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Valganciclovir hydrochloride polymorph and pharmaceutical composition thereof

A technology of ciclovir hydrochloride crystal form and valerian hydrochloride, which is applied in the field of valganciclovir hydrochloride polymorph and its preparation, can solve the problem that there are no literature reports on valganciclovir hydrochloride crystal form or data

Inactive Publication Date: 2016-05-25
NINGBO BESTDRUG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] 虽然有很多文献涉及结晶性(如WO9727194;WO9727195;WO9727196;WO9727197;WO9727198;WO2005092891;EP1837336;EP1870411;CN201010504756.1)或无定性(如CN200910056091.X;US2007129385;US2009062538;US2010298564;WO2010036904;WO2011064793)盐酸缬 The preparation of ganciclovir, but so far there is no crystal form or data of valganciclovir hydrochloride reported in literature

Method used

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  • Valganciclovir hydrochloride polymorph and pharmaceutical composition thereof
  • Valganciclovir hydrochloride polymorph and pharmaceutical composition thereof
  • Valganciclovir hydrochloride polymorph and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Valganciclovir hydrochloride 10g, add water 10mL, isopropanol 55mL, heat to 60°C and stir to dissolve, slowly cool down to 5-10°C, crystallize at 5-10°C for 6 hours, filter, and vacuum dry to obtain Valganciclovir hydrochloride Ciclovir crystal form A.

Embodiment 2

[0044] Add 10g of valganciclovir hydrochloride to a mixed solution of 5.0mL of water and 15.0mL of ethanol, heat to 60°C and stir to dissolve, slowly cool down to 5-10°C, crystallize at 5-10°C for 6 hours, filter, and vacuum dry The crystal form A of valgaclovir hydrochloride was obtained.

Embodiment 3

[0046] Valganciclovir hydrochloride 10g, add water 10mL, n-propanol 90mL, stir, dissolve after heating to 60°C. Slowly cool down to 5-10°C, continue to cool down, crystallize at 5-10°C for 6 hours, filter, and vacuum-dry to obtain valganciclovir hydrochloride crystal form A.

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Abstract

The invention provides a polymorphic substance of valganciclovir hydrochloride, and in particular relates to a crystal form A and a crystal form B. The invention further provides a preparation method of the polymorphic substance of valganciclovir hydrochloride, and an application of a medical composition containing the crystal form A and the crystal form B of polymorphic substance of valganciclovir hydrochloride in treating cytomegalovirus infection.

Description

technical field [0001] The invention relates to the field of chemical pharmacy, in particular to polymorphs of valganciclovir hydrochloride and its preparation method and application. Background technique [0002] Cytomegalovirus infection, especially cytomegalovirus retinitis, is a common syndrome that threatens the vision of AIDS patients, bone marrow and organ transplant patients (liver, kidney, heart, etc.), and usually requires long-term maintenance treatment after induction treatment. Ganciclovir has a good curative effect in the treatment of cytomegalovirus infection, but its oral bioavailability is very low, so it can only be injected intravenously. Intravenous injection is used for long-term treatment, which is inconvenient and unacceptable to patients. Valganciclovir hydrochloride is the prodrug of ganciclovir, oral administration can achieve the curative effect of injection ganciclovir, suitable for long-term treatment of cytomegalovirus infection. The chemical ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D473/18A61K31/522A61P31/22A61P31/20A61P31/14A61P31/18
Inventor 金春华李峰程花英
Owner NINGBO BESTDRUG PHARMA CO LTD
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