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Medicine of lansoprazole composition 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 the quality of medicines and unsatisfactory results, and achieve the effects of good stability, excellent fluidity, and low content of insoluble particles

Inactive Publication Date: 2015-12-02
杨献美
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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 of lansoprazole composition for treating digestive system diseases
  • Medicine of lansoprazole composition for treating digestive system diseases
  • Medicine of lansoprazole composition for treating digestive system diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1: Preparation of Lansoprazole Crystals

[0031] (1) Dissolving the crude product of lansoprazole into a mixed solution of methanol and carbon tetrachloride whose volume is 10 times the weight of lansoprazole at 35°C, the volume ratio of methanol and carbon tetrachloride is 4:2.5 ;

[0032] (2) adding activated carbon with a weight of 0.2 times the weight of lansoprazole for decolorization, and filtering to obtain a lansoprazole solution;

[0033] (3) Warm up the lansoprazole solution to 45°C, add distilled water dropwise to the lansoprazole solution under stirring conditions, the volume of distilled water is 8 times the weight of lansoprazole, and dropwise at a uniform speed within 0.5h, The stirring rate is 30rmp;

[0034] (4) After the dropwise addition, cool down to -15°C at a rate of 15°C / h, continue stirring at a stirring rate of 15rmp for 2h, let stand for 3h to precipitate crystals, filter, wash, and vacuum dry to obtain lansoprazole crystals.

[00...

Embodiment 2

[0036] Example 2: The preparation of lansoprazole composition

[0037] The composition is: 1 part by weight of the lansoprazole crystal prepared by the present invention, and 0.002 part by weight of sodium dihydrogen phosphate.

[0038] The preparation method is:

[0039] (1) Weigh lansoprazole crystals and sodium dihydrogen phosphate in proportion and mix them thoroughly;

[0040] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0041] Example 3: The preparation of lansoprazole composition

[0042] The composition is: 1 part by weight of the lansoprazole crystal prepared by the present invention, and 0.003 part by weight of sodium dihydrogen phosphate.

[0043] The preparation method is:

[0044] (1) Weigh lansoprazole crystals and sodium dihydrogen phosphate in proportion and mix them thoroughly;

[0045] (2) Dispense into sterilized vials and stopper them.

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Abstract

The invention discloses medicine of a lansoprazole composition for treating digestive system diseases, and belongs to the technical field of medicine. The composition consists of lansoprazole and monosodium orthophosphate. The lansoprazole is a novel crystal form compound; an X-ray powder diffraction figure obtained through Cu-Ka ray measurement is shown as the Figure 1; the lansoprazole composition belongs to the lansoprazole different from that reported in the prior art. Experiments show that the lansoprazole crystal form compound provided by the invention does not contain impurities E; in addition, the content of impurities A and the content of impurities B are obviously reduced; the content change is small along with the storage time increase; good flowability is realized; the dissolution rate is obviously improved; powder injection prepared from the novel crystal form compounds has high stability; the stability is high after the composition is matched with solvents; the content of insoluble micro particles is very low; the lansoprazole composition is very suitable for clinic application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug lansoprazole composition for treating diseases of the digestive system. 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 of gastric parietal cells. + -K + -ATPase, which makes parietal cell H + It cannot be transported to the stomach, so that the amount of gastric acid in the gastric juice is greatly reduced. 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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61P1/04C07D401/12
Inventor 杨献美
Owner 杨献美
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