Crystal forms of palonosetron hydrochloride and preparation method thereof

A technology of hydrochloric acid and crystal form, applied in the crystal form of palonosetron hydrochloride and the field of preparation thereof, can solve the problem that the crystal form and preparation method of palonosetron hydrochloride are not mentioned, the spectral characteristics of crystal form are not mentioned, etc. question

Inactive Publication Date: 2010-08-04
HANGZHOU JIUYUAN GENE ENG +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] However, the above-mentioned documents do not mention the crystal form and preparation method of palonosetron hydrochloride, nor mention the spectral characteristics of the relevant crystal form.

Method used

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  • Crystal forms of palonosetron hydrochloride and preparation method thereof
  • Crystal forms of palonosetron hydrochloride and preparation method thereof
  • Crystal forms of palonosetron hydrochloride and preparation method thereof

Examples

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Embodiment 1

[0037] The preparation of embodiment 1 palonosetron hydrochloride A crystal form one

[0038] Take 5 g of palonosetron hydrochloride, add 115 ml of isopropanol and 4 ml of water, and heat to dissolve it. After all the solids are dissolved, continue heating, distill 36ml of liquid under normal pressure, cool to 0°C, stir, crystallize for 2 hours, filter after crystallization, and vacuum dry at 80°C for 4 hours to obtain 4.4g of pure crystals. The purity by HPLC was 99.7%.

Embodiment 2

[0039] The preparation of embodiment 2 palonosetron hydrochloride A crystal form two

[0040] Take 8 g of palonosetron hydrochloride, add 124 ml of isopropanol and 6.4 ml of water, and heat to dissolve it. After all the solids were dissolved, 54ml of isopropanol was added, cooled to 0°C, stirred, crystallized for 4 hours, filtered after crystallization, and vacuum-dried at 80°C for 4 hours to obtain 7.56g of pure crystals, the purity of which was determined by HPLC as 99.6%.

Embodiment 3

[0041] The preparation of embodiment 3 palonosetron hydrochloride B crystal form one

[0042] Take 5 g of palonosetron hydrochloride, add 200 ml of ethanol, heat to dissolve the solid, cool, stir and crystallize at 10°C for 2 hours, filter, and dry in vacuum at 80°C for 4 hours to obtain 4.3 grams of pure crystals, which are detected by HPLC The purity is 99.2%.

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Abstract

The invention relates to two crystal forms of palonosetron hydrochloride, i.e., A and B crystal forms. The X-ray diffraction for the powder of A and B crystal forms has characteristic diffraction peaks under the condition of Cu-Kalpha radiation when the Bragg angle 2 x theta is 0-50 degrees. The results of the differential thermal analysis of the A and B crystal forms show that the A crystal form has an endothermic peak at a temperature of about 320.678 DEG C, and the B crystal form has an endothermic peak at a temperature of about 320.68 DEG C. In addition, the invention also relates to a method for preparing the crystal forms and a drug composition containing the crystal forms.

Description

[0001] This application is a divisional application of a Chinese patent application filed on January 24, 2008, with application number 200810059527.6 and title of invention "a crystal form of palonosetron hydrochloride and its preparation method". technical field [0002] The present invention relates to a crystal form of palonosetron hydrochloride, a preparation method thereof and a pharmaceutical composition containing these crystal forms. Background of the invention [0003] Palonosetron hydrochloride (Palonosetron hydrochloride, trade name Aloxi) is a selective 5-HT3 receptor antagonist developed by Switzerland Helsinn company, chemical name: (3aS)-2-[(3S)-1-aza The molecular structure of bicyclo[2.2.2]octyl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-phenylhydrazine[de]isoquinoline hydrochloride is as follows. On July 25, 2003, the product was approved by the US Food and Drug Administration (FDA) for the treatment of acute and delayed nausea and vomiting caused by moderate or high...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D453/02A61K31/473A61P1/08
Inventor 陈学军张海欧李勇徐飞虎孙汉栋
Owner HANGZHOU JIUYUAN GENE ENG
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