprazole dry suspension

[0046] Prescription: in parts by weight, 0.15 parts of lansoprazole crystal form compound prepared in Example 1, 1.5 parts of lactose, 1.3 parts of mannitol, 0.5 parts of disodium hydrogen phosphate, 0.1 part of xanthan gum, 0.02 part of sucralose , 0.05 parts of silicon dioxide.

[0047] Preparation:

[0048] 1) Processing of raw and auxiliary materials: pass the raw material lansoprazole through a 80-mesh sieve with a vibrating sieving machine;

[0049] 2) Weighing: Weigh each raw and auxiliary material according to the process prescription quantity;

[0050] 3) Total mixing: Add all the raw and auxiliary materials of the prescribed amount into the three-dimensional mixer, the mixing speed is 12r / min, and the mixer is turned on for 45 minutes;

[0051] 4) Subpackage: Add the granules to the granule packaging machine for subpackage, and control the difference in the filling volume to meet the internal con...

Embodiment 3

[0052] Example 3: The preparation of lansoprazole dry suspension

[0053] Prescription: in parts by weight, 0.15 parts of the lansoprazole crystal form compound prepared in Example 1, 1.6 parts of lactose, 1.4 parts of mannitol, 0.6 parts of disodium hydrogen phosphate, 0.15 parts of xanthan gum, and 0.03 parts of sucralose , 0.06 parts of silicon dioxide.

[0054] Preparation:

[0055] 1) Processing of raw and auxiliary materials: pass the raw material lansoprazole through a 80-mesh sieve with a vibrating sieving machine;

[0056] 2) Weighing: Weigh each raw and auxiliary material according to the process prescription quantity;

[0057] 3) Total mixing: Add all the raw and auxiliary materials of the prescribed amount into the three-dimensional mixer, the mixing speed is 12r / min, and the mixer is turned on for 45 minutes;

[0058] 4) Subpackage: Add the granules to the granule packaging machine for subpackage, and control the difference in the filling volume to meet the i...

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Abstract

The invention relates to a medicine lansoprazole compound dry suspension treating gastropathy, and belongs to the technical field of medicine. The compound dry suspension is prepared from lansoprazole, lactose, mannitol, disodium hydrogen phosphate, xanthan gum, sucralose and silicon dioxide. The lansoprazole is a new crystal type compound. An X-ray powder diffraction diagram obtained through Cu-Kalpha ray measurement is shown as the figure 1. The lansoprazole is different from lansoprazole reported in the prior art. As is found through a test, the lansoprazole crystal compound does not contain an impurity E, the content of an impurity A and the content of an impurity B are obviously reduced, and besides the content changes little along with prolonging of storage time. The dry suspension has good flowability and remarkably improves the dissolution rate, and the lansoprazole dry suspension prepared from the crystal type compound is 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 dry suspension of lansoprazole composition for treating stomach 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 gastric parietal cells, so that the H+ of 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 conditions...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4439A61P1/04A61P31/04
Inventor 刘春同
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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