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Novel acotiamide hydrochloride hydrate crystal form and preparation method thereof

A technology of acotiamide hydrochloride and hydrate, which is applied in the field of new crystal form of acotiamide hydrochloride monohydrate and its preparation, and can solve the problem of the crystal form and preparation of acotiamide hydrochloride monohydrate that have not been mentioned in the literature method, did not mention the spectral characteristics of the crystal form, etc., to achieve the effect of stable crystal form and good solubility

Inactive Publication Date: 2014-08-27
HANGZHOU XINBOSI BIOMEDICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] So far, no literature has mentioned the crystal form and preparation method of acotiamide hydrochloride monohydrate, let alone the spectral characteristics of its crystal form

Method used

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  • Novel acotiamide hydrochloride hydrate crystal form and preparation method thereof
  • Novel acotiamide hydrochloride hydrate crystal form and preparation method thereof
  • Novel acotiamide hydrochloride hydrate crystal form and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Dissolve 3.0 g of acotiamide hydrochloride trihydrate in 12 g of DMF, heat to reflux until dissolved, cool to 20° C., and filter. The filter cake was air-dried at 50°C, and placed in the air at room temperature for 24 hours until the water content was 3.0%-5.0%, to obtain 1.75 g of type B crystalline acotiamide hydrochloride hydrate with a yield of 62.5%.

Embodiment 2

[0032] Dissolve 3.0 g of acotiamide hydrochloride trihydrate in 12 g of methanol, heat to reflux until dissolved, cool to 20° C., and filter. The filter cake was air-dried at 50°C, and left in the air at room temperature for 24 hours until the water content was 3.0%-5.0%, to obtain 1.16 g of type B crystalline acotiamide hydrochloride hydrate with a yield of 41.4%.

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PUM

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Abstract

The invention relates to a novel acotiamide hydrochloride hydrate crystal form shown in a chemical formula (I) and a preparation method thereof, and particularly discloses a B-type crystal acotiamide hydrochloride hydrate and a preparation method thereof. An X-ray powder diffraction (XRPD) characteristic peak is shown in a figure 1. The B-type crystal acotiamide hydrochloride hydrate prepared by the method is stable in crystal form, good in solubleness, and applicable to drug development, and the used preparation method is safe, simple and convenient, and strong in maneuverability.

Description

[0001] technical field [0002] The invention relates to the technical field of medicine, in particular to a new crystal form of acotiamide hydrochloride monohydrate and a preparation method thereof. Background technique [0003] On June 6, 2013, the acotiamide hydrochloride trihydrate jointly developed by Zari Shinyaku Co., Ltd. and Ansteris Pharmaceuticals Co., Ltd. was launched in Japan with the trade name Acofide®. Chemical name: N-[2-(diisopropylamino)ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]-4-thiazolecarboxamide hydrochloride Salt trihydrate is a drug for functional dyspepsia, mainly used for the prevention and treatment of epigastric discomfort, nausea, vomiting, heartburn, anorexia, flatulence, chronic gastritis, reflux esophagitis and post-gastrectomy syndrome . [0004] With the change of environment and diet structure, the incidence of dyspepsia increases year by year. The incidence rate of dyspepsia patients in the world is close, accounting for about ...

Claims

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Application Information

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IPC IPC(8): C07D277/56
CPCC07D277/56
Inventor 杜焕达丁建圣郑阳峰王万青刘艳华
Owner HANGZHOU XINBOSI BIOMEDICAL CO LTD
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