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New crystal form of flumatinib mesylate and its preparation method and medical application

A flumatinib mesylate and crystal form technology, applied in the field of flumatinib mesylate, can solve the problems of chronic myelogenous leukemia patients, such as occurrence, structural changes, and inability to combine with Gleevec

Active Publication Date: 2019-09-06
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, many chronic myeloid leukemia patients taking Gleevec have been found to develop drug resistance in recent years
In most cases, resistance arises because of a mutation in BCR-ABL that changes the structure of the enzyme so that Gleevec cannot bind to it

Method used

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  • New crystal form of flumatinib mesylate and its preparation method and medical application
  • New crystal form of flumatinib mesylate and its preparation method and medical application
  • New crystal form of flumatinib mesylate and its preparation method and medical application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Put 1.0g of flumatinib mesylate and 2.0ml of water in a round bottom flask, heat to 65°C, the solid matter is completely dissolved, cool naturally to 25°C while stirring, add 1,4-dioxine dropwise Hexacyclic 20ml, stirred for 24 hours, precipitated solid, filtered to obtain crystal form D, after detection, its XRD pattern is as follows figure 1 shown.

Embodiment 2

[0021] Put 1.0 g of flumatinib mesylate and 3.0 ml of ethanol in a round-bottomed flask, heat to 45 ° C, the solids are completely dissolved, slowly add 2.0 ml of isopropyl ether dropwise under stirring conditions, and keep stirring for 1 hour. Precipitate solid, filter, vacuum dry to obtain crystal form D, after detection, its XRD collection of patterns and figure 1 Almost identical, it can be confirmed that the obtained product is crystal form D.

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Abstract

The invention discloses a novel crystal form of flumatinib mesylate as well as a preparation method and medical use of the novel crystal form and particularly relates to application of a pharmaceutical composition containing an effective treatment dose of the compound and application of the pharmaceutical composition in the treatment of chronic myelogenous leukemia. The novel crystal form is good in reproducibility, stable, easily available and very applicable to preparation.

Description

technical field [0001] The invention relates to a new crystal form of flumatinib mesylate, a preparation method thereof, and a pharmaceutical composition containing the compound in a therapeutically effective amount. Background technique [0002] More than 95% of patients with chronic myelogenous leukemia are due to chromosomal translocation, resulting in BCR-ABL fusion protein, resulting in high expression of ABL tyrosine activating enzyme activity, and a large number of abnormal white blood cells. [0003] In the prior art, drugs used to treat chronic myelogenous leukemia include recombinant interferon α-2a, cytarabine, homoharringtonine and imatinib. Gleevec (imatinib) is the main drug for the treatment of chronic myelogenous leukemia. The therapeutic mechanism is to inhibit the proliferation of cancer cells by inhibiting the activity of BCR-ABL, and at the same time induce apoptosis of cancer cells; 95% of patients are taking the drug After one to three months, it will ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D401/14A61K31/506A61P35/02
Inventor 杨宝海何雷潘必高吕爱锋
Owner JIANGSU HANSOH PHARMA CO LTD